News Release

Clinical update call featuring LAVA-051 investigator Dr. Arnon Kater and Company management summarized initial Phase 1/2a clinical trial data presented at 2022 ASCO and EHA meetings

UTRECHT, The Netherlands and PHILADELPHIA, June 16, 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, hosted a clinical update call focused on encouraging initial Phase 1/2a clinical data for LAVA-051 in patients with chronic lymphocytic leukemia (CLL) and multiple myeloma (MM) patients following poster presentations at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting held June 3-7, 2022, and the European Hematology Association (EHA) 2022 Congress, held June 9-12, 2022.

“While treatment options for hematologic malignancies such as CLL and MM have advanced in recent years, a large number of patients who do not respond adequately to current therapies need new options,” 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. “Although preliminary, these data support our view of LAVA-051 as a promising therapeutic candidate that has the potential to overcome challenges of existing T-cell approaches which frequently show cytokine release syndrome very close to their efficacious dose. The early clinical data from the first four cohorts presented at this year’s ASCO and EHA meetings demonstrate early signals of potential anti-tumor activity in CLL and MM patients, as well as an attractive safety profile. Importantly, the pharmacodynamic determinations gathered from the patients in this early clinical study reflect the mechanism of action of LAVA-051.”

LAVA’s chief scientific officer, Hans van der Vliet, M.D., Ph.D., and Benjamin Winograd, M.D., Ph.D., chief medical officer, reviewed LAVA-051’s mechanism of action (MOA) and clinical trial design and objectives on the call.

Dr. van der Vliet remarked, “LAVA-051 has been designed to target CD1d, which is expressed on tumors cells in a high proportion of patients with CLL, MM and acute myeloid leukemia (AML), and to selectively activate the strong antitumor properties of both Vγ9Vδ2 (Vgamma9 Vdelta2) T cells and type 1 NKT cells. Based on extensive preclinical work, we believe our approach has the potential to lead to substantial improvement for patients.”       

In the Phase 1/2a clinical study of LAVA-051 in patients with CLL and MM, the primary objectives are to investigate safety and tolerability and determine the recommended Phase 2 dose, while the secondary objectives are to evaluate pharmacokinetics, pharmacodynamics, immunogenicity and preliminary anti-tumor activity. Following intravenous dosing, subcutaneous dosing will also be evaluated. AML patients will be included later in the study.

Dr. Winograd commented, “The LAVA Therapeutics team is intent on transforming treatment for people living with cancer with our Gammabody platform drug candidates. We are encouraged by the early Phase 1/2a clinical data for LAVA-051 as we enroll patients for additional dose-finding cohorts in Europe and the U.S., and we look forward to providing additional clinical data updates in 2022.”

This event follows the Company’s presentation of new early clinical data during poster presentations at the 2022 ASCO Annual Meeting and the EHA 2022 Congress. The ASCO and EHA posters can be found here and here, respectively.

A replay of the presentation is accessible on the “Events” tab on the Investor Relations section of the LAVA Therapeutics website and will be archived for at least 30 days at: https://ir.lavatherapeutics.com/news-events/events.

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.

About LAVA Therapeutics
LAVA Therapeutics N.V. is a clinical stage immuno-oncology company utilizing its proprietary Gammabody™ platform to develop a portfolio of bispecific gamma delta T cell engagers for the potential treatment of solid and hematologic malignancies. The Company utilizes bispecific antibodies engineered to selectively kill cancer cells by triggering Vγ9Vδ2 (Vgamma9 Vdelta2) T cell antitumor effector functions upon cross-linking to tumor-associated antigens. LAVA-051, the Company’s lead candidate for the treatment of multiple myeloma, chronic lymphocytic leukemia, and acute myeloid leukemia, is enrolling patients in a Phase 1/2a clinical study (NCT04887259). A Phase 1/2a clinical study to evaluate LAVA-1207 in patients with metastatic castration-resistant prostate cancer (mCRPC) is also enrolling (NCT05369000). For more information, please visit www.lavatherapeutics.com, and follow us on LinkedIn, Twitter and YouTube.

LAVA’s Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements, including with respect to the company’s anticipated growth and clinical development plans, including the timing of clinical trials. Words such as “anticipate,” “believe,” “could,” “will,” “may,” “expect,” “should,” “plan,” “intend,” “estimate,” “potential” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. These forward-looking statements are based on LAVA’s expectations and assumptions as of the date of this press release and are subject to various risks and uncertainties that may cause actual results to differ materially from these forward-looking statements. Forward-looking statements contained in this press release include, but are not limited to, statements about the preclinical data, clinical development and scope of clinical trials, and the potential use of our product candidates to treat various tumor targets. Many factors, risks and uncertainties may cause differences between current expectations and actual results including, among other things, the timing and results of our research and development programs and preclinical and clinical trials, our ability to obtain regulatory approval for and commercialize our product candidates, our ability to leverage our initial programs to develop additional product candidates using our Gammabody™ platform, and the failure of LAVA’s collaborators to support or advance collaborations or our product candidates. The COVID-19 pandemic may disrupt our business and that of the third parties on which we depend, including delaying or otherwise disrupting our clinical trials and preclinical studies, manufacturing, and supply chain, or impairing employee productivity. In addition, there may be adverse effects on our business condition and results from general economic and market conditions and overall fluctuations in the United States and international equity markets, including deteriorating market conditions due to investor concerns regarding inflation and hostilities between Russia and Ukraine. LAVA assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available.

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