FDA grants fast track to BioAtla's ozuriftamab vedotin

BioAtla has achieved a significant milestone with its antibody drug conjugate (ADC) ozuriftamab vedotin (BA3021) receiving fast track designation from the US Food and Drug Administration (FDA). This designation is for its use in treating a specific type of head and neck cancer, specifically recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN). This cancer type typically shows progression despite prior treatments such as platinum-based chemotherapy and anti-PD-1/PD-L1 antibody therapy.

Ozuriftamab vedotin is an innovative ADC that targets the receptor tyrosine kinase ROR2, commonly found in various solid tumors. ROR2, a non-canonical wnt5A signaling receptor, is often linked with poor outcomes and resistance to conventional treatments in cancer patients. This fast track designation is a nod to the potential of ozuriftamab vedotin in addressing a significant unmet medical need for patients with SCCHN.

The FDA's fast track designation aims to expedite the review process, potentially bringing this therapy to patients sooner. Currently, ozuriftamab vedotin is under evaluation in a multi-center, open-label Phase II clinical trial (NCT05271604) to assess its efficacy and safety for this indication. Preliminary data from this trial indicates that the treatment is generally well-tolerated among participants, although full results are still awaited.

In the United States, head and neck cancers affect over 400,000 people, according to the American Cancer Society. The American Association for Cancer Research estimates that more than 70,000 new cases will emerge in 2024. Approximately half of those with locally advanced disease will experience recurrence or develop refractory disease, leaving them with limited treatment options.

BioAtla CEO and co-founder Jay Short, PhD, highlighted the significance of the FDA designation in a press release on July 23. He noted that ozuriftamab vedotin has demonstrated promising clinical activity in patients with treatment-refractory SCCHN, who had an average of three prior lines of therapy. Additionally, he emphasized that the safety profile of the drug has remained manageable, with no new safety concerns reported.

BioAtla is at the forefront of developing novel therapeutic products, including reversibly active monoclonal and bispecific antibodies. The company operates both in the US and China, leveraging its patented conditionally active biologics (CAB) technology to develop innovative treatments. Ozuriftamab vedotin is one of several promising antibody therapies in BioAtla’s pipeline, showcasing their commitment to advancing cancer treatment.

Overall, the FDA’s fast track designation for ozuriftamab vedotin represents a pivotal step in developing new treatment options for patients with difficult-to-treat head and neck cancers. BioAtla’s ongoing research and development efforts offer hope for improved outcomes for individuals battling this challenging condition.

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