Weekly Digest - July 2024

Weekly Digest - July 2024

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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