BioAtla, Inc. presented a poster and discussion entitled "Phase 2 Trial of Mecbotamab Vedotin (BA3011), a CAB-AXL-ADC, Alone or in Combination with Nivolumab in Patients with Non-Squamous NSCLC" at the IASLC Conference December 1-3 and at a virtual KOL Event held December 4, 2023. Mecbotamab vedotin, CAB-AXL- ADC, is a conditionally and reversibly active antibody drug conjugate targeting the receptor tyrosine kinase AXL. This Phase 2 stage clinical asset is targeting multiple solid tumor types, including soft tissue and bone sarcoma and non-small cell lung cancer (NSCLC) that have previously progressed on PD-1/L1, EGFR or ALK inhibitor therapies.

The Office of Orphan Drug Products (OODP) at FDA granted Orphan Drug Designation to mecbotamab vedotin for the treatment of soft tissue sarcoma. BioAtla has an ongoing multicenter, Phase 2, open-label clinical study evaluating the efficacy and safety of BA3011 alone and in combination with nivolumab. As of June 30, 2023, the study has enrolled 40 non-squamous and 4 squamous histology patients who are confirmed with locally advanced or metastatic NSCLC, ECOG performance status of 0 or 1, treatment failure of a PD-1/L1 inhibitor or approved therapy for EGFR or ALK genomic tumor aberrations, and AXL-positive tumor statining (TmPS 1%).

Utilizing its proprietary Conditionally Active Biologics (CAB) technology, BioAtla develops novel, reversibly active monoclonal and bispecific antibodies and other protein therapeutic product candidates. BioAtla has two first-in-class CAB programs currently in Phase 2 clinical testing, mecbotamab vEDotin,BA3011, a novel conditionally active AXL-targeted antibody-drug conjugate (CAB-ROR2-ADC). Examples of forward-looking statements include, among others, statements regarding business plans and prospects and whether clinical trials will support registration; results, conduct, progress and timing of research and development programs and clinical trials; and the potential regulatory approval path for pro duct candidates.

Factors that could cause actual results to differ include, among others: potential delays in clinical and pre-clinical trials; the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials, regulatory submission dates, or regulatory approval dates, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data; whether regulatory authorities will be satisfied with the design of and results from the clinical studies or take favorable regulatory actions based on results from the clinical studies; dependence on the success of CAB technology platform; ability to enroll patients in the ongoing and future clinical trials; the successful selection and prioritization of assets to focus development on selected product candidates and indications; ability to form collaborations and partnerships with third-party partners with third-party partners with the FDA and other partners.