- LAVA Therapeutics NV LVTX announced initial data from its first clinical study with LAVA-051.
- The presentation will include data from the first three cohorts of the LAVA-051 Phase 1/2a trial, along with preclinical data on its two lead programs, LAVA-051 and LAVA-1207.
- The first three dose-escalation cohorts showed LAVA-051 to be safe and well-tolerated with no dose-limiting toxicities or observed cytokine release syndrome.
- Per the study protocol, the cohort three dose was 33-times that of the cohort one dose.
- Drug exposure and Vγ9Vδ2, T cell receptor occupancy of LAVA-051, increased with LAVA-051 dose increases and peripheral blood Vγ9Vδ2 T cells also expressed higher levels of activation markers after LAVA-051 dosing.
- One patient with chronic lymphocytic leukemia (CLL) experienced multiple enlarged tender diseased lymph nodes one week after first dosing that subsequently regressed, reminiscent of tumor flare.
- Additional data from the dose-escalation phase of the trial is expected in Q2 of 2022 and from the disease-specific expansion cohorts in 2H of 2022.
- In October last year, the FDA granted orphan drug designation to LAVA-051 to treat chronic lymphocytic leukemia (CLL).
- The Phase 1/2a trial for LAVA-051 is initially being conducted in Europe. LAVA expects to file an Investigational New Drug (IND) application with the FDA, if accepted, will subsequently include patients in the U.S.
- Price Action: LVTX shares are up 5.14% at $4.61 during the market session on the last check Monday.
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