BioAtla Announces FDA Alignment on Ozuriftamab Vedotin Phase 3 Trial Design.

BioAtla announced FDA alignment on the Phase 3 ozuriftamab vedotin trial design, dosing regimen, and endpoints to support potential accelerated approval. The company aims to advance the study with a strategic partner early next year. BioAtla maintains its previous guidance for completing a strategic partnership with one of its advanced clinical assets this year. Ozuriftamab vedotin is a conditionally and reversibly active antibody drug conjugate directed against ROR2 for the treatment of solid tumors.

BioAtla, Inc. (Nasdaq: BCAB) has received positive regulatory alignment from the United States Food and Drug Administration (FDA) for its Phase 3 trial of ozuriftamab vedotin (Oz-V), a conditionally and reversibly active antibody drug conjugate (CAB) directed against ROR2 for the treatment of solid tumors. The FDA's Type B meeting provided key insights into the trial design, dosing regimen, and endpoints, paving the way for potential accelerated approval.

The pivotal trial will enroll approximately 300 patients with oropharyngeal squamous cell carcinoma (OPSCC) who will be randomized and stratified one to one between two open-label treatment arms. Patients in the investigational arm will receive Oz-V at a dose of 1.8 mg/kg every other week, while those in the control arm will receive either cetuximab, docetaxel, or methotrexate monotherapy. The primary endpoint for accelerated approval is a statistically significant improvement in confirmed overall response rate (ORR) by Blinded Independent Central Review (BICR), supported by an adequately characterized duration of response (DOR) without detriment in overall survival (OS).

BioAtla's CEO, Jay M. Short, Ph.D., highlighted the significance of this regulatory alignment, stating, "This actionable regulatory alignment is a critical milestone for BioAtla, enabling the initiation of the first Phase 3 study of a CAB ADC in an indication that represents a sizable and growing population poorly served by current standard of care agents."

The company aims to advance the study with a strategic partner early next year, aligning with its previous guidance to complete a strategic partnership with one of its advanced clinical assets this year. Ozuriftamab vedotin has demonstrated compelling clinical data in HPV+ OPSCC, with an overall response rate of 45% and a median overall survival of 11.6 months in a Phase 2 trial, compared to an ORR of 0-3.4% and a median OS of 4.4 months with standard of care regimens.

BioAtla's proprietary CAB platform technology offers more selective targeting, greater efficacy with lower toxicity, and more cost-efficient manufacturing than traditional antibodies. The company maintains extensive and worldwide patent coverage for its CAB technology, with over 780 active patent matters.

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[1] https://www.stocktitan.net/news/BCAB/bio-atla-announces-regulatory-update-on-clinical-development-plan-j2g88bcg8lwv.html