- Cesalatamig is Currently Being Evaluated in Phase 1/2 Studies in the United States (NCT06635785) and in China (CTR20253261)
- Fast Track Designation Supports Expedited Development of Cesalatamig for Non-small Cell Lung Cancer (NSCLC) that Progressed after Concurrent or Sequential PD-(L)1-targeted Immunotherapy and Platinum-based Chemotherapy
ROCKVILLE, Md., Sept. 16, 2026 /PRNewswire/ — OncoC4 Inc., a late clinical-stage biopharmaceutical company developing novel medicines for cancer and neurodegenerative diseases, today announced 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.
“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.
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.
More information: www.oncoc4.com
CONTACTS
Media Relations
Helen Schiltz
[email protected]
Investor Relations
Ryan Cui
[email protected]
View original content to download multimedia:https://www.prnewswire.com/apac/news-releases/oncoc4-receives-fda-fast-track-designation-for-cesalatamig-an-investigational-pd-1vegf-bispecific-antibody-302879965.html
SOURCE OncoC4
