Excellent safety observed across initial dose escalation with objective response at the lowest dose tested (1 mg/kg of AI-081)
ROCKVILLE, Md., July 22, 2025 (GLOBE NEWSWIRE) -- OncoC4, Inc., a late-stage biopharmaceutical company developing novel medicines for cancer today announced the first patient has been dosed in the Phase 2 portion of the Phase 1/2 BIPAVE-001 trial (NCT06635785) evaluating AI-081, a potentially best-in-class PD-1 and VEGF bispecific antibody.
“We are encouraged by the excellent safety, favorable pharmacokinetics and promising efficacy seen across the initial dose escalation of AI-081. Importantly, objective anti-tumor response was observed at the lowest dose tested, which is lower than other VEGF and PD-1/PD-L1 bispecific therapies in clinical development,” said Pan Zheng, MD, PhD, Co-Founder and Chief Medical Officer. “This early clinical signal is consistent with AI-081’s best-in-class potential demonstrated by data from multiple preclinical cancer models. We look forward to further dose optimization in the Phase 2 trial with initial focus in non-small cell lung cancer (NSCLC).”
The BIPAVE-001 Phase 1/2 trial is designed to evaluate the safety, pharmacokinetic, and efficacy of AI-081 in two integrated parts. Part A is an ongoing, first-in-human Phase 1 dose escalation and dose expansion study in patients with advanced solid tumors. Part B, the Phase 2 portion, includes dose optimization trials comparing the safety and clinical activities of AI-081 either as monotherapy or in combination therapy with standard of care in selected indications. The study is being carried out in the United States with 11 clinical sites actively enrolling patients. The Chinese regulatory agency also cleared the study.
About AI-081
AI-081 is a PD-1 and VEGF bispecific antibody with best-in-class potential for the treatment of advanced solid tumors. Combining two proprietary and clinical-stage high-affinity anti-PD1 (AI-025) and anti-VEGF (AI-011) antibodies, AI-081 employs a tested and clinically proven head-and-tail bispecific configuration. Designed for strong cooperative interactions, AI-081 uses additional Fc silencing mutations to preserve immune effector cells. In molecular, cellular, and in vivo preclinical studies used to support the investigational new drug (IND) application, AI-081 demonstrated higher affinity for both targets, more effective cooperation between pathways, and enhanced in vivo activities over drug candidates in the same class. These findings highlight the high affinity and cooperative interactions of AI-081 have potential to deliver powerful, dual-targeted immune responses by enhancing 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 the treatment of cancer and immunological diseases. OncoC4’s pipeline features assets with first-in-class and best-in-class potential targeting both novel and well validated targets across oncology and immunological diseases. Among them, AI-081 is a fully owned and potentially best-in-class bispecific antibody candidate targeting PD-1 and VEGF. AI-081 is currently enrolling patients in a Phase1/2 trial that could enable two or more pivotal studies. In addition, OncoC4 has a strategic collaboration with BioNTech to co-develop gotistobart (BNT316/ONC-392), a next-generation anti-CTLA-4 antibody candidate, in multiple solid tumor indications, including an ongoing pivotal clinical trial in squamous non-small cell lung cancer.
For more information, please visit www.oncoc4.com.
CONTACTS
OncoC4
Investor Contact:
Bill Begien
OncoC4, Inc.
bbegien@oncoc4.com
Alexandra Folias
LifeSci Advisors
afolias@lifesciadvisors.com
Media Contact:
Jason Braco, Ph.D.
LifeSci Communications
jbraco@lifescicomms.com
