BioAtla Gets FDA Clearance for BA3361 Drug for Multiple Tumors

BioAtla, Inc. (Nasdaq: BCAB), a global biotechnology company in the clinical-stage of development, has received clearance from the U.S. Food and Drug Administration (FDA) for its investigational new drug (IND) application for BA3361 (CAB-Nectin-4) antibody drug conjugate (ADC). This treatment is aimed at multiple types of tumors, highlighting the potential of ADC as a versatile treatment approach. BioAtla's proprietary Conditionally Active Biologic (CAB) technology is designed to mitigate on-target, off-tumor and off-target, off-tumor toxicities.

At the American Association for Cancer Research (AACR) Annual Meeting in April 2024, data presented showcased the distinctiveness of their anti-Nectin-4-ADC. This was achieved through both in vitro and in vivo studies that characterized its next-generation carbohydrate linker system. This advanced linker system is essential for minimizing off-target toxicities, significantly enhancing serum stability, increasing hydrophilicity, and thereby boosting the drug's potency. The novel CAB NextGen anti-Nectin-4-ADC achieved complete tumor regression in various cell line-derived xenograft models. It also demonstrated superior efficacy compared to an enfortumab vedotin analogue in a patient-derived xenograft model for pancreatic cancer, while exhibiting reduced toxicity due to CAB selectivity. BA3361 is BioAtla’s pioneering glycoconjugate CAB-Nectin-4-ADC.

“We are thrilled to continue showcasing differentiated product candidates thanks to our CAB technology, particularly with the recent FDA IND clearance of our first glycoconjugate, CAB-Nectin-4-ADC, BA3361,” stated Jay M. Short, Ph.D., Chairman, Chief Executive Officer, and co-founder of BioAtla, Inc. “The combination of our CAB technology and the NextGen linker system opens up opportunities to maximize the therapeutic index and expand indications across multiple tumor types.”

BA3361, also known as CAB-Nectin-4-ADC, is an antibody drug conjugate that is conditionally and reversibly active against Nectin-4, a molecule involved in cell adhesion that is overexpressed in several human cancers. The binding domains of BA3361 have been optimized to bind under tumor microenvironment conditions and to reduce binding under normal physiological conditions. This molecule is the first to feature BioAtla’s novel NextGen ADC linkers, which offer improved stability and targeted payload release within tumors. BA3361 has shown superior performance in patient-derived pancreatic cancer xenograft models.

BioAtla, Inc., operates globally with offices in San Diego, California, and Beijing, China, through its relationship with BioDuro-Sundia, which provides preclinical development services. The company leverages its proprietary CAB technology to develop innovative, reversibly active monoclonal and bispecific antibodies, along with other protein therapeutic product candidates. CAB products are engineered for enhanced selectivity, greater efficacy with lower toxicity, and more cost-effective and predictable manufacturing compared to traditional antibodies. BioAtla holds extensive patent coverage for its CAB technology and products, including over 765 active patent matters and more than 485 issued patents globally. These patents encompass methods of making, screening, and manufacturing CAB product candidates in various formats and compositions.

Currently, BioAtla has two first-in-class CAB programs in Phase 2 clinical testing: mecbotamab vedotin (BA3011), an AXL-targeted ADC, and ozuriftamab vedotin (BA3021), a ROR2-targeted ADC. Additionally, their Phase 2 stage CAB-CTLA-4 antibody, BA3071, is designed to reduce systemic toxicity, potentially enabling safer combination therapies with checkpoint inhibitors like the anti-PD-1 antibody. The company’s first dual CAB bispecific T-cell engager antibody, BA3182, is in Phase 1 development, targeting EpCAM on many adenocarcinomas while engaging CD3-expressing T cells.

BioAtla continues to push the boundaries of what is possible in cancer treatment, utilizing its innovative CAB technology to develop therapies that are more effective and less toxic, with the goal of improving patient outcomes across a range of malignancies.