Tr1X Announces First Patient Dosed in Proof of Concept GvHD Trial Evaluating TRX103, a First-in-Class Type 1 Treg (Tr1) Cell Therapy
July 10 2024 - 8:00AM
Tr1X, Inc. (pronounced “Trix”), a biopharmaceutical company
developing engineered Treg and CAR-Treg cell therapies, announced
the successful dosing of the first patient in the company’s
TRX103-01 proof of concept trial for prevention of Graft versus
Host Disease (GvHD) and improved outcomes in patients with
hematologic malignancies undergoing mismatched hematopoietic stem
cell transplantation (HSCT).
The study’s primary goal is to determine the safety,
pharmacokinetics and pharmacodynamics of TRX103. The secondary goal
of the study is to create immune tolerance to prevent GvHD and
improve HSCT outcomes. The first patient had no serious adverse
events, and the multi-center dose escalation trial continues to
enroll.
TRX103, a first-in-class Type 1 Treg (Tr1) cell therapy, is
specifically designed for patients with autoimmune and inflammatory
disorders, including those undergoing HSCT. TRX103 is an
off-the-shelf, engineered Type 1 Treg (Tr1) cell therapy designed
to reduce inflammation, prevent harmful T cell proliferation, and
reset the immune system. This therapy harnesses unique properties
of Tr1 cells that include trafficking to inflamed tissues and lymph
nodes, lowering of inflammatory cytokines, control of harmful T
cell responses, and creation of immune tolerance.
Compared to other cell therapies, such as effector CAR-T cells,
TRX103 Treg cells aim to treat autoimmune diseases with fewer side
effects, potentially without the need for lymphodepletion. These
cells are naturally shielded from the immune system, enhancing
their persistence and minimizing potentially dangerous immune
response.
“This first patient to receive an allogeneic engineered Tr1 cell
therapy, TRX103, is a significant achievement for our company, our
scientists, and the field of cell and gene therapy,” said Maria
Grazia Roncarolo, Co-founder, President and Head of Research and
Development at Tr1X. “This is a key step in advancing our pipeline.
We believe our allogeneic Tr1 Treg and CAR-Treg therapies can
overcome the limitations of current treatments by controlling
harmful T cells and B cells and creating immune tolerance,
potentially curing a wide range of autoimmune and inflammatory
disorders.”
The TRX103-01 study builds on academic research that has shown
the safety and efficacy of Tr1 Treg cell therapies for various
autoimmune and inflammatory conditions, including prevention of
GvHD and treatment of severe inflammatory bowel disease. The
company has produced enough clinical doses from its first
manufacturing runs using its proprietary closed process to complete
the trial, which is designed to treat up to 36 patients with a
one-time infusion of TRX103.
Tr1X also plans to file an IND for TRX103 for
treatment-refractory Crohn’s Disease in the second half of
2024.
About TRX103 TRX103 is an investigational
allogeneic off-the-shelf engineered T cell product generated from
CD4+ cells sourced from healthy donors. These CD4+ cells are
engineered to become cells that mimic the function of Tr1
regulatory T cells, called TRX cells. Tr1X is developing TRX103 for
the treatment of several immune and inflammatory disorders.
Multiple preclinical studies have shown TRX103 to be tolerable and
effective and to have the potential to reset the immune system to a
healthy state. TRX103 has the potential to overcome major
limitations of current cell therapies for autoimmune diseases,
which include limited persistence and side effects including
cytokine release syndrome (CRS) and neurotoxicity.
About Tr1X Tr1X is a private biotechnology
company focused on curing immune mediated and inflammatory
diseases. Founded by industry experts, including the scientists who
discovered Tr1 cells, the company is developing a pipeline of
off-the-shelf allogeneic cell therapies to treat and potentially
cure autoimmune diseases with high unmet medical need. The company
is supported by leading investors, including The Column Group, NEVA
SGR, and Alexandria Venture Investments, and has received
additional grant support from the California Institute for
Regenerative Medicine (CIRM). For more information, visit
www.tr1x.bio.
Investor/Media ContactsInvestors@tr1x.bio