US-based OncoC4, Inc. has announced that it has received clinical clearance from the US Food and Drug Administration (FDA) for its innovative bispecific antibody, AI-081, which targets both PD-1 and VEGF pathways.
Composition and Mechanism of AI-081
AI-081 is composed of proprietary high-affinity clinical-stage anti-PD-1 (AI-025) and anti-VEGF (AI-011) antibodies. This dual-targeting approach is designed to enhance the immune response against cancer cells while also inhibiting angiogenesis, a process critical for tumor growth and survival.
Upcoming BIPAVE-001 Phase I/II Trial
OncoC4 expects to initiate the BIPAVE-001 Phase I/II trial in the first quarter of 2025. This trial will assess the safety, pharmacokinetics, and efficacy of AI-081 in patients with advanced solid tumors. The Part A portion of the trial is a first-in-human dose escalation study, which aims to determine the recommended Phase II dose of AI-081 monotherapy for patients with advanced solid tumors.-Fineline Info & Tech
