September 8, 2025 — Leads & Copy — BioAtla, Inc. (Nasdaq: BCAB) announced outcomes from its Type B meeting with the United States Food and Drug Administration (FDA) regarding ozuriftamab vedotin (Oz-V), a CAB-ROR2-ADC for solid tumors, including head and neck cancer.
The FDA has aligned on the Phase 3 trial design, including the dosing regimen and endpoints to support potential accelerated approval. The company is preparing to initiate the Phase 3 study and aims to advance it with a strategic partner early next year. BioAtla maintains its guidance for completing a strategic partnership with one of its advanced clinical assets this year.
Oz-V has shown clinical data in HPV+ OPSCC in a Phase 2 trial with a 45% overall response rate and a median overall survival of 11.6 months. The FDA granted Fast Track Designation to Oz-V for recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) who have previously experienced progression on PD-1/L1 therapies and platinum chemotherapy.
Key outcomes from the FDA Type B meeting include a pivotal trial design with approximately 300 OPSCC patients, an Oz-V dose of 1.8 mg/kg every other week, and an investigator’s choice control arm. The accelerated approval endpoint is based on an interim analysis of enrolled patients, with the goal of showing a statistically significant improvement of confirmed ORR.
According to BioAtla CEO Jay M. Short, Ph.D., the regulatory alignment is a milestone for the company. It allows them to initiate the first Phase 3 study of a CAB ADC in a sizable population poorly served by current treatments.
Contacts:
Richard Waldron, Chief Financial Officer, BioAtla, Inc., rwaldron@bioatla.com, 858.356.8945
Joyce Allaire, LifeSci Advisors, LLC, jallaire@lifesciadvisors.com
Source: BioAtla, Inc.
