Regulatory Update on Ozuriftamab Vedotin in Oropharyngeal Squamous Cell Carcinoma (OPSCC) Following Productive Type B (End of Phase 2) Meeting with FDA Announced
“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,” said Jay M. Short, Ph.D., Chairman, Chief Executive Officer and co-founder of BioAtla, Inc. “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.”
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