Tr1X recently 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. And the funding was led by The Column Group, with participation from NEVA SGR and Alexandria Ventures. The company appointed William Lis as Chief Executive Officer, strengthened its leadership team with other biopharma industry veterans, and announced a Board of Directors and Scientific Advisory Board members.
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. And Tr1 cells, a differentiated subpopulation of regulatory T cells, are crucial for maintaining homeostasis and tolerance in healthy individuals and have several important functions. This includes dampening local inflammation and downregulating the inflammasome, suppressing 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, enabling 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 the 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. And the company is developing additional pipeline programs to treat inflammatory bowel disease, Type 1 diabetes and multiple B-cell mediated autoimmune diseases.
Chief Executive Officer William “Bill” Lis has over 25 years of biotech executive leadership experience in building companies and product pipelines from R&D stage through commercialization. And 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 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 in 2020. Previously, Lis held executive positions at Scios (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, COR Therapeutics, and Rhone Poulenc Rorer. He is a director of Zai Laboratories.
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. And 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 also 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. Before 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.
Along with Lis, Dr. Roncarolo and 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 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
KEY QUOTES:
“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. 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.”
– Leon Chen, Ph.D., MBA, Partner at The Column Group and Tr1X Board Member
“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. 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.”
– Dr. Roncarolo, Scientific Founder, President and Head of R&D at Tr1X
“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. 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.”
– William Lis, CEO of Tr1X
