OncoC4, Inc., a Rockville, Maryland-based biopharmaceutical company, announced on September 16, 2026 that the FDA granted Fast Track Designation to cesalatamig, an investigational PD-1/VEGF bispecific antibody, for treating non-small cell lung cancer (NSCLC) that has progressed after PD-(L)1-targeted immunotherapy and platinum-based chemotherapy.
Co-founder, CEO and Chief Scientific Officer Dr. Yang Liu said: “This designation reflects the clinical safety and efficacy signals we have seen in our global Phase 1/2 trials, BiPAVE-001 US and BiPAVE-001 China. We are rapidly advancing to registrational phase 3 development in PD-(L)1-refractory or resistant NSCLC and other indications.”
A Bispecific Built for Higher VEGF Affinity
Cesalatamig combines high PD-1 affinity with VEGF affinity roughly 40-fold higher than comparable bispecific agents, and includes Fc-silencing modifications intended to preserve PD-1 positive effector T cells. It’s being developed for advanced NSCLC that is refractory or resistant to PD-(L)1-targeted therapy, an area with limited treatment options once patients progress past standard immunotherapy and chemotherapy. The release doesn’t spell out what Fast Track designation specifically confers beyond describing it as supporting an expedited development pathway — it doesn’t detail whether OncoC4 plans to pursue rolling review, more frequent FDA interactions, or eligibility for accelerated approval, benefits the designation typically makes available.
A Global Trial Already Running at 50+ Sites
Cesalatamig is currently in the BiPAVE-001 Phase 1/2 trials running in parallel in the United States (NCT06635785) and China (CTR20253261) across more than 50 clinical sites, evaluating the drug’s safety, efficacy, and pharmacokinetics. Part A of the program covers dose escalation and expansion, while Part B examines both monotherapy and combination approaches. With Fast Track designation now in hand, OncoC4 says it’s moving toward registrational Phase 3 development specifically in PD-(L)1-refractory or resistant NSCLC and other indications, though the release doesn’t disclose a timeline for when that Phase 3 program might begin.
About OncoC4
Based in Rockville, Maryland, OncoC4 is a privately held, late clinical-stage biopharmaceutical company that is actively engaged in the discovery and development of novel biologics 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, cesalatamig is a wholly owned and highly differentiated PD-1/VEGF bispecific antibody currently undergoing rapid global clinical development in multiple oncology indications. ONC-841 is a first-in-class anti-SIGLEC-10 antibody currently in a Phase 2 trial for oncology indications and a Phase 1 trial for neurodegenerative diseases. OncoC4 has a strategic collaboration with BioNTech to co-develop gotistobart (BNT316/ONC-392), a tumor microenvironment-selective Treg depletion candidate targeting CTLA-4, in multiple solid tumor indications, including an ongoing pivotal clinical trial in squamous non-small cell lung cancer.
