Lava Therapeutics has jettisoned its only wholly owned clinical-stage asset after the blood cancer drug “did not reach Lava’s internal benchmarks.”
The Dutch biotech had been evaluating the candidate, dubbed LAVA-1207, in a phase 1 trial for prostate-specific membrane antigen-positive metastatic castration-resistant prostate cancer (mCRPC). LAVA-1207 is a bispecific gamma delta T-cell engager designed to conditionally activate Vgamma9 Vdelta2 T cells.
Lava teamed up with Merck & Co. at the start of the year to include a Keytruda combination arm as part of the ongoing phase 1/2a trial in patients with mCRPC. But Lava announced Tuesday morning that it has decided to discontinue work on LAVA-1207 due to the phase 1 portion of the trial not reaching the company’s “predetermined success criteria.”
The move was not linked to any safety concerns, stressed Lava, which also alluded to some potentially promising signs from the data.
“Clinical signals recorded in several patients, including PSA reductions and extended time on study for patients with higher baseline circulating Vd2 T cells, as well as the encouraging safety and tolerability profile, are consistent with the intended mechanism of action and support further investigation of the platform,” the biotech said in its third-quarter earnings release.
“Learnings, especially related to the favorable overall safety profile and tolerability of LAVA-1207, will be incorporated into further development of the company’s pipeline programs,” the company added.
“The longer time to progression, with several patients on trial beyond six months, and duration of treatment observed for patients with higher circulating gamma delta2 T cells are consistent with the mechanism of action and supports continued clinical investigation of the platform,” Chief Medical Officer Charlie Morris, M.D., explained in the release.
In LAVA-1207’s absence, Lava will now be bumping up LAVA-1266, which is due to enter the clinic before the end of the year. The CD123-targeting T-cell engager will initially be focused on acute myeloid leukemia and myelodysplastic syndrome.
The company also has an EGFR and bispecific gamma delta T-cell-receptor-targeted therapy for solid tumors in a phase 1 trial in partnership with Pfizer, while a Johnson & Johnson-partnered CD33 and Vδ2 T cells-targeting bispecific gamma delta T-cell engager is being readied for an early-stage study.
With $79 million in the bank, Lava said it expects that canning LAVA-1207 will mean its existing funds stretch into 2027.