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BioAtla Receives FDA Clearance for Investigational New Drug Application for BA3361, a CAB-Nectin-4 Antibody Drug Conjugate Targeting Multiple Tumors

Tuesday, May 07, 2024

BioAtla, Inc. (Nasdaq: BCAB) has received clearance from the U.S. Food and Drug Administration (FDA) to proceed with its investigational new drug (IND) application for BA3361 (CAB-Nectin-4), an antibody drug conjugate (ADC) aimed at treating various tumor types. This milestone marks a significant step forward in the development of innovative therapies for solid tumors.

ADCs represent a promising avenue for treating a wide range of tumors, offering the potential for targeted therapy while minimizing off-target effects. BioAtla's CAB technology is specifically engineered to enhance the safety and efficacy of ADCs by reducing both on-target, off-tumor and off-target, off-tumor toxicities.

At the recent AACR Annual Meeting in April 2024, BioAtla presented compelling data on BA3361, showcasing its differentiated approach to targeting Nectin-4. Through innovative in vitro and in vivo studies, the company demonstrated the effectiveness of its NextGen carbohydrate linker system in minimizing off-target toxicity while improving serum stability and potency. Notably, BA3361 exhibited complete tumor regression in various preclinical models and outperformed existing treatments in pancreatic cancer models, all while showing reduced toxicity due to CAB selectivity.

BioAtla, expressed enthusiasm for the FDA's clearance of BA3361, emphasizing the potential of Nectin-4 as a therapeutic target. He highlighted the combination of CAB technology with the NextGen linker system as a means to maximize therapeutic benefits and broaden the scope of indications for this novel ADC.

BA3361, CAB-Nectin4-ADC, targets Nectin4, a cell-cell adhesion molecule overexpressed in various cancers. Engineered to be conditionally and reversibly active, BA3361 is designed to optimize binding under tumor microenvironment conditions while minimizing binding under normal physiological conditions. It is the first of BioAtla's molecules to incorporate the NextGen ADC linker, enhancing stability and enabling tumor-specific payload release, leading to superior activity in preclinical models of pancreatic cancer.

BioAtla's progress with BA3361 underscores its commitment to advancing innovative therapies for cancer treatment, leveraging cutting-edge technology to address unmet medical needs and improve patient outcomes.



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