FDA Clears IND Application for Humanized Gamma-Delta BiTE Antibody

By Leah Lawrence - Last Updated: November 16, 2022

The U.S. Food and Drug Administration (FDA) has cleared the investigational new drug (IND) application for LAVA-051, humanized Gammabody designed to activate both Vγ9Vδ2 T cells and type 1 NKT cells to kill CD1d-expressing tumor cells. This drug candidate is being tested for the treatment of relapsed or refractory chronic lymphocytic leukemia (CLL), multiple myeloma (MM), and acute myeloid leukemia (AML).

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According to a press release, LAVA-051 consists of two single domain antibodies linked via a short five amino acid glycine-serine linker. One domain antibody recognizes the Vδ2 chain of the Vγ9Vδ2 T cell receptor, and the other domain antibody is specific for CD1d, a glycoprotein involved in the presentation of (glyco)lipid antigens to distinct T-cell populations, including type 1 NKT cells, and that can be expressed on a wide range of hematological malignancies, including CLL, MM, and AML.

A phase I/IIa trial of LAVA-051 includes patients with relapsed or refractory CLL and multiple myeloma. AML patients will be included later in the study.

LAVA-51 also received Orphan Drug Designation for the treatment of CLL.

“FDA clearance of our IND application for LAVA-051 marks the second IND for LAVA and enables us to expand patient enrollment into the United States for our ongoing phase I/IIa 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.”

Source: Lava Therapeutics Press Release, May 2022

Post Tags:BiTEFDAIND
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