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NEW YORK, Feb. 05, 2024 (GLOBE NEWSWIRE) -- Lexeo Therapeutics, Inc. (Nasdaq: LXEO), a clinical stage genetic medicine company dedicated to pioneering treatments for genetically defined cardiovascular diseases and APOE4-associated Alzheimer's disease, today announced new executive appointments to lead the evolution of the company’s pipeline into late-stage clinical development. “The accumulating talent bench at Lexeo has overseen some of the most transformative clinical development programs, drug approvals and product launches in rare disease and precision cardiovascular medicine,” said R. Nolan Townsend, Chief Executive Officer of Lexeo Therapeutics. “We look forward to benefiting from this group’s thought leadership and operational experience as we progress the Lexeo pipeline towards late-stage studies.” The appointments include: Sandi See Tai, MD, has been promoted to Chief Development Officer. Prior to Lexeo, Dr. See Tai was VP & Development Head for Rare Disease at Pfizer, responsible for setting the Rare Disease internal portfolio strategy and delivering its clinical development portfolio of investigational products and in-line assets. She served as the Medicine Team Lead for clinical programs across multiple therapeutic areas including Rare Cardiovascular, Neurology, Renal and Pulmonary disease areas. During her tenure, Dr. See Tai led the late-stage clinical development program of tafamidis for ATTR cardiomyopathy (ATTR-ACT), which achieved global regulatory approvals, and the Phase 3 LMNA dilated cardiomyopathy clinical program. In addition to late-stage clinical development, Dr. See Tai was responsible for strategic clinical planning for early-stage development candidates such as those for other genetic cardiomyopathies and Duchenne Muscular Dystrophy. With almost 20 years of experience in the pharmaceutical industry, Dr. See Tai held multiple roles of increased scope and responsibility across Global Medical Affairs in Transplantation at Wyeth Pharmaceuticals before moving into clinical development at Pfizer. Prior to joining the pharmaceutical industry, Dr. See Tai was Assistant Professor of Pediatrics at Drexel University College of Medicine and Attending Physician in Pediatric Nephrology at St. Christopher’s Hospital for Children, Philadelphia, where she also completed her General Pediatrics residency and Pediatric Nephrology fellowship. She received her MD from Tufts University School of Medicine, Boston.Eric Adler, MD, has been appointed Chief Medical Officer & Head of Research. As a pioneer and thought leader in cardiovascular gene therapy, Dr. Adler formerly served as Chief Scientific Officer at Lexeo since joining in 2022. Prior to this role, Dr. Adler served as Professor of Medicine, head of the Heart Failure Section, Director of the Strauss Center for Cardiomyopathy, and the Czarina and Humberto S. Lopez Chancellor’s Endowed Chair in Cardiology at the University of California, San Diego (UCSD). Dr. Adler’s work has led to the development of a novel cardiovascular gene therapy candidate entering late-stage clinical development. His research is focused on the study and treatment of cardiomyopathy, and he has published over 100 papers in peer reviewed journals on the topic. Dr. Adler is currently an associate editor of Circulation Hearth Failure and has served on leadership, grant review, and guidelines committees for the American Heart Association, the Heart Failure Society of America, the International Society of Heart and Lung Transplant, and the National Institute of Health. Dr. Adler earned his medical degree from the Boston University School of Medicine.Rajiv Patni, MD, has been appointed Senior Advisor to the Chief Executive Officer and Board of Directors of Lexeo. Dr. Patni was formerly Chief Research and Development Officer at Reata Pharmaceuticals (acquired by Biogen for $7.3 billion), a commercial-stage biopharmaceutical company that received approval for Skyclarys, the first FDA-approved therapy for Friedreich’s ataxia. Prior to this role, Dr. Patni served as Chief Medical Officer at several public, small-cap, commercial-stage biopharmaceutical companies including Portola (acquired by Alexion for $1.4 billion) and Global Blood Therapeutics (acquired by Pfizer for $5.4 billion) and at those companies, Dr. Patni oversaw the clinical studies leading to the approvals of Andexxa and Oxbryta. Dr. Patni joined these companies at inflection points in their research and development growth trajectories and significantly supported their successful acquisitions. Over his 24-year industry tenure in global product development, Dr. Patni has contributed to the development of 21 new chemical entities in several therapeutic areas including cardiology, diabetology, hepatology, neurology, and benign hematology. His experience in fostering successful teams from 35 to 250 colleagues contributed to the approval of 11 medicines from the US FDA, EMA, and other regulatory agencies. The recent approvals include medicines for several rare diseases such as pulmonary arterial hypertension, advanced Parkinson’s disease, sickle cell disease, and Friedrich’s ataxia. Dr. Patni received his MD from the Mount Sinai School of Medicine in New York City as part of an accelerated BS/MD Program. He completed his internal medicine residency and adult cardiology fellowship at the Albert Einstein College of Medicine, also in New York City, where he continued as an attending physician-scientist before joining the biopharmaceutical industry. Jenny R. Robertson has been appointed Chief Business and Legal Officer. Ms. Robertson formerly served as Chief Legal and Administrative Officer at Lexeo, leading legal, human resources, information technology, information security, and facilities strategies and activities. Prior to Lexeo, Ms. Robertson served as Chief Counsel to Pfizer’s Oncology Business Unit and held other senior legal roles including Chief Counsel for Pfizer’s Rare Disease Business Unit, where she led the global legal team for five years. Across positions at Pfizer, Ms. Robertson counseled clients on a range of business and legal matters including commercialization, disclosure, business development, alliance management, clinical development, intellectual property issues and litigation. Before joining Pfizer in 2010, Ms. Robertson spent 10 years in private practice with a large international law firm in New York and Washington, D.C., engaged in complex commercial litigation with a healthcare focus. Ms. Robertson holds a Bachelor of Arts Degree in Political Science from Southern Illinois University and a J.D. from the Georgetown University Law Center, where she co-founded and served as Editor-in-Chief of The Georgetown Journal of Gender and the Law. About Lexeo TherapeuticsLexeo Therapeutics is a New York City-based, clinical stage genetic medicine company dedicated to transforming healthcare by applying pioneering science to fundamentally change how genetically defined cardiovascular diseases and APOE4-associated Alzheimer’s disease are treated. Using a stepwise development approach, Lexeo is leveraging early proof-of-concept functional and biomarker data to advance a pipeline of cardiovascular and APOE4-associated Alzheimer’s disease programs. Media Response:Janine Bogris(201) 245-6838janine.bogris@canalecomm.com Investor Response:Laurence Watts(619) 916-7620laurence@gilmartinir.com

SAN DIEGO, CA, USA I January 17, 2024 I Tr1X, Inc. today announced its emergence from stealth with a $75 million Series A financing to bring universal allogeneic regulatory T (Treg) and CAR-Treg cell therapies to the clinic to treat and potentially cure autoimmune and inflammatory diseases. The financing was led by Bay Area-based The Column Group, with participation from NEVA SGR and Alexandria Ventures. The Company appointed William Lis Chief Executive Officer, strengthened its leadership team with other biopharma industry veterans, and announced members of the Board of Directors and Scientific Advisory Board. "We are thrilled to partner with Bill Lis, Maria Grazia Roncarolo and Tr1X's world-class team to revolutionize the field through its innovative, breakthrough science," said Leon Chen, Ph.D., MBA, Partner at The Column Group and Tr1X Board Member. "With its experienced management team at the helm, we are confident in Tr1X's ability to bring curative cell therapies to patients who currently require life-long treatment and management." Science and Pipeline The Company's science is primarily based on the work of Tr1X's Scientific Founder Maria Grazia Roncarolo, M.D., the discoverer of Type 1 regulatory T (Tr1) cells, which have features that can benefit patients with autoimmune and inflammatory diseases. Tr1 cells, a differentiated subpopulation of regulatory T cells, are crucial for maintaining homeostasis and tolerance in healthy individuals and have several important functions. These include dampening of local inflammation and downregulation of the inflammasome, suppression of pathogenic effector T cell responses, and induction of long-term tolerance as observed in preclinical models and patients. Tr1X's proprietary technology enables the conversion of CD4 + T cells isolated from healthy donors into Treg-like cells that have a similar function and profile to naturally occurring Tr1 cells. These cells can be further engineered to target specific tissues or organs to enable local, targeted immunomodulation. With a proprietary, GMP-grade, closed-loop system that provides consistency, quality and reliability at scale, Tr1X can enable production of its products at commercial volume. Currently, Tr1X is working on its first investigational Tr1 cell therapy, TRX103, which it plans to evaluate in a Phase 1 trial to prevent Graft versus Host Disease (GvHD) in patients undergoing mismatched hematopoietic stem cell transplant. The Company is developing additional pipeline programs to treat inflammatory bowel disease, Type 1 diabetes and multiple B-cell mediated autoimmune diseases. "The ability to develop a pipeline of medicines based on our work on regulatory T cells represents the culmination of decades of discovery and research into the underpinnings of immunological tolerance and autoimmunity," said Dr. Roncarolo, Scientific Founder, President and Head of R&D at Tr1X. "Tr1 cells have unique properties and represent the ideal therapeutic platform from which to develop 'immune reset' products. Our two platforms have the required attributes to address a broad set of indications, including dual targeting of pathogenic T and B cells. These engineered cells have the potential to induce tolerance, which could transform the lives of people living with chronic autoimmune diseases by providing them with a cure instead of ongoing treatment." Proven Leadership Team, Board of Directors and Scientific Advisory Board Tr1X is led by industry veterans with cell therapy expertise who have a track record of discovery, development and commercialization of more than a dozen novel first- or best-in-class medicines. Chief Executive Officer William "Bill" Lis has more than 25 years of biotech executive leadership experience in building companies and product pipelines from R&D stage through commercialization. He most recently served as Chairman and interim CEO of Jasper Therapeutics, Inc., from 2019 to 2022, where he led the company's Series A and follow-on financings and successful brequilimab Phase 1 study readouts in hematopoietic stem cell transplantation. Before that, he served as Chief Executive Officer and a Director of Portola Pharmaceuticals, Inc. from 2008 to 2018 after serving as Chief Operating Officer, where he built the company from a private research-stage startup into a multi-billion dollar public company that launched Andexxa ® and Bevyxxa ® . Portola was acquired by Alexion Pharmaceuticals, Inc. in 2020. Previously, Mr. Lis held executive positions at Scios, Inc. (a Johnson & Johnson company) where he last served as Senior Vice President of New Product Development and Business Development, leading in-licensing efforts, development and commercial P&L operations for Xarelto ® and the company's therapeutics pipeline. Earlier in his career, he held positions at Millennium Pharmaceuticals, Inc., COR Therapeutics, Inc. and Rhone Poulenc Rorer. He is a director of Zai Laboratories, Inc. Scientific Founder, President and Head of R&D Dr. Maria Grazia Roncarolo is the George D. Smith Professor in Stem Cell and Regenerative Medicine, Professor of Pediatrics and Medicine, Founder of the Center for Definitive and Curative Medicine, and former Co-Director of the Institute for Stem Cell Biology and Regenerative Medicine at Stanford University. Dr. Roncarolo has spent her career translating discoveries in immune-mediated diseases and regenerative medicine into novel patient therapies. She and her team were the first to discover Type 1 regulatory T cells in patients and the first to develop curative treatments for ADA-SCID. A pediatric immunologist by training, she was instrumental in bringing novel cell and gene therapies to market, including Strimvelis ® and Libmeldy ® . She is a Co-Founder of the gene-editing companies Graphite Bio and Kamau Therapeutics. Co-Founder and Chief Operating Officer David de Vries has over a decade of experience founding and scaling companies at the intersection of healthcare, biology and technology. Prior to Tr1X, he was Co-Founder and Chief Operating Officer of Arine, a medication intelligence and therapeutic optimization company he helped start, launch and scale to serve millions of patients, working with some of the largest healthcare organizations in the U.S. Previously, he worked at Proteus Digital Health, an innovative drug-device company and the first in the field to obtain FDA approval for a digital medicine, Abilify MyCite ® . "Tr1X is committed to bringing cures to millions of patients suffering from autoimmune diseases through our scalable, universal allogeneic cell therapy process that has been demonstrated to yield billions of cells in a single run," said Mr. Lis, CEO of Tr1X. "In just 18 months, the Tr1X team has successfully closed a Series A financing and extension, assembled an experienced leadership team, board of directors and scientific advisory board, and established a scalable GMP-grade manufacturing process. We are well positioned to advance our pipeline of first-of-their kind allogeneic engineered Treg and CAR-Treg cell therapies that have the potential to address the significant limitations of current cell therapies for autoimmune diseases, which include, among others, poor trafficking, lack of stability, limited persistence and induction of cytokine-associated toxicities, at a fraction of the cost per dose." In addition to Mr. Lis, Dr. Roncarolo and Mr. de Vries, the Tr1X leadership team includes Xavier Paliard, Pharm.D., Ph.D., Chief Scientific Officer; James Adams, MBA, Chief Technical Officer; Jonathan Perrin, J.D., Co-Founder and General Counsel; and Erik Poulsen, M.S., Head of Regulatory Affairs. Joining Mr. Lis and Dr. Roncarolo on Tr1X's Board of Directors are: Tr1X has recruited experts in immunology, stem cell and gene therapy, T-cell biology and immune-mediated diseases to join its Scientific Advisory Board. They include: About Tr1X Tr1X is a privately held biotechnology company focused on engineering cures for immune and inflammatory diseases. Founded by industry veterans, including the scientists behind the discovery of Tr1 cells, the company's pipeline of universal allogeneic cell therapies is being developed for diseases with high unmet medical need. The company is headquartered in San Diego, has developed a robust intellectual property portfolio, and is backed by leading investors, including The Column Group, NEVA SGR and Alexandria Ventures. For more information visit: www.tr1x.bio . SOURCE: Tr1X