On December 10, 2022 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, reported a poster presentation highlighting updated data, including safety, pharmacodynamics (PD) and pharmacokinetics (PK) from the ongoing Phase 1/2a clinical trial of LAVA-051 in patients with relapsing/refractory (R/R) chronic lymphocytic leukemia (CLL) and multiple myeloma (MM) at the 64th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition, taking place in New Orleans, Louisiana and virtually December 10–13, 2022 (Press release, Lava Therapeutics, DEC 10, 2022, View Source [SID1234625024]). The presentation includes initial data from patients receiving LAVA-051 subcutaneously, along with updates on the intravenous dosing-cohorts.

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"To date, the Phase 1 data, as presented, showed that dose escalation of LAVA-051 up to 200 µg could be achieved in patients with R/R MM and CLL without evidence of dose-limiting toxicity and cytokine release syndrome (CRS). Often, such toxicities are a significant safety challenge for T-cell engager therapies," said Arnon Kater, M.D., Ph.D., chairman of the Dutch/Belgium HOVON CLL working group and professor of translational hematology at the Amsterdam University Medical Center, and LAVA-051 clinical trial investigator. "I am pleased that this first clinical study with a gamma delta T-cell engager has progressed into more relevant dose levels." In the phase 1/2a study of LAVA-051 in patients with relapsed/ refractory (R/R) CLL, MM and AML (NCT04887259), the primary objectives are to investigate safety and tolerability of LAVA-051 and determine the recommended Phase 2 dose (RP2D) of LAVA-051. The secondary objectives include evaluation of PK, PD, immunogenicity, and preliminary anti-tumor activity.

In addition to the favorable safety profile demonstrated as of the data cutoff (November 11, 2022), LAVA-051 showed predictable and linear pharmacokinetics and on-mechanism pharmacodynamic parameters consistent with Vγ9Vδ2-T cell engagement, including increasing occupancy of patient Vγ9Vδ2-T cells with LAVA-051 and consistent increases in the expression of T-cell activation markers. Moreover, potential signs of clinical activity of LAVA-051 were seen.

"The LAVA Therapeutics team is committed to transforming treatment for people living with cancer," said Stephen Hurly, president and chief executive officer of LAVA Therapeutics. "We are pleased with the encouraging findings so far from this clinical trial and dose escalation is continuing in the US and EU. I am excited about the potential of LAVA-051 as a novel therapy that may overcome the challenges associated with current T cell-engager approaches."

Details of the poster presentation session are as follows:

Abstract #: 2014
Abstract Title: LAVA-051, a Novel Bispecific Gamma-Delta T-Cell Engager (Gammabody), in Relapsed/Refractory MM and CLL: Pharmacodynamic and Early Clinical Data
Session Name: Cellular Immunotherapies: Early Phase and Investigational Therapies: Poster I
Session #: 704
Session Date: Saturday, December 10, 2022
Session Time: 5:30 p.m.–7:30 p.m. CT
Presenter: Arnon P. Kater, M.D., Ph.D., chairman of the Dutch/Belgium HOVON CLL working group and professor of translational hematology at the Amsterdam University Medical Center

A PDF copy of the presentation is available here.

About LAVA-051
LAVA-051 is a humanized Gammabody designed to activate both Vγ9Vδ2 (Vgamma9 Vdelta2) T cells and type 1 NKT cells to kill CD1d-expressing tumor cells. 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, that can be expressed on a wide range of hematologic malignancies, including chronic lymphocytic leukemia, multiple myeloma, and acute myeloid leukemia.