LAVA Therapeutics Announces Collaboration with Merck & Co., Inc., Rahway, NJ, USA to Evaluate LAVA-1207 in Combination with KEYTRUDA®

Collaboration will support the initiation of a combination arm in the ongoing Phase 1/2a trial in patients with mCRPC

Enrollment will continue in the monotherapy and IL-2 combination arms of the study

UTRECHT, The Netherlands and PHILADELPHIA, Jan. 25, 2024 (GLOBE NEWSWIRE) -- LAVA Therapeutics N.V. (NASDAQ:LVTX), today announced that it has entered into a clinical trial collaboration and supply agreement with Merck & Co., Inc., Rahway, NJ, USA to evaluate its anti-PD-1 therapy KEYTRUDA® (pembrolizumab) in combination with LAVA-1207, a Gammabody® designed to target the prostate-specific membrane antigen (PSMA) to trigger the potent and preferential killing of PSMA-positive tumor cells, in patients with therapy refractory metastatic castration-resistant prostate cancer (mCRPC).

Under the terms of the agreement, Merck & Co., Inc., Rahway, NJ, USA will provide pembrolizumab for the dose escalation and expansion phases of LAVA's ongoing Phase 1/2a study of LAVA-1207 (NCT05369000), with the combination arm expected to be initiated in the first half of 2024. Enrollment and dose escalation will also continue in the LAVA-1207 monotherapy and interleukin-2 arms of the study.

"We are excited to work with Merck & Co., Inc., Rahway, NJ, USA as we continue to unlock the therapeutic potential of LAVA-1207 and explore its potential capabilities in combination with KEYTRUDA®," said Stephen Hurly, President and Chief Executive Officer, LAVA. "To date, LAVA-1207 has demonstrated a favorable safety profile and shown preliminary signs of anti-tumor activity. Prostate cancer has presented challenges for immune checkpoint therapies in the past – we are hopeful the combination of our products may deliver important clinical outcomes."

"The immunosuppressive tumor microenvironment in most mCRPC patients has resulted in overall low antitumor activity for immune checkpoint inhibitors," commented Hans van der Vliet, M.D., Ph.D., Chief Scientific Officer, LAVA. "Increased numbers of Vγ9Vδ2 T cells have been shown to be related to improved outcomes in prostate cancer patients. With LAVA-1207, we aim to promote the antitumor activity of Vγ9Vδ2 T cells present in these tumors and drive more of these cells into the tumors, where their activation may result in increased PD-1 expression. By utilizing LAVA-1207 and pembrolizumab, our goal is to evaluate the potential activation of Vγ9Vδ2 T cells to directly attack prostate cancer cells and trigger a broader antitumor immune response that may also benefit from inhibition of PD-1 through pembrolizumab."

KEYTRUDA® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co. LLC, Rahway, NJ, USA.

About LAVA-1207

LAVA-1207 is a proprietary Gammabody® that conditionally activates Vγ9Vδ2 (Vgamma9 Vdelta2) T cells, upon crosslinking to prostate-specific membrane antigen (PSMA), to trigger the potent and preferential killing of PSMA-positive tumor cells in patients with prostate cancer, including metastatic castration-resistant prostate cancer (mCRPC).

About LAVA Therapeutics

LAVA Therapeutics N.V. is a clinical-stage immuno-oncology company focused on advancing its proprietary Gammabody® platform to develop a portfolio of bispecific gamma-delta T cell engagers for the potential treatment of solid tumors 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. A Phase 1/2a dose escalation study to evaluate LAVA-1207 in patients with metastatic castration-resistant prostate cancer (mCRPC) is actively enrolling in Europe and the United States (NCT05369000). The Company is collaborating with Seagen for the clinical development of SGN-EGFRd2 (LAVA-1223) and Merck & Co., Inc., Rahway, NJ, USA for the clinical development of LAVA-1207. For more information, please visit www.lavatherapeutics.com, and follow us on LinkedIn, X, 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 and results of clinical trials. Words such as "anticipate," "believe," "could," "will," "may," "expect," "should," "plan," "intend," "estimate," "potential," "suggests" 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 clinical development and the scope of clinical trials, including the availability of data therefrom, the timing of initiation of clinical trials, including the dose escalation and expansion phase of the Phase 1/2a trial to evaluate LAVA-1207 in combination with KEYTRUDA®, the potential benefits of the combination of LAVA-1207 and KEYTRUDA®, and the potential use of the Company's product candidates to treat various tumor targets and improve patient outcomes. Many factors, risks and uncertainties may cause differences between current expectations and actual results, including, among other things, the timing and results of LAVA's research and development programs and preclinical and clinical trials, the risk that results obtained in clinical trials to date may not be indicative of results obtained in ongoing or future trials, the Company's ability to obtain regulatory approval for and commercialize its product candidates, the Company's ability to leverage its initial programs to develop additional product candidates using our Gammabody® platform, and the failure of LAVA's collaborators to support or advance collaborations or LAVA's product candidates. There may be adverse effects on the Company's business condition and results from general economic and market conditions and overall fluctuations in the United States and international equity markets, including as a result of inflation, heightened interest rates, recent and potential future pandemics and other health crises, hostilities between Russia and Ukraine or Israel and Hamas, and recent and potential future disruptions in access to bank deposits or lending commitments due to bank failures. These and other risks are described in greater detail under the caption "Risk Factors" and included in LAVA's filings with the Securities and Exchange Commission. 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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