FDA Okays IND Application of BA3182 for Advanced Adenocarcinoma


A phase 1 dose-escalation and -expansion clinical trial will evaluate BA3182, a potential anticancer therapy, for patients with advanced adenocarcinoma based on the clearance of an investigational new drug application from the FDA.

The FDA has cleared an investigational new drug (IND) application to evaluate BA3182 for the treatment of patients with advanced adenocarcinoma, according to BioAtla, Inc.

As a result of the IND, the company plans to initiate and advance a phase 1 dose-escalation and dose-expansion clinical trial in 2023, which will evaluate the safety, pharmacokinetics, and efficacy of BA3182 in patients with advanced adenocarcinoma.

BA3182 is a potential anticancer therapy being developed for the treatment of patients with advanced adenocarcinoma. The therapy is a conditionally active biologic (CAB) EpCAM/CD3 bispecific T-cell engager antibody which works by having 2 binding sites for EpCAM, as well as 2 binding sites for CD3ε.

“While we continue to advance our CAB-ADC and CAB immuno-oncology antibodies across multiple tumor types, we are now expanding our pipeline with the recent FDA IND clearance for our potentially first-in-class bispecific antibody, BA3182,” said Jay M. Short, PhD, chairman, chief executive officer and co-founder of BioAtla, in the press release. “Our goal is to continue executing and pursuing indications with large unmet medical needs that potentially have the highest impact for patients and our shareholders worldwide. We believe our current cash position is sufficient to fund our operations into 2025 through several value generating milestones for our current clinical programs as well as the initiation of the BA3182 clinical trial.”

The binding sites for EpCAM and CD3ε have been designed to attach their respective targets specifically and reversibly under the conditions found in the TME and to have reduced binding outside of the TME. To activate the T cell engagement against the tumor, the CAB selective binding to both the CAB EpCAM and CAB CD3ε arms are required. This then enables the combined selectivity of each CAB binding arm in the bispecific antibody.

Though high-level expression of EpCAM in solid tumors makes it an attractive target for antibody molecules to treat epithelial cancers, including adenocarcinomas, it is highly prevalent on normal cells.

EpCAM/CD3 bispecific antibodies have been developed in previous years and have led to beneficial clinical outcomes for patients with various cancers. However, they have led to dose limiting toxicities with wide target distribution in normal tissues and potent T cell activation.

Within in vitro studies, BA3182 binds to the target proteins, human EpCAM and human CD3, and demonstrates high specificity and affinity under the characteristic acidic conditions of the tumor microenvironment and its binding was highly reduced under normal cells’ alkaline physiological conditions. Then in in vivo studies, BA3182 improved the therapeutic index by more than 100-fold relative to non-CAB variants. These findings support the possible differentiation of CAB bispecific antibodies compared with more traditional bispecific antibodies.

Because adenocarcinoma is the most common subtype of carcinoma that can develop almost anywhere in the body, investigators are hopeful that the initiation of the BA3182 clinical trial may lead to a promising development for this patient population and address the most common subtypes of adenocarcinoma including colon, breast, pancreas, lung, and prostate.

BioAtla announces FDA clearance of investigational new drug application for BA3182, a CAB-EpCAMxCAB-CD3 bispecific T-cell engager for the treatment of advanced adenocarcinoma. News release. BioAtla, Inc. February 23, 2023. Accessed February 23, 2023. https://bit.ly/3ZcbO4g
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