JNJ-3413 / J&J, LAVA Therap - LARVOL DELTA

Discovery of JNJ-89853413, a First-in-Class CD33xVδ2 T-Cell Engager for the Treatment of Acute Myeloid Leukemia (ASH 2024) - "In addition, JNJ-89853413 inhibited tumor growth of disseminated AML in in vivo regression xenograft models with expanded enriched Vδ2 T cells as effectors. Taken together, JNJ-89853413 represents a novel potential best- and first-in-class opportunity for AML immunotherapy that is progressing to clinical trials with a potential for cure and improved tolerability compared to existing treatments."

IO biomarker • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology • CD33 • CD34

Johnson & Johnson (J&J) Partnered Program (JNJ-89853413) - Phase 1 Trial (NCT06618001) (GlobeNewswire) - "J&J is enrolling patients in a Phase 1, open label, multi-center trial, currently underway in Canada and Spain. The trial includes a dose escalation and dose expansion segment to evaluate JNJ-89853413 in approximately 100 adults with R/R AML or R/R higher risk type of MDS."

Trial status • Acute Myelogenous Leukemia • Myelodysplastic Syndrome

LAVA Reports First Quarter 2025 Financial Results, Provides Business Update (GlobeNewswire) - "Enrollment in LAVA-1266 Phase 1 continues to progress...J&J is enrolling patients in a Phase 1, open label, multi-center study, underway in Canada and Spain. The study includes a dose escalation and dose expansion segment to evaluate JNJ-89853413 in approximately 100 adults with relapsed/refractory (R/R) AML or R/R higher risk of MDS; Pfizer is enrolling patients in a Phase 1 open label, multi-center study, underway in the U.S. and UK. The study is intended to evaluate PF08046052 in approximately 275 subjects...Research and development expenses were $4.2 million and $5.6 million for the quarters ended March 31, 2025 and 2024, respectively. The decrease in the quarter ended March 31, 2025 was primarily due to lower clinical costs associated with the discontinuation of LAVA-1207, announced in December 2024, slightly offset by accruals related to restructuring activities and startup activities for LAVA-1266."

Commercial • Enrollment status • Acute Myelogenous Leukemia • Myelodysplastic Syndrome • Solid Tumor

Johnson & Johnson (J&J) Partnered Program (JNJ-89853413) (GlobeNewswire) - "Milestone: Development milestone of $5 million received from J&J in Q4 2024 related to the IND filing for JNJ-89853413."

Commercial • Oncology

A Study of JNJ-89853413 for Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Neoplasms (clinicaltrials.gov) - P1 | N=100 | Recruiting | Sponsor: Janssen Research & Development, LLC | Not yet recruiting ➔ Recruiting

Enrollment open • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology

LAVA…Announces Pipeline Reprioritization and Cash Runway Extension into 2027 (GlobeNewswire) - "Reprioritized pipeline to focus on LAVA-1266, with continued support for partnered programs with Pfizer (PF-08046052) and Johnson and Johnson (JNJ-89853413)....'LAVA is well capitalized, with approximately $79 million in cash, and with this pipeline reprioritization, we expect our cash balance to fund the Company into 2027.'"

Financing • Pipeline update • Acute Myelogenous Leukemia • Myelodysplastic Syndrome • Solid Tumor

LAVA Reports Third Quarter 2024 Financial Results and Announces Pipeline Reprioritization and Cash Runway Extension into 2027 (GlobeNewswire) - "Portfolio Highlights: LAVA-1266 – In Phase 1 Trial (ACTRN12624001214527)...Current Status: Phase 1 dose escalation study initiated in Australia...Johnson and Johnson has filed with health authorities to start a Phase 1 study. Johnson & Johnson presented preclinical data for JNJ-89853413 at the Annual Meeting of the American Society of Hematology (ASH 2024) on December 7, 2024 (Abstract 2054: 2054)....Development milestone of $5 million received from Johnson and Johnson in Q4 2024 related to the IND filing for JNJ-89853413."

Financing • New P1 trial • Preclinical • Trial status • Acute Myelogenous Leukemia • Myelodysplastic Syndrome

A Study of JNJ-89853413 for Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Neoplasms (clinicaltrials.gov) - P1 | N=100 | Not yet recruiting | Sponsor: Janssen Research & Development, LLC | Trial completion date: Jul 2027 ➔ Aug 2028

Trial completion date • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology