The California Institute for Regenerative Medicine (CIRM) in California, US, has awarded an $8m grant to biotechnology company Tr1X to support its Phase I/IIa trial of TRX103, a drug designed to prevent graft-versus-host disease (GvHD) in individuals with blood cancer.
The trial of the allogeneic engineered type 1 regulatory (Tr1) Treg cell therapy is intended for individuals who are undergoing ‘mismatched’ stem cell transplants.
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Last year, the CIRM granted $4m to Tr1X for its late-stage preclinical research, which aimed to progress the therapy to human trials.
Subjects are currently being enrolled at stem cell transplant centres across the US. The trial involves a one-time infusion of the cell therapy to treat subjects undergoing haploidentical or mismatched transplants.
Tr1X’s data from the first two subject cohorts have shown ‘positive’ initial persistence and safety, with further data expected later this year.
Tr1X president, co-founder and head of research and development Dr Maria Grazia Roncarolo is leading the trial.
Dr Roncarolo said: “With CIRM’s support, TRX103 has rapidly advanced from promising preclinical findings into clinical trials, bringing us closer to transforming mismatched stem cell transplants into safer, life-saving options.
“By harnessing the unique power of engineered Tr1 cells, our goal is to prevent graft-versus-host disease, improve immune reconstitution and induce tolerance to host cells—therefore expanding access to curative therapies for patients who urgently need them.”
Tr1X said that TRX103 could enhance transplant accessibility for patients who lack a matched donor while also minimising GvHD risks.
The drug is an off-the-shelf engineered T cell product derived from healthy donor clusters of differentiation 4+ (CD4+) cells.
It is also being studied in a Phase I/IIa trial for individuals with treatment-refractory Crohn’s disease.
Last July, Tr1X dosed the first subject in the TRX103-01 clinical trial to assess TRX103’s ability to prevent GvHD.
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