Category Archives: Immunology

Immunology

Researchers discover the molecule responsible for guiding T cells toward tumors – News-Medical.Net

Immunotherapy, particularly CAR T-Cell treatment for cancer, is extending the lives of many patients. But sometimes the therapy randomly migrates to places it shouldn't go, tucking into the lungs or other noncancerous tissue and causing toxic side effects. A University of Rochester/Wilmot Cancer Institute team discovered the molecule responsible for guiding T cells toward tumors, setting the stage for scientists to improve upon the groundbreaking treatment.

The next step is to find a drug that can manipulate the key T-cell protein, ST3GAL1, said Minsoo Kim, Ph.D., corresponding author of an article in Nature Immunology that describes the research. If the investigation evolves as planned, such a drug could be added to the CAR T-cell regimen to ensure that T cells hit their targets, Kim said.

His lab is collaborating with other Wilmot investigators to screen for drugs that will accomplish that feat, while also minimizing the risk of life-threatening side effects.

You can create very powerful treatments, but if they can't get to their targets or they go to the wrong place, it does not provide the outcome you intended."

Minsoo Kim, Ph.D., corresponding author, co-leader of Wilmot's Cancer Microenvironment research program at the UR

Enlisting a patient's own immune system to wipe out cancer has emerged as one of the most promising advances in cancer care.

CAR T-cell therapy involves extracting a patient's own T cells, a type of white blood cell, and re-engineering them outside of the body to recognize cancer. Once the reprogrammed cells are infused back into the patient, they act as a "living drug," searching for proteins on cancer cells for assault. In 2016, Wilmot was selected as one of the few national sites to begin clinical trials for this procedure, and later, upon FDA approval, became one of the first cancer centers in the U.S. to offer CAR T-cell treatment for eligible patients.

CAR T-cell therapy is only approved to treat blood cancers, including some forms of lymphoma, leukemia, and multiple myeloma, according to the National Cancer Institute. It's easier for the altered T cells to drift toward cancer hot spots in the bloodstream, Kim explained -; but finding their way to solid tumors such as breast, lung, brain cancer, or melanoma is a completely different story. The T cells have to work harder to migrate through tissues and organs and identify a solid tumor.

In fact, clinical trials testing this treatment in solid tumors have not been as favorable, Kim said.

Wilmot research suggests that something occurs during the re-engineering of T cells that blunts their homing properties.

In 2019, Kim and Wilmot colleagues Patrick Reagan, M.D., and Richard Waugh, Ph.D., received a $2.8 million National Institutes of Health grant to investigate the downside of CAR T-cell treatment, specifically what takes place when T cells sequester in noncancerous tissues.

Their discovery of the crucial migration-control gene that expresses ST3GAL1 came about through "unbiased genomic screening," a more effective way to study the problem, Kim said. Investigators used a cutting-edge CRISPR technique to edit thousands of genes expressed in T cells, and then tested the migration-control abilities of those genes, one-by-one over the course of nearly four years, in mouse models.

Kim credited Yeonsun Hong, Ph.D., a staff scientist in his lab and first author of the Nature Immunology report, for leading the work, as well as assistance from faculty and staff at Wilmot's highly rated Shared Resource facilities, led by John Ashton, Ph.D., M.B.A., director of the UR Genomics Research Center. Advanced imaging and use of microscope technologies with V. Kaye Thomas, Ph.D., allowed researchers to study the nuances of T-cell migration patterns, for example.

Kim is a Dean's professor of Microbiology and Immunology, and professor of Pharmacology and Physiology at the UR Medical Center. Co-author Reagan, an associate professor of Hematology/Oncology, specializes in CAR T-cell patient care at Wilmot and has been involved in CAR T-cell research since the earliest clinical studies took place locally and nationally. Waugh, professor of Biomedical Engineering and Vice Provost of Research at the University of Rochester, collaborates with Kim by studying the mechanical properties of T cells. Funding was primarily provided by the NIH, in addition to Wilmot support.

Source:

Journal reference:

Hong, Y., et al. (2023). ST3GAL1 and II-spectrin pathways control CAR T cell migration to target tumors. Nature Immunology. doi.org/10.1038/s41590-023-01498-x.

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Researchers discover the molecule responsible for guiding T cells toward tumors - News-Medical.Net

Immunology

X4 Pharmaceuticals Announces Late-Breaking Abstract of WHIM Phase 3 Clinical Data Accepted for Oral Presentation at the 2023 Annual Meeting of the…

X4 Pharmaceuticals

X4 to host virtual investor event on Tuesday, May 16

CIS oral presentation to take place on Sunday, May 21

BOSTON, April 12, 2023 (GLOBE NEWSWIRE) -- X4 Pharmaceuticals, Inc. (Nasdaq: XFOR), a leader in the discovery and development of novel small molecule therapeutics to benefit patients with diseases of the immune system, today announced that its submitted late-breaker abstract entitled "Results of a Phase 3 Trial of an Oral CXCR4 Antagonist, Mavorixafor, for Treatment of Patients With WHIM Syndrome" has been accepted for oral presentation at the Annual Meeting of the Clinical Immunology Society (CIS), which is taking place May 18-21, 2023, in St. Louis, MO. New data related to clinical secondary endpoints, among other assessments, are to be presented.

In addition, X4 announced that the company will host a virtual event to present and discuss new data from the 4WHIM Phase 3 clinical trial at 4:00 pm ET on Tuesday, May 16, following expected publication of conference abstracts. In November 2022, X4 announced that the 4WHIM trial had met its primary endpoint and a key secondary endpoint, and that mavorixafor was generally well tolerated in the trial, with no treatment-related serious adverse events reported and no discontinuations for safety events. New data to be presented during the event will focus on additional secondary endpoints, including the impact of oral, once-daily mavorixafor on the rate, severity, and duration of infections, among other outcomes metrics, as measured during the 52-week trial period.

Additionally, the company expects to provide an update on its U.S. regulatory activities in support of its potential New Drug Application-submission for mavorixafor for the treatment of WHIM syndrome, which is expected early in the second half of 2023.

The X4 live-event webcast will be accessible on the investor relations section of the X4 website at http://www.x4pharma.com. Following the completion of the event, a replay will be available on the website.

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At the CIS Conference, Dr. Raffaele Badolato, Professor of Pediatrics at the University of Brescia (Italy) and an investigator in the 4WHIM clinical trial, will present at 11:30 am CT on Sunday, May 21. Although the session will only be accessible live to conference attendees, X4 will post the slides on its website concurrent with the presentation.

About Mavorixafor and WHIM SyndromeWHIM (warts, hypogammaglobulinemia, infections, and myelokathexis) syndrome is a rare, inherited, combined immunodeficiency disease caused by reduced mobilization and trafficking of white blood cells from the bone marrow due to over-signaling of the CXCR4/CXCL12 pathway. People with WHIM syndrome characteristically have very low blood levels of neutrophils (neutropenia) and lymphocytes (lymphopenia), and as a result, experience frequent, recurrent infections with a high risk of lung disease, refractory warts from underlying human papillomavirus (HPV) infection, limited antibody production due to low levels of immunoglobulin, and an increased risk of developing certain types of cancer. Mavorixafor is an investigational small-molecule antagonist of CXCR4 being developed as a once-daily oral therapy to correct the dysfunction resulting from the underlying causes of WHIM. For the WHIM indication, mavorixafor has been granted Breakthrough Therapy Designation, Fast Track Designation, and Rare Pediatric Designation in the U.S., and Orphan Drug Status in both the U.S. and European Union.

About the 4WHIM Phase 3 Clinical TrialThe 4WHIM Phase 3 clinical trial was a global, randomized, double-blind, placebo-controlled, multicenter study designed to evaluate the efficacy and safety of oral, once-daily mavorixafor in people with genetically confirmed WHIM syndrome. Originally designed to enroll 18-28 patients, the trial enrolled 31 patients aged 12 and older who received either 400 mg mavorixafor (n=14) or placebo (n=17) orally once daily for 52 weeks.

About X4 Pharmaceuticals X4 Pharmaceuticals is a late-stage clinical biopharmaceutical company focused on the discovery and development of novel therapies for people with diseases of the immune system. Our lead clinical candidate is mavorixafor, a small molecule antagonist of chemokine receptor CXCR4 that is being developed as an oral, once-daily therapy. Due to its ability to increase the mobilization of mature, functional white blood cells from the bone marrow into the bloodstream, we believe that mavorixafor has the potential to provide therapeutic benefit across a variety of chronic neutropenic disorders, including WHIM (Warts, Hypogammaglobulinemia, Infections, and Myelokathexis) syndrome, a rare, primary immunodeficiency. Following announcement of positive top-line data from our global, pivotal, 4WHIM Phase 3 clinical trial, we are currently preparing a U.S. regulatory submission seeking approval of oral, once-daily mavorixafor in the treatment of people aged 12 years and older with WHIM syndrome. We are also currently evaluating mavorixafor in a Phase 2 clinical trial in people with certain chronic neutropenic disorders following positive results from a Phase 1b clinical trial of mavorixafor in people with congenital, idiopathic, or cyclic neutropenia. We continue to leverage our insights into CXCR4 and immune system biology at our corporate headquarters in Boston, Massachusetts and at our research center of excellence in Vienna, Austria. For more information, please visit our website at http://www.x4pharma.com.

Forward-Looking StatementsThis press release contains forward-looking statements within the meaning of applicable securities laws, including the Private Securities Litigation Reform Act of 1995, as amended. These statements may be identified by the words may, will, could, would, should, expect, plan, anticipate, intend, believe, estimate, predict, project, potential, continue, target, or other similar terms or expressions that concern X4's expectations, strategy, plans, or intentions. Forward-looking statements include, without limitation, statements regarding the clinical progress of X4s pipeline development programs, including the anticipated New Drug Application submission for mavorixafor for the treatment of WHIM syndrome and the timing thereof. Any forward-looking statements in this press release are based on management's current expectations and beliefs. Actual events or results may differ materially from those expressed or implied by any forward-looking statements contained herein, including, without limitation, on account of uncertainties inherent in the initiation and completion of clinical trials and clinical development; the risk that trials and studies may not have satisfactory outcomes; the risk that the outcomes of preclinical studies or earlier clinical trials will not be predictive of later clinical trial results; the risk that initial or interim results from a clinical trial may not be predictive of the final results of the trial or the results of future trials; the potential adverse effects arising from the testing or use of mavorixafor or other product candidates; the risk that the Food and Drug Administration (FDA) may not support and accept a regulatory submission for mavorixafor, and that X4s interactions with the FDA may not have satisfactory outcomes; the risks related to X4s ability to raise additional capital; the impacts of macroeconomic conditions, including the COVID-19 pandemic, the conflict in Ukraine, rising inflation, and uncertain credit and financial markets on X4s business, clinical trials and financial position; and other risks and uncertainties, including those described in the section entitled Risk Factors in X4s Annual Report on Form 10-K filed with the Securities and Exchange Commission (SEC) on March 21, 2023, and in other filings X4 makes with the SEC from time to time. X4 undertakes no obligation to update the information contained in this press release to reflect new events or circumstances, except as required by law.

Contacts:Daniel Ferry (investors)Managing Director, LifeSci Advisorsdaniel@lifesciadvisors.com (617) 430-7576

Cherilyn Cecchini, M.D. (media)LifeSci Communicationsccecchini@lifescicomms.com

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X4 Pharmaceuticals Announces Late-Breaking Abstract of WHIM Phase 3 Clinical Data Accepted for Oral Presentation at the 2023 Annual Meeting of the...

Immunology

WVU Today | WVU research team steers students through murky … – WVU Today

West Virginia University researchers are studying how high school seniors and college students can utilize ChatGPT to learn how to code, while recognizing the potential shortcomings of the AI-powered chatbot. (WVU Photo/Alyssa Reeves)

West Virginia University researchers are preparing high school seniors and college students to harness the power of ChatGPT, the popular artificial intelligence chatbot, through coding while addressing the platforms potential shortcomings.

In a paper published in Quantitative Biology, a team led by Gangqing Michael Hu, assistant professor in the WVU School of Medicine Department of Microbiology, Immunology and Cell Biology, explored how they could help students overcome the fear of learning code and enhance their critical thinking skills.

This is like kids wading in the muddy shoreline seeking beautiful seashells, Hu said. The kids are the beginning students and the muddy shoreline is ChatGPT. The beautiful seashells represent all the attractive opportunities which beginners cannot resist. But the ChatGPT shoreline is muddy with challenges such as the uncertainty from the chatbots response including misleading artifacts and students overreliance on AI for coding.

ChatGPT produces human-like responses to text-based conversations and is being used by multiple companies to respond to customer inquiries and provide general information. Anyone can use it to seek information on a plethora of subjects.

One of the responses from ChatGPT can be code, and in this case the platform becomes a coding tool through prompting.

This is a new tool of learning coding and there are some misconceptions, Hu said. Students may think coding is not important because of prompting or they may have a fear in trying to learn it. We need to educate them on the purpose of this chatbot-assisted learning. Because some of the code from the chatbot can be wrong, students need to use critical thinking to be able to tell if the answer is correct and, if it is not, how to find a solution.

One of the biggest drawbacks to ChatGPT is that generated responses to questions can be either correct, incorrect or incomplete. In fact, it takes a human to provide carefully crafted prompts to fully harness the tool in providing valid and robust results.

Inspired by adaptive learning in educational literature, the team used the OPTIMAL model to facilitate chatbot-aided scientific data analysis. OPTIMAL, which stands for Optimization of Prompts Through Iterative Mentoring and Assessment, involves a series of steps to improve communication with a chatbot. In this case, it was geared toward bioinformatics, the science of collecting and analyzing large amounts of biological, medical and health information. Researchers say the model can be used for other purposes as well, such as finance and economics.

The OPTIMAL model is like rubber boots for the children to wear at the muddy shoreline, Hu said. The boots protect the kids from getting dirty much like the model is a protective mechanism to prevent the students from being misled by inaccurate information from the chatbot. The model aims to improve both coding skills and prompting skills through an iterative communication with a chatbot guided by critical thinking and assessment.

Following the OPTIMAL model, students review all the information needed for input and receive guidance on how to create a set of draft prompts. Once they input the prompt, the chatbot produces code and students are ready to give it a test.

If error messages result after running the code, students must evaluate the error and determine the best way to proceed, such as instructing the chatbot to revise the code or debugging the code manually.

The process continues until the code no longer issues errors and outputs a result for critical assessment. At the end of the session, students reflect on the entire communication process and review the code to identify any missing details to finalize the prompts.

The research team found that merely using the chatbot as a code-generating tool may limit creative thinking and that reviewing the code at the end of each session is just as important as optimizing the prompts.

The work brought together researchers from a spectrum of disciplines: Evelyn Shue, student volunteer in the Department of Microbiology, Immunology and Cell Biology; Bingxin Li, WVU John Chambers College of Business and Economics; Xin Li, WVU Benjamin M. Statler College of Engineering and Mineral Resources; Zifeng Feng, University of Texas at El Paso; and Li Liu, Arizona State University.

The team plans to evaluate the OPTIMAL models effectiveness in enhancing traditional bioinformatics education for beginners in the classroom.

This assessment should encompass improvements in coding skills, prompting skills, problem-solving abilities, and critical thinking during interactions with a chatbot, Hu said.

Future research will delve into more profound insights and strategies on applying ChatGPT to precision education.

There are certainly other sorts of rubber boots, Hu said.

-WVU-

ls/04/13/23

MEDIA CONTACT: Jake StumpDirectorWVU Research Communications304-293-5507; jake.stump@mail.wvu.edu

Call 1-855-WVU-NEWS for the latest West Virginia University news and information from WVUToday.

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WVU Today | WVU research team steers students through murky ... - WVU Today

Immunology

argenx Demonstrates Commitment to Redefining Treatment Goals … – GlobeNewswire

Amsterdam, the Netherlands [04/18/2023] argenx SE (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, today announced that it will present six abstracts further demonstrating its long-term commitment to the generalized myasthenia gravis (gMG) community during the 75th American Academy of Neurology (AAN) Annual Meeting, which is taking place from April 22-27, 2023 in Boston, MA. The presentations include clinical and real-world efgartigimod data that demonstrate the potential of neonatal Fc receptor (FcRn) blockade in transforming treatment for gMG and other IgG-mediated autoimmune diseases.

Our presentations at AAN will showcase the depth of evidence we are generating in support of the clinical and real-world profile of efgartigimod to address the often-underappreciated needs of people living with gMG, said Luc Truyen, M.D. Ph.D., Chief Medical Officer, argenx. We have a unique opportunity to recalibrate expectations for patients and their supporters by setting a new standard for what well-controlled means in gMG and across autoimmunity more broadly.

Power of Individualized Dosing from Long-term Extension StudiesThe presentations include results from the open-label extension studies of VYVGART (efgartigimod alfa-fcab) and subcutaneous (SC) efgartigimod following long-term treatment in ADAPT+ (217.5 patient-years follow-up) and ADAPT-SC+ (72 patient-years follow-up). Long-term treatment, administered in individualized dosing cycles, led to consistent and repeatable reductions in IgG antibody levels and improved clinical outcomes.

A cross-indication review of the safety profile of efgartigimod will also be presented across multiple IgG-mediated autoimmune diseases, reinforcing the consistent safety profile observed with efgartigimod.

Potential in Patients Early in gMG Disease CourseA new exploratory analysis will be presented from the ADAPT Phase 3 trial showing that a greater percentage of gMG patients with fewer than three years disease duration were responders and achieved minimum symptom expression (MSE) compared with placebo.

New Opportunities with Patient Support ProgramsAs part of its commitment to address access for gMG patients impacted by social determinants of health challenges, argenx will present quantitative and qualitative research that identified potential opportunities to expand patient support program offerings, including the establishment of an information hotline and symptom tracking app, a patient mentoring program, an innovative giving strategy and broadened awareness campaigns of nurse case manager services.

Details for the poster presentations are as follows:

Title: Long-Term Safety, Tolerability, And Efficacy of Efgartigimod in Patients with Generalized Myasthenia Gravis: Concluding Analyses from the ADAPT+Session Date & Time: Oral Presentation - Sunday, April 23 at 2:00pm ETPresenter: Dr. Mamatha PasnoorAbstract Number: S5.006

Title: Long-Term Safety, Tolerability, and Efficacy of Subcutaneous Efgartigimod PH20 in Patients with Generalized Myasthenia Gravis: Interim Results of the ADAPT-SC+ StudySession Date & Time: Poster Session 1, Sunday, April 23, 8-9 am ETPresenter: Dr. James F. HowardAbstract Number: P1.5-014

Title: Dose Selection and Clinical Development of Efgartigimod Ph20 Subcutaneous Inpatients With Generalized Myasthenia GravisSession Date & Time: Poster Session 1, Sunday, April 23, 8-9 am ETPresenter: Dr. George LiAbstract Number: P1.5-017

Title: Overview of the Safety Profile from Efgartigimod Clinical Trials in Participants with Diverse IgG-Mediated Autoimmune DiseasesSession Date & Time: Poster Session 1, Sunday, April 23, 8-9 am ETPresenter: Dr. Kelly GwathmeyAbstract Number: P1.5-001

Title: Efgartigimod Demonstrates Consistent Improvements in Generalized Myasthenia Gravis Patients of Shorter Disease DurationSession Date & Time: Poster Session 1, Sunday, April 23, 8-9 am ETPresenter: Dr. Vera BrilAbstract Number: P1.5-015

Title: Patient Support Program Enhancements In Patients Diagnosed With Generalized Myasthenia Gravis Facing Social Determinants of Health ChallengesSession Date & Time: Poster Session 4, Monday, April 24, 8-9 am ETPresenter: Dr. Tom HughesAbstract Number: P4.9-006

See the full Prescribing Information for VYVGART in the U.S., which includes the below Important Safety Information. For more information related to VYVGART in Japan, visit argenx.jp.

Important Safety Information for VYVGART (efgartigimod alfa-fcab) intravenous (IV) formulation (U.S. prescribing information)

What is VYVGART (efgartigimod alfa-fcab)?VYVGART is a prescription medicine used to treat a condition called generalized myasthenia gravis, which causes muscles to tire and weaken easily throughout the body, in adults who are positive for antibodies directed toward a protein called acetylcholine receptor (anti-AChR antibody positive).

What is the most important information I should know about VYVGART?VYVGART may cause serious side effects, including:

Before taking VYVGART, tell your health care provider about all of your medical conditions, including if you:

Tell your health care provider about all the medicines you take, including prescription and over- the-counter medicines, vitamins, and herbal supplements.

What are the common side effects of VYVGART?

The most common side effects of VYVGART are respiratory tract infection, headache, and urinary tract infection.

These are not all the possible side effects of VYVGART. Call your doctor for medical advice about side effects. You may report side effects to the US Food and Drug Administration at 1- 800-FDA-1088.

Please see the full Prescribing Information for VYVGART and talk to your doctor.

About Generalized Myasthenia GravisGeneralized myasthenia gravis (gMG) is a rare and chronic autoimmune disease where IgG autoantibodies disrupt communication between nerves and muscles, causing debilitating and potentially life-threatening muscle weakness. Approximately 85% of people with MG progress to gMG within 24 months, where muscles throughout the body may be affected. Patients with confirmed AChR antibodies account for approximately 85% of the total gMG population.

About VYVGART (efgartigimod alfa-fcab)VYVGART is a human IgG1 antibody fragment that binds to the neonatal Fc receptor (FcRn), resulting in the reduction of circulating immunoglobulin G (IgG) autoantibodies. It is the first and only approved FcRn blocker. VYVGART is approved in the United States and Europe for the treatment of adults with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody positive and in Japan for the treatment of adults with gMG who do not have sufficient response to steroids or non-steroidal immunosuppressive therapies (ISTs). VYVGART is being studied in adults with primary immune thrombocytopenia (ITP) and other IgG autoantibody-mediated diseases.

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., the EU and UK, and Japan. The Company is evaluating efgartigimod in multiple serious autoimmune diseases and advancing several earlier stage experimental medicines within its therapeutic franchises. For more information, visit http://www.argenx.com and follow us on LinkedIn, Twitter, and Instagram.

For further information, please contact:

Media:Erin Murphyemurphy@argenx.com

Investors:Beth DelGiaccobdelgiacco@argenx.com

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 concerning argenxs long-term commitment to the generalized myasthenia gravis (gMG) community, the potential of neonatal Fc receptor (FcRn) blockade in transforming treatment for gMG and other IgG-mediated autoimmune diseases, the expected long-term safety, tolerability and efficacy of VYVGART (efgartigimod alfa-fcab) in adult patients with gMG; and potential opportunities to expand patient support program offerings. By their nature, forward-looking statements involve risks and uncertainties and readers are cautioned that any such forward-looking statements are not guarantees of future performance. argenxs actual results may differ materially from those predicted by the forward-looking statements as a result of various important factors. A further list and description of these risks, uncertainties and other risks can be found in argenxs U.S. Securities and Exchange Commission (SEC) filings and reports, including in argenxs most recent annual report on Form 20-F filed with the SEC as well as subsequent filings and reports filed by argenx with the SEC. Given these uncertainties, the reader is advised not to place any undue reliance on such forward-looking statements. These forward-looking statements speak only as of the date of publication of this document. argenx undertakes no obligation to publicly update or revise the information in this press release, including any forward-looking statements, except as may be required by law.

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argenx Demonstrates Commitment to Redefining Treatment Goals ... - GlobeNewswire

Immunology

Alberto Pugliese, M.D., Joins City of Hope as Director of The Wanek Family Project for Type 1 Diabetes and Chair of the Department of Diabetes…

CONTACTLetisia Marquez626-476-7593lemarquez@coh.org

LOS ANGELES Alberto Pugliese, M.D., has joined City of Hope as the Samuel Rahbar Endowed Chair in Diabetes & Drug Discovery, chair of the Department of Diabetes Immunology, and director of The Wanek Family Project for Type 1 Diabetes within the Arthur Riggs Diabetes & Metabolism Research Institute.

Pugliese has dedicated his 35-year career to studying type 1 diabetes from the preclinical period to the clinical diagnosis and, afterward, the setting of transplantation. His work has contributed to a greater understanding of genetic and cellular mechanisms that regulate immunological self-tolerance, specifically to molecules targeted in diabetes. Pugliese has provided seminal contributions in the field of type 1 diabetes genetics, immunology, pathology and clinical trials, and his work has been published in major international journals.

City of Hope is fortunate to welcome Dr. Pugliese as he shares our dedication to advancing type 1 diabetes research through scientific excellence, open collaboration and the training of new investigators, said Debbie C. Thurmond, Ph.D., director of the Riggs Institute and Ruth B. & Robert K. Lanman Chair in Gene Regulation & Drug Discovery Research.

Pugliese comes to City of Hope by way of the University of Miami, where he served as The J. Enloe and Eugenia J. Dodson Chair in Diabetes Research. He was also a tenured professor of medicine, Division of Diabetes Endocrinology and Metabolism, and a professor of microbiology and immunology, as well as serving as deputy director for Immune Tolerance Research at the Diabetes Research Institute, Leonard Miller School of Medicine, University of Miami.

I am humbled and honored to join City of Hopes legendary diabetes research department that has made pivotal discoveries about diabetes for more than 50 years, Pugliese said. My team and I will continue and enhance that spirit of innovation and scientific pioneering, digging deeper into the secrets of genetics and the immune system, metabolism and diabetic complications.

A native of Italy, Pugliese earned his medical degree and postdoctoral research fellowship at the University of Palermo. He completed postdoctoral research fellowships at that university, and then trained with the late George Eisenbarth at the Joslin Diabetes Center at Harvard Medical School and the Barbara Davis Center for Childhood Diabetes at the University of Colorado Health Sciences Center.

Pugliese is a champion of collaboration and team-science approaches, which has been recognized by the Helmsley Charitable Trust with the George S. Eisenbarth nPOD Award for Team Science. He has served on research grant review committees of the National Institutes of Health (NIH), the JDRF and other funding organizations internationally. He also served as chair of the American Diabetes Associations Grant Review Panel. He has been a steering committee member of the Type 1 Diabetes TrialNet, a clinical trial network funded by the NIH, under which auspices he has chaired several committees and initiatives.

Pugliese is also executive co-director of the JDRF Network for Pancreatic Organ Donors with Diabetes (nPOD), a collaborative project that recovers tissues from organ donors with type 1 diabetes and distributes samples to investigators worldwide to support a comprehensive understanding of the disease.

# # #

About City of HopeCity of Hope's mission is to deliver the cures of tomorrow to the people who need them today. Founded in 1913, City of Hope has grown into one of the largest cancer research and treatment organizations in the U.S. and one of the leading research centers for diabetes and other life-threatening illnesses. As an independent, National Cancer Institute-designated comprehensive cancer center, City of Hope brings a uniquely integrated model to patients, spanning cancer care, research and development, academics and training, and innovation initiatives. Research and technology developed at City of Hope has been the basis for numerous breakthrough cancer medicines, as well as human synthetic insulin and monoclonal antibodies. A leader in bone marrow transplantation and immunotherapy, such as CAR T cell therapy, City of Hopes personalized treatment protocols help advance cancer care throughout the world.With a goal of expanding access to the latest discoveries and leading-edge care to more patients, families and communities, City of Hopes growing national system includes its main Los Angeles campus, a network of clinical care locations across Southern California, a new cancer center in Orange County, California and Cancer Treatment Centers of America. City of Hopes affiliated family of organizations includes Translational Genomics Research Institute and AccessHopeTM. For more information about City of Hope, follow us on Facebook, Twitter, YouTube, Instagram and LinkedIn.

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Alberto Pugliese, M.D., Joins City of Hope as Director of The Wanek Family Project for Type 1 Diabetes and Chair of the Department of Diabetes...

Immunology

Gritstone to Host Data Update on CORAL and Discuss the Application of Self-amplifying mRNA (samRNA) in Infectious Diseases – Yahoo Finance

Gritstone bio

-- Data to be presented from CORAL-BOOST and CORAL-CEPI trials evaluating Gritstones samRNA vaccine candidates against SARS-CoV-2 --

EMERYVILLE, Calif., Oct. 19, 2022 (GLOBE NEWSWIRE) -- Gritstone bio, Inc. (Nasdaq: GRTS), a clinical-stage biotechnology company that aims to develop the worlds most potent vaccines, today announced that it will host a webinar on October 25, 2022 to present data from its CORAL program and discuss the application of its self-amplifying mRNA (samRNA) vaccine platform for infectious diseases. During the webinar, lead investigators will present data from the ongoing Phase 1 CORAL-BOOST and CORAL-CEPI trials which are evaluating the companys samRNA vaccine candidates against SARS-CoV-2. Following the data presentations, Lawrence Larry Corey, M.D., an internationally renowned expert in virology, immunology and vaccine development, will speak to the potential application of samRNA vaccines against infectious diseases.

Presenters and Content

Professor Andrew Ustianowski, National Clinical Lead for the UK NIHR COVID Vaccine Research Programme, will present data from CORAL-BOOST. This presentation will expand on study data being presenting at IDWeek 2022.

Professor Shabir Madhi, Dean of the Faculty of Health Sciences, Professor of Vaccinology at the University of the Witwatersrand, Johannesburg, South Africa, will present the interim data from CORAL-CEPI. This presentation will include data on virus-nave subjects.

Larry Corey, M.D., virology, immunology and vaccine development expert, former President & Director of Fred Hutchinson Cancer Center (Fred Hutch) and Board Member of Gritstone bio, will speak to the landscape and broad potential application of samRNA.

Company management will also provide an overview of self-amplifying mRNA (samRNA) as a novel vaccine platform for the prevention and treatment of infectious diseases.

The presentations will be followed by a Q&A session.

Webinar DetailsDate and time: 8:00 9:00am ET on Tuesday, October 25Link: To register for the webinar, please click here

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A replay of the webinar will be accessible for 30 days following the event on the events page of the companys website: https://ir.gritstonebio.com/investors/events.

About the CORAL ProgramGritstones CORAL program is evaluating the companys infectious disease approach, which is designed to drive both B cell and T cell immunity using a self-amplifying mRNA (samRNA) vector, against SARS-CoV-2. The program currently includes three ongoing Phase 1 trials: CORAL-BOOST, which is evaluating one construct in a boost setting (following primary series of currently-approved COVID-19 vaccines); CORAL-CEPI, which is evaluating multiple constructs in virus-nave, convalescent, and HIV+ subjects in South Africa; and CORAL-NIH, which is being run by the National Institute of Allergy and Infectious Disease (NIAID), is evaluating multiple constructs in previously vaccinated healthy volunteers. The program serves as proof-of-concept for the application of Gritstones platform against coronaviruses and other infectious diseases and is supported by theBill & Melinda Gates Foundation,NIAID and theCoalition for Epidemic Preparedness Innovations(CEPI).

About Gritstone bioGritstone bio, Inc. (Nasdaq: GRTS) is a clinical-stage biotechnology company that aims to create the worlds most potent vaccines. We leverage our innovative vectors and payloads to train multiple arms of the immune system to attack critical disease targets. Independently and with our collaborators, we are advancing a portfolio of product candidates to treat and prevent viral diseases and solid tumors in pursuit of improving patient outcomes and eliminating disease. http://www.gritstonebio.com

Gritstone Forward-Looking StatementsThis press release contains forward-looking statements, including, but not limited to, statements related to the potential of Gritstones therapeutic programs; the advancements in Gritstones ongoing clinical trials; the timing of data announcements related to ongoing clinical trials and the initiation of future clinical trials. Such forward-looking statements involve substantial risks and uncertainties that could cause Gritstones research and clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in the drug development process, including Gritstones programs clinical stage of development, the process of designing and conducting preclinical and clinical trials, the regulatory approval processes, the timing of regulatory filings, the challenges associated with manufacturing drug products, Gritstones ability to successfully establish, protect and defend its intellectual property and other matters that could affect the sufficiency of existing cash to fund operations. Gritstone undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of the company in general, see Gritstones most recent Annual Report on Form 10-K filed on March 10, 2022, as well as Gritstones Quarterly Reports on Form 10-Q filed on May 5, 2022 and August 4, 2022 and any current and periodic reports filed with the Securities and Exchange Commission. The forward-looking statements in this press release are based on information available to Gritstone as of the date hereof. Gritstone disclaims any obligation to update any forward-looking statements, except as required by law.

Gritstone ContactsInvestors:George E. MacDougallDirector, Investor Relations & Corporate CommunicationsGritstone bioir@gritstone.com

Media:Dan Budwick1AB(973) 271-6085dan@1abmedia.com

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Gritstone to Host Data Update on CORAL and Discuss the Application of Self-amplifying mRNA (samRNA) in Infectious Diseases - Yahoo Finance

Immunology

Bright Peak Therapeutics Announces Formation of World Class Immuno-Oncology Scientific Advisory Board – StreetInsider.com

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SAN DIEGO & BASEL, Switzerland, Oct. 18, 2022 (GLOBE NEWSWIRE) -- Bright Peak Therapeutics, a privately held biotechnology company leveraging a revolutionary chemical protein engineering platform to develop next-generation multifunctional cytokine-based immunotherapies, today announced the formation of a Scientific Advisory Board ("SAB") comprised of world-renowned experts in immuno-oncology basic, translational and clinical research.

"Bright Peak is truly privileged and excited to have such an accomplished and dedicated group of scientific and clinical experts to advise on our discovery and clinical development programs," said Fredrik Wiklund, Chief Executive Officer of Bright Peak. "Their combined resume includes some of the most groundbreaking discoveries in immuno-oncology, from basic biology through clinical investigation." Jon Wigginton, M.D., President of Research and Development at Bright Peak added, "We are honored to welcome this outstanding group of investigators to the Bright Peak SAB and look forward to leveraging their expertise in our shared mission to develop transformative precision immunotherapies that address significant unmet needs for patients with cancer."

The members of Bright Peak's Scientific Advisory Board include:

Gordon Freeman, Ph.D., Professor of Medicine at the Dana-Farber Cancer Institute (DFCI) and Harvard Medical School, is renowned for discovering the PD-L1 and PD-L2 proteins. Dr. Freeman showed that PD-L1 and PD-L2 bound to PD-1 to turn off the immune response and that blockade of PD-L1/PD-1 enhanced immune responses. He further showed that PD-L1 is highly expressed on many tumors and allows these tumors to resist immune attack. Dr. Freemans work led directly to the development of a successful strategy for cancer immunotherapy - blocking the PD-1-ligand interaction. Dr. Freeman has published over 400 scientific papers and holds over 90 US patents on immunotherapies. He was elected to the National Academy of Sciences and the National Academy of Inventors, is a Fellow of the AACR and SITC Academies, and has received numerous awards, including the William B. Coley Award for Distinguished Research in Tumor Immunology, the Warren Alpert Foundation Prize, and the Richard Smalley, MD, Memorial Award. Dr. Freeman received his Ph.D. degree in Microbiology and Molecular Genetics from Harvard University.

Thomas Gajewski, M.D., Ph.D., is the AbbVie Foundation Professor in Cancer Immunotherapy, leader of the Immunology and Cancer program, and Director of Melanoma Oncology at the University of Chicago. Dr. Gajewski's notable discoveries includethe identification of the STING pathway and how it stimulates the body's innate immune system to attack cancer, downstream pathways including Wnt/-catenin that enable tumors to evade immune responses, and the connection between the immune system's response to cancer and the gut microbiota. An author of more than 250 manuscripts, Dr. Gajewski is past president of SITC, a founding editor of the Journal for Immunotherapy of Cancer, past chair of the Cancer Immunopathology and Immunotherapy grant review study section at the NIH, has served on the program committees for ASCO and AACR, a grant reviewer for the Melanoma Research Alliance and Cancer Research Institute, and editor for Cancer Research. Among numerous honors, Dr. Gajewski has received theWilliam B. Coley Awardfor Distinguished Research in Tumor Immunology, the ESMO award in Immuno-oncology, the American Cancer Society-Jules L. Plangere Jr. Family Foundation Professorship in Cancer Immunotherapy, and Distinguished Professor designation at the University of Chicago. He holds a B.S., Ph.D. in Immunology, and M.D. degrees from the University of Chicago where he also completed Internal Medicine Residency and Hematology/Oncology Fellowship.

Jason Luke, M.D., is the Director of the Immunotherapy and Drug Development Center at UPMC Hillman Cancer Center and Associate Professor at the University of Pittsburgh. Dr. Luke is an internationally recognized investigator in translational immuno-oncology, early phase drug development and the clinical management of cutaneous malignancies. Dr. Luke has designed and led two practice-changing studies in melanoma - the combination of anti-PD1 + low-dose anti-CTLA4 Ab in PD1 refractory disease, and establishing the role for, and FDA/EMA approval of, adjuvant anti-PD1 for stage IIB/C melanoma. More generally, Dr Luke has been a lead investigator for many first-in-human trials of novel immunotherapies and a major contributor toward the investigation of radiation, the microbiome and bioinformatic approaches in relation to cancer immunotherapy. Dr. Luke is an At Large member of the Board of Directors for SITC and has held leadership roles in SMR, AACR & ASCO. He is a member of the NCI Investigational Drug Steering Committee and the Immunotherapy Task Force co-Chair. He has received numerous awards including the Melanoma Research Foundation Humanitarian Award, ASCO Merit Award, and the NCI Cancer Clinical Investigator Team Leadership Award. Dr. Luke received an M.D. from Rosalind Franklin University of Medicine and Science/Chicago Medical School, completed Internal Medicine Residency at Boston University Medical Center and Medical Oncology Fellowship at Memorial Sloan-Kettering Cancer Center and Weill Cornell Medical Center.

Ignacio Melero, M.D., Ph.D., is Co-Director of the Department of Immunology and Immunotherapy and Professor of Immunology at the Clinica Universidad de Navarra and at the Center for Applied Medical Research (CIMA) of the University of Navarra, Spain. Dr. Melero is an international leader in translational tumor immunotherapy research who focuses on cytokine gene therapy, immune-stimulatory monoclonal antibodies, and cell therapy for cancer. Dr. Melero is renowned for seminal discoveries in the function of NK cell inhibitory receptors (KIRs) and T-cell co-stimulation via CD137 (4-1BB). Dr. Melero has served as principal investigator in numerous clinical trials of cancer immunotherapy and has won multiple awards including the BIAL Prize of Medicine, the Conde de Cartagena Award from the Royal Academy of Medicine, Doctor Durantez LAIR Foundation Award and a Cancer Research Institute research award. Dr. Melero earned an M.D. degree from the University of Navarra School of Medicine, completed Residency in Immunology at the Hospital Universitario de la Princesa (Madrid) and earned a Ph.D. in Immunology at La Princesa Hospital, Autonomous University of Madrid, Spain.

Anthony Tolcher, M.D., is founder and CEO of NEXT Oncology, one of the most successful and respected Phase 1 programs in oncology research. Prior to founding NEXT Oncology, Dr. Tolcher was President and Co-Founder of START LLC, one of the world's largest Clinical Phase I and early drug development operations in cancer medicine. Dr. Tolcher is a medical oncologist with over 25 years' experience in early drug development and clinical trials and has been involved in more than 21 of the initial Phase 1 studies of new oncology agents that subsequently were FDA approved, including PD-(L)1 inhibitors, antibody-drug conjugates, anti-tumor-associated antigen antibodies, and numerous targeted therapies, and he is currently the principal investigator of over 20 Phase 1 studies. He has over 130 peerreviewed publications in scientific journals and has chaired the Developmental Therapeutics Review Committee for ASCO. Dr. Tolcher obtained his M.D. degree from the University of British Columbia and then completed Internal Medicine Residency at the University of Toronto, Oncology Fellowship at the University of British Columbia and a research fellowship at the NCI, Bethesda.

About Bright Peak TherapeuticsBright Peak is a privately held biotechnology company based in Basel, Switzerland and San Diego, CA. We are rapidly advancing a robust portfolio of next-generation, multi-functional, cytokine-based immunotherapies for the treatment of patients with cancer and autoimmune disease. We accomplish this by leveraging our world class protein engineering capabilities and our unique cell-free technology platform to chemically synthesize and conjugate novel protein therapeutics that reflect state-of-the-art insights into cytokine and immune checkpoint biology. Our pipeline stretches from discovery to IND-enabling and encompasses enhanced cytokines, antibody-cytokine conjugates and other novel formats. Bright Peak is funded by a syndicate of leading healthcare investors.

Contact:[emailprotected]

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Bright Peak Therapeutics Announces Formation of World Class Immuno-Oncology Scientific Advisory Board - StreetInsider.com

Immunology

argenx to Report Third Quarter – GuruFocus.com

October 20, 2022

Amsterdam, the Netherlands argenx (Euronext & ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, today announced that it will host a conference call and audio webcast on Thursday, October 27, 2022 at 2:30 pm CET (8:30 am ET) to discuss its third quarter 2022 financial results and provide a business update.

A webcast of the live call may be accessed on the Investors section of the argenx website at argenx.com/investors. A replay of the webcast will be available on the argenx website for approximately one year following the presentation.

Dial-in numbers:

Use the access code 3810049 to join the call. Please dial in 15 minutes prior to the live call.

Belgium 32 800 50 201United Kingdom 44 800 358 0970United States 1 888 415 4250All other locations 1 646 960 0294

About argenx

argenx 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., the EU and Japan. The Company is evaluating efgartigimod in multiple serious autoimmune diseases and advancing several earlier stage experimental medicines within its therapeutic franchises. For more information, visit http://www.argenx.com and follow us on LinkedIn, Twitter, and Instagram.

For further information, please contact:

Media:

Kelsey Kirk[emailprotected]

Investors:

Beth DelGiacco[emailprotected]

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argenx to Report Third Quarter - GuruFocus.com

Immunology

Labour board finds Sask. professor was wrongly disciplined over COVID-19 posts – Saskatoon Star-Phoenix

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University failed to follow collective bargaining agreement when it ordered Kyle Anderson to cut employment references from his social profiles.

An arbitrator has ruled that the University of Saskatchewan never should have sent a letter telling an outspoken faculty member to remove references to his employment from his social media accounts.

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Lawyer Eric Cline presided over the labour board hearing between the university and its faculty association, which acted on behalf of Kyle Anderson, a tenured assistant professor in the College of Medicines department of biochemistry, microbiology and immunology.

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The decision, reached last month, outlines Andersons rise on social media during the early stages of the COVID-19 pandemic, to eventually being ordered to strip all references to his faculty positions from his public communications.

Anderson scored his first hit in August 2020 with a 50,000-view Facebook video calling for pool testing of schoolchildren. By December 2020, hed racked up about 1.2 million views on various posts about the pandemic. He was also getting favourable notes from his supervisors, and being tapped to do interviews when media called the university with questions about COVID-19.

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In a rancorous Twitter exchange in December 2020, Anderson hurled personal insults at an unnamed person who was reportedly posting misinformation about the pandemic. This led to his first brush with university authorities, who had a communications specialist from the medical school provide him with training on best practices for social media.

Andersons postings again came to the attention of university leadership when, on April 14, 2021, he tweeted a post critical of Premier Scott Moe, including the line It sounds like there are already plots and maneuverings in motion to take down the Mad King of Saskeros in reference to the Saskatchewan premier. This led the RCMP to question Anderson to ensure there was no threat to Moes safety.

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A tweet on April 22, 2021 drew the letter from the administration that was at the heart of Clines decision.

On that day, while advocating for tighter pandemic measures in schools, Anderson re-tweeted a post suggesting a maskless child repeatedly coming to school while infectious with COVID-19 was responsible for infecting a Moose Jaw educational assistant who later died from the disease. The information turned out to be inaccurate, prompting Anderson to later take it down.

The grievance before Cline concerned a letter sent to Anderson after the April 22 tweet, signed by the universitys president, vice-president academic and the dean of the College of Medicine. In the letter, the signees noted the university had received multiple complaints about Andersons post, describing it as hateful and unconscionable, and that it amounted to a targeted victimization of a vulnerable family for singling out a child who, it was subsequently revealed, had autism.

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The universitys letter went on to say that Andersons post was reflecting badly on the university, by virtue of him identifying himself as a faculty member. It ordered him to remove all references to his employment from his social media and public communications, or potentially face further discipline.

The faculty association argued the letter amounted to a disciplinary action against a member outside of whats prescribed in the collective agreement with the university.

Clines decision is in favour of the unions position, noting the university failed to follow a key section of the collective agreement by not bringing the complaints against Anderson to his attention before sending him the letter, and therefore denying him an opportunity to be heard.

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Cline acknowledged that Andersons re-posting of unverified, inaccurate information was wrong, and perhaps even reckless, but added that he also never heard any evidence from anyone who signed the letter, leaving him with no idea of the number or content of the complaints against Anderson, and no evidence to show Andersons tweets damaged the universitys reputation.

Cline ruled the letter was a disciplinary measure that is not allowed under the collective agreement, and ordered that it be removed from any university files.

The news seems to be flying at us faster all the time. From COVID-19 updates to politics and crime and everything in between, it can be hard to keep up. With that in mind, the Saskatoon StarPhoenix has created an Afternoon Headlines newsletter that can be delivered daily to your inbox to help make sure you are up to date with the most vital news of the day. Click here to subscribe.

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Labour board finds Sask. professor was wrongly disciplined over COVID-19 posts - Saskatoon Star-Phoenix