LAVA Doses First Patient in Phase 1 LAVA-1266 Study in Hematological Cancers

Core Insights - LAVA Therapeutics N.V. has initiated dosing of the first patient in a Phase 1, first-in-human study of LAVA-1266, a CD123-targeted Gammabody for treating hematologic cancers such as acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) [1][4] - The company is optimistic about LAVA-1266's preclinical safety and efficacy profile, which demonstrated tumor cell lysis with limited off-target effects [1][3] - Initial results from the dose escalation study are expected by the end of 2025 [7] Company Overview - LAVA Therapeutics is a clinical-stage immuno-oncology company focused on developing bispecific gamma-delta T cell engagers using its proprietary Gammabody platform [6] - The company aims to selectively kill cancer cells by activating Vγ9Vδ2 T cell anti-tumor functions [6] Product Details - LAVA-1266 is designed to target CD123+ tumor cells and engage Vγ9Vδ2-T cells, showing high potency and a wide therapeutic window [2] - Preclinical studies confirmed that LAVA-1266 preferentially targets and kills CD123+ cells while inducing Vγ9Vδ2-T cell activation, leading to significant tumor cell lysis and increased survival in AML models [3] Clinical Study Information - The Phase 1 study is open-label and multi-center, enrolling approximately 50 adults with CD123+ relapsed/refractory AML and certain grades of MDS [4][5] - Patients will receive doses every two weeks, starting with an initial target dose of 100 µg for the first cohort [4] Pipeline Overview - LAVA's pipeline includes three clinical-stage bispecific gamma-delta T cell engagers targeting various cancers, including LAVA-1266 for CD123+ cancers, PF-08046052 for EGFR, and JNJ-89853413 for hematological cancers [8]