Accutar Biotechnology Receives FDA Fast Track Designation for AC699 in ER+ / HER2- Breast Cancer

CRANBURY, N.J.--(BUSINESS WIRE)--Accutar Biotechnology, Inc., a biotechnology company focusing on artificial intelligence (AI)-enabled drug discovery, announced today that the US Food and Drug Administration (FDA) has granted the investigation of AC699 a Fast Track designation for the treatment of patients with estrogen receptor (ER)-positive, human epidermal growth factor receptor-2 (HER2)-negative, estrogen receptor 1 (ESR1)-mutated advanced or metastatic breast cancer with disease progression on or after at least 1 line of endocrine-based therapy. AC699 is an investigational orally bioavailable, chimeric degrader of estrogen receptor (ER) α currently in a Phase 1 trial.

ER-positive/HER2-negative subtype is the most common subtype of breast cancer (~70%), and mutations in the estrogen receptor 1 (ESR1) gene are common (20-40%) among ER-positive/HER2-negative patients who received endocrine therapy in the metastatic setting. AC699 has demonstrated objective response rate (ORR) of 50% in patients with an ESR1 mutation, in an ongoing Phase 1 trial, presented at ASCO 2024.

"Receiving Fast Track designation for AC699 from the FDA highlights their recognition of the serious and life-threatening nature of this malignancy, the critical unmet medical needs not fully addressed by existing therapies, and the potential of AC699 to fill in the gap," said Jie Fan, Ph.D., Chief Executive Officer of Accutar Biotechnology, Inc. "We look forward to working closely with the FDA to optimize and expedite the development program."

The FDA’s Fast Track process is designed to facilitate the development and expedite the review of novel drugs intended to treat serious conditions and address significant unmet medical needs. Companies that receive Fast Track designation are eligible for more frequent meetings and communications with the FDA during clinical development and potentially accelerated approval and priority review, if relevant criteria are met. For more information on Fast Track Designation, please visit the FDA’s website at https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/fast-track.

About AC699 and the Phase 1 Study (AC699-001)

AC699 is an investigational orally bioavailable, chimeric degrader of estrogen receptor (ER) α. In preclinical studies, AC699 has demonstrated potent and selective protein degradation of ERα wildtype and mutants with favorable pharmacological properties, as well as promising anti-tumor activities in ER-positive animal tumor models.

The purpose of the Phase 1 multi-center, open-label study is to assess the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of AC699 treatment in patients with ER-positive / HER2-negative locally advanced or metastatic breast cancer (NCT05654532). Additional information on this clinical trial can be found on www.clinicaltrials.gov.

About Accutar Biotechnology, Inc.

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

Be transformative. For patients.

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

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