BioAtla Secures FDA Guidance To Advance Pivotal Oz-V Trial In HPV+ Oropharyngeal Cancer

BioAtla, Inc., a biotechnology company developing Conditionally Active Biologic (CAB) antibody therapeutics for solid tumors, announced the outcomes of its Type B meeting with the U.S. FDA regarding its lead program, ozuriftamab vedotin (Oz-V). Oz-V is a CAB-ROR2-ADC antibody drug conjugate targeting ROR2, a protein commonly overexpressed in HPV-driven cancers, including oropharyngeal squamous cell carcinoma (OPSCC), where up to 80% of U.S. cases are linked to HPV.

In a Phase 2 trial, Oz-V showed a 45% overall response rate (ORR) and a median overall survival of 11.6 months, significantly outperforming standard monotherapies such as cetuximab, docetaxel, and methotrexate, which historically deliver ORRs of 0–3.4% and median OS of 4.4 months. OPSCC represents a rapidly growing cancer population with limited treatment options, making Oz-V a promising candidate to address this unmet need.

“The actionable regulatory alignment represents an important milestone for BioAtla as it enables initiation of the first Phase 3 study of a CAB ADC in an indication that represents a sizable and steadily growing population that is poorly served by current standard of care agents, including EGFR inhibitors. Having a clear registrational path with the potential for accelerated approval is very positive for our near-term strategic partnering objectives and enabling initiation of the Oz-V Phase 3 study with a partner. This underscores the potential of the CAB platform technology, which includes clinical readouts on our dual CAB EpCAM T-cell engager (BA3182) later this year,” said Jay M. Short, Ph.D., Chairman, Chief Executive Officer and co-founder of BioAtla, Inc. 

Following discussions with the FDA, BioAtla will move forward with a pivotal trial involving approximately 300 patients randomised 1:1 between Oz-V (1.8 mg/kg every two weeks) and an investigator’s choice control arm (cetuximab, docetaxel, or methotrexate). The trial will seek accelerated approval based on improvements in confirmed ORR by Blinded Independent Central Review (BICR) and full approval contingent on demonstrating statistically significant improvement in overall survival (OS).