FDA Clears OncoC4's IND for PD-1/VEGF Bispecific AI-081 in Advanced Tumors

OncoC4, Inc., a biopharmaceutical company focused on the development of innovative treatments for cancer and neurological diseases, announced that the U.S. Food and Drug Administration (FDA) has approved an investigational new drug (IND) application for their novel bispecific antibody, AI-081. This antibody targets PD-1 and VEGF, and is designed to treat advanced solid tumors. Following the FDA's notification, OncoC4 plans to commence the BIPAVE-001 Phase 1/2 trial in the first quarter of 2025.

AI-081 is a unique bispecific antibody that combines high-affinity anti-PD1 and anti-VEGF antibodies. These antibodies are intended to enhance the effectiveness of checkpoint therapy by promoting cooperative interactions. Dr. Yang Liu, the Co-Founder, CEO, and Chief Scientific Officer of OncoC4, noted that AI-081 has exhibited superior PD-1 blockade in the presence of VEGF, leading to significant anti-tumor activity in various preclinical studies. The company is eager to begin clinical trials with the first patient expected to be dosed in early 2025.

The BIPAVE-001 trial is structured in two parts: Phase 1 and Phase 2. The initial phase, Part A, is a dose-escalation study aimed at determining the recommended dose for Phase 2. This study focuses on the safety, pharmacokinetics, and efficacy of AI-081 monotherapy in patients with advanced solid tumors.

AI-081 incorporates high-affinity anti-PD1 (AI-025) and anti-VEGF (AI-011) antibodies, arranged in a bispecific configuration. It also includes Fc silencing mutations to protect immune effector cells. Preclinical studies demonstrated that AI-081 has higher affinity for both PD-1 and VEGF targets, improving cooperative interactions and enhancing in vivo activities compared to other drugs in the same category. These results suggest that AI-081 has the potential for best-in-class performance, combining robust anti-tumor activity with effective PD-1 blockade in the presence of VEGF.

OncoC4, headquartered in Rockville, Maryland, is a privately held company dedicated to discovering and developing novel biologicals for cancer and neurodegeneration treatments. The company’s leading clinical candidate is gotistobart (BNT316/ONC-392), an anti-CTLA-4 antibody that maintains its protective function against autoimmune diseases while boosting anti-tumor activity. In March 2023, OncoC4 announced a strategic partnership with BioNTech to co-develop and commercialize ONC-392 for various solid tumor indications. This collaboration brought in $200 million upfront, with potential for additional payments upon reaching development, regulatory, and commercial milestones, as well as double-digit royalties.

Besides gotistobart, OncoC4's pipeline includes other first-in-class and best-in-class assets targeting both new and well-established oncology and neurology targets. The company continues to make strides in the biopharmaceutical field, leveraging their innovative approaches to create effective treatments for challenging diseases.