BioAtla Announces FDA Clearance of Investigational New Drug Application for BA3361, a CAB-Nectin-4 Antibody Drug Conjugate for the Treatment of Multiple Tumors

SAN DIEGO, May 06, 2024 (GLOBE NEWSWIRE) -- BioAtla, Inc. (Nasdaq: BCAB), a global clinical-stage biotechnology company focused on the development of Conditionally Active Biologic (CAB) antibody therapeutics for the treatment of solid tumors, today announced that the U.S. Food and Drug Administration (FDA) has cleared its investigational new drug (IND) application to evaluate BA3361 (CAB-Nectin-4) antibody drug conjugate (ADC) for the treatment of multiple tumor types.

ADC is a promising treatment modality with broad applicability across multiple tumor indications. The CAB technology is designed to eliminate or reduce both on-target, off-tumor and off-target, off-tumor toxicities. At the AACR Annual Meeting in April 2024, data showed differentiated anti-Nectin-4-ADC via in vitro and in vivo characterization of its novel next-generation carbohydrate linker system. The NextGen linker system helped eliminate off-target, off-tumor toxicity with substantially improved serum stability and increased hydophilicity thereby improving potency. BioAtla’s CAB NextGen anti-Nectin-4-ADC demonstrated: complete tumor regression observed in several cell line derived xenograft models, superior efficacy to an enfortumab vedotin analogue in a patient-derived xenograft pancreatic cancer model, and reduced toxicity through CAB selectivity. BA3361 is the Company’s first glycoconjugate CAB-Nectin-4-ADC.

“BioAtla continues to demonstrate differentiated product candidates through the use of the CAB technology with this most recent FDA IND clearance of our first glycoconjugate, CAB-Nectin-4-ADC, BA3361,” said Jay M. Short, Ph.D., Chairman, Chief Executive Officer and co-founder of BioAtla, Inc. “We are excited to advance Nectin-4 as a target, particularly since the combination of our CAB technology with the NextGen linker system offers the opportunity to maximize the therapeutic index and expand indications across multiple tumor types.”

About BA3361
BA3361, CAB-Nectin4-ADC, is a conditionally and reversibly active antibody drug conjugate directed against Nectin4, a cell-cell adhesion molecule overexpressed in multiple human malignancies. The Nectin4-binding domains of BA3361 have been optimized for binding under tumor microenvironment (TME) conditions and reduced binding under normal physiological conditions. BA3361 is the first molecule containing one of BioAtla’s novel NextGen ADC linkers with improved stability and tumor specific payload release. BA3361 showed superior activity in patient-derived pancreatic cancer xenograft models.