26 July 2024: BioAtla’s Ozuriftamab Vedotin Receives FDA Fast Track Designation for Recurrent or Metastatic Head and Neck Cancer
BioAtla announced that the U.S. FDA granted Fast Track Designation (FTD) to ozuriftamab vedotin, their conditionally and reversibly active ROR2 ADC for recurrent or metastatic SCCHN
Ozuriftamab vedotin has shown manageable safety profiles in treatment-refractory SCCHN patients
Ozuriftamab vedotin targets ROR2, associated with poor prognosis in various solid tumors, and is in Phase 2 trials for multiple indications, including SCCHN PD-1/L-1 progressor patients
Company plans to discuss a potential registrational trial with the FDA in the second half of 2024
BioAtla develops CAB technology-based antibodies for selective targeting, greater efficacy, lower toxicity, and cost-efficient manufacturing, with extensive patent coverage and multiple clinical-stage programs
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