FDA Fast Tracks Ozuriftamab Vedotin for Recurrent/Metastatic Head and Neck Carcinoma

BioAtla, Inc., a biotechnology company based in San Diego, California, announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) to ozuriftamab vedotin. This conditionally and reversibly active antibody drug conjugate targets ROR2 and is designed for patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) who have experienced disease progression following platinum-based chemotherapy and anti-PD-1/L1 antibody therapy.

Jay M. Short, Ph.D., the Chairman, CEO, and co-founder of BioAtla, commented on the FDA’s decision, emphasizing the significant unmet medical need in refractory head and neck cancer, where current treatment options yield suboptimal results. He noted that ozuriftamab vedotin has shown promising clinical activity in SCCHN patients who had undergone an average of three prior lines of therapy. The drug has maintained a manageable safety profile without new safety concerns. BioAtla is planning to consult with the FDA in the second half of 2024 regarding a potential registrational trial.

Fast Track Designation is an FDA process designed to facilitate the development and expedite the review of drugs intended to treat serious or life-threatening conditions that address unmet medical needs. This designation offers benefits such as more frequent meetings with the FDA and potential priority review of a Biologics License Application (BLA), provided the clinical data supports it.

Ozuriftamab vedotin is a conditionally and reversibly active antibody drug conjugate (CAB-ROR2-ADC) that targets ROR2, a tyrosine kinase receptor found in various solid tumors, including those in the head and neck, lungs, triple-negative breast cancer (TNBC), and melanoma. ROR2 overexpression is linked to poor prognosis and resistance to current chemo- and immunotherapies. This Phase 2 clinical asset is aimed at treating SCCHN patients who have progressed after PD-1/L1 therapies, with or without platinum chemotherapy.

BioAtla is a global clinical-stage biotechnology company with operations in San Diego and Beijing, China, through its partnership with BioDuro-Sundia. The company employs its proprietary Conditionally Active Biologics (CAB) technology to develop innovative, reversibly active monoclonal and bispecific antibodies, as well as other protein therapeutic candidates. These CAB products are designed for precise targeting, enhanced efficacy with reduced toxicity, and cost-effective, predictable manufacturing compared to traditional antibodies. BioAtla holds extensive patent coverage for its CAB technology and products, with over 750 active patent matters, including more than 500 issued patents worldwide.

BioAtla's pipeline includes two first-in-class CAB programs in Phase 2 clinical trials: mecbotamab vedotin, an AXL-targeted antibody-drug conjugate (CAB-AXL-ADC), and ozuriftamab vedotin, the ROR2-targeted antibody-drug conjugate (CAB-ROR2-ADC). Additionally, the company is developing a Phase 2 CAB-CTLA-4 antibody aimed at reducing systemic toxicity and enabling safer combination therapies with checkpoint inhibitors like anti-PD-1 antibodies. BioAtla's first bispecific T-cell engager antibody, BA3182, is in Phase 1 development. BA3182 targets EpCAM, which is frequently expressed in many adenocarcinomas, while engaging human CD3-expressing T cells. The company has also received FDA IND clearance for its next-generation CAB-Nectin4-ADC, BA3361, which is BioAtla’s first glycoconjugate.

BioAtla continues to advance its innovative therapies, leveraging its proprietary technology to address significant unmet needs in oncology, particularly in solid tumors.