BioAtla Granted FDA Fast Track Designation for Ozuriftamab Vedotin (CAB-ROR2-ADC) for Treatment of Patients with Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck

Core Insights - BioAtla, Inc. has received Fast Track Designation from the FDA for ozuriftamab vedotin, an antibody drug conjugate targeting ROR2, aimed at treating recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) [1][2] - The company is preparing to meet with the FDA in the second half of 2024 to discuss plans for a potential registrational trial [1][2] Group 1: Clinical Development - Ozuriftamab vedotin has demonstrated promising clinical activity in treatment-refractory SCCHN patients, with a median of 3 prior lines of therapy [2] - The drug maintains a manageable safety profile with no new safety signals reported [2] - The Fast Track Designation allows for expedited development and review processes, including potential priority review during the Biologics License Application (BLA) submission [2] Group 2: Product and Technology Overview - Ozuriftamab vedotin is a conditionally and reversibly active antibody drug conjugate that targets ROR2, a receptor associated with poor prognosis in various solid tumors [3] - The drug is part of a broader pipeline targeting multiple solid tumor indications, including SCCHN patients who have progressed on PD-1/L1 therapies [3] - BioAtla utilizes its proprietary Conditionally Active Biologics (CAB) technology to develop therapeutics that aim for selective targeting and greater efficacy with lower toxicity [4] Group 3: Company Background - BioAtla is a global clinical-stage biotechnology company with operations in San Diego, California, and Beijing, China [4] - The company has over 750 active patent matters, with more than 500 issued patents covering its CAB technology and products [4] - BioAtla is currently advancing two first-in-class CAB programs in Phase 2 clinical testing, including mecbotamab vedotin and ozuriftamab vedotin [4]