On June 14, 2023 LAVA Therapeutics N.V. (Nasdaq: LVTX), a clinical-stage immuno-oncology company focused on developing its proprietary Gammabody platform of bispecific gamma-delta T cell engagers, reported its decision to rationalize its pipeline and prioritize its lead solid tumor program (Press release, Lava Therapeutics, JUN 14, 2023, View Source [SID1234632728]). The Company will continue to advance LAVA-1207, its Gammabody program designed to target the prostate-specific membrane antigen (PSMA) as well as earlier stage programs. The ongoing clinical trial of LAVA-051 targeting CD1d expressing hematological tumors, including multiple myeloma (MM), chronic lymphocytic leukemia (CLL), and acute myeloid leukemia (AML) will be discontinued (NCT04887259).
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LAVA-051 was being evaluated in an open-label, muti-center Phase 1/2a clinical trial in patients with relapsed or refractory CLL and MM to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and preliminary anti-tumor activity of LAVA-051. The decision to discontinue LAVA-051’s clinical trial follows a recent review of the competitive landscape that has continued to evolve. The decision is not due to safety concerns.
"We started this trial to investigate the potential for a bispecific gamma-delta T cell engager to help patients with hematological malignancies. We are pleased the trial data to date showed a favorable safety profile, gamma delta T cell activation, and early signals of potential anti-tumor activity in CLL and MM," said Steve Hurly, chief executive officer at LAVA. "However, there have been significant advancements in the treatment of multiple myeloma and chronic lymphocytic leukemia. As a result, we have decided to discontinue this trial and focus our resources on LAVA-1207, partnered programs, and our pipeline. This is a decision to prioritize our programs with the greatest potential to benefit patients. We are grateful to the patients, their families, and the investigators who participated in the trial and contributed to this research on the Gammabody platform. We garnered a lot of knowledge from this trial and are resolute in our commitment to apply these learnings to the Gammabody platform, to contribute to the development of immuno-oncology products to treat patients with cancer in areas of unmet need."
LAVA-1207 is a Gammabody designed to target the prostate-specific membrane antigen (PSMA) to trigger the potent and preferential killing of PSMA-positive tumor cells in patients with metastatic castration-resistant prostate cancer (mCRPC). The ongoing Phase 1/2a study of LAVA-1207 in patients with therapy refractory mCRPC has thus far demonstrated a favorable safety profile as well as preliminary signs of anti-tumor activity with disease stabilization and PSA reduction during dose escalation in this heavily pretreated patient population.
Dr. Charles Morris, LAVA’s Chief Medical Officer, added, "We are excited about the potential for LAVA-1207 in patients with mCRPC. Immunotherapies have yet to firmly establish a role in the treatment of mCRPC and there is a clear unmet need for new therapies in patients who have progressed on currently approved treatments. Enrollment in our Phase 1/2a study of LAVA-1207 has been encouraging and we remain optimistic about the potential for the Gammabody platform."
The Company expects that the discontinuation of this LAVA-051 trial and its focus on the LAVA-1207 program will result in cost savings that will extend its cash runway further into 2026.