On February 16, 2023 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 initial clinical data from its ongoing Phase 1/2a study of LAVA-1207 in patients with therapy refractory metastatic castration resistant prostate cancer (mCRPC) (Press release, Lava Therapeutics, FEB 16, 2023, View Source [SID1234627309]). The data are presented in a poster presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Genitourinary Cancers Symposium (ASCO GU) taking place in San Francisco from February 16-18, 2023.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"These early data from the first five cohorts of our Phase 1/2a study indicate LAVA-1207 to have a favorable safety profile in patients with therapy refractory metastatic castration resistant prostate cancer. Importantly, preliminary signs of clinical activity were observed with disease stabilization and PSA reduction during dose escalation in these heavily pretreated patients," said Niven Mehra, M.D., Ph.D., medical oncologist at the Radboud University Medical Center in Nijmegen, The Netherlands. "We are encouraged by the progress of this trial and will continue to enroll patients for additional cohorts."

LAVA-1207 is an Fc-containing humanized bispecific antibody that directly engages prostate-specific membrane antigen (PSMA) and the Vδ2-T cell receptor chain of Vγ9Vδ2-T cells to mediate potent killing of PSMA-expressing prostate cancer cells. The objectives of the Phase 1/2a study (EudraCT 2021-001789-39; NCT05369000) are to investigate safety and tolerability, evaluate pharmacokinetic and pharmacodynamic effects, immunogenicity and preliminary antitumor activity of LAVA-1207. LAVA-1207 is administered via intravenous infusion every two weeks.

The data presented to date show that a total of 20 patients have been treated with doses ranging from 1.5 to 120 micrograms of LAVA-1207, with treatment duration ranging from 4 to 38 weeks. The safety profile is favorable to date, without occurrence of high grade (>2) cytokine release syndrome or dose-limiting toxicities. LAVA-1207 showed predictable and linear pharmacokinetics and on-mechanism pharmacodynamics including Vγ9Vδ2-T cell activation. Preliminary signs of anti-tumor activity were observed at week 8, with iRECIST stable disease (iSD) in 8 out of 14 evaluable patients and PSA levels stabilizing or decreasing. The largest overall decrease in PSA was 61% (46% vs baseline). The patient improved clinically with improvement in pain and fatigue. Dose escalation is continuing both in Europe and the U.S.

"We are encouraged by these initial data for LAVA-1207," said Stephen Hurly, president and chief executive officer of LAVA Therapeutics. "At LAVA Therapeutics, we are committed to transforming cancer therapy. I am thrilled to see our second clinical asset continuing to move forward, and an emerging safety profile with the potential for differentiation from prior generation PSMA directed bispecific T-cell engagers."

Details of the poster presentation are as follows:

Abstract #: 153

Abstract Title: Early dose escalation of LAVA-1207, a novel bispecific gamma-delta T cell engager (Gammabody), in metastatic castration-resistant prostate cancer (mCRPC) patients

Session Title: Poster Session A: Prostate Cancer

Poster Board #: E13

Session Date: Thursday, February 16, 2023

Session Time: 11:30 AM-1:00 PM PT; 5:45 PM-6:45 PM PT
Presenter: Niven Mehra, MD, PhD, Department of Medical Oncology, Radboud University Medical Center, Nijmegen, The Netherlands

LAVA-1207

LAVA-1207 is a 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, including metastatic castration-resistant prostate cancer (mCRPC).