Accutar Biotechnology Announces FDA Clearance of IND Application for Phase 1 Trial of AC0676 in B-cell Malignancies

CRANBURY, N.J.--(BUSINESS WIRE)--Accutar Biotechnology, Inc., a biotechnology company focusing on artificial intelligence (AI)-empowered drug discovery, today announced that the U.S. Food and Drug Administration (FDA) has cleared the company’s investigational new drug application (IND) for AC0676 for the treatment of patients with relapsed/refractory B-cell malignancies. AC0676 is an orally bioavailable, chimeric degrader molecule designed to target and degrade Bruton's Tyrosine Kinase (BTK) with high potency, selectivity, and broad mutant coverage. BTK plays a crucial role in the B-cell receptor (BCR) signaling pathway, and its constitutive activation is essential to the pathophysiology of many B-cell malignancies. Accutar expects to begin enrollment of a Phase 1 clinical trial for AC0676 in the beginning of the second quarter of 2023.

“The IND clearance for AC0676 is another important validation that our protein crystallography and AI platforms can support and advance the discovery of potentially differentiated clinical candidates quickly, especially complex compounds such as chimeric degraders. It marks Accutar as the first company to successfully bring oral chimeric degraders against three different targets into clinics,” said Jie Fan, Ph.D., Chief Executive Officer, Accutar Biotechnology, Inc. “The IND clearance for AC0676 is also critical towards offering a potential new treatment option for B-cell malignancies based on a differentiated mechanism of action from covalent and non-covalent BTK inhibitors by removing both kinase and scaffolding functions of BTK. We look forward to the clinical benefit that AC0676 treatment can potentially provide to patients.”

The Phase 1 study will assess the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of AC0676 treatment in patients with relapsed/refractory B-cell malignancies.

About AC0676

AC0676 is an investigational orally bioavailable, chimeric degrader of Bruton's Tyrosine Kinase (BTK) for the potential treatment of relapsed/refractory B-cell malignancies. In preclinical studies, AC0676 has demonstrated potent and selective BTK protein degradation with broad coverage of BTK wildtype and mutants (including C481S, L528W, and others), favorable pharmacological properties, as well as promising anti-tumor activities in animal models.

About Accutar Biotechnology, Inc.

Accutar is a clinical stage biotech company focused on AI-empowered drug discovery, and its application to the discovery and development of clinically differentiated medicines.

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To learn more about Accutar, please visit us at www.accutarbio.com.