Pharma Focus Asia

BioAtla Announces FDA Clearance of Investigational New Drug Application for BA3182

Thursday, February 23, 2023

BioAtla announced that the U.S. Food and Drug Administration (FDA) has cleared the investigational new drug (IND) application to evaluate BA3182 (CAB-EpCAMxCAB-CD3 bispecific T-cell engager) for the treatment of advanced adenocarcinoma. BioAtla plans to initiate and advance a Phase 1 dose-escalation and expansion clinical study in 2023.

BA3182 is a conditionally active biologic (CAB) EpCAM/CD3 bispecific T cell engager antibody containing two binding sites for EpCAM and two binding sites for CD3ε. The binding sites for EpCAM and CD3ε is designed to bind the respective targets specifically and reversibly under the conditions found in the TME and to reduce binding outside of the TME. The CAB selective binding to both the CAB EpCAM and CAB CD3ε arms are required to activate the T cell engagement against the tumour, thus enabling the combined selectivity of each CAB binding arm in the bispecific antibody. BioAtla recently received FDA IND clearance to conduct a first-in-human, Phase 1 study to evaluate the safety, pharmacokinetics, and efficacy of BA3182 in advanced adenocarcinoma patients.   

The high-level expression of EpCAM in solid tumours has become an attractive target for antibody molecules to treat epithelial cancers, particularly adenocarcinomas. EpCAM/CD3 bispecific antibodies developed by others have shown beneficial clinical outcomes in cancer patients, but are hampered by dose limiting toxicities due to wide target distribution in normal tissues and potent T cell activation. In vitro studies have shown that dual CAB bispecific antibody, BA3182, binds to the target proteins, human EpCAM and human CD3, with high specificity and affinity under the characteristic acidic conditions of the tumour microenvironment (TME), while its binding is highly reduced under normal cells’ alkaline physiological conditions (pH 7.4). In vivo studies with BA3182 resulted a greater than 100-fold improvement in therapeutic index compared to non-CAB variants, supporting the potential differentiation of CAB bispecific antibodies from more traditional bispecific antibodies.

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