LAVA-1266 / LAVA Therap - LARVOL DELTA

A PHASE 1 OPEN-LABEL TRIAL OF LAVA-1266, A CD123-TARGETING BISPECIFIC Vγ9VΔ2-T CELL ENGAGER, IN PATIENTS WITH CD123 POSITIVE RELAPSED/REFRACTORY ACUTE MYELOID LEUKEMIA (AML) AND INTERMEDIATE TO EXTREMELY HIGH-RISK MYELODYSPLASTIC SYNDROME (MDS) (EHA 2025) - P1 | "The primary endpoints are the frequency and severity of AEs using the ASTCT grading for CRS and ICANS and the CTCAE version 5.0 for other DLTs. The secondary endpoints are rates and duration of remission for AML and MDS according to ELN 2022 Criteria and IWG 2023 Response Criteria for Higher-Risk MDS, respectively. Other secondary endpoints include time to relapse, number of patients with a best response of PR or better, number of patients who transitioned to HSCT, the overall survival rate at 6 and 12 months from the first IMP administration, percent change in blast count, PK parameters, incidence and prevalence of anti-LAVA-1266 antibodies.This study will be conducted in Australia and Spain."

Clinical • P1 data • Acute Graft versus Host Disease • Acute Myelogenous Leukemia • Bone Marrow Transplantation • Chronic Graft versus Host Disease • Graft versus Host Disease • Hematological Malignancies • Immunology • Leukemia • Myelodysplastic Syndrome • Oncology • CD123 • IL3RA

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

LAVA Announces Evaluation of Strategic Options (GlobeNewswire) - "LAVA will continue to enroll in the Phase 1 clinical study evaluating the safety and pharmacokinetics of LAVA-1266 in hematologic malignancies, including acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS), and support its partnerships with Pfizer and Johnson and Johnson....The Company will explore and evaluate diverse strategic options to maximize shareholder value, including in-licensing of assets, a sale, licensing agreement, merger, acquisition, or other strategic transactions. There can be no assurance that this process will result in any such transaction."

Commercial • Enrollment status • Acute Myelogenous Leukemia • Myelodysplastic Syndrome

LAVA Doses First Patient in Phase 1 LAVA-1266 Study in Hematological Cancers (GlobeNewswire) - "LAVA Therapeutics N.V...announced dosing of the first patient in the Phase 1, first-in-human study of the CD123-targeted Gammabody, LAVA-1266, an investigational agent in development for the treatment of hematologic cancers including acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS)....'We are eager to evaluate the safety, pharmacokinetics and pharmacodynamic properties and potential activity of LAVA-1266 and provide initial results from the dose escalation study by the end of the year.'"

P1 data • Trial status • Acute Myelogenous Leukemia • Myelodysplastic Syndrome

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 clinical trial to assess the safety, distribution, effects on certain immune cells and anti-leukaemia effects of LAVA-1266 in patients with acute myeloid leukaemia or certain types of myelodysplastic syndrome (ANZCTR) - P1 | N=50 | Not yet recruiting | Sponsor: LAVA Therapeutics N.V.

New P1 trial • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology • IL3RA

LAVA Reports Second Quarter 2024 Financial Results and Business Update (GlobeNewswire) - "LAVA-1266: Planning to initiate the Phase 1 trial of LAVA-1266 by year-end 2024 in Australia."

New P1 trial • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology

LAVA Provides Business Updates and Reports Fourth Quarter and Year-End Financial Results (GlobeNewswire) - "LAVA 1207 – In Phase 1/2a -- Next update expected H2 2024 targeting a medical conference....The first-in-human Phase 1/2a clinical trial is enrolling patients in monotherapy and combination arms; Completed enrollment in dose level 9 monotherapy arm. Expect to begin enrolling in the dose escalation and dose expansion arm, in combination with KEYTRUDA (pembrolizumab) in the coming months....LAVA-1266 – IND Submission Expected in Q2 2024."

IND • P1/2 data • Trial status • Acute Myelogenous Leukemia • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Hematological Malignancies • Leukemia • Metastatic Castration-Resistant Prostate Cancer • Myelodysplastic Syndrome • Oncology • Prostate Cancer • Solid Tumor

LAVA Therapeutics Provides Business Update and Reports Second Quarter Financial Results (GlobeNewswire) - "Recent Pipeline and Business Highlights: (i) LAVA-051: Additional clinical data are expected in the fourth quarter of 2022; (ii) LAVA-1207: Initial Phase 1 data readout is expected in the fourth quarter of 2022; (iii) LAVA-1266, a CD123 Gammabody for the treatment of hematologic malignancies: A CTA and/or IND is planned for late 2023."

IND • P1 data • Genito-urinary Cancer • Hematological Malignancies • Oncology • Prostate Cancer • Solid Tumor

LAVA Therapeutics Provides Business Update and Reports Fourth Quarter and Year End 2021 Financial Results (GlobeNewswire) - "Early-Stage Pipeline Development: In addition to LAVA’s two lead programs, the Company is developing a portfolio of earlier stage Gammabody™ programs including LAVA-1223, a Gammabody™ directed at the epidermal growth factor receptor (EGFR) for the treatment of solid tumors, for which a clinical trial application (CTA) is planned for late 2022....LAVA today announces the addition of LAVA-1266, a CD123 Gammabody™, to its pipeline for the treatment of hematological malignancies. A CTA is planned for late 2023."

Non-US regulatory • Oncology • Solid Tumor