NEW YORK – Biomea Fusion this week announced the nomination of a second product candidate, BMF-500, which it wants to explore in clinical trials as a treatment for FLT3-mutated acute myeloid leukemia. Around 30 percent of AML patients have a FLT3 mutation. The company has designed BMF-500, a third-generation FLT3 inhibitor, to be active against FLT3 variants that drive resistance in patients who have stopped responding to first- and second-generation drugs. The Redwood City, California-based firm received clearance from the US Food and Drug Administration last year to start a Phase I trial of its selective irreversible menin inhibitor BMF-219 in advanced AML patients with certain molecular aberrations. Biomea believes BMF-500 may have synergistic activity with BMF-219.
Immatics said this week it is moving its T-cell redirecting cell therapy (TCR-T), dubbed IMA203, into a Phase Ib dose expansion cohort, based on positive findings in the Phase Ia dose escalation portion of the trial. In the Phase Ib portion, Immatics will further evaluate IMA203's safety, biological activity, and initial anti-tumor activity in combination with Bristol Myers Squibb's immune checkpoint inhibitor Opdivo (nivolumab). This part of the study will involve 18 patients with solid tumors enrolled at 10 sites in Germany and the US.
BMS is providing Opdivo for the trial under a clinical supply agreement. IMA203 targets an HLA-A*02-presented peptide derived from PRAME, and the company believes the addition of Opdivo will enhance the potency of its engineered T cells and strengthen antitumor activity in patients. The first patient has been enrolled in the Phase Ib cohort, and Immatics expects the first data readout by year end. The firm is also enrolling patients into a trial of IMA203 as a single agent, which will report data in the second half of this year. Another study, of IMA203CD8, a next-generation cell therapy comprising IMA203-engineered T cells that are co-transduced with a CD8αβ co-receptor, will begin this year and read out initial data by year-end.
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