Category Archives: Immunology

Immunology

Tonix Pharmaceuticals to Present at the 2022 ThinkEquity Conference – Yahoo Finance

Tonix Pharmaceuticals Holding Corp.

CHATHAM, N.J., Oct. 19, 2022 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a clinical-stage biopharmaceutical company, announced today that Jessica Morris, Chief Operating Officer of Tonix Pharmaceuticals, will present at the ThinkEquity Conference on Wednesday, October 26, 2022, at 10:30 a.m. ET, and host investor meetings. The conference is being held at the Mandarin Oriental, New York in New York City.

Investors interested in arranging a meeting with the Companys management during the conference should contact the ThinkEquity conference coordinator. A webcast of the presentation will be available under the IR Events tab of the Tonix website at http://www.tonixpharma.com.

Tonix Pharmaceuticals Holding Corp.*

Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing therapeutics to treat and prevent human disease and alleviate suffering. Tonixs portfolio is composed of central nervous system (CNS), rare disease, immunology and infectious disease product candidates. Tonixs CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Tonixs lead CNS candidate, TNX-102 SL (cyclobenzaprine HCl sublingual tablet), is in mid-Phase 3 development for the management of fibromyalgia with a new Phase 3 study launched in the second quarter of 2022 and interim data expected in the second quarter of 2023. TNX-102 SL is also being developed to treat Long COVID, a chronic post-acute COVID-19 condition. Tonix initiated a Phase 2 study in Long COVID in the third quarter of 2022 and expects interim data in the first half of 2023. TNX-1300 (cocaine esterase) is a biologic designed to treat cocaine intoxication and has been granted Breakthrough Therapy designation by the FDA. A Phase 2 study of TNX-1300 is expected to be initiated in the first quarter of 2023. TNX-1900 (intranasal potentiated oxytocin), a small molecule in development for chronic migraine, is expected to enter the clinic with a Phase 2 study in the fourth quarter of 2022. TNX-601 ER (tianeptine hemioxalate extended-release tablets) is a once-daily formulation of tianeptine being developed as a potential treatment for major depressive disorder (MDD) with a Phase 2 study expected to be initiated in the first quarter of 2023. Tonixs rare disease portfolio includes TNX-2900 (intranasal potentiated oxytocin) for the treatment of Prader-Willi syndrome. TNX-2900 has been granted Orphan Drug designation by the FDA. Tonixs immunology portfolio includes biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is a humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of allograft and xenograft rejection and for the treatment of autoimmune diseases. A Phase 1 study of TNX-1500 is expected to be initiated in the first half of 2023. Tonixs infectious disease pipeline consists of a vaccine in development to prevent smallpox and monkeypox, next-generation vaccines to prevent COVID-19, and a platform to make fully human monoclonal antibodies to treat COVID-19. TNX-801, Tonixs vaccine in development to prevent smallpox and monkeypox, also serves as the live virus vaccine platform or recombinant pox vaccine (RPV) platform for other infectious diseases. A Phase 1 study of TNX-801 is expected to be initiated in Kenya in the first half of 2023. Tonixs lead vaccine candidate for COVID-19 is TNX-1850, a live virus vaccines based on Tonixs recombinant pox live virus vector vaccine platform.

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*All of Tonixs product candidates are investigational new drugs or biologics and have not been approved for any indication.

This press release and further information about Tonix can be found at http://www.tonixpharma.com.

Forward Looking Statements

Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as anticipate, believe, forecast, estimate, expect, and intend, among others. These forward-looking statements are based on Tonix's current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to the failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; delays and uncertainties caused by the global COVID-19 pandemic; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2021, as filed with the Securities and Exchange Commission (the SEC) on March 14, 2022, and periodic reports filed with the SEC on or after the date thereof. All of Tonix's forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.

Contacts

Jessica Morris (corporate)Tonix Pharmaceuticalsinvestor.relations@tonixpharma.com(862) 904-8182

Olipriya Das, Ph.D. (media)Russo PartnersOlipriya.Das@russopartnersllc.com (646) 942-5588

Peter Vozzo (investors)ICR Westwickepeter.vozzo@westwicke.com(443) 213-0505

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Tonix Pharmaceuticals to Present at the 2022 ThinkEquity Conference - Yahoo Finance

Immunology

Cancer Research Institute and Israel Cancer Research Fund Announce Co-Funding of a Translational Immunotherapy Research Grant – Newswise

Newswise NEW YORK, October 11, 2022 The Cancer Research Institute (CRI) and Israel Cancer Research Fund (ICRF) have partnered to award and co-fund, respectively, a Clinic and Laboratory Integration Program (CLIP) grant to support the promising immunotherapy research of Yifat Merbl, PhD, of the Weizmann Institute of Science in Israel. The CLIP grant, providing $200,000 in research funding over two years, was established by CRI to support investigators who are studying critical topics at the intersection of laboratory and clinical research. This collaboration builds on another partnership that supported immunotherapy research conducted in Israel The Immunotherapy Promise betweenCRI, the leading funder of immunotherapy research internationally, and ICRF, North Americas largest nonprofit dedicated to supporting cancer research in Israel and the largest non-governmental funder of Israeli cancer research.

Professor Merbls project, Controlling Proteasomal Degradation for Enhancing Anti-Tumor Immunity, hopes to characterize the proteasome degradation landscape in melanoma, aiming to gain insight into the mechanisms of immune evasion and lack of patient response to immunotherapy. This approach should ultimately lead to a novel system to target proteasome degradation in order to improve cancer treatment. While immunotherapy first emerged as a form of FDA-approved cancer treatment in the late 1980s, it is only within the past decade that this class of therapy has begun to deliver significant survival benefit to more cancer patients, bringing it to the forefront of public attention. New immunotherapeutic approaches have been shown in clinical trials to effectively treat patients with bladder, head and neck, kidney, and lung cancers as well as leukemia, lymphoma, and melanoma, with clinical trials under way for more than 25 other types of cancer.

The Cancer Research Institute and Israel Cancer Research Fund have teamed up again to bring philanthropic support of immunology research to scientists in Israel who are working to harness the immune systems power to fight all types of cancer, and this latest joint initiative furthers our shared goal of finding effective answers to cancer to save more lives and cure as many patients as possible, said Jill ODonnell-Tormey, Ph.D., CEO and director of scientific affairs at the Cancer Research Institute.

Commenting on the partnership, David Abramson, president of ICRF said, We know how crucial immunotherapy is in the area of cancer research and our unique partnership with the Cancer Research Institute has the potential to yield breakthrough discoveries in the field. It is our hope that many more Israeli scientists will benefit from our collaboration with CRI.

About the Cancer Research InstituteThe Cancer Research Institute (CRI), established in 1953, is the worlds leading nonprofit organization dedicated exclusively to transforming cancer patient care by advancing scientific efforts to develop new and effective immune system-based strategies to prevent, diagnose, treat, and eventually cure all cancers. Guided by a world-renowned Scientific Advisory Council that includes four Nobel laureates and 27 members of the National Academy of Sciences, CRI has invested $500 million in support of research conducted by immunologists and tumor immunologists at the worlds leading medical centers and universities and has contributed to many of the key scientific advances that demonstrate the potential for immunotherapy to change the face of cancer treatment. To learn more, go to https://www.cancerresearch.org/.

About Israel Cancer Research FundICRF, a 501(c)(3) organization, is the largest charitable organization outside of Israel solely devoted to supporting cancer research in Israel. Grants issued by ICRF have gone to hundreds of researchers at two dozen leading research institutions, universities, and hospitals across Israel. The efforts of Israeli cancer researchers have resulted in significant cancer breakthroughs which were vital in the development of breakthrough cancer drugs, including Doxil, Gleevec, and Velcade. To learn more, go to https://www.icrfonline.org/.

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Cancer Research Institute and Israel Cancer Research Fund Announce Co-Funding of a Translational Immunotherapy Research Grant - Newswise

Immunology

$2.5 million CDC contract to fund one of the largest SARS-CoV-2 surveillance programs in the U.S. – News-Medical.Net

A team led by Scripps Research scientists has been awarded a contract by the U.S. Centers for Disease Control & Prevention (CDC) in support of one of the largest SARS-CoV-2 surveillance programs in the United States.

The two-year, $2.5 million contract will fund the large-scale, near real-time sequencing of SARS-CoV-2 isolates from hospitals and local public health agencies in San Diego and nearby northwestern Mexico, and the development of software for tracking the evolution and geographical spread of SARS-CoV-2 variants.

The contract, an extension of one originally awarded in 2020, will be carried out by the San Diego Epidemiology and Research for COVID Health (SEARCH) Alliance, which was co-founded by Scripps Research, the University of California San Diego (UC San Diego), and Rady Children's Hospital-San Diego.

CDC's support for SEARCH's genomic surveillance program has already led to significant COVID-19 public health advances as well as new science on SARS-CoV-2, and we expect much more progress in both areas as a result of this new award."

Kristian Andersen, PhD, Principal Investigator, Professor, Department of Immunology and Microbiology at Scripps Research

Since the start of the pandemic, SEARCH has been conducting genomic surveillance of SARS-CoV-2 using clinical samples collected at San Diego hospitals and from sources across the border in Baja California. SEARCH has also developed key protocols and analysis tools to track the emergence and spread of SARS-CoV-2 variants in wastewater. Moreover, SEARCH investigators are actively involved in understanding the emergence of SARS-CoV-2, and in several high-profile publications have found evidence for an initial spread from animals sold at the Huanan Market in Wuhan, China.

SEARCH's efforts involve multiple collaborations, including with the CDC, San Diego County's Health & Human Services Agency, the California Department of Public Health, Sharp Health, Scripps Health, the viral surveillance company Helix, and the Salud Digna healthcare network in Mexico. Since the start of the pandemic, these efforts have yielded publications and analyses of more than 70,000 SARS-CoV-2 sequences.

Under the new contract, SEARCH will accelerate its virus-sequencing workflow to produce more timely and actionable information on local virus spread and evolution-;including the emergence of new variants and subvariants of concern.

"The current process of sampling, sequencing and analyzing a batch of virus samples from local hospital cases and wastewater treatment plants can take several weeks," says Mark Zeller, PhD, project scientist in the Andersen lab. "We're aiming to get that down to a matter of days, which would enable us to monitor the transmission chains in local outbreaks in near real-time."

Working with the County of San Diego, the state of California and Mexican public health labs, the researchers will also continue to analyze the transmission of SARS-CoV-2 across the busy California-Baja border. Additionally, they'll expand their genomic surveillance efforts to additional Mexican border states and popular tourist destinations, including Puerto Vallarta. The team will continue to post their analyses on SEARCH's online dashboards.

The project includes the further development of open-source software tools to support the tracking of local SARS-CoV-2 evolution and transmission.

"The tools we've developed in recent years are already being used widely by the public health community for SARS-CoV-2 sequencing and analysis," says Joshua Levy, PhD, postdoctoral research associate in the Andersen lab. "Under this new contract, we will be developing the technology to permanently transform how genomic surveillance will be used to strengthen our public health response."

These open-source software tools are available at https://andersen-lab.com/secrets/code/. The SEARCH Alliance's SARS-CoV-2 surveillance dashboards are at https://searchcovid.info/Dashboards/.

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$2.5 million CDC contract to fund one of the largest SARS-CoV-2 surveillance programs in the U.S. - News-Medical.Net

Immunology

Evommunes Human Tissue-based Approach Enables Discovery and Development of Safer, Innovative Chronic Inflammation Therapies – BioSpace

Evommune team/courtesy of Evommune

Evommunes novel human tissue-based assay system is proving to be a key differentiator as the company develops therapies to control chronic inflammation in autoimmune diseases.

Working with human tissue puts us closer to the target and yields a model that is much more predictive of outcomes in the human immune system, said Luis Pea, CEO of Evommune, in an interview with BioSpace.

Skin has all of the cell types that are needed to induce specific inflammatory pathways, said Eugene Bauer, M.D., CMO of Evommune. The companys human tissue model is an ex vivo system that uses living skin from human donors, allowing the model to reflect all the immune responses that occur across various tissues in the body that drive inflammation.

Consequently, in this context, it is more robust, predictive and relevant than animal modeling. This most closely mimics a real-time look at immune pathways and how to find the best way to target and modify inflammation. The miniaturized technology enables hundreds of assays to be conducted to study both systemic and topical therapies.

Evolving Immunology

In seeking to evolve immune therapy, Evommune is looking at the following opportunities in treating patients: early intervention in their disease state, improving efficacy, increasing response rates in patients and enhancing safety.

Autoimmune diseases are, in fact, systemic inflammatory conditions that are often associated with serious co-morbidities including infections, cardiovascular events, renal disease and mental health issues, making early intervention and preventing disease progression extremely important, Pea said. The entire body is in an accelerated immune-response mode. So, we are trying to modulate the immune system to dial down some of these responses.

Existing therapeutics have improved our ability to treat inflammatory conditions, but in most diseases, they still only elicit a response in about half the patients treated and achieve a great response rate in only one-third of those, he continued. Creating medicines that have better efficacy and that induce remission is the goal for us.

Improving the safety profile for drugs that treat autoimmune diseases could make a meaningful impact in this space. We want to develop therapies that improve patients quality of life without putting them at risk for other factors, Pea said.

Evommunes senior leadership and scientific teams are primed to do just that. Throughout their careers, they have helped bring more than 25 medicines to patients in need. As Pea noted, the combination of scientific insights, drug development expertise and building companies makes this team a unique group.

Accomplished Team of Experts

A testament to this is that Pea and Bauer were co-founders of Dermira, which Eli Lilly acquired for $1.1 billion to get the rights to lebrikizumab. The two had originally helped acquire this asset from Genentech, despite the drug having failed in prior Phase III trials for a different indication.

We saw that lebrikizumab had promise in atopic dermatitis. We believed lebrikizumab had been under-dosed in previous atopic dermatitis trials, mostly because of a focus on asthma, Pea explained. We adjusted the dose in a Phase II atopic dermatitis program and delivered strong data. Lilly bought us because of that drug and since then, lebrikizumab has had great data from their Phase III studies. We believe lebrikizumab will become a significant therapy for atopic dermatitis and the team at Evommune had the vision to make that happen, he said.

Before Dermira, Bauer was president and CMO of Peplin, Inc. (acquired by LEO Pharma) and shepherded Picato through a global submission, which included the FDA and resulted in an approval for actinic keratosis.

Additionally, the Evommune development team has been responsible for multiple new drug applications or biologics license applications, several investigational new drug applications and numerous other interactions with regulators, including four global clinical development programs.

That combination of intimate knowledge of both immunology and drug development is what separates Evommune from other companies in terms of our ability to move these novel therapies forward, Pea said.

Evommune is committed to this promise with the ongoing expansion of the team, including new management positions across R&D, CMC, legal, strategy and finance who also bring a wealth of diverse drug discovery and development expertise.

A Multifaceted Pipeline

Evommune currently has four programs in the pipeline.

"The goal for all of our programs is to be best in class, Pea said. EVO101 for atopic dermatitis is an IRAK4 inhibitor, which is a very novel target. A randomized, blinded, placebo-controlled Phase IIa clinical trial for patients with mild-to-moderate atopic dermatitis was initiated in Q3 2022.

We define mild-to-moderate atopic dermatitis as affecting between 4 and 12% of an individuals body surface area. For perspective, the palm of your hand is 1%, Bauer elaborated. Study participants will apply a 0.1% cream to the lesions twice daily for eight weeks. Results will be scored using the eczema area severity index (EASI), which measures redness, scaling and thickness of lesions, as well as the extent and severity of the disease.

In EVO101s development work, Evommunes human tissue model enabled researchers to recapitulate disease pathology and inflammatory mediators of atopic dermatitis. Adding low-, mid- and high-potency topical steroids (current standard-of-care therapeutics) to the human tissue model provided a control set of efficacy data a baseline by which we could then compare the performance of EVO101, Bauer explained.

EVO101, at the dosage being used for patients in the clinical trial, lowered inflammation levels to those comparable with doses of ultra-high potency steroids, but with high selectivity.

We believe this could become an alternative to standard-of-care therapies for atopic dermatitis, Bauer said, that may be used to treat both adult and pediatric patients.

In addition, we now have a development stage program that could potentially be a ground-breaking oral therapy for mast cell-mediated diseases, he said.

EVO756 is a completely novel compound that will target the treatment of mast cell-mediated diseases and inflammatory itch, Pea said. EVO756 targets MRGPRX2, a receptor that exists on mast cells and peripheral neurons and regulates mast cell degranulation. EVO756 is targeted for the treatment of mast cell-mediated disorders with highly prevalent populations such as chronic spontaneous urticaria, interstitial cystitis and hereditary alpha-tryptasemia.

In addition, preclinical data have shown that itch can be completely eliminated in mice: knocking out that receptor made it impossible to induce itch. For patients with inflammatory diseases, itch can be severe and have a significant, negative impact on a patients quality of life. We think EVO756 could be a great oral therapy, that can act quickly to relieve itch, Pea continued.

Another program, EVO390, is in development for the treatment of mild-to-moderate psoriasis in the hope of slowing or halting disease progression. This therapeutic agent targets RORt and has the potential to be best-in-class and the agent of choice for these patients. It may also serve as an adjunct therapy in more severe cases. We believe it could be a broadly used therapy for psoriasis, Pea added.

Our fourth program, currently in discovery, targets protein kinase C (PKC) theta, Pea continued. The company has identified several potent molecules that may have broad anti-inflammatory activity, highly targeted to T-effector cell inhibition and T-regulatory cell activation. This may have utility across a number of inflammatory conditions such as rheumatoid arthritis, IBD, atopic dermatitis and psoriasis. In addition, because it is highly targeted, it has the potential to be safer than the JAK inhibitors and other systemic anti-inflammatory agents.

As a company, we understand the importance of working on multiple targets and managing a portfolio of compounds. This approach provides the opportunity to work on different agents, impact many diseases and make a difference in patients lives, Pea said. The companys discovery engine is working to identify new targets so the team can extend its therapeutic impact.

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Evommunes Human Tissue-based Approach Enables Discovery and Development of Safer, Innovative Chronic Inflammation Therapies - BioSpace

Immunology

NexImmune Announces Research Collaboration with National Institute of Neurological Disorders and Stroke (NINDS) of the National Institutes of Health…

GAITHERSBURG, Md., Oct. 06, 2022 (GLOBE NEWSWIRE) -- NexImmune, Inc.(Nasdaq: NEXI), a clinical-stage biotechnology company developing a novel approach to immunotherapy designed to orchestrate a targeted immune response by directing the function of antigen-specific T cells, today announced a collaboration with the National Institute of Neurological Disorders and Stroke(NINDS), a division of the U.S. National Institutes of Health (NIH). The collaboration will focus on enriching and expanding virus-specific T cell populations and determining their activity against infected human cell lines. The goal of this collaboration is to develop adoptive cell therapies that may benefit patients afflicted with immunological disorders related to these viral infections. Initially, we will focus our efforts on studying Epstein-Barr virus (EBV) and Human T-cell Leukemia Virus, type 1 (HTLV-1).

NexImmune is committed to developing novel therapies for the treatment of oncology, infectious disease and autoimmune disorders, said Kristi Jones, Chief Executive Officer of NexImmune. Compelling evidence exists that several autoimmune diseases are mediated by virally-infected cells. Current therapeutic approaches in these diseases broadly target cell populations that may or may not be expressly involved in the disease. NexImmunes AIM platform has the potential to selectively target and eliminate EBV-infected B cells in multiple sclerosis (MS), or HTLV-1-infected cells in HTLV-1 associated myelopathy (HAM), which may offer a unique benefit over current approaches. We will be working with the NINDS to evaluate EBV and HTLV-1 as therapeutic targets in the pathophysiology of neurological immune diseases. This important collaboration will enable us to leverage the AIM platform to develop potentially innovative antigen-specific therapies for these patients.

There is a clear causal relationship between HLTV-1 infection and HTLV-1 Associated Myelopathy and a potential relationship between EBV infection and MS, stated David Hafler, M.D., FANA, and member of NexImmunes Scientific Advisory Board. This work will help advance our understanding of the role immune responses to viral infection play in different neuroimmunological diseases.

AboutNexImmune

NexImmune is a clinical-stage biotechnology company developing a novel approach to immunotherapy designed to employ the bodys own T cells to generate a specific, potent, and durable immune response.

NexImmunes lead programs, NEXI-001, NEXI-002 and NEXI-003, are in Phase 1/2 clinical trials for the treatment of relapsed AML after allogeneic stem cell transplantation, multiple myeloma refractory to 3 or more prior lines of therapy and HPV-related cancers, respectively. NexImmune is also developing AIM nanoparticle constructs and modalities for potential clinical evaluation in oncology and in disease areas outside of oncology, including autoimmune disorders and infectious disease.

The backbone of NexImmunes approach is a proprietary Artificial Immune Modulation (AIM) nanoparticle technology platform. The AIM technology enables NexImmune to construct nanoparticles that function as synthetic dendritic cells capable of directing a specific T cell-mediated immune response. AIM constructed nanoparticles employ natural biology to engage, activate and expand endogenous T cells in ways that combine anti-tumor attributes of antigen-specific precision, potency and long-term persistence with reduced potential for off-target toxicities.

For more information, visit http://www.neximmune.com

AboutThe National Institute of Neurological Disorders and Stroke and its Viral Immunology Section

Created by the U.S. Congress in 1950, the National Institute of Neurological Disorders and Stroke (NINDS) has occupied a central position in the world of neuroscience for over 70 years. The mission of NINDS is to reduce the burden of neurological diseasea burden borne by every age group, every segment of society, and people all over the world.

To accomplish this goal, the Institute supports and conducts basic, translational, and clinical research on the healthy and diseased nervous system; fosters the training of investigators in the basic and clinical neurosciences; and seeks better understanding, diagnosis, treatment, and prevention of neurological disorders.

The Viral Immunology Section studies the role of human viruses in the pathogenesis of chronic progressive neurologic disease. As part of its work, the laboratory is studying virological, immunological, and molecular mechanisms associated with the human T lymphotropic virus type-I associated myelopathy/tropical spastic paraparesis and the association of virus in multiple sclerosis.

Forward Looking Statements

This press release may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are based on the beliefs and assumptions and on information currently available to management of NexImmune, Inc. (the Company). All statements other than statements of historical fact contained in this press release are forward-looking statements, including statements concerning our planned and ongoing clinical studies for the Companys product candidates, including NEXI-001 and NEXI-002; the initiation, enrollment, timing, progress, release of data from and results of those planned and ongoing clinical studies; and the utility of prior preclinical and clinical data in determining future clinical results. In some cases, you can identify forward-looking statements by terminology such as may, will, should, expects, plans, anticipates, believes, estimates, predicts, potential or continue or the negative of these terms or other comparable terminology. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause the Companys actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. These risks and uncertainties include, but are not limited to, the risks and uncertainties set forth in the Risk Factors section of our Annual Report on Form 10-K for the year ended December 31, 2020 filed with the Securities and Exchange Commission (SEC) on March 31, 2021, and subsequent reports that we file with the SEC. Forward-looking statements represent the Companys beliefs and assumptions only as of the date of this press release. Although the Company believes that the expectations reflected in the forward-looking statements are reasonable, it cannot guarantee future results, levels of activity, performance or achievements. Except as required by law, the Company assumes no obligation to publicly update any forward-looking statements for any reason after the date of this press release to conform any of the forward-looking statements to actual results or to changes in its expectations.

Contacts

Investors:Chad Rubin, SVP Corporate AffairsNexImmune, Inc.646.319.3261crubin@neximmune.com

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NexImmune Announces Research Collaboration with National Institute of Neurological Disorders and Stroke (NINDS) of the National Institutes of Health...

Immunology

Immunology – Clinical Care Options – ClinicalOptions

Disclaimer: The materials published on the Clinical Care Options Sites reflect the views of the reviewers or authors of the CCO material, not those of Clinical Care Options, LLC, the accredited provider, or the companies providing educational grants. The materials may discuss uses and dosages for therapeutic products that have not been approved by the United States Food and Drug Administration. A qualified healthcare professional should be consulted before using any therapeutic product discussed. Readers should verify all information and data before treating patients or using any therapies described in these materials.

2022 Clinical Care Options, LLC. All rights reserved.

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Immunology

PhD candidate in immunology wins three awards at Health Research Forum – UM Today

September 20, 2022

Marina Costa Fujishima, a PhD candidate in immunology in the Max Rady College of Medicine, took home three prestigious awards at the Canadian Student Health Research Forum, a national event held this past summer at UM.

She received the Dean of Medicine Poster Award, the Canadian Institutes of Health Research Sex and Gender Research Gold Award and the Gairdner Award.

Costa Fujishima, who is from Brazil, conducts research focused on how the vaginal microbiome interacts with the immune system, and how the outcome of these interactions can play a role in reproductive health and susceptibility to disease.

Earlier this year, her achievements and potential were acknowledged when she became the inaugural recipient of the Dr. Forough Khadem Scholarship.

The scholarship was established to honour the life, spirit and work of Khadem, a student from Iran who earned her PhD in immunology at UM. It recognizes an outstanding international female graduate student who demonstrates leadership and a desire to have an impact on the world through science.

We recently spoke with Costa Fujishima about her PhD research.

What drew you to immunology?

I took an immunology class during the fourth year of my bachelors in microbiology. My current supervisor gave a guest lecture in the class, and I was just in love with it immediately.

What is the main focus of your research?

Im currently looking at how the composition of the vaginal microbiome can influence the immune system in the female genital tract. This is very interesting because human cohort studies have shown that certain microbial communities present in the vaginal canal can increase susceptibility to disease, including spontaneous pre-term birth and sexually transmitted infections like HIV, but we still dont understand why.

Those same studies showed a high abundance of white blood cells called neutrophils in the genital tract of these women, which also seemed to correlate with increased susceptibility to disease. So my research is trying to understand: How can these vaginal microbial species influence neutrophils? What exactly are neutrophils doing when they encounter different bacteria? Could neutrophils response result in adverse health outcomes, specifically increased HIV infection?

How did it feel to win three awards at this years Canadian Student Health Research Forum?

It was great! Im not a native English speaker, so I usually get very nervous thinking I will forget how to say everything I want in English. I was not expecting to win, but it was amazing. I loved explaining my research to the judges.

Can you tell us more about what you presented at the forum?

I talked about the mouse model we have set up in our lab. I have been able to show that neutrophils rapidly enter the vaginal tissue in the presence of certain bacteria species, but not others. Neutrophils not only come in, but I also found that they cause a lot of bystander damage in the vaginal tissue, which allows the HIV virus to enter the body more easily. When we prevent neutrophils from entering the vaginal tissue, there is less damage despite the presence of the bacteria.

Why did you choose UM for your PhD?

The immunology department and HIV research here at UM are so strong. There is so much cool work done here by world-renowned scientists and so much collaboration that it creates the perfect environment for young researchers like me.

Who are your mentors?

My supervisor, Dr. Thomas Murooka, is the best mentor I could have asked for. I look up to him a lot. Also my committee members, Dr. Lyle McKinnon, Dr. Catherine Card and Dr. Sam Kung.

What are your plans after you finish your PhD?

I want to stay in academia and become an independent researcher. I want to understand how the immune system can recognize and tolerate microbes that live within us, and how it decides whether those microbes are our friends or enemies. I am fascinated by this topic, so I want to stay in the field.

ALLYN LYONS

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PhD candidate in immunology wins three awards at Health Research Forum - UM Today

Immunology

New study reveals breakthrough infections increase immunity to COVID-19 – OHSU News

Health care systems encourage everyone eligible to get a COVID-19 vaccination and booster. (Getty Images)

Vaccine boosters and breakthrough infections following vaccination both provide a substantial and potentially pandemic-breaking immunity against COVID-19, according to new laboratory research from Oregon Health & Science University.

The study, published Wednesday in the journal Med, is the latest in a series of OHSU discoveries using blood samples to characterize immune response to the SARS-CoV-2 virus.

As the number of omicron subvariant cases rise and as global vaccination and booster campaigns continue, an increasing proportion of the worlds population will acquire potent immune responses that may be protective against future SARS-CoV-2 variants, the researchers conclude.

The research measured a powerful immune response among samples from 99 OHSU employees who had blood drawn for the research. Notably, researchers measured an equally potent immune response to the virus with dramatic increases in magnitude, potency and breadth among people whose blood was drawn three months after a third vaccine booster dose and another group one month after a breakthrough infection.

In addition, the study found the immune response was just as powerful among people 65 and older.

Marcel Curlin, M.D. (OHSU)

Early in the pandemic, we had very high mortality in certain vulnerable groups, such as older adults in nursing homes, but that reality is slowly changing, said co-senior author Marcel Curlin, M.D., associate professor of medicine (infectious diseases) in the OHSU School of Medicine and medical director of OHSU Occupational Health. Our study bolsters the idea that vaccination is a pathway to a milder illness. Even if youre older, your chances of having a severe illness if youre re-infected down the line appears to be much lower than it was at the start of the pandemic.

Fikadu Tafesse, Ph.D. (OHSU)

Co-senior author Fikadu Tafesse, Ph.D., associate professor of molecular microbiology and immunology in the OHSU School of Medicine, said he would expect an even more robust immune response among people receiving the new bivalent vaccine booster targeting the BA.4 and BA.5 variants.

We anticipate that updated vaccine strategies with variant-specific regimens will significantly improve the breadth of the immune response and provide better protections against the SARS-CoV-2 variants, he said.

In contrast to the onset of the pandemic, the SARS-CoV-2 virus is no longer novel to the human immune system. Most people in the world have now been vaccinated, infected or both meaning the virus is running up against a much more effective immune response with each new infection.

Curlin said the new study most likely reflects the fact that the virus is evolving to become more transmissible but less harmful.

Evolutionary pressure is driving the virus to find more ways to infect people at the cost of pathogenicity, most likely, he said. Pathogenicity refers to the capacity to cause symptoms associated with the disease.

Funding for this study was supported by the M.J. Murdock Charitable Trust; the OHSU Foundation; the National Institutes of Health training grant T32HL083808; and a grant from the OHSU Innovates IDEA fund. The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH.

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New study reveals breakthrough infections increase immunity to COVID-19 - OHSU News

Immunology

First person to ever be treated with CRISPR-based HIV gene therapy – Interesting Engineering

Observation and evaluation

The person who received the first single-dose intravenous infusion EBT-101 therapy is being observed and evaluated for rebound of the HIV virus. Since this treatment has never been done before, researchers want to make sure the treatment stops the virus from replicating itself in the body. The research team is hoping that the individual will no longer need to use the antiretroviral therapy, which is currently the standard in HIV treatment.

Launching the EBT-101 phase 1/2 clinical trial

The trial was launched by Kamel Khalili, PhD, Laura H. Carnell, professor and chair of the Department of Microbiology, Immunology, and Inflammation, director of the Center for Neurovirology and Gene Editing and director of the Comprehensive NeuroAIDS Center, and Tricia H. Burdo, PhD, professor and vice chair of the Department of Microbiology, Immunology, and Inflammation at the Katz School of Medicine.

Dr. Khalili mentioned that there are still no curative treatments for HIV after more than 40 years since the virus was discovered. Nearly 40 million people worldwide suffer from HIV. He said EBT-101 can potentially address long-standing unmet needs of individuals living with HIV/AIDS by removing viral DNA from their cells, thereby eradicating infection.

Details of the trial

The trial is a study meant to evaluate the safety and efficacy of EBT-101 in approximately nine participants living with HIV-1. These individuals undergoing the study are suppressed on antiretroviral therapy. Its goal is to assess the tolerability of a single dose of EBT-101 in participants and their response to it. There was an initial 48-week follow up period for the trial, with an intended long-term follow up.

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First person to ever be treated with CRISPR-based HIV gene therapy - Interesting Engineering

Immunology

Study: Children With Primary Immunodeficiency Disease May Have Higher Mortality from COVID-19 – Pharmacy Times

In a recent study, researchers observed that more than one-third of children with a primary immunodeficiency disease died from COVID-19.

Children with certain immunodeficiency diseases have a higher mortality rate due to COVID-19, suggests new research out of the Karolinska Institutet published in the Journal of Allergy and Clinical Immunology.

Most children infected with COVID-19 are asymptomatic or have mild symptoms, but those with certain immunodeficiency diseasesalso called inborn errors of immunity (IEI)may have mutated genes that affect the immune system, preventing it from protecting itself against infections. This could lead to severe, or deadly, complications.

Mortalityis much higher among children with primary immunodeficiency diseases infected with SARS-CoV-2. Our results indicate that basic immunological examination and genetic analysis should be conducted in children with severe COVID-19 or multi-inflammatory syndrome (MIS-C). The clinicians will then be able to help these children with more precise therapies based on their genetic changes, said study leader Qiang Pan-Hammarstrm, professor at the Department of Biosciences and Nutrition, Karolinska Institutet, in a press release.

Among children with primary immunodeficiency diseases (examples include hereditary and congenital diseases of the immune system), certain individuals have mild or no symptoms after contracting infection from COVID-19, whereas others experience severe symptoms. There is controversial evidence explaining why the range of symptoms differs greatly, according to the authors of the current study.

Researchers at Karolinska Institutet set out to understand whether genetics play a role in the severity of some COVID-19 cases among children with primary immunodeficiency diseases. Between August 2020 and September 2020, researchers identified 31 unvaccinated children in Iran who had the same primary immunodeficiency disease. The participants, aged 5 months to 19 years, suffered from a severe or critical COVID-19 infection.

After performing genetic and immunological analyses, researchers found that 11 children died from SARS-CoV-2 complications. Among participants, 5 (16%) children were diagnosed with MIS-C.

The research suggests that patients with MIS-C differ from those without MIS-C because they cannot produce their own antiviral antibodies. Consequently they, would not have the full benefit of vaccination, said lead author Hassan Abolhassani, assistant professor at the Department of Biosciences and Nutrition, Karolinska Institutet, in the press release.

Further, the genetic analyses showed that more than 90% of children with primary immunodeficiency diseases had a mutation that affected proteins (interferons) that regulate the immune system during a viral infection. These mutated genes could explain why their immune defenses were not functioning properly.

The researchers performed an additional literature review of global reports that studied this population. The team identified the mortality rate from COVID-19 to be 8% among children with an IEI.

The study was limited to researching patients with severe COVID-19 cases, those infected with the original strain, and non-vaccinated children.

Our results clarify the molecular mechanism of these immune diseases, which opens up the possibility of developing a more targeted therapy. The knowledge acquired from the study also allows us to develop better strategies for the treatment and prevention of severe COVID-19 disease in these patients, Pan-Hammarstrm said in the press release.

Reference

Karolinska Institutet. Higher risk of serious COVID-19 complications in children with primary immunodeficiency. EurekAlert! September 16, 2022. Accessed on September 19, 2022. https://www.eurekalert.org/news-releases/964997

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Study: Children With Primary Immunodeficiency Disease May Have Higher Mortality from COVID-19 - Pharmacy Times