LAVA Therapeutics has entered into a clinical trial collaboration and supply agreement with Merck & Co. 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, 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,” said 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.”