Vion Pharmaceuticals, Inc.

Dr. Sznol to guide clinical investigation of Resolvin-based therapies in metastatic melanoma ESSEX, CT., November 7, 2023. Thetis Pharmaceuticals LLC (“Thetis”), a biopharmaceutical company developing a first-in-class small molecule ChemR23 agonist to treat cancer and autoimmune diseases small molecule (TP-317) to treat cancer and autoimmune diseases, announced today that Dr. Mario Sznol has joined its Scientific Advisory Board (SAB). Dr. Sznol is Professor of Medicine, Clinical Research Team Leader (Melanoma-Renal Cancer Program), and Co-Leader of Cancer Immunology Program at the Yale Cancer Center. Gary Mathias, Chief Executive Officer of Thetis, commented, “Dr. Sznol has an international reputation with unique expertise and experience in cancer immunotherapy, drug development for cancer, and treatment of patients with melanoma and renal cell carcinoma, which makes him a perfect choice to help Thetis in the development of TP-317 to treat metastatic melanoma. Dr. Sznol is an expert in clinical application of immune checkpoint inhibitors and brings an important perspective to our clinical strategy for TP-317, which in preclinical studies has shown single agent efficacy comparable to standard-of-care immunotherapy and chemotherapy and enhanced efficacy when combined with these other agents.” Dr. Sznol noted that “TP-317 offers a highly differentiated strategy to address resistance to immunotherapy in the tumor microenvironment (TME), which is an important target in cancer drug development. I am delighted to join the Thetis SAB to help develop this promising small molecule drug for metastatic melanoma.” Dr. Sznol joins the Thetis SAB with 35 years of experience in cancer research and development. He graduated from Baylor College of Medicine where he subsequently trained in internal medicine, and then completed a medical oncology fellowship in the Department of Neoplastic Diseases at Mount Sinai Hospital. He spent the next twelve years in the Cancer Therapy Evaluation Program of the National Cancer Institute. From 1999-2004, he served as Vice President of Clinical Development and Executive Officer of Vion Pharmaceuticals in New Haven, Connecticut. In 2004, he joined the medical oncology faculty of the Yale University School of Medicine as co-leader of the Melanoma Program and is currently Professor of Internal Medicine, Leader of the Melanoma-Renal Cancer Clinical Research Team, and Co-Director of Cancer Immunology Program. About TP-317 and Disease Programs TP-317 is a patent-protected small molecule drug that delivers Resolvin E1 (RvE1), an endogenous lipid mediator that restores immune homeostasis. Unlike anti-inflammatory drugs and anti-cancer agents that are immuno-suppressive, TP-317 activates innate and adaptive immune pathways to treat disease without compromising host-protective immunity. Cancer Program: In cancer, TP-317 is being developed as an adjunct to immune checkpoint inhibitors in refractory metastatic melanoma and advanced non-small cell lung cancer (NSCLC), and as adjunct to chemotherapy in pancreatic cancer. TP-317 has demonstrated potent single agent activity in melanoma, lung cancer and pancreatic cancer tumor models, and enhanced efficacy when combined with immune checkpoint inhibitors or chemotherapy in “immune cold” and immune-responsive tumors. In the same studies, TP-317 has been shown to promote myeloid directed antigen presentation and increased IFN-y response in the tumor microenvironment, which may contribute to TP-317’s robust anti-tumoral effects. IBD Program: In inflammatory bowel disease, TP-317 is being developed as a first-line oral therapy for mild-to-moderate Crohn’s disease and as second-line oral therapy for mild-to-moderate ulcerative colitis patients who are not well controlled on 5-ASA or corticosteroids. In colitis models, oral TP-317 dosed once daily has shown efficacy in DSS, TNBS, TNFΔARE and T-cell transfer colitis models. In DSS-induced colitis, TP-317 has shown comparable efficacy to 5-ASA and the JAK inhibitor filgotinib and enhanced efficacy when combined with 5-ASA. Mechanistically, RvE1 has demonstrated a unique ability to shift the inflamed mucosa towards immune homeostasis and promote intestinal barrier repair, a key driver and measure of efficacy in human IBD. About Thetis Pharmaceuticals Thetis is a biopharmaceutical company dedicated to improving the lives of patients suffering from cancer and inflammatory bowel disease. Thetis’ proprietary HEALER™ technology enables the pharmaceutical development of Resolvins, overcoming the stability, manufacturing, and formulation hurdles that have limited their commercial development. Thetis is supported by venture capital investors, NIH, and leading private philanthropies, including the Helmsley Charitable Trust, the Crohn’s & Colitis Foundation, and the Kenneth Rainin Foundation. Disclaimer TP-317 is an investigational drug product that has not been approved by the U.S. Food and Drug Administration. For more information, please visit Thetis Pharmaceuticals’ website ( ). Contact Information Gary Mathias, CEO gmathias@thetispharma.com

SOUTH SAN FRANCISCO, Calif. & NEW HAVEN, Conn.--(BUSINESS WIRE)-- Simcha Therapeutics (“Simcha”), a clinical-stage immunobiology company pioneering first-in-class cytokine treatments in cancer, today announced the formation of a scientific advisory board that will support the company’s efforts to realize the potential of IL-18-focused therapeutic approaches. “IL-18 has a significant range of potential therapeutic uses across multiple modalities, and Simcha is eager to identify and evaluate the applications with the most promise for yielding transformational outcomes for patients,” said Sanuj Ravindran, M.D., CEO of Simcha. “Our scientific advisory board of experts in immunology and cancer will help guide our efforts to broaden the applications for decoy-resistant IL-18, and drive explorations in new directions.” The members of the advisory board are: W. Nicholas Haining, BM, BCh, is chief scientific officer and co-founder of ArsenalBio. He is a physician-scientist, and prior to co-founding ArsenalBio, he was the vice president of discovery oncology and immunology at Merck Research Laboratories. Dr. Haining received his undergraduate and medical degree from Oxford University and completed his medical training in pediatrics at Boston Children’s Hospital, and subsequently in pediatric hematology/oncology at Dana-Farber Cancer Institute. As an associate professor of pediatrics at Harvard Medical School and an associate member of the Broad Institute of MIT and Harvard, his lab defined some of the key transcriptional and epigenetic regulators of T cell exhaustion and used in vivo genetic screens to identify immune vulnerabilities of cancer cells in mouse models. He also led a multi-disciplinary organization at Merck that focused on using innovative approaches to identify new therapeutic strategies for cancer and immunological disease. Susan Kaech, Ph.D., is professor and director of the NOMIS Center for Immunobiology & Microbial Pathogenesis and holds the NOMIS Chair at the Salk Institute. Her work focuses on understanding how memory T cells are produced during infection and vaccination to provide long-term immunity and sometimes fail to do so. She is also a leader in field of cancer immunology and elucidating metabolic control of immune cells in cancer. She was previously a Waldemar Von Zedwitz Professor in the Department of Immunology at Yale University. She holds a Ph.D. in developmental biology from Stanford University and completed her postdoctoral fellowship in the department of microbiology and immunology at Emory University. Jeffrey Miller, M.D., is professor of medicine, University of Minnesota and deputy director, Masonic Cancer Center and the Roger L. and Lynn C. Headrick Chair in cancer therapeutics. Dr. Miller has more than 25 years of experience studying the biology of natural killer (NK) cells and other immune effector cells and their use in clinical immunotherapy with over 300 peer-reviewed publications. After completing a post-doctoral fellowship in hematology, oncology and transplantation at the University of Minnesota, he joined the faculty in 1991. Previously, he completed an internship and residency in Internal Medicine at the University of Iowa in Iowa City. Dr. Miller received a BSc degree from Northwestern University in Evanston, Illinois and received his M.D. from Northwestern University School of Medicine. Aaron Ring, M.D., Ph.D., is the founder of Simcha Therapeutics and currently serves as associate professor and Anderson Family Chair for Immunotherapy at Fred Hutchinson Cancer Center. Prior to this, he was associate professor of immunobiology at Yale University. His research is focused on understanding and manipulating the communication circuitry of the immune system using precision immunopharmacology and systems immunology. His seminal work identifying the “jamming signal” called IL-18BP produced by tumors that prevents IL-18 binding and activation is the foundation of Simcha’s therapeutic approach. He holds M.D. and Ph.D. degrees from Stanford University. Emmett Schmidt, M.D., Ph.D., is vice president of early oncology development for Merck Research Labs where he oversees more than 46 company collaborations involving more than 95 clinical studies. He joined Merck in 2010 as a senior principal scientist and has continued to take on additional responsibilities in the development of oncology therapies. Prior to joining Merck, Dr. Schmidt was a professor of pediatrics at Harvard Medical School and Massachusetts General Hospital. Dr. Schmidt holds M.D. and Ph.D. degrees from Duke University and earned a M.A in biology from Harvard University. Mario Sznol, M.D., professor of medicine and clinical research leader in the melanoma program and co-leader, cancer immunology program at Yale Cancer Center. Dr. Sznol conducts clinical research for melanoma and kidney cancer patients with a major focus on immunotherapies. Before joining Yale in 2004, Dr. Sznol served as vice president, clinical affairs of Vion Pharmaceuticals where he oversaw development of the company’s anticancer drug candidates. Prior to that, he served as head of the Biologics Evaluation Section, Investigational Drug Branch at the National Cancer Institute. Dr. Sznol earned a M.D. from Baylor College of Medicine and a B.S. in biochemistry from Rice University. About Simcha Therapeutics Simcha Therapeutics is a clinical-stage immunobiology company pioneering the development of first-in-class engineered cytokine therapeutics with transformational promise for patients. The company is built on a foundation of scientific rigor to overcome biological challenges in clinically translatable pathways, exemplified by the first decoy-resistant interleukin-18 (IL-18). By unlocking the potential of IL-18, Simcha is developing its lead program (ST-067) as monotherapy and in combination with potentially several other anticancer agents. ST-067 is currently being studied both as a monotherapy and in combination with KEYTRUDA® (pembrolizumab) in Phase 1/2 clinical trials, in patients with solid tumors and who have progressed on other immunotherapeutic agents. Simcha is seeking to explore additional modalities for IL-18-based therapeutics and capture the full potential of this potentially transformational cytokine. For more information, please visit .

CAMBRIDGE, Mass.--( BUSINESS WIRE )--PROMETRIKA, LLC has announced that it has expanded its strategic regulatory consulting services under the leadership of Aileen Ryan, MS, Senior Regulatory Advisor, who has been providing regulatory consulting services to PROMETRIKA’s client companies on a part-time basis for the past 2 years has now joined the company on a full-time basis. Ms. Ryan brings to this position over 40 years of diverse experience in pharmaceutical regulatory affairs, including regulatory strategy, submission preparation (IND/NDA/BLA/MAA), and health authority interactions. Her experience spans submissions in the US, Canada, EU, and Japan. Other leadership roles have included supervision of clinical quality assurance, medical writing, and safety functions. At PROMETRIKA, Ms. Ryan will spearhead regulatory affairs activities and will be available to provide its sponsors with strategic consulting and regulatory support from the pre-IND phase through marketing application preparation and approval, and continuing with life-cycle management. Ms. Ryan will also be providing the regulatory perspective to PROMETRIKA’s Clinical Operations, Pharmacovigilance, Biostatistics, and Medical Writing functions, which will further enhance PROMETRIKA’s delivery of best-in-class services. “Aileen’s experience and approach are a natural fit for our company,” commented Miganush Stepanians, President & CEO. “As a leader in regulatory affairs, she has always excelled at translating business and scientific objectives by providing regulatory support and guidance to clinical plans, ensuring high levels of quality and efficiency. This approach is one of the many reasons I am excited to have her join our leadership team.” Prior to joining PROMETRIKA, Ms. Ryan’s leadership roles have included Head of Regulatory Affairs and Compliance at the Ludwig Institute for Cancer Research, Vice President of Regulatory Affairs at Allos Therapeutics, Ophtherion, and Vion Pharmaceuticals, and Head of Global Regulatory Strategy for Oncology at Bayer Pharmaceuticals. Her work has covered drugs, biologics, and devices across a wide range of therapeutic areas. Recent areas of focus have centered on oncology, particularly early phase studies of immunotherapy treatments. “I am eager to bring my years of experience to PROMETRIKA and its clients,” said Ms. Ryan “I am equally as enthusiastic to be part of an organization that sees the value in a collaborative team approach to clinical trials, and look forward to working with the entire team.” Ms. Ryan received her Bachelor of Science degree in Biochemistry from the University Massachusetts at Amherst and a Master’s of Science in Basic Medical Sciences from New York Medical College. About PROMETRIKA, LLC - www.prometrika.com Founded in 2003 and based in Cambridge, Massachusetts, PROMETRIKA is a unique Clinical Research Organization (CRO), utilizing a collaborative approach to clinical development and execution with a close‑knit, highly‑experienced senior leadership team involved in all phases of trials. PROMETRIKA’s services include complete clinical operations and clinical trial management, data management, pharmacovigilance, biostatistics and programming, medical writing, and regulatory submissions.