OncoC4 Announces FDA Clearance of IND Application for Potential Best-in-Class PD-1/VEGF Bispecific AI-081 in Advanced Solid Tumors

AI-081 is a differentiated bispecific antibody with robust cooperative interactions between PD1 and VEGF

Dosing of first patient in BIPAVE-001 Phase 1/2 trial expected in Q1 2025

/EIN News/ -- ROCKVILLE, Md., Dec. 02, 2024 (GLOBE NEWSWIRE) -- OncoC4, Inc., a late-stage biopharmaceutical company developing novel medicines for cancer and neurological diseases, announced that the United States Food and Drug Administration (FDA) has cleared an investigational new drug (IND) application for AI-081, a potentially best-in-class PD-1 and VEGF bispecific antibody for the treatment of advanced solid tumors. Following receipt of a Study May Proceed notification from the FDA, OncoC4 expects to initiate the BIPAVE-001 Phase 1/2 trial for advanced solid tumors in the first quarter of 2025.

“AI-081 leverages two proprietary clinical stage high affinity anti-PD1 and anti-VEGF antibodies designed to further expand the application of checkpoint therapy,” said Yang Liu, PhD, Co-Founder, CEO and Chief Scientific Officer (CSO) of OncoC4. “Through optimal cooperative interactions, AI-081 has displayed superior PD-1 blockade in the presence of VEGF which translates into robust, superior anti-tumor activities in multiple preclinical studies. We look forward to initiating clinical development of AI-081 with the dosing of the first patient in our BIPAVE-001 Phase 1/2 trial in early 2025.”

BIPAVE-001 is a Phase 1/2 trial designed to evaluate the safety, pharmacokinetic, and efficacy of AI-081. The Part A portion is a first-in-human dose escalation study that will determine the recommended Phase 2 dose of AI-081 monotherapy in patients with advanced solid tumors.

AI-081 is made up of proprietary high-affinity clinical-stage anti-PD1 (AI-025) and anti-VEGF (AI-011) antibodies. Employing a tested and proven head-and-tail bispecific configuration, AI-081 is designed for more robust cooperative interactions and uses additional Fc silencing mutations to preserve immune effector cells. In molecular, cellular, and in vivo preclinical studies used to support the IND, AI-081 demonstrated higher affinity for both targets, significantly improved cooperative interactions, and enhanced in vivo activities over drug candidates in the same class in several mouse models. Collectively, these findings demonstrate AI-081 has best-in-class potential through high affinity and cooperative interactions that enable robust, synergistic anti-tumor activities with enhanced PD-1 blockade in the presence of VEGF.

About OncoC4

Based in Rockville, Maryland, OncoC4 is a privately held, late-stage biopharmaceutical company that is actively engaged in the discovery and development of novel biologicals for treatment of cancer and neurodegeneration. Its lead clinical candidate is gotistobart (BNT316/ONC-392), a next generation anti-CTLA-4 antibody that allows CTLA-4 to recycle and maintain its protective function against autoimmune diseases while enhancing anti-tumor activity at the same time. In March 2023, OncoC4 announced a strategic collaboration with BioNTech to co-develop and commercialize ONC-392 in multiple solid tumor indications. OncoC4 received $200M upfront and is eligible to receive development, regulatory, and commercial milestone payments in addition to double digit royalties. In addition, OncoC4 has a pipeline of first-in-class and best-in-class assets targeting both novel and well validated oncology and neurology targets. For more information, please visit www.oncoc4.com.

Investor Contact:

Bill Begien
OncoC4, Inc.
bbegien@oncoc4.com

Alexandra Folias
LifeSci Advisors
afolias@lifesciadvisors.com

Media Contact:

Kristin Politi, Ph.D. 
LifeSci Communications
kpoliti@lifescicomms.com