BioAtla has received a fast track designation from the US Food and Drug Administration (FDA) for its antibody drug conjugate (ADC) ozuriftamab vedotin (BA3021) to treat a certain type of head and neck cancer.  

Ozuriftamab vedotin is a conditionally and reversibly active ADC targeted against ROR2, a receptor tyrosine kinase present in many solid tumours. ROR2 is a non-canonical wnt5A signalling receptor, the overexpression of which is associated with poor prognosis and resistance to standard therapies.

This fast track designation concerns the use of ozuriftamab vedotin in treating patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) for whom the disease has progressed despite platinum-based chemotherapy and anti-PD-1/PD-L1 antibody treatment.

The ADC is the subject of an ongoing multi-centre, open label Phase II trial (NCT05271604) investigating the therapy’s efficacy and safety for this indication. Though a full readout is still pending, interim data from the trial suggests the treatment is generally well-tolerated.

In the US alone, over 400,000 people live with cancer of the head and neck as per the American Cancer Society. Over 70,000 new cases are estimated to arise in 2024, according to American Association for Cancer Research. Around half of those cases with locally advanced disease develop recurrent or refractory disease for which treatment options are limited.

Announcing the FDA designation in a 23 July press release, BioAtla CEO and cofounder Jay Short, PhD, said, “To date, ozuriftamab vedotin has shown promising clinical activity in treatment-refractory SCCHN patients who had a median of three prior lines of therapy. In addition, ozuriftamab vedotin continues to have a manageable safety profile with no new safety signals.”

BioAtla is developing a cohort of novel, reversibly active monoclonal and bispecific antibodies and other therapeutic products, with operations both in the US and China. Ozuriftamab vedotin is one of several antibody therapies being developed through the company’s patented conditionally active biologics (CAB) technology.

According to GlobalData’s projections, the revenue from ozuriftamab vedotin is estimated to reach $59m annually in the US by 2038.