Core Insights - BioAtla, Inc. announced promising Phase 2 trial results for Ozuriftamab Vedotin (Oz-V) in HPV+ OPSCC patients, showing a 45% overall response rate (ORR) and a 100% disease control rate (DCR) [1][4] - The trial highlights a significant unmet need in the second-line and beyond HPV+ OPSCC patient population, where standard treatments have reported an ORR of only 3.4% [1][4] - The company plans to finalize the Phase 3 trial design for Oz-V with the FDA [1] Group 1: Clinical Trial Details - In the Phase 2 clinical trial, 40 heavily pretreated SCCHN patients received Oz-V at a dosage of 1.8 mg/kg, administered either every two weeks or on specific days of a 21-day cycle [2][7] - Tumor assessments were conducted via CT or MRI every 6 weeks for the first 12 weeks, then every 8 weeks up to one year [2] - Among the 40 patients, 22 had HPV+ OPSCC, with a median of 3 prior lines of therapy and a high failure rate of previous anti–PD-1 and platinum therapies [7] Group 2: Efficacy and Safety Data - In HPV+ OPSCC patients, Oz-V demonstrated an ORR of 45% (5 out of 11 patients) and a DCR of 100% (11 out of 11 patients) [7] - The median duration of response was 9.9 months, with median progression-free survival at 4.7 months and median overall survival at 11.6 months [7] - Most adverse events were low grade, with fatigue (57%) and anemia (32%) being the most common; only 15% experienced grade ≥3 adverse events [7] Group 3: Regulatory and Market Potential - The company believes there is potential for accelerated approval and full approval of Oz-V in the HPV+ OPSCC market [4] - Oz-V has received Fast Track Designation from the FDA to facilitate discussions regarding the proposed Phase 3 study [7][8] - The drug targets ROR2, a receptor associated with poor prognosis and resistance to therapies, indicating a strategic focus on addressing significant market needs in solid tumors [8]

Core Insights - BioAtla, Inc. is a clinical-stage biotechnology company focused on developing Conditionally Active Biologic (CAB) antibody therapeutics for solid tumors [1][2] - The company will provide a corporate update and participate in one-on-one investor meetings at the Citizens Life Sciences Conference on May 7-8, 2025, in New York [1][2] Company Overview - BioAtla operates in San Diego, California, and Beijing, China, through a partnership with BioDuro-Sundia for preclinical development services [2] - The company utilizes its proprietary CAB platform technology to develop novel monoclonal and bispecific antibodies, aiming for selective targeting, greater efficacy, lower toxicity, and cost-efficient manufacturing compared to traditional antibodies [2] - BioAtla holds extensive patent coverage with over 780 active patent matters, including more than 500 issued patents, covering methods of making, screening, and manufacturing CAB product candidates [2] Product Development - BioAtla's first dual CAB bispecific T-cell engager antibody, BA3182, is in Phase 1 development, targeting EpCAM, which is commonly expressed in adenocarcinomas [2] - The company has two first-in-class CAB programs in Phase 2 clinical testing: mecbotamab vedotin (CAB-AXL-ADC) and ozuriftamab vedotin (CAB-ROR2-ADC) [2] - The Phase 2 CAB-CTLA-4 antibody, evalstotug, is designed to reduce systemic toxicity and enable safer combination therapies with checkpoint inhibitors [2]

Core Insights - BioAtla, Inc. is a clinical-stage biotechnology company focused on developing Conditionally Active Biologic (CAB) antibody therapeutics for solid tumors [1][3] - The company will present a Phase 2 trial of ozuriftamab vedotin (BA3021) at the 2025 ASCO Annual Meeting [1][2] Company Overview - BioAtla operates in San Diego, California, and Beijing, China, through a partnership with BioDuro-Sundia for preclinical development services [3] - The company utilizes its proprietary CAB platform technology to create novel monoclonal and bispecific antibodies, aiming for selective targeting, greater efficacy, lower toxicity, and cost-efficient manufacturing [3] - BioAtla holds extensive patent coverage with over 780 active patent matters, including more than 500 issued patents, covering methods of making, screening, and manufacturing CAB product candidates [3] Clinical Development - BioAtla's first dual CAB bispecific T-cell engager antibody, BA3182, is in Phase 1 development, targeting EpCAM on adenocarcinomas [3] - The company has two first-in-class CAB programs in Phase 2 clinical testing: mecbotamab vedotin (CAB-AXL-ADC) and ozuriftamab vedotin (CAB-ROR2-ADC) [3] - The Phase 2 CAB-CTLA-4 antibody, evalstotug, is designed to reduce systemic toxicity and enable safer combination therapies with checkpoint inhibitors [3]