Tr1X, Inc. Announces $75 Million Series A Financing to Develop Best-in-Class Universal Allogeneic Regulatory T (Treg) and CAR-Treg Cell Therapies to Treat and Potentially Cure Autoimmune and Inflammatory Diseases

• Financing led by The Column Group, with participation from NEVA SGR and Alexandria Ventures, will enable immediate and expedited execution to advance Tr1X’s proprietary pipeline of first-of-their kind allogeneic engineered Treg and CAR-Treg cell therapies to treat major autoimmune diseases affecting millions of patients worldwide
• Tr1X’s products are the first engineered Tr1 therapeutics to be derived from universal donors to recapitulate function of naturally occurring Tr1 cells
• Industry veterans and leading experts William Lis appointed CEO and Director; Scientific Founder Maria Grazia Roncarolo, M.D., appointed President and Head of R&D and Director; Tao Fu, MBA, and Katherine A. High, M.D., appointed Independent Directors
• Company expects to be in Phase 1 clinical trials in multiple indications in 2024

SAN DIEGO, Jan. 17, 2024 /PRNewswire/ -- 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:

• Leon Chen, Ph.D., MBA, Partner, The Column Group
• Jan E. de Vries, Ph.D., (observer), Co-Founder of Tr1X; a renowned immunologist responsible for the development of six blockbuster drugs, including Beyfortus™, Gilenya^®, Elidel^®, Ilaris^®, Mayzent^® and Cosentyx^®; former CEO of AIMM Therapeutics; and former Head of the Novartis Institutes for Biomedical Research Basel
• Katherine A. High, M.D., a pioneering scientist in the realm of gene therapies for genetic disease; Director of Incyte and CRISPR Therapeutics; Co-Founder, former Board member, President and Head of R&D at Spark Therapeutics; Emeritus Professor at the Perelman School of Medicine at the University of Pennsylvania; and former Director of the Center for Cellular and Molecular Therapeutics at the Children’s Hospital of Philadelphia
• Tao Fu, MBA, M.S., Founder and Chief Executive Officer of Attovia Therapeutics; former President and Chief Operating Officer of Zai Lab; and former Head of M&A Business Development and Alliance Management at Bristol Myers Squibb and Johnson and Johnson

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:

• Richard A. Flavell, Ph.D., FRS, (chair), the Sterling Professor of Immunobiology at Yale University School of Medicine, and an Investigator of the Howard Hughes Medical Institute
• Vijay Kuchroo, D.V.M., Ph.D., the Samuel L. Wasserstrom Professor of Neurology at Harvard Medical School; Senior Scientist at Brigham and Women’s Hospital; Co-Director of the Center for Infection and Immunity at the Brigham Research Institutes, Boston; and founding Director of the Evergrande Center for Immunologic Diseases at Harvard Medical School and Brigham and Women’s Hospital
• Luigi Naldini, M.D., Ph.D., Professor of Cell and Tissue Biology and of Gene and Cell Therapy at the San Raffaele University School of Medicine and Scientific Director of the San Raffaele Telethon Institute for Gene Therapy in Milan, Italy
• Marco Londei, M.D., former Chief Executive Officer of Gadeta; former Chief Development Officer and Chief Medical Officer of AnaptysBio; and former Therapeutic Area Head, Immunosciences, at Bristol Myers Squibb

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.

Investor Contact:
Tr1X Investor Relations
investors@tr1x.bio

Media Contact:
Julie Normart
jnormart@realchemistry.com

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