Pharma Focus Asia

Hinova Pharmaceuticals Receives FDA Fast Track Designation for HP518 to Treat AR+ Triple-Negative Breast Cancer

Saturday, July 06, 2024

Hinova Pharmaceuticals Inc. (688302.SH), a leading biopharmaceutical company focused on innovative cancer therapies, announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for HP518, an investigational treatment for Androgen-receptor positive (AR+) triple-negative breast cancer (TNBC). This designation aims to accelerate the development and review process for drugs that address serious conditions and unmet medical needs.

HP518 is a potent PROTAC AR degrader, demonstrating significant antitumor activity in AR+ TNBC animal models during preclinical studies. These studies showed notable tumor reduction and a favorable safety profile. TNBC, which accounts for approximately 15-20% of all breast cancer cases, is particularly aggressive due to the absence of estrogen and progesterone receptors and HER2 expression. Up to 50% of TNBC cases express the androgen receptor, making AR-targeted therapies like HP518 potentially impactful.

HP518 is an oral AR PROTAC protein degrader that targets both wild-type AR and clinically relevant AR ligand-binding domain (LBD) mutants, including L702H. A Phase 1 clinical trial in Australia demonstrated several long-term PSA50 and partial responses (PR), indicating promising efficacy and an acceptable safety profile in mCRPC patients. A Phase 1/2 clinical trial in China is ongoing to further evaluate HP518 in mCRPC patients.

The FDA's Fast Track program is designed to speed up the development and review process for drugs that treat serious conditions and address unmet medical needs. This designation allows for more frequent communication with the FDA about the drug's development plan and provides eligibility for Accelerated Approval and Priority Review if relevant criteria are met.

"We are thrilled to receive Fast Track designation from the FDA for HP518," said Dr. Yuanwei Chen, Chief Executive Officer of Hinova. "This designation underscores the significant need for new treatment options for patients with TNBC and highlights the potential of our investigational therapy to make a meaningful impact on this devastating disease. The discovery of HP518's novel mechanism of action provides new hope for effective treatment. We look forward to working closely with the FDA to advance HP518 through the clinical development process as efficiently as possible."

Hinova plans to update the existing IND (IND 164902) for TNBC development in the near future. The company is dedicated to accelerating the development of HP518 and bringing this promising therapy to patients in need.



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