US-based Regeneron Pharmaceuticals Inc., (NASDAQ: REGN) has reported in its Q2 2023 financial results the suspension of enrollment in a clinical trial for the experimental bispecific antibody (BsAb) drug, REGN5678. This drug, which targets PSMA and CD28, is under Phase I assessment for treating prostate cancer, both as a monotherapy and in combination with the PD-1 inhibitor Libtayo (cemiplimab).
Patient Deaths Lead to Suspension of Combination Arm
According to the company’s statement, the combination arm of the trial with Libtayo has experienced two immune-mediated patient deaths, prompting the suspension of enrollment for this part of the study. This decision underscores the importance of patient safety in clinical trials and the necessity of closely monitoring treatment responses.
Continuation of REGN5678 Development Plans
Despite the suspension of the combination arm, Regeneron plans to continue the development of REGN5678. The company intends to explore the drug as a monotherapy and in combination with Libtayo at lower dosage points. Additionally, Regeneron is considering combining REGN5678 with other immunotherapy modalities to treat prostate cancer, indicating a commitment to advancing potential new therapies for the disease.-Fineline Info & Tech
