Category Archives: Immunology

Immunology

Cannabis-derived products have flooded US market Two … – Down To Earth Magazine

Products likedelta-8 THC and delta-10 THC arerapidly proliferating;there are many unknowns about their safety and psychoactive properties

These days you see signs for delta-8 THC, delta-10 THC and CBD, or cannabidiol, everywhere at gas stations, convenience stores, vape shops and online. Many people are rightly wondering which of these compounds are legal, whether it is safe to consume them and which of their supposed medicinal benefits hold up to scientific scrutiny.

The rapid proliferation of cannabis products makes clear the need for the public to better understand what these compounds are derived from and what their true benefits and potential risks may be.

We are immunologists who have been studying the effects of marijuana cannabinoids on inflammation and cancer for more than two decades.

We see great promise in these products in medical applications. But we also have concerns about the fact that there are still many unknowns about their safety and their psychoactive properties.

Cannabis sativa, the most common type of cannabis plant, has more than 100 compounds called cannabinoids.

The most well-studied cannabinoids extracted from the cannabis plant include delta-9-tetrahydrocannabinol, or delta-9 THC, which is psychoactive. A psychoactive compound is one that affects how the brain functions, thereby altering mood, awareness, thoughts, feelings or behavior.

Delta-9 THC is the main cannabinoid responsible for the high associated with marijuana. CBD, in contrast, is non-psychoactive.

Marijuana and hemp are two different varieties of the cannabis plant. In the U.S., federal regulations stipulate that cannabis plants containing greater than 0.3 per cent delta-9 THC should be classified as marijuana, while plants containing less should be classified as hemp.

The marijuana grown today has high levels from 10 per cent to 30 per cent of delta-9 THC, while hemp plants contain 5 per cent to 15 per cent CBD.

In 2018, the Food and Drug Administration approved the use of CBD extracted from the cannabis plant to treat epilepsy. In addition to being a source of CBD, hemp plants can be used commercially to develop a variety of other products such as textiles, paper, medicine, food, animal feed, biofuel, biodegradable plastic and construction material.

Recognizing the potential broad applications of hemp, when Congress passed the Agriculture Improvement Act, called the Farm Bill, in 2018, it removed hemp from the category of controlled substances. This made it legal to grow hemp.

When hemp-derived CBD saturated the market after passage of the Farm Bill, CBD manufacturers began harnessing their technical prowess to derive other forms of cannabinoids from CBD. This led to the emergence of delta-8 and delta-10 THC.

The chemical difference between delta-8, delta-9 and delta-10 THC is the position of a double bond on the chain of carbon atoms they structurally share. Delta-8 has this double bond on the eighth carbon atom of the chain, delta-9 on the ninth carbon atom, and delta-10 on the 10th carbon atom.

These minor differences cause them to exert different levels of psychoactive effects.

Delta-9 THC was one of the first forms of cannabinoid to be isolated from the cannabis plant in 1964. The highly psychoactive property of delta-9 THC is based on its ability to activate certain cannabinoid receptors, called CB1, in the brain.

The receptor, CB1, is like a lock that can be opened only by a specific key in this case, delta-9 THC allowing the latter to affect certain cell functions.

Delta-9 THC mimics the cannabinoids, called endocannabinoids, that our bodies naturally produce.

Because delta-9 THC emulates the actions of endocannabinoids, it also affects the same brain functions they regulate, such as appetite, learning, memory, anxiety, depression, pain, sleep, mood, body temperature and immune responses.

The FDA approved delta-9 THC in 1985 to treat chemotherapy-induced nausea and vomiting in cancer patients and, in 1992, to stimulate appetite in HIV/AIDS patients.

The National Academy of Sciences has reported that cannabis is effective in alleviating chronic pain in adults and for improving muscle stiffness in patients with multiple sclerosis, an autoimmune disease.

That report also suggested that cannabis may help sleep outcomes and fibromyalgia, a medical condition in which patients complain of fatigue and pain throughout the body. In fact, a combination of delta-9 THC and CBD has been used to treat muscle stiffness and spasms in multiple sclerosis.

This medicine, called Sativex, is approved in many countries but not yet in the U.S.

Delta-9 THC can also activate another type of cannabinoid receptor, called CB2, which is expressed mainly on immune cells. Studies from our laboratory have shown that delta-9 THC can suppress inflammation through the activation of CB2.

This makes it highly effective in the treatment of autoimmune diseases like multiple sclerosis and colitis as well as inflammation of the lungs caused by bacterial toxins.

However, delta-9 THC has not been approved by the FDA for ailments such as pain, sleep, sleep disorders, fibromyalgia and autoimmune diseases. This has led people to self-medicate against such ailments for which there are currently no effective pharmacological treatments.

Delta-8 THC is found in very small quantities in the cannabis plant. The delta-8 THC that is widely marketed in the U.S. is a derivative of hemp CBD.

Delta-8 THC binds to CB1 receptors less strongly than delta-9 THC, which is what makes it less psychoactive than delta-9 THC. People who seek delta-8 THC for medicinal benefits seem to prefer it over delta-9 THC because delta-8 THC does not cause them to get very high.

However, delta-8 THC binds to CB2 receptors with a similar strength as delta-9 THC. And because activation of CB2 plays a critical role in suppressing inflammation, delta-8 THC could potentially be preferable over delta-9 THC for treating inflammation, since it is less psychoactive.

There are no published clinical studies thus far on whether delta-8 THC can be used to treat the clinical disorders such as chemotherapy-induced nausea or appetite stimulation in HIV/AIDS that are responsive to delta-9 THC.

However, animal studies from our laboratory have shown that delta-8 THC is also effective in the treatment of multiple sclerosis.

The sale of delta-8 THC, especially in states where marijuana is illegal, has become highly controversial. Federal agencies consider all compounds isolated from marijuana or synthetic forms, similar to THC, Schedule I controlled substances, which means they currently have no accepted medical use and have considerable potential for abuse.

However, hemp manufacturers argue that delta-8 THC should be legal because it is derived from CBD isolated from legally cultivated hemp plants.

Delta-10 THC, another chemical cousin to delta-9 and delta-8, has recently entered the market.

Scientists do not yet know much about this new cannabinoid. Delta-10 THC is also derived from hemp CBD. People have anecdotally reported feeling euphoric and more focused after consuming delta-10 THC. Also, anecdotally, people who consume delta-10 THC say that it causes less of a high than delta-8 THC.

And virtually nothing is known about the medicinal properties of delta-10 THC. Yet it is being marketed in similar ways as the other more well-studied cannabinoids, with claims of an array of health benefits.

Research and clinical trials using marijuana or delta-9 THC to treat many medical conditions have been hampered by their classification as Schedule 1 substances.

In addition, the psychoactive properties of marijuana and delta-9 THC create side effects on brain functions; the high associated with them causes some people to feel sick, or they simply hate the sensation. This limits their usefulness in treating clinical disorders.

In contrast, we feel that delta-8 THC and delta-10 THC, as well as other potential cannabinoids that could be isolated from the cannabis plant or synthesized in the future, hold great promise.

With their strong activity against the CB2 receptors and their lower psychoactive properties, we believe they offer new therapeutic opportunities to treat a variety of medical conditions.

Prakash Nagarkatti, Professor of Pathology, Microbiology and Immunology, University of South Carolina and Mitzi Nagarkatti, Professor of Pathology, Microbiology and Immunology, University of South Carolina

This article is republished from The Conversation under a Creative Commons license. Read the original article.

We are a voice to you; you have been a support to us. Together we build journalism that is independent, credible and fearless. You can further help us by making a donation. This will mean a lot for our ability to bring you news, perspectives and analysis from the ground so that we can make change together.

More here:
Cannabis-derived products have flooded US market Two ... - Down To Earth Magazine

Immunology

How my training helps me to address health disparities in multiple … – Nature.com

Irene Ghobrial (front, centre, blue dress) leads a multidisciplinary team that addresses health disparities in multiple myeloma at the Dana-Farber Cancer Institute.Credit: Dana-Farber Cancer Institute

Irene Ghobrial leads the Stand Up To Cancers Multiple Myeloma Dream Team, part of the research charity that investigates conditions that could lead to this type of bone marrow cancer, which kills 106,000 people annually. Ghobrial, a medical oncologist at the Dana-Farber Cancer Institute and Harvard Medical School, both in Boston, Massachusetts, describes her journey as an immigrant woman of colour to the United States. She explains why translational research is key to advancing personalized treatments and how her team addresses health disparities.

I graduated in medicine from Cairo University in 1999 and moved to Detroit, Michigan, for training opportunities that were inaccessible to me in Egypt. I faced many challenges and mistreatment, sometimes driven by discrimination towards me as a woman and an immigrant. The chances of getting into elite training programmes when you belong to a minority group are slim. Sometimes, I was oblivious to these barriers, and not knowing about them helped me to persevere and persist.

Outlook: Multiple myeloma

I couldnt have dreamt of this life when I was younger. Sometimes, I pinch myself and say, Im living the American dream, right? as an Egyptian immigrant and woman of colour who is now an associate professor of medicine at Harvard Medical School. But, as the saying goes, it took a village. My parents and mentors inspired me to dream big. And despite barriers to success faced by minority groups, the US system still allows people to thrive regardless of where they came from and who they are.

In 2000, I worked in an immunology laboratory run by Karen Hedin at the Mayo Clinic in Rochester, Minnesota, looking at chemokine receptor signalling in immune cells. Ive been in love with research ever since. As a clinician-researcher, you can take samples from your patients, do whole-genome sequencing, get the answers you need and use them to personalize treatment. This back-and-forth is gratifying and exciting.

Multiple myeloma is a cancer of plasma cells, white blood cells that make antibodies. In myeloma, these cells grow uncontrollably in the bones and produce an overabundance of abnormal immunoglobulin proteins.

Collection: Co-production of research

Myeloma develops in about 160,000 people every year worldwide. Although rare, it is the most common blood cancer in African Americans, who are twice as likely to have it as white Americans. Theyre also likely to develop it at a younger age.

Myeloma might cause no symptoms in its early stages, but people with more-advanced forms of the disease can have bone pain, fractures, recurring infections, hypercalcaemia (higher-than-normal calcium levels) and anaemia.

The condition is not yet curable. But there are treatments to prevent and manage symptoms, slow disease progression and improve a persons quality of life. Treatment might involve chemotherapy and other cancer-fighting drugs, as well as steroids, bone-modifying medications and bone-marrow transplants.

Confronting racism in Black maternal health care in the United States

I trained at Mayo with Robert (Bob) Kyle, whom I call the grandfather of myeloma, who influenced my interest in multiple myeloma. He named two of the precursor conditions that cause no symptoms but might develop into myeloma: monoclonal gammopathy of undetermined significance (MGUS) and smouldering multiple myeloma (SMM).

Unlike many of his peers in the 1970s, Bob didnt dismiss these conditions simply because they seemed benign. Instead, he focused on understanding what causes them to develop into myeloma, and he emphasized that people with precursor conditions should be monitored closely.

Our patients need our research to answer their health concerns, not in the next 10 or 15 years, but now. If we can diagnose and treat myeloma early, we can make a difference.

My team works fast and hard to sequence and do mass spectrometry to analyse patient samples and get the data back to them. Working this way takes a lot of effort but its also a lot of fun.

My team is multidisciplinary and includes people with MDs or PhDs, as well as students. They work in biology, chemistry, bioinformatics, epidemiology, medicine and statistics. Every person on the team is complementary to the others.

Our team received a US$10 million award and began work in April 2018. Our study, called PROMISE, focuses on understanding these precursor conditions to predict the risk of developing myeloma. We will screen 30,000 individuals at risk of myeloma, including African Americans, people of African descent and people with first-degree family members who have had blood cancer.

How I fused passions for art and medicine into a medical illustration career

To help potential participants gain trust and confidence in our research, we educate them about multiple myeloma and its prevalence in African Americans, and explain that screening for precursor conditions can improve survival outcomes.

In July 2022, we screened 200 African American people at a health-fair event in Indianapolis. One woman was scared because she had a relative with myeloma. After convincing her, she took the test. Her results showed that she might have gone on to develop myeloma with kidney failure in a few weeks. We therefore referred her for standard myeloma therapy that week, which should protect her from developing myeloma and kidney damage.

We published results1 for the first 7,600 patients screened by mass spectrometry for monoclonal gammopathies, the abnormal immunoglobulins in the blood. We were surprised that 13% of the participants had MGUS, a high proportion compared with the 35% prevalence expected in the general population.

We also found that another 20% of participants had very low levels of these abnormal proteins, and we named this new precursor condition monoclonal gammopathy of indeterminate potential, or MGIP. Now, were trying to understand what MGIP is. So far, our findings suggest that it might be a sign of early B-cell malignancies such as chronic lymphocytic leukaemia. If so, its possible that MGIP could be treated and cured in some people, before it progresses to later stages of blood cancers. Its exciting that we have the potential of understanding MGIP better, to help prevent the progression of blood cancers.

Read this article:
How my training helps me to address health disparities in multiple ... - Nature.com

Immunology

Positive trial results for RSV infant treatment: Sanofi – Medical Xpress

This article has been reviewed according to ScienceX's editorial process and policies. Editors have highlighted the following attributes while ensuring the content's credibility:

fact-checked

reputable news agency

proofread

The virus is the most common cause of bronchiolitis, which in some cases can make infants seriously ill.

French pharmaceutical giant Sanofi announced trial results on Friday that showed its preventative treatment for respiratory syncytial virus (RSV) reduced the rate of babies being hospitalized by more than 80 percent.

The virus infects around nine out of 10 children by the age of two and is the most common cause of bronchiolitis, a respiratory infection that is normally mild but in some cases can make infants seriously ill.

Sanofi and British-Swedish firm AstraZeneca, which jointly developed the drug nirsevimab, marketed as Beyfortus, say it is the first treatment to prevent severe illness from RSV in infants.

The phase three trial used real-world data from the 2022-2023 RSV season and involved more than 8,000 infants under 12 months across France, Germany and the UK, Sanofi said in a statement.

The results showed an 83 percent reduction in hospitalizations for infants with RSV-related illnesses who received a single dose of nirsevimab, compared to a control group who did not receive the treatment.

The results suggest that "the overall burden on healthcare systems could be reduced significantly if all infants receive nirsevimab," Sanofi said.

Global medical costs worldwide were estimated to be 4.8 billion euros ($5.2 billion) in 2017, it added.

While not a vaccine, nirsevimab is a monoclonal antibody treatment that has a similar aim: to give protection against RSV with a single injection.

More attention has been paid to RSV since a combination of the virus, Covid-19 and influenza dubbed a "tripledemic" put pressure on hospitals in several countries during the Northern Hemisphere's last winter.

Peter Openshaw, a specialist in lung immunology at Imperial College London, pointed out that the trial data was collected when RSV was rebounding after a dip in cases during Covid lockdowns.

The data "adds to the evidence that use of long-acting monoclonal antibody may prevent moderate to severe RSV disease after a convenient single dose," he said, adding that further studies were needed for older children.

"The cost of nirsevimab will be a critical determinant of how widespread its use can be," Openshaw said.

The drug has already been approved in the European Union, the UK and Canada, and an application in the United States is under review.

Several major pharmaceutical firms have developed vaccines for RSV in adults, and are currently racing to get them approved.

Last week, the US became the first country to approve an RSV vaccine, giving the greenlight to GSK's Arexvy for adults aged 60 or older.

Follow this link:
Positive trial results for RSV infant treatment: Sanofi - Medical Xpress

Immunology

How Can You Find Out If You’re Allergic to a Medication Before You … – Verywell Health

Key Takeaways

Starting a new medication can be nerve-wracking, especially if youre worried about side effects or even having an allergic reaction to a drug youve never taken.

While its not possible to find out if you have a medication allergy before you start taking it, there are a few ways you can work with your prescribing provider to mitigate your risk of a reaction.

If you have a history of drug allergies or have had reactions to medications in the past, tell your healthcare provider. They can start you with a small test dose of a medication to see how you react.

Most drug allergy symptoms come on within hours of taking a medication, but reactions can be delayed for up to two weeks later.

The key is to keep in mind that an allergy to a medication is rare, Maya R. Jerath, MD, PhD, clinical director of the Division of Allergy and Immunology at Washington University in Saint Louis, told Verywell. Adverse side effects or intolerances certainly happen more often, but these are not true allergies.

Heres how the two are different:

Many people believe that having a family history of a drug allergy will also make them develop the same allergybut Jerath said thats not necessarily true.

People do not inherit medication allergies, said Jerath. The tendency to be an allergic person is inherited, but specific allergies are not.

While family history alone does not play a major role in the development of drug allergies, other factors can make a drug allergy more likely.

Jyothi Tirumalasetty, MD, clinical assistant professor at Stanford University with a focus on allergy and immunology, told Verywell that certain genetic factors and chronic health conditions can make drug allergies more likely.

Some risk factors for medication allergies include:

ADRs are fairly common, affecting up to 25% of people taking certain medications. However, only 5%10% of ADRs are true allergies. Women are more likely to develop a drug allergy than men.

Diagnosing a drug allergy can be tricky, but allergists typically start with a complete medical history that includes:

Always tell your provider about any reactions youve had to any medications. Experts recommend drug allergy testing for people who have had adverse drug reactions in the past, as well as when there is not a safe alternative to the drug prescribed.

All drugs carry the risk of an allergic reaction, but there are certain classes of medications that are more common for people to be allergic to, including:

These drugs are frequently used to treat many acute and chronic conditions, so patients may run into situations where they are allergic to a medication thats being recommended for them.

Jerath said that while this happens often, there are desensitization procedures that allow providers to work around it.

For example, if a patient is allergic to penicillin and has an infection that requires penicillin, Jerath said that there is a certain way of administering the medicine in a graded incremental fashion that makes your immune system not react.

While this method does not cure an allergy, it does allow a patient to get the needed medication in an emergency.

If your provider prescribes a new medication for you, talk to them about side effects and the possibility of an adverse reaction. While you cant know for sure if youll react before you start a medication, there are some clues you can be on the lookout for.

The signs and symptoms of ADR and allergic reactions are different. Allergic reactions start on the skin, while ADR usually comes on as gastrointestinal symptoms like nausea, vomiting, stomach cramps, and diarrhea.

Signs that you might be having a reaction to a medication include:

Its less common but some people develop a severe, life-threatening allergic reaction (anaphylaxis) to a drug. If symptoms like trouble breathing, itching, dizziness, confusion, and swelling in your lips or face come on suddenly after you take a medication, call 911.

True drug allergies are rare but they can happen. If youre starting a new medication and youre nervous about side effects or adverse reactions, talk to your provider. While you cant know for sure if youre allergic until you take the drug, your provider can start you on a lower dose and watch for symptoms or recommend an alternative.

American Academy of Allergy, Asthma, and Immunology. Medications and drug allergic reactions.

Wheatley LM, Plaut M, Schwaninger JM, et al. Report from the National Institute of Allergy and Infectious Diseases workshop on drug allergy. J Allergy Clin Immunol. 2015;136(2):262-271.e2. doi:10.1016/j.jaci.2015.05.027

De Martinis M, Sirufo MM, Suppa M, Di Silvestre D, Ginaldi L. Sex and gender aspects for patient stratification in allergy prevention and treatment. Int J Mol Sci. 2020;21(4):1535. doi:10.3390/ijms21041535

American College of Allergy, Asthma, and Immunology. Drug allergies.

By Amy Isler, RN, MSN, CSNAmy Isler, RN, MSN, CSN, is a registered nurse with over six years of patient experience. She is a credentialed school nurse in California.

Thanks for your feedback!

What is your feedback?

More:
How Can You Find Out If You're Allergic to a Medication Before You ... - Verywell Health

Immunology

HUTCHMED Announces Appointment of Independent Non … – GlobeNewswire

HONG KONG and SHANGHAI, China and FLORHAM PARK, N.J., May 10, 2023 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (HUTCHMED or the Company) (Nasdaq/AIM:HCM, HKEX:13) today announces that Professor Solange Peters is appointed as an Independent Non-executive Director, member of the Technical Committee and member of the Audit Committee of the Company with effect from the conclusion of the annual general meeting of the Company to be held on May 12, 2023. Professor Peters is a renowned scientist and educator who possesses expertise and extensive experience in oncology and immunology. The Board of HUTCHMED is of the view that Professor Peters will make significant contributions to the Company.

Mr Simon To, Chairman of HUTCHMED said On behalf of the Board, I would like to extend a warm welcome to Professor Peters to the Company. We believe that her expertise in biopharmaceutical research in oncology and immunology would be of immense value to the Company and she would be instrumental in assisting the Company in achieving its goals.

Professor Peters, aged 50, is the chair of medical oncology and thoracic malignancies in the Department of Oncology at the University Hospital of Lausanne in Lausanne, Switzerland. After completing her clinical education in medical oncology and molecular biology in Switzerland and Italy, she specialized in thoracic tumors, lung cancer, and pleural tumors. Professor Peters was the youngest president of the European Society for Medical Oncology (ESMO) for an extended period of three years from 2020 to 2022, and she is active in the educational programmes of ESMO, where she created the Women for Oncology Committee. Professor Peters was also a member of the board of directors of the International Association for the Study of Lung Cancer (IASLC) from 2013 to 2017.

Professor Peters is currently in charge of teaching and patient care in thoracic malignancies at Lausanne University, where she is building a translational programme in collaboration with the Swiss Federal Institute of Technology and the Ludwig Institute. Her main fields of interest are new biomarker discovery and validation in preclinical and clinical settings, multimodality strategies for locally advanced non-small cell lung cancer (NSCLC), as well as cancer immunotherapy. Her current research projects are mainly focused on innovative immunotherapy combinations and new immuno-modulating treatments across thoracic malignancies. She acts as the local principal investigator (PI) for lung trials opened at Lausanne Cancer Centre and is a co-PI of several other trials.

Professor Peters acts as the scientific committee chair and foundation council member of the ETOP IBCSG Partners Foundation. She was recently nominated as the strategic advisory board president of the Paris Saclay Cancer Cluster and is part of the board of directors of the Swiss National Cancer League. She is also the president of International Cancer Foundation. Professor Peters is also an independent director of Galenica AG, which is listed on the SIX Swiss Exchange.

Professor Peters has authored more than 500 peer-reviewed manuscripts and book chapters, acts as Associate Editor of the Annals of Oncology, Deputy Editor of Lung Cancer, and serves on the editorial board of several other oncology journals. She was the deputy editor of the Journal of Thoracic Oncology for ten years. She received both her doctorate in medicine and PhD from the University Hospital of Lausanne.

Save for the appointments listed above, Professor Peters has held no other directorships or partnerships during the period of five years prior to her appointment as a director of HUTCHMED. She does not have any relationship with any Directors, senior management or substantial or controlling shareholders of HUTCHMED. Professor Peters does not have any interest in the ordinary shares of HUTCHMED within the meaning of Part XV of the Securities and Futures Ordinance (Cap.571 of the Laws of Hong Kong). The initial term of the appointment of Professor Peters as an Independent Non-executive Director of the Company shall end at the next general meeting of the Company, subject to retirement in accordance with the Articles of Association of the Company and applicable legal and regulatory requirements. The initial term shall be automatically renewed for successive 12-month periods, unless she is not re-elected at the next general meeting or her appointment is otherwise terminated earlier by either party in writing. The directors fees of Professor Peters as an Independent Non-executive Director, member of the Technical Committee and member of the Audit Committee of the Company under her appointment letter are US$76,000, US$8,000 and US$13,500 per annum respectively. Such fees are subject to review from time to time and proration for any incomplete year of service.

Save for the information disclosed above, there is no other information in relation to Professor Peters that is required to be disclosed pursuant to Rule 17 and Schedule 2(g) of the AM Rules for Companies or Rule 13.51(2) of the HK Listing Rules and there are no other matters concerning the appointment of Professor Peters that are required to be brought to the attention of the shareholders of HUTCHMED.

About HUTCHMED

HUTCHMED (Nasdaq/AIM:HCM; HKEX:13) is an innovative, commercial-stage, biopharmaceutical company. It is committed to the discovery and global development and commercialization of targeted therapies and immunotherapies for the treatment of cancer and immunological diseases. It has approximately 5,000 personnel across all its companies, at the center of which is a team of about 1,800 in oncology/immunology. Since inception it has focused on bringing cancer drug candidates from in-house discovery to patients around the world, with its first three oncology drugs now approved and marketed in China. For more information, please visit: http://www.hutch-med.com or follow us on LinkedIn.

Forward-Looking Statements

This announcement contains forward-looking statements within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements reflect HUTCHMEDs current expectations regarding future events. Forward-looking statements involve risks and uncertainties. Such risks and uncertainties include, among other things, the risk that current or future appointees to HUTCHMEDs board of directors are not eective in their respective positions, the diiculty in locating and recruiting suitable candidates for its board of directors and the management diiculties which may arise from changes in HUTCHMEDs board of directors. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. For further discussion of these and other risks, see HUTCHMEDs filings with the U.S. Securities and Exchange Commission, on AM and with The Stock Exchange of Hong Kong Limited. HUTCHMED undertakes no obligation to update or revise the information contained in this announcement, whether as a result of new information, future events or circumstances or otherwise.

CONTACTS

Read this article:
HUTCHMED Announces Appointment of Independent Non ... - GlobeNewswire

Immunology

The Wistar Institute, Pennsylvania Biotechnology Center and Baruch S. Blumberg Institute Forge Strategic Collaboration to Support Regional Biotech…

Newswise PHILADELPHIA (MAY 9, 2023) The Wistar Institute has formed a new strategic collaboration with the Pennsylvania Biotechnology Center (PABC) and the Baruch S. Blumberg Institute to accelerate the advancement of bench to bedside biomedical research discoveries in the tri-state region by collectively supporting the seeding, launching and maturation of life science startups.

The Wistar Institute is a Philadelphia-based world leader in discovery science in the areas of cancer, immunology and infectious disease. The PABC is a highly successful nonprofit incubator promoting regional economic development and fostering the development of startup companies in the life sciences. The Blumberg Institute, which manages the PABC, is a nonprofit organization focused on translation research in the life sciences. The two organizations share a campus with their sister institution, the Hepatitis B Foundation, in Doylestown, Pennsylvania.

The PABC and Blumberg Institute will leverage the institutes scientists and the PABCs member companies and collaborative entrepreneurial ecosystem with Wistars growing pipeline of technologies including NK and T-Cell engaging antibodies, multivalent biologics, small-molecule oncology and immunooncology therapies, cell and gene therapies, and vaccine and diagnostic assets.

As Wistars SVP of Business Development and Executive Director of Technology Transfer Heather A. Steinman, Ph.D., MBA, explained, Through this important collaboration, we see the opportunity to leverage Wistars pre-clinical assets in both oncology and infectious diseases with PABC/BSBIs access to capital, infrastructure and life science sector talent pool to further enhance the innovation ecosystem in the region.

This collaboration will involve use of Blabs at Cira Centre, a state-of-the-art incubator in University City, which is managed by the PABC and was conceived, designed and built by Brandywine Realty Trust. Jerry Sweeney, President & CEO of Brandywine Realty Trust, said he is pleased to be furthering the advancement of Philadelphias life sciences community.

This is a welcome reminder of the powerful possibilities that collaborations like this can generate, Sweeney said. Were delighted to provide the physical platform to support the promising startups at B+labs at Cira Centre and look forward to seeing their missions become realized through this dynamic ecosystem.

Louis P. Kassa III, MPA, Chief Executive Officer of the Hepatitis Foundation, Blumberg Institute and PABC foresees this collaborative model as a prototype to attract talent, new capital and support startups more broadly throughout the Pennsylvania, New Jersey and Delaware life sciences cluster.

This agreement represents a major new chapter in the PABCs progress and the evolution of the Blumberg Institute, Kassa said. Were thrilled to be collaborating with The Wistar Institute and we see our relationship growing significantly in the years and months ahead.

Through their new collaboration, The Wistar Institute and the Pennsylvania Biotechnology Center are planning to co-host a new translational science seminar series, as well as an early-stage life sciences startup how-to seminar series for supporting trainees and entrepreneurial scientists to advance basic research discoveries to clinical therapies.

###

The Wistar InstituteThe Wistar Institute, the first independent, nonprofit biomedical research institute in the United States, marshals the talents of an international team of outstanding scientists through a culture of biomedical collaboration and innovation. Wistar scientists are focused on solving some of the worlds most challenging and important problems in the field of cancer, infectious disease, and immunology. Wistar has been producing groundbreaking advances in world health for more than a century. Consistent with its legacy of leadership in biomedical research and a track record of life-saving contributions in immunology and cell biology, Wistar scientists early-stage discoveries shorten the path from bench to bedside. wistar.org.

The Pennsylvania Biotechnology Center (PABC)The PABC uses a highly successful services-based approach to nurture and guide its member companies to success, advance biotechnology, maximize synergies among nonprofit scientists and their commercial colleagues, and launch new ideas and discoveries that will make a positive impact. The PABC has nearly 100 member companies and organizations, mostly small to mid-size science, research and pharmaceutical companies. Nearly 50 of those companies operate on the Doylestown campus, which is home to the Hepatitis B Foundation and the Blumberg Institute. The PABC also manages B+labs a Cira Centre, a new incubator in Philadelphia, in partnership with Brandywine Realty Trust. PABC companies have produced numerous FDA-approved drugs and medical devices, and a recent study found that the PABCs economic impact exceeded $7.3 billion and created more than 1,100 new jobs during 2016-2021.

The Baruch S. Blumberg InstituteAn independent, nonprofit research organization, the Blumberg Institute was launched in 2003 by the Hepatitis B Foundation to advance its research mission. Today, the Institute is one of the nations leading centers for translational research in hepatitis B and liver cancer. The Institute supports drug discovery, biomarker discovery and translational biotechnology around common research themes such as chronic hepatitis, liver disease and liver cancer in an environment conducive to interaction, collaboration and focus.

Read this article:
The Wistar Institute, Pennsylvania Biotechnology Center and Baruch S. Blumberg Institute Forge Strategic Collaboration to Support Regional Biotech...

Immunology

Humanized Mouse and Rat Model Market worth $338 million | MarketsandMarkets – Yahoo Finance

CHICAGO, May 8, 2023 /PRNewswire/ -- The humanized mouse and rat model industry is expected to witness significant growth in the near future. These models are essential tools in biomedical research and drug development, allowing scientists to better understand human diseases and evaluate the efficacy and safety of potential treatments. Humanized mouse and rat models are created by introducing human genes, cells, or tissues into the animal models, enabling the simulation of human physiological and pathological processes. With advancements in gene-editing technologies like CRISPR-Cas9, the creation of more precise and sophisticated humanized models is becoming possible. This opens up new avenues for studying complex diseases, such as cancer, autoimmune disorders, and infectious diseases, and facilitates the development of targeted therapies. The use of humanized models in preclinical studies can help accelerate the drug discovery process, reduce costs, and improve the success rates of clinical trials. As a result, the humanized mouse and rat model industry is poised to play a pivotal role in advancing biomedical research and personalized medicine in the near future.

MarketsandMarkets_Logo

Humanized Mouse and Rat Model Marketin terms of revenue was estimated to be worth $237 million in 2022 and is poised to reach $338 million by 2027, growing at a CAGR of 7.4% from 2022 to 2027 according to a new report by MarketsandMarkets. Factors such as advances in genomics, proteomics, and metabolomics; completion of the human genome map; the development of targeted diagnostics and therapeutics; and the growing emphasis on health, wellness, and preventive measures are driving the demand for personalized medicine and, subsequently the demand for relevant humanized mouse and rat research models. Also, grants from government and private organizations for cancer research have also supported the development of humanized models in oncology. For instance, in 2020, the US NIH funded a large-scale project to find treatments for rare genetic diseases with a five-year grant of USD 10,625,000 to The Jackson Laboratory Center for Precision Genetics. In the same year, The Jackson Laboratory received a grant from the NIH for its Mouse Mutant Resource and Research Centers (MMRRC) program, established in 2009. The new grant provides a total of USD 6,119,082 over five years to the MMRRC. With such grants and funding from the government and private sectors, the demand for humanized mouse models is expected to increase.

Story continues

Download an Illustrative overview: https://www.marketsandmarkets.com/pdfdownloadNew.asp?id=131763955

Browse in-depth TOC on "Humanized Mouse and Rat Model Market"

140 - Tables27 - Figures177 - Pages

Humanized Mouse and Rat Model MarketScope:

Report Coverage

Details

Market Revenue in 2022

$237 million

Estimated Value by 2027

$338 million

Growth Rate

Poised to grow at a CAGR of 7.4%

Market Size Available for

2020-2027

Forecast Period

20222027

Forecast Units

Value (USD Million)

Report Coverage

Revenue Forecast, Competitive Landscape, Growth Factors, and Trends

Segments Covered

Type, Application, End User, and Region

Geographies Covered

North America, Europe, Asia Pacific, Latin America (LATAM) and Middle East and Africa (MEA)

Report Highlights

Updated financial information / product portfolio of players

Key Market Opportunities

Rising demand for humanized PDX models

Key Market Drivers

Increasing research activities using humanized models

The genetic humanized mouse model segment accounted for the largest share of the humanized mouse model segment in the humanized mouse and rat model market in 2021.

Based on type, the humanized mouse and rat model market has been segmented into humanized mouse models and humanized rat models. The humanized mouse models' segment is further divided into genetic humanized mouse models and cell-based humanized mouse models. In 2021, genetic humanized mouse segment accounted for the largest share of humanized mouse model market. Advances in genetic engineering technologies, such as gene targeting and gene editing, have led to the development of genetically engineered humanized mouse models that serve as an important tool for a variety of research applications. In addition to the widespread use of these mice in diverse research areas, the emerging CRISPR technology, increasing focus on personalized medicine with the continuous introduction of new models, and various licensing agreements are expected to drive market growth.

The immunology and infectious diseases segment accounted for the second largest share of the application segment in the humanized mouse and rat model market in 2021.

Based on application, the humanized mouse and rat model market is segmented into oncology, immunology and infectious diseases, neuroscience, Hematopoiesis, toxicology, and other applications. Immunology and Infectious diseases segment accounted for the second largest share of the humanized mouse and rat model market in 2021. Mouse models are used in immunology and inflammation studies as they help assess the physiological relevance of an experimental finding. The use of mouse models allows suitable alterations in the mouse genome at random or in specific regions, enabling a detailed study of immunological processes. They also assist in identifying the function of newly identified surface receptors in host defense as well as the developmental consequences of a disturbed signaling pathway or removing a transcription factor. Such mouse models are developed on a large scale in laboratories or institutes and are used for application in Immunology and Infectious diseases segment. Thus, making it the second largest segment in the market.

The Asia Pacific region is the fastest-growing region of the humanized mouse and rat model market in 2021.

Based on the region, the humanized mouse and rat model market is segmented into five major regions: North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa. The Asia Pacific market is estimated to register the highest growth during the forecast period. Global pharmaceutical firms are increasingly moving to APAC to tap into its thriving market and lower their production costs by shifting manufacturing and laboratory testing to the region. The rapidly increasing demand for the outsourcing of quality control safety testing (including efficacy testing) in countries such as China, India, Japan, and Singapore is expected to drive market growth in the Asia Pacific during the forecast period.

Inquiry Before Buying: https://www.marketsandmarkets.com/Enquiry_Before_BuyingNew.asp?id=131763955

Humanized Mouse and Rat Model Market Dynamics:

Drivers:

Increasing research activities using humanized models

Rising demand for personalized medicine

Continuous support and initiatives from government and private sectors for cancer research

Growing R&D activities in pharmaceutical and biotechnology sectors

Restraints:

High cost of custom humanized models

Laws and regulations for ethical use of animal models in research

Opportunities:

Rising demand for humanized PDX models

Emergence of CRISPR as a powerful tool in biomedical research

Rising demand for humanized rat models

Challenges:

Alternatives for animal testing

Limitations of humanized mouse models

Key Market Players:

Key players in the humanized mouse and rat model Market include Charles River Laboratories International, Inc. (US), The Jackson Laboratory (JAX) (US), Taconic Biosciences, Inc. (US), Crown Bioscience (US), and Envigo (US).

Get 10% Free Customization on this Report: https://www.marketsandmarkets.com/requestCustomizationNew.asp?id=131763955

Recent Developments:

In January 2022, Taconic Biosciences, Inc. (US) launched the huNOG-EXL EA (early access) humanized immune system (HIS) mouse.

In October 2021, The Jackson Laboratory (US) acquired RMS Business of Charles River Laboratories Japan, Inc. (Japan) which is Charles River Laboratories Japan's Research Models & Services (RMS) business as a wholly-owned subsidiary.

In September 2021, Biocytogen (US) collaborated with Envigo (US) in order to support the research applications of the triple immunodeficient B-NDG mouse. Envigo is the exclusive provider of B-NDG mice in the US, Europe, and certain APAC regions.

In March 2021, Charles River Laboratories International, Inc. (US) acquired Cognate BioServices, Inc. (US) a cell and gene therapy contract development and manufacturing organization (CDMO) offering comprehensive manufacturing solutions for cell therapies. The acquisition expanded Charles River's broad capabilities across the major CDMO platforms for cell and gene therapies.

Humanized Mouse and Rat Model Market Advantages:

Enhanced translatability: Humanized mouse and rat models closely mimic human physiology and disease conditions, allowing for more accurate translation of research findings to human patients. This increases the likelihood of successful translation from preclinical studies to clinical trials.

Study of human-specific diseases: Humanized models enable the study of human-specific diseases that cannot be effectively studied in traditional animal models. These models provide insights into the mechanisms of diseases such as cancer, autoimmune disorders, and infectious diseases, leading to the development of targeted therapies.

Evaluation of drug efficacy and safety: Humanized models allow researchers to evaluate the efficacy and safety of potential drug candidates in a more relevant and predictive manner. This leads to more informed decision-making in drug development, reducing the likelihood of failures in later stages of clinical trials.

Personalized medicine advancements: Humanized models enable the exploration of personalized medicine approaches by allowing researchers to assess the response of specific patient populations to different therapies. This can aid in the development of tailored treatments and improve patient outcomes.

Reduction in animal usage: By using humanized models, researchers can minimize the reliance on traditional animal models, reducing the number of animals used in research studies while obtaining more clinically relevant data.

Humanized Mouse and Rat Model Market - Report Highlights:

Refinements in the chapters of the humanized mouse and rat model market

Updated financial information/service portfolio of players

Updated market developments of profiled players

Related Reports:

Mice Model Market- Global Forecasts to 2028

CRO Services Market- Global Forecasts to 2028

PDX Models Market- Global Forecasts to 2026

In Vivo Toxicology Market- Global Forecasts to 2025

Life Science Instrumentation Market- Global Forecasts to 2025

About MarketsandMarkets:

MarketsandMarkets is a blue ocean alternative in growth consulting and program management, leveraging a man-machine offering to drive supernormal growth for progressive organizations in the B2B space. We have the widest lens on emerging technologies, making us proficient in co-creating supernormal growth for clients.

The B2B economy is witnessing the emergence of $25 trillion of new revenue streams that are substituting existing revenue streams in this decade alone. We work with clients on growth programs, helping them monetize this $25 trillion opportunity through our service lines - TAM Expansion, Go-to-Market (GTM) Strategy to Execution, Market Share Gain, Account Enablement, and Thought Leadership Marketing.

Built on the 'GIVE Growth' principle, we work with several Forbes Global 2000 B2B companies - helping them stay relevant in a disruptive ecosystem. Our insights and strategies are molded by our industry experts, cutting-edge AI-powered Market Intelligence Cloud, and years of research. The KnowledgeStore (our Market Intelligence Cloud) integrates our research, facilitates an analysis of interconnections through a set of applications, helping clients look at the entire ecosystem and understand the revenue shifts happening in their industry.

To find out more, visit http://www.MarketsandMarkets.comor follow us on Twitter, LinkedInand Facebook.

Contact:Mr. Aashish MehraMarketsandMarkets INC.630 Dundee RoadSuite 430Northbrook, IL 60062USA: +1-888-600-6441Email: sales@marketsandmarkets.comResearch Insight: https://www.marketsandmarkets.com/ResearchInsight/humanized-mouse-model-market.aspVisit Our Website: https://www.marketsandmarkets.com/Content Source: https://www.marketsandmarkets.com/PressReleases/humanized-mouse-model.asp

Logo: https://mma.prnewswire.com/media/660509/MarketsandMarkets_Logo.jpg

Cision

View original content:https://www.prnewswire.com/news-releases/humanized-mouse-and-rat-model-market-worth-338-million--marketsandmarkets-301818314.html

SOURCE MarketsandMarkets

See the original post:
Humanized Mouse and Rat Model Market worth $338 million | MarketsandMarkets - Yahoo Finance

Immunology

Nektar Therapeutics (NASDAQ:NKTR) Q1 2023 Earnings Call Transcript – Yahoo Finance

Nektar Therapeutics (NASDAQ:NKTR) Q1 2023 Earnings Call Transcript May 9, 2023

Operator: Good day and thank you for standing by. Welcome to the Nektar Therapeutics First Quarter 2023 Financial Results Conference Call. Please be advised that todays conference is being recorded. I would now like to hand the conference over to your speaker today, Vivian Wu. Please go ahead.

Vivian Wu: Thank you, Crystal and good afternoon everyone. Thank you for joining us today. With us on the call are Howard Robin, our President and CEO; Dr. Jonathan Zalevsky, our Chief of Research and Development; Dr. Mary Tagliaferri, our Chief Medical Officer; and Sandra Gardiner, our acting Chief Financial Officer. On todays call, we expect to make forward-looking statements regarding our business, including statements regarding the therapeutic potential of and future development plans for drug candidates and research programs, the timing of the initiation of clinical studies and the availability of clinical data for our drug candidates, the timing and plans for future clinical data presentations, the formation future development plans or success of our collaboration arrangements, the expectations following our corporate restructuring and reorganization, financial guidance and certain other statements regarding the future of our business.

Because forward-looking statements relate to the future, they are subject to uncertainties and risks that are difficult to predict and many of which are outside of our control. Our actual results may differ materially from these statements. Important risks and uncertainties are set forth in our Form 10-K that was filed on February 28, 2023, which is available at sec.gov. We undertake no obligation to update any of these forward-looking statements, whether as a result of new information, future developments or otherwise. A webcast of this call will be available on the IR page of Nektars website at nektar.com. With that said, I would like to hand the call over to our President and CEO, Howard Robin. Howard?

Story continues

Howard Robin: Thank you, Vivian, and thank you all for joining us today. As you know, a few weeks ago, we announced our plans to implement a new strategic plan and cost restructuring at Nektar. And Im pleased to report today that we enacted the plan quickly and that we will begin to see ongoing expense savings starting in the third quarter of this year. The new plan focuses our company more clearly on immunology and importantly, also extends our cash runway through at least the middle of 2026. A core element of our new pipeline focus and plan is on the advancement of REZPEG, and we intend to move quickly to initiate a well-powered randomized Phase 2b study for REZPEG in patients with atopic dermatitis. We were incredibly pleased to have regained the rights to this first-in-class regulatory T cell program from Lilly.

Importantly, there are no royalties owed to Lilly for this transfer and REZPEG now becomes a wholly owned asset of Nektars. Atopic dermatitis, as a target indication for REZPEG, is attractive to us for several reasons, not the least of which is the strength of the data that has been generated for REZPEG in patients with atopic dermatitis. The non-topical biologic treatment landscape is significantly growing. The approvals of DUPIXENT and other IL-13 based biologics have driven this growth. In the U.S. alone, approximately 16 million people are living with atopic dermatitis with 3 out of 4 of these affected by moderate to severe disease. In 2021, biologic sales for atopic dermatitis were close to $5 billion and sales continue to grow. That being said, atopic dermatitis is a disease area where there is still a very high unmet need for novel biologic treatment options.

Most notably, the mechanisms available to patients today after they fail topical treatments overlap and fall into either the category of IL-13 based mechanisms or JAK inhibitor. Both mechanisms have limitations on efficacy and both have some notable safety challenges, which include black box warnings with the JAK inhibitor class. Even with the growth in the adoption of these mechanisms, at least 50% of patients dont respond to these therapies at all, and many patients see a rebound in their disease after coming off these therapies. This opens a real opportunity for REZPEG to be introduced as the first regulatory T cell mechanism that is differentiated from these overlapping existing mechanisms. The Phase 1b data for REZPEG was compelling and set the stage for us to measure the potential for REZPEG be a remitted therapy with longer-term disease control and less frequent maintenance dosing.

JZ will review the data reported for REZPEG in a few minutes, including the quality and durability of responses we saw in patients. Now as we mentioned in our reprioritization plan with a focus on immunology, well also continue the development of our IL-15 program, NKTR-255 in cancer, while we explore strategic partnership options. NKTR-255 is being developed in combination with cell therapies, and we believe it could be a valuable adjuvant therapy for companies focused in the area of cell therapy. Our Phase 2 study of NKTR-255 in combination with approved cell therapies, BREYANZI and Yescarta, as well as the Phase 2 JAVELIN Bladder Medley study with Mercy KGaA will continue while we seek a development partner. We continue to see great value in NKTR-255 and early data showed its promise as a potentiator of cell therapies that could benefit patients suffering from very difficult-to-treat cancers.

Our goal is to find a strategic co-development partner this year. As Ive stated earlier, our primary focus is on immunology. And to that end, we have 2 preclinical candidates advancing, a TNFR2 antibody program and a PEG CFS 1 program, which JZ will discuss in a moment. Our goal is to have an IND ready in 2024 for at least 1 of these programs. Were deeply grateful to our employees for their commitment and dedication to Nektar and the patients we aim to serve. The decisions over the past month to further reduce our head count have been difficult, but we believe these are the right decisions to maximize the success of REZPEG and our immunology programs. Were confident that our focus on immunology is the best path forward to bring important potential therapies to patients and to create value for our shareholders.

And now Ill pass the call to JZ to review the programs in more detail.

Jonathan Zalevsky: Thanks, Howard. Starting with REZPEG. This is a unique molecule that has shown promising efficacy in multiple clinical trials as a single agent. Our goal with this program is to address the underlying Treg deficiencies and consequent overactivity of effector T cells in these diseases by selectively activating and expanding Tregs. REZPEG is uniquely positioned as the most advanced IL-2-based Treg mechanism in the clinic with opportunity and potential in a number of autoimmune disease indications. . Now Howard touched on 1 of these indications, atopic dermatitis. Management of atopic dermatitis has a few main goals. The first goal is the rapid efficacious treatment of the acute phase of the plant. And second, this is a far more challenging control of the chronic disease in the long term.

And given that most patients with moderate to severe disease need medication for many years, the safety profile is also critically important. The current treatment landscape for patients with moderate to severe disease that requires systemic therapy has 2 major classes of medicines currently approved for standard of care. One class of these target key cytokines that drive the TH2 inflammation pathway, the flagship in this class is DUPIXENT or dupilumab, which blocks the IL-4 and IL-13 pathways. Lebrikizumab which is expecting approval later this year and the recentfly approved Adbry both target and block IL-13 only. While DUPIXENT is a very successful drug, there is now real-world data that describes some of its limitations. One real-world evidence study shows the lack of durable efficacy in that 79% of patients that discontinued DUPIXENT lost disease control after an average of 4 months and needed to restart therapy.

Another real-word study showed that 27% of patients taking DUPIXENT developed moderate to severe conjunctivitis, requiring treatment with anti-inflammatory eye drops or appointments. The other major class of therapies for atopic dermatitis are the JAK inhibitors. These interfere with T cell activation and thus suppress inflammation in the dermis. JAK inhibitors show impressive efficacy in atopic dermatitis, but they carry multiple black-box warnings making them less attractive for chronic use. Because the JAK inhibitors are associated with these multiple safety risks, the FDA had only granted a label for the JAK inhibitors in patients whose disease is not adequately controlled with other systemic drug products, including biologics. In the clinic, because of the black-box warnings, dermatologists acknowledge that JAK inhibitors are not suited for many of their patients, including individuals greater than 65 years old or those with the comorbidities associated with the black-box warning.

Like DUPIXENT, patients that discontinue JAK inhibitors also quickly lose disease control and relapse. Unlike IL-13 blockers and JAK inhibitors, which both block their respective pathways, REZPEG is designed to target the IL-2 receptor complex and stimulate the expansion and function of Treg cells. These in turn suppress the harmful T cells that are driving the underlying pathology of atopic dermatitis. REZPEG aims to restore homeostasis in the immune system through the proliferation of T-reg cells rather than just blocking effector cells. And consequently, REZPEG provides a completely different mechanism of action compared to the other drugs that are currently approved or under development in the atopic dermatitis space. The Phase 1b data from our first initial proof-of-concept study in moderate-to-severe atopic dermatitis reinforces our conviction in REZPEG.

Laboratory, Medicine, Health

Photo by National Cancer Institute on Unsplash

The 12-week Phase 1b study conducted by Lilly tested two doses of REZPEG compared to placebo and then followed patients for 36 additional weeks after the last dose of therapy. Last September, we presented the interim data from this trial. REZPEG demonstrated a dose-dependent reduction in eczema area and severity index scores in patients, also known as the ES score with approximately a 70% reduction in scores at week 12 at the highest dose tested. We also saw a dose-dependent improvement in the investigator global assessment for atopic dermatitis and itch responder rates through week 12 of treatment. Consistent with the REZPEG mechanism of action, total Tregs and CD25bright Tregs increased versus placebo through week 12. The efficacy observed at 12 weeks of treatment with REZPEG is in line with efficacy observed after 16 weeks of treatment with DUPIXENT.

But clearly, the most fascinating observation from the study was that when we looked at patients 36 weeks after we stopped dosing REZPEG, their skin scores and other measurements of disease activity remain very low. And this is an effect that is not observed with DUPIXENT. This has us and KOLs very enthusiastic about the potential for long-lasting responses and infrequent maintenance dosing with REZPEG in the setting of atopic dermatitis.. We have now received the final data for this study from Eli Lilly, and the study results positively extend the interim results previously reported. In addition, these data include additional efficacy endpoints that were not covered in last years EADV presentation. To briefly touch on some of these, we observed a dose-dependent decrease in the percentage of body surface area involved with atopic dermatitis, also known as BSA in patients treated with REZPEG with patients at the highest dose level reaching a 72% reduction in BSA at week 12 as a reminder, BSA continuous measurement that correlates with EASI.

We also observed dose-dependent reductions in 2 patient-reported outcome measures, the Dermatology Life Quality Index, also known as DLQI, and the patient-oriented eczema measure or POEM. In addition, the final data set has data for more patients completing the 36-week observation period. We are very excited about the data obtained in this study. REZPEG showed efficacy across all measures of physician-reported disease activity and patient-reported outcomes. And these effects were durable and maintained after patients stopped REZPEG administration at week 12. We look forward to ending in the coming months. When we develop REZPEG at Nektar, our hypothesis was that restoring Treg populations in patients with autoimmune disease would restore the normal balance of the immune system and potentially provide a disease-modifying therapy.

We are excited to see the long duration of sustained response observed in the atopic dermatitis study, consistent with this hypothesis. These collective data demonstrate REZPEGs potential as a remit of therapy and support the quick advancement of REZPEG to move into a Phase 2b study in atopic dermatitis later this year. We are now finalizing the Phase 2b study, which will give the industry standard Phase 2 study design similarly to Phase 2 work conducted for approved IL-13 and other agents. This will allow us to evaluate multiple dose regimens of REZPEG in a 16-week induction period followed by a 28-week maintenance period. We believe the study design will enable data to be better compared to prior Phase 2 studies at a 16-week primary endpoint readout at the end of the induction period.

We have assembled a scientific steering committee for this trial and we are pleased to announce that Dr. Jonathan Silverberg from the George Washington University School of Medicine and Health Sciences will be the Chair of this committee. We are truly excited for REZPEGs potential as a first-in-class Treg stimulator, and we look forward to initiating this Phase 2b study in patients with moderate-to-severe atopic dermatitis this year. The Phase 2 top line data reported in lupus earlier this year also demonstrated clinically meaningful improvements as compared to placebo across key secondary end points, including BICLA and LLDAS at the mid-dose level. And since we reported the data, we have had time to meet with many thought leaders in the field of lupus.

Their reaction to our study results has been positive and provided us with many insights. In their feedback, the thought leaders focused on REZPEGs rapid onset of BICLA and LLDAS response as well as the magnitude of the effect on these endpoints was observed. There is agreement that the Phase 2b data provides ample evidence to design a Phase 3 registrational study around these approvable end points. While we remain very interested in lupus, to be clear, we are prioritizing first the Phase 2b study in atopic dermatitis because it will allow us to rapidly reach a definitive result in a randomized study. We may have the opportunity to revisit a development strategy in lupus once we get the results from this atopic dermatitis study. We are extremely excited about REZPEG now being a wholly owned component of our pipeline.

While our near-term focus is on atopic dermatitis, we continue to believe that REZPEG has broad potential in multiple indications. As development of this program progresses, we will continue to evaluate further opportunities and indications for REZPEG. Moving to NKTR-255. We are evaluating strategic partnership options for the asset, while we continue our NKTR-sponsored Phase 2study of NKTR-255 in combination with cell therapies and the Phase 2 JAVELIN Bladder Medley Study with our partner, Merck KGaA. NKTR-255 is an agent that engages the full biology of the IL-15 pathway to provide functional activation and homeostatic control of IL-15 responses of immune cells, mainly natural killer cells, CD8 T cells and immune memory subsets. As the full agonist of the IL-15 pathway, it can signal through both cis and trans presentation of the TRIMERIC-IL-15 receptor complex.

NKTR-255 can be combined with multiple mechanisms ranging from targeted therapies, to cell therapies, including CAR-T and even TCR therapies and checkpoint inhibitors to potentially improve the efficacy of these agents. While we continue to see great value in this program with NKTR-255 showing broad potential applicability across oncology indications, we believe prioritizing our immunology programs provides great opportunity to create value for our shareholders. We believe further development of NKTR-255 with the strategic partner is, therefore, the best path forward for our program, and our goal is to find a partner this year. With this reprioritization, the NKTR-255 study in combination with DARZALEX FASPRO in multiple myeloma and in combination with cetuximab in solid tumors are wrapping up as we prioritize the cell therapy in bladder cancer sites.

Now turning to our preclinical research programs. We are advancing our research pipeline with a focus on autoimmune disease. The first program we are working on is our new PEG colony-stimulating factor, also known as CSF1 program. PEG CSF1 is the polyethylene glycol or PEG modified version of the CSF1 protein. This molecule was engineered to optimize their receptor interaction and the exposure to selectively modulate the resolution processes of inflammation. We believe this program has applications in a number of therapeutic indications, including acute and chronic inflammation as well as fibrosis. And we are excited to be ramping up the program. Our second preclinical program is our TNFR2 agonist antibody being developed in collaboration with biologic design.

TNFR2 is highly expressed on Tregs, neuronal cells and endothelial cells, and TNFR2 agonism has been shown to potentiate the suppressive effect and overall functional properties of Tregs. If absent, it is associated with CNS autoimmunity. While its presence has been associated with protective effects for neuronal cells as well as other cell populations and tissues in the body. The lead antibodies we have identified shows selective Treg binding and signaling, which enables them to be developed specifically for autoimmune disease. We are very excited about this program and its potential to suppress inflammation and promote the human resolution. We plan to file an IND for at least one of these programs in 2024 and look forward to keeping you updated on our progress as these programs mature.

And with that, I will turn the call over to Sandy for a review of our cost restructuring plan and financial guidance.

Sandra Gardiner: Thank you, JZ, and good afternoon, everyone. Id like to first outline the actions we are taking currently in the second quarter as part of our cost restructuring plan to reduce operating expenses. And then I will provide 2023 financial guidance. We ended the first quarter with approximately $457 million in cash and investments with no debt on our balance sheet. As we announced in April, we have reduced our San Francisco-based workforce by approximately 60%. Costs related to the restructuring will be paid by the end of June in the second quarter. We now have approximately 55 employees based in San Francisco going forward. On an annual run rate basis, the reduction to personnel represents approximately $30 million a year in operating expense reductions.

We will have quarterly savings beginning in the third quarter of 2023, and we expect to fully realize these annual savings in 2024. With these reductions in annual operating expenses, as Howard stated, our plan allows for Nektar to have a cash runway through at least the middle of 2026 with our existing cash on hand. Any cash brought in from partnering or other strategic activities would further extend this runway and bolster the balance sheet. Before I move on to 2023 financial guidance, I will note a few non-cash items that were recorded during the first quarter of 2023. First, we recorded a one-time non-cash charge of $76.5 million to impair the goodwill that was previously recorded on our balance sheet, primarily from two acquisitions made over 17 years ago, the 2001 acquisition of Share Water Corporation and the 2005 acquisition of Aerogen.

In Q1, we also recorded a $13.2 million noncash impairment primarily for leased assets. These aggregate non-cash impairment charges of $89.7 million contributed $0.48 to our net loss per share in Q1 2023. Excluding these non-cash impairment charges, net loss on a non-GAAP basis for the first quarter of 2023 and was $47.3 million or $0.25 basic and diluted loss per share. Ill now review our 2023 financial guidance. We expect to end 2023 with at least $315 million in cash and investments. In the second quarter of 2023, we will have non-recurring cash payments of approximately $8 million in connection with our reduction in head count. We expect our net cash usage to decrease in the second half of the year after these payments are made in June.

As I said earlier, this reduction in net cash utilization extends our cash runway through at least the middle of 2026. Our GAAP revenue for full year 2023 is expected to be between $80 million and $90 million. This revenue includes $65 million to $70 million in non-cash royalties and $15 million to $20 million in product sales. We anticipate full year 2023 GAAP R&D operating expenses will range between $105 million and $115 million, which includes approximately $15 million to $20 million of non-cash depreciation and stock compensation expense. We expect G&A operating expense for full year 2023 and to be between $75 million and $80 million, which includes approximately $15 million to $20 million of noncash depreciation and stock compensation expense.

For the full year 2023, we expect to recognize restructuring, impairment and costs of terminated programs of approximately $30 million to $35 million, $13.2 million of which is a non-cash impairment that I mentioned earlier and was recognized in Q1 2023. Our full year 2023 non-cash interest expense is expected to be between $20 million and $25 million. And with that, well now open the call for questions. Operator?

See also 20 Most Used Prescription Drugs In The USand 15 Biggest Immunotherapy Companies in the World.

To continue reading the Q&A session, please click here.

Read this article:
Nektar Therapeutics (NASDAQ:NKTR) Q1 2023 Earnings Call Transcript - Yahoo Finance

Immunology

Mercks $10.8 billion takeover of Prometheus gives it a foothold in immunology – MarketWatch

Merck & Co.s $10.8 billion acquisition of Prometheus Biosciences Inc., which it announced Sunday, is a strategic positive that will help the drug company diversify its portfolio and reduce the risk of an overreliance on its cancer drug Keytruda, analysts said Monday.

San Diego, Calif.-based Prometheus RXDX is a clinical-stage biotechnology company focusing on autoimmune treatments, such as PRA023, a treatment under development for illnesses such as ulcerative colitis and Crohns disease.

This transaction adds further diversity to our overall portfolio and is an important building block in strengthening the sustainable innovation engine that will drive our long-term success, Merck Chief Executive Rob Davis told analysts on a call to discuss the deal, according to a FactSet transcript.

BofA analysts said diversity is a key goal for Merck, given that Keytruda is expected to account for more than 45% of total revenue by 2025.

Whilewe wouldnt expect todays proposed transaction to meaningfully move Mercks shareson Monday given its relative size, we see the deal as a strategic positive and another step in the right direction to diversify Keytruda concentration risk, analysts led by Geoff Meacham wrote in a note to clients.

Also see:Moderna, Merck combo cancer-vaccine treatment shows significant promise

BofA has a buy rating on Merck MRK

Prometheus had a market cap of about $5.42 billion as of Fridays close. Its stock is up 3.7% year to date but has skyrocketed 225% over the past 12 months, with much of the gains coming afterPRA023 advanced to Phase 3 clinical trialsin December. The news of the Merck deal with its 70% premium sent the stock up 69% on Monday.

PRA023 is an antibody that binds TL1A,a target associated with both intestinal inflammation and fibrosis, said the BofA analysts. Phase 2 studies have demonstrated the best-in-class potential for the drug, which is a potential disrupter in the inflammatory and immunology space and has a pipeline that stretches beyond inflammatory bowel disease, or IBD, they wrote.

Read now: Merck and Eisai report disappointing results from trials of combination treatment for melanoma and colorectal cancer

IBD is the umbrella term used to describe diseases including Crohns and ulcerative colitis, both of which cause chronic inflammation of the gastrointestinal tract, leading to diarrhea, rectal bleeding, abdominal pain, fatigue and weight loss.

Prometheus has a roughly $5 billion potential by 2030, the analysts said, although they noted that with Phase 3 studies to be launched this year, there is still a lot of wood to chop before commercialization, which is expected by 2026.

Stifel analysts led by Annabel Samimy said: We see Merck as having captured a plum asset with potentially little competition (due to exposure overlap amongst most other large pharma) adding a strong franchise in immune-mediated/fibrotic conditions to its current focus areas in oncology, infectious disease, and cardio-metabolic disorders.

Stifel is not anticipating any major antitrust issues to arise, given that the deal is Mercks first foray into the immune-mediated space, while other big drug companies, including Bristol Myers Squibb Co. BMY , AbbVie Inc. ABBV , Pfizer Inc. PFE and Johnson & Johnson

See now: Moderna is developing a vaccine against the tick-borne Lyme disease, in a first for the company

Guggenheim analysts led by Yatin Suneja said the deal is the cherry on top of its Best Idea for 2023, which was to buy Prometheus stock.

PRA023 is a potential game changer that could break through the efficacy ceiling that has plagued the [IBD] space for years, they wrote. The deal is not just good for Merck, either Prometheus gets the global infrastructure and resources of a big pharma company to help push through Phase 3 trials.

Given the big opportunity for 2023 in IBD, we see this valuation as reasonable and dont expect any competing offers, they wrote.

Guggenheim has a buy rating on Merck.

Mercks stock was down 0.5% Monday but has gained 3.4% in the year to date, while the S&P 500 SPX has gained 7.8%.

Read the original post:
Mercks $10.8 billion takeover of Prometheus gives it a foothold in immunology - MarketWatch

Immunology

Genmab and argenx Enter Partnership to Advance Antibody Therapies in Immunology and Oncology – GlobeNewswire

Media Release

COPENHAGEN, Denmark; April 17, 2023

GenmabA/S(Nasdaq:GMAB) andargenx(Euronext & Nasdaq:ARGX) announced today that Genmabandargenxhave entered into a collaboration agreement to jointly discover, develop and commercialize novel therapeutic antibodies with applications in immunology, as well as in oncology therapeutic areas.Themultiyear collaboration will leverage the antibody engineering expertise and knowledge of disease biology of both companies to accelerate the identification and development of novel antibody therapeutic candidates with a goal to address unmet patient needs in immunology and cancer.

Genmabis entering the therapeutic area of immunologyand inflammationas asteppingstoneto achievingitsvision that by 2030, our knock-your-socks-offKYSOantibody medicines will be transforming the lives of people with cancer and other serious diseases, said Jan van de Winkel, Ph.D., Chief ExecutiveOfficer,Genmab. By partnering with argenx, we will be able to combine our deep knowledge of the biology and therapeutic power of antibodies and have an opportunity to address patients needs in oncology as well as in immunology and inflammation.

Our core mission is to innovate on behalf of patients by translating immunology breakthroughs into novel pipeline candidates. We do this through a model of co-creation which has led to eight molecules demonstrating human proof-of-concept in our pipeline, said Tim Van Hauwermeiren, Chief Executive Officer, argenx. Through our collaboration with Genmab, we are bringing together our combined antibody discovery, development and commercialization expertise to unlock insights on the disease pathways that we will address. This allows us to broaden our capabilities and maximize the opportunity to generate novel therapeutic antibodies within autoimmunity or cancer.

Collaboration DetailsAs per the agreement,argenxandGenmabwill each have access to the suites of proprietary antibody technologies of both companies to advance the identification of lead antibody candidates against differentiated disease targets. Under the terms of the agreement, argenx and Genmab will jointly discover, develop and commercialize products emerging from the collaboration while equally sharing costs as well as any potential future profits. The collaboration will initially focus on two differentiated targets, including one within immunology and one within cancer, with the potential to expand to more.

About Genmab Genmab is an international biotechnology company with a core purpose guiding its unstoppable team to strive towards improving the lives of patients through innovative and differentiated antibody therapeutics. For more than 20 years, its passionate, innovative and collaborative team has invented next-generation antibody technology platforms and leveraged translational research and data sciences, which has resulted in a proprietary pipeline including bispecific T-cell engagers, next-generation immune checkpoint modulators, effector function enhanced antibodies and antibody-drug conjugates. To help develop and deliver novel antibody therapies to patients, Genmab has formed 20+ strategic partnerships with biotechnology and pharmaceutical companies. By 2030, Genmabs vision is to transform the lives of people with cancer and other serious diseases with Knock-Your-Socks-Off (KYSO) antibody medicines.

Established in 1999, Genmab is headquartered in Copenhagen, Denmark with locations in Utrecht, the Netherlands, Princeton, New Jersey, U.S. and Tokyo, Japan. For more information, please visit Genmab.com and follow us on Twitter.com/Genmab.

About argenxargenx is a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases. Partnering with leading academic researchers through its Immunology Innovation Program (IIP), argenx aims to translate immunology breakthroughs into a world-class portfolio of novel antibody-based medicines. argenx developed and is commercializing the first-and- only approved neonatal Fc receptor (FcRn) blocker in the U.S., Japan, and the EU. The Company is evaluating efgartigimod in multiple serious autoimmune diseases and advancing several earlier stage experimental medicines within its therapeutic franchises. For more information, visitwww.argenx.comand follow us onLinkedIn,Twitter,andInstagram.

Genmab Contacts

Media

Jyoti Sharma, Director, Communications T: +1 609 480 9844; E: jysh@genmab.com

Investor Relations

Andrew Carlsen, Vice President, Head of Investor RelationsT: +45 3377 9558; E: acn@genmab.com

argenx Contacts

Media

Erin Murphyemurphy@argenx.com

Investors

Beth DelGiaccobdelgiacco@argenx.com

Genmab Forward-looking Statements This Media Release contains forward looking statements. The words believe, expect, anticipate, intend and plan and similar expressions identify forward looking statements. Actual results or performance may differ materially from any future results or performance expressed or implied by such statements. The important factors that could cause our actual results or performance to differ materially include, among others, risks associated with pre-clinical and clinical development of products, uncertainties related to the outcome and conduct of clinical trials including unforeseen safety issues, uncertainties related to product manufacturing, the lack of market acceptance of our products, our inability to manage growth, the competitive environment in relation to our business area and markets, our inability to attract and retain suitably qualified personnel, the unenforceability or lack of protection of our patents and proprietary rights, our relationships with affiliated entities, changes and developments in technology which may render our products or technologies obsolete, and other factors. For a further discussion of these risks, please refer to the risk management sections in Genmabs most recent financial reports, which are available on http://www.genmab.com and the risk factors included in Genmabs most recent Annual Report on Form 20-F and other filings with the U.S. Securities and Exchange Commission (SEC), which are available at http://www.sec.gov. Genmab does not undertake any obligation to update or revise forward looking statements in this Media Release nor to confirm such statements to reflect subsequent events or circumstances after the date made or in relation to actual results, unless required by law.

Genmab A/S and/or its subsidiaries own the following trademarks: Genmab; the Y-shaped Genmab logo; Genmab in combination with the Y-shaped Genmab logo; HuMax; DuoBody; DuoBody in combination with the DuoBody logo; HexaBody; HexaBody in combination with the HexaBody logo; DuoHexaBody and HexElect.

argenx Forward-looking StatementsThe contents of this announcement include statements that are, or may be deemed to be, forward- looking statements. These forward-looking statements can be identified by the use of forward- looking terminology, including the terms believes, hope, estimates, anticipates, expects, intends, may, will, or should and include statements argenx makes regarding the impact of the transitionof the chief operatingofficer; its launchstrategytomake VYVGARTavailable inthe EU, China, Canadaandselect otherregions;the VYVGARTmulti-dimensional expansionstrategy; its expansionthroughpotential regulatoryapprovals andlaunches and the planned launchof SC efgartigimod, ifapproved;the timingofdata readoutsandnew clinical efficacydata; theregulatory reviews andregulatoryapproval timinginthe United States,EU andJapan forSCefgartigimod forthe treatment ofgMG andthe long-term safety andtolerability ofSC efgartigimod; thetherapeutic potentialof itsproduct candidates; the intendedresults of itsstrategy andits collaborationpartners,advancement of, andanticipated clinical developmentandregulatorymilestonesandplans, including the timing of planned clinical trials; and the design of future clinical trials and the timing and outcome of regulatory filings and regulatory approvals. By their nature, forward-looking statements involverisksanduncertainties, andreadersarecautionedthatanysuchforward-lookingstatementsarenotguaranteesoffutureperformance.argenxsactualresultsmaydiffermateriallyfrom thosepredictedbytheforward-lookingstatementsasaresultofvariousimportantfactors, includingtheeffectsoftheCOVID-19pandemic,inflationanddeflationandthecorrespondingfluctuationsininterestrates;regionalinstabilityandconflicts,suchastheconflictbetweenRussiaandUkraine,argenxsexpectationsregardingtheinherentuncertainties associatedwithcompetitivedevelopments,preclinicalandclinicaltrialandproductdevelopmentactivitiesandregulatoryapprovalrequirements;argenxsrelianceoncollaborationswiththirdparties;estimatingthecommercialpotentialof argenxsproductcandidates;argenxsabilitytoobtainandmaintainprotectionofintellectualpropertyfor itstechnologiesanddrugs; argenxslimitedoperatinghistory;andargenxsabilitytoobtainadditionalfundingforoperationsandtocompletethedevelopmentandcommercializationofitsproductcandidates.Afurtherlistanddescriptionofthese risks, uncertainties andotherrisks canbe foundin argenxsU.S. Securities andExchange Commission(SEC)filings andreports, includingin argenxsmostrecent annual report onForm20-Ffiled with the SEC as well assubsequent filingsandreports filed byargenxwith theSEC.Giventhese uncertainties,the readeris advised not toplace any undue reliance onsuchforward-lookingstatements.Theseforward-lookingstatements speak onlyas ofthe dateof publicationof this document. argenx undertakesnoobligationto publicly update or revisethe informationinthis pressrelease, including any forward-looking statements, except as may be required by law.

Media Releaseno.04CVR no. 2102 3884LEI Code 529900MTJPDPE4MHJ122

Genmab A/SKalvebod Brygge 431560 Copenhagen VDenmark

See more here:
Genmab and argenx Enter Partnership to Advance Antibody Therapies in Immunology and Oncology - GlobeNewswire