OncoC4 Receives FDA Fast Track Designation for Bispecific Antibody Cesalatamig
核心洞察
OncoC4 (搜索) said on September 16, 2026 that the FDA granted Fast Track Designation to cesalatamig (搜索) for non-small cell lung cancer (搜索) progressing after PD-(L)1 immunotherapy and platinum chemotherapy.
Cesalatamig (搜索) is a PD-1 (搜索)/VEGF (搜索) bispecific antibody with VEGF affinity roughly 40-fold higher than comparable agents and Fc-silencing modifications to preserve PD-1 positive effector T cells.
The drug is in the parallel Phase 1/2 BiPAVE-001 trials in the US and China across more than 50 sites, with registrational Phase 3 development planned in PD-(L)1-refractory NSCLC.
OncoC4 (搜索), Inc. announced on September 16, 2026 that the FDA granted Fast Track Designation to cesalatamig (搜索), an investigational PD-1 (搜索)/VEGF (搜索) bispecific antibody, for non-small cell lung cancer (搜索) (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 the designation reflects clinical safety and efficacy signals seen in the company's global Phase 1/2 trials, BiPAVE-001 US and BiPAVE-001 China, and that OncoC4 is advancing to registrational Phase 3 development in PD-(L)1-refractory or resistant NSCLC and other indications.
Cesalatamig (搜索) combines high PD-1 (搜索) affinity with VEGF (搜索) affinity roughly 40-fold higher than comparable bispecific agents, and carries Fc-silencing modifications intended to preserve PD-1 positive effector T cells. It is being developed for advanced NSCLC that is refractory or resistant to PD-(L)1-targeted therapy, a setting with limited options after progression on standard immunotherapy and chemotherapy. The announcement did not specify which Fast Track benefits OncoC4 (搜索) intends to pursue, such as rolling review, more frequent FDA interactions or eligibility for accelerated approval.
The BiPAVE-001 Phase 1/2 program is running in parallel in the United States (NCT06635785) and China (CTR20253261) across more than 50 clinical sites, evaluating safety, efficacy and pharmacokinetics. Part A covers dose escalation and expansion, while Part B examines monotherapy and combination approaches. OncoC4 (搜索) said it is moving toward registrational Phase 3 development in PD-(L)1-refractory or resistant NSCLC and other indications, without disclosing a timeline. The Rockville, Maryland-based privately held company also has ONC-841, a first-in-class anti-SIGLEC-10 (搜索) antibody in Phase 2 for oncology and Phase 1 for neurodegenerative diseases, and a BioNTech collaboration on the CTLA-4 (搜索) candidate gotistobart (BNT316/ONC-392).
Source: biobuzz.io