Accutar's AC699 Earns FDA Fast Track For ER+/HER2- Breast Cancer
Accutar Biotechnology, Inc. has announced that the US Food and Drug Administration (FDA) has granted Fast Track designation for their investigational drug AC699. This designation is for treating patients with estrogen receptor (ER)-positive, human epidermal growth factor receptor-2 (HER2)-negative, estrogen receptor 1 (ESR1)-mutated advanced or metastatic breast cancer. These patients have experienced disease progression after at least one line of endocrine-based therapy.
The ER-positive/HER2-negative subtype represents about 70% of breast cancer cases. Among these patients, mutations in the ESR1 gene are common, occurring in 20-40% of those who received endocrine therapy in the metastatic setting. AC699 has shown an objective response rate (ORR) of 50% in patients with an ESR1 mutation during an ongoing Phase 1 trial presented at ASCO 2024.
FDA's Fast Track Designation
The FDA's Fast Track process aims to speed up the development and review of drugs intended to treat serious conditions and address significant unmet medical needs. Companies receiving this designation benefit from more frequent meetings and communications with the FDA during clinical development. They may also qualify for accelerated approval and priority review if they meet relevant criteria.
"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."
About AC699 and Its Clinical Trials
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. It also showed promising anti-tumor activities in ER-positive animal tumor models.
The Phase 1 multi-center, open-label study aims to evaluate 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.
Accutar Biotechnology's Mission
Accutar Biotechnology is a clinical-stage biotech company focused on AI-enabled drug discovery. The company applies artificial intelligence to discover and develop clinically differentiated medicines.
The Fast Track designation underscores the urgent need for new treatments for advanced or metastatic breast cancer that current therapies do not fully address. This recognition by the FDA could potentially accelerate AC699's path to market, offering hope to many patients battling this challenging condition.
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