LAVA Therapeutics Announces FDA IND Clearance for LAVA-051 for the Treatment of Hematologic Malignancies
UTRECHT, The Netherlands and PHILADELPHIA, May 12, 2022 (GLOBE NEWSWIRE) -- 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 to transform the treatment of cancer, today announced that the U.S. Food and Drug Administration (FDA) has cleared its investigational new drug (IND) application for LAVA-051, the Company’s lead product candidate for the treatment of relapsed or refractory chronic lymphocytic leukemia (CLL), multiple myeloma (MM) and acute myeloid leukemia (AML).
“FDA clearance of our IND application for LAVA-051 marks the second IND for LAVA and enables us to expand patient enrollment into the U.S. for our ongoing Phase 1/2a clinical trial,” said Stephen Hurly, president and chief executive officer of LAVA Therapeutics. “Supported by encouraging preclinical and preliminary clinical data, we believe in the potential of LAVA-051 to address unmet patient needs. We look forward to providing updates at the 2022 ASCO Annual Meeting, where we will present additional interim data from the dose-escalation phase of this trial.”
The Phase 1/2a clinical trial currently includes patients with relapsed or refractory CLL and MM. AML patients will be included later in the study. In October 2021, the FDA granted Orphan Drug Designation for LAVA-051 for the treatment of CLL.
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