BioAtla(US:BCAB) Globenewswire·2025-09-08 12:00Core Insights - BioAtla, Inc. announced outcomes from its Type B meeting with the FDA regarding its investigational drug Ozuriftamab vedotin (Oz-V) for treating solid tumors, particularly HPV+ oropharyngeal squamous cell carcinoma (OPSCC) [1][4][6] Company Overview - BioAtla is a clinical-stage biotechnology company focused on developing Conditionally Active Biologic (CAB) antibody therapeutics using its proprietary CAB platform [1][12] - The company operates in San Diego, California, and has a partnership with BioDuro-Sundia in Beijing for preclinical development services [12] Product Details - Ozuriftamab vedotin (Oz-V) is a conditionally active antibody drug conjugate targeting ROR2, which is overexpressed in various solid tumors, including head and neck cancers [2][7] - The drug has shown a 45% overall response rate (ORR) in a Phase 2 trial for HPV+ OPSCC, with a median overall survival (OS) of 11.6 months, compared to 0-3.4% ORR and 4.4 months OS for standard treatments [3][4] FDA Meeting Outcomes - The pivotal trial design for full approval involves approximately 300 OPSCC patients randomized between two treatment arms: Oz-V and an Investigator's Choice control arm [4][5] - The dosing regimen for Oz-V is set at 1.8 mg/kg every other week [4] - The endpoints for accelerated approval include statistically significant improvement in confirmed ORR and duration of response, while full approval will require significant improvement in OS [5][6] Strategic Implications - The FDA's alignment on the trial design is seen as a significant milestone for BioAtla, facilitating the initiation of the Phase 3 study with a strategic partner [6][8] - The company aims to complete a strategic partnership for one of its advanced clinical assets within the year [8] Market Context - OPSCC is a rapidly growing patient population, with HPV infections accounting for approximately 80% of cases in the U.S., highlighting the unmet medical need in this area [10]