Dive Brief: Biotechnology company Tr1x on Wednesday became the latest startup to raise tens of millions of dollars in venture funding to develop a new type of cell therapy for autoimmune conditions. The San Diego-based startup launched with $75 million and plans to advance a pipeline of regulatory T cell, or “Treg,” therapies for graft-versus-host disease, inflammatory bowel disease and other disorders. It plans to begin multiple clinical trials later this year, according to a statement. Tr1x is led by Bill Lis, the longtime CEO of Portola Pharmaceuticals, a biotech Alexion Pharmaceutical acquired in 2020. It’s built on research by Maria Grazia Roncarolo, a Stanford Medicine scientist credited for discovering the type of immune cells — Tr1 cells — that are the company’s focus. Dive Insight: Cell therapy is evolving and Tr1x’s emergence is the latest proof. The first generation of treatments, among them the blood cancer therapies Kymriah and Yescarta, created blueprints for future research. They showed how an effective treatment could be made by genetically altering a patient’s cells to boost their disease-fighting capabilities. Researchers, biotech startups and larger drugmakers have tried to build on that success in multiple ways. Some have tried to develop more convenient “off-the-shelf” alternatives to the personalized CAR-T therapies, like Yescarta, that have proven successful. Others have experimented with different types of cells, hoping to capitalize on their unique characteristics in different diseases. Tr1x is part of the latter group. It’s one of several well-funded startups, like Sonoma Biotherapeutics and Quell Therapeutics, to launch with plans to modify Treg cells, a specialized type of immune cell. These therapies are designed to rebalance the immune systems of patients with autoimmune conditions. Developers believe they could help produce long-lasting effects without impairing the immune system’s ability to ward off infections. Though their work remains early, several companies have drawn the interest of larger drugmakers. Regeneron, AstraZeneca and Bristol Myers Squibb have each formed partnerships with young Treg cell therapy developers over the last few years. Tr1x’s twist is a focus on “Type 1 regulatory” or Tr1 cells, a subset of Treg cells that suppress inflammation and are thought to be important in autoimmune disease. It is developing a technology that’s designed to convert donor-derived T cells into Treg-like cells that “have a similar function and profile” to natural Tr1 cells, the company said. Tr1x claims these cells can be engineered to target specific tissues or organs, and that it has the capability to manufacture them at scale. If successful in testing, they could address shortcomings of other cell therapies in autoimmune diseases, such as a limited ability to persist in the body, CEO Lis said in the statement. Roncarolo, in an email, added that the cells Tr1X is engineering have certain “homing and trafficking capabilities to sites of inflammation” that other Treg cells don’t. Like its rivals, though, Tr1x hasn’t yet proven its approach can work in patients. Its first therapy, for graft-versus-host disease, should begin a Phase 1 trial later this year.
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