OncoC4 Receives FDA Fast Track Designation for Cesalatamig, an Investigational PD-1/VEGF Bispecific Antibody

On September 16, 2026 OncoC4 Inc., a late clinical-stage biopharmaceutical company developing novel medicines for cancer and neurodegenerative diseases, reported that the U.S. FDA has granted Fast Track Designation to its PD-1/VEGF bispecific antibody cesalatamig (also known as AI-081) for the treatment of patients with NSCLC whose disease has progressed following concurrent or sequential PD-(L)1-targeted immunotherapy and platinum-based chemotherapy.

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"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," said Dr. Yang Liu, Co-founder, Chief Executive Officer and Chief Scientific Officer of OncoC4. "We are rapidly advancing to registrational phase 3 development in PD-(L)1-refractory or resistant NSCLC and other indications".

The global BiPAVE-001 Phase 1/2 trials are designed to evaluate the safety, efficacy and pharmacokinetics of cesalatamig in patients with advanced cancer. Part A is Phase 1 dose escalation and expansion study. Part B is the Phase 2 dose optimization studies consisting of multiple cohorts evaluating the safety and clinical activities of cesalatamig either as monotherapy or in combination therapy with standard of care or novel agents. The trials are being conducted at more than 50 clinical sites across the United States and China, with majority of the patients enrolled from the United States.

About cesalatamig

Cesalatamig is a differentiated PD-1/VEGF bispecific antibody with high affinity for PD-1 and more than 40-fold higher affinity for VEGF than bevacizumab-based bispecific PD-(L)1/VEGF inhibitors. As a result, cesalatamig shows best-in-class potential with a stronger cooperative interaction that favors its action in a PD-1 and VEGF-rich tumor microenvironment. Cesalatamig also has more effective Fc-silencing modifications to avoid the depletion of PD-1 positive effector T cells.

(Press release, OncoC4, SEP 16, 2026, View Source [SID1234670906])