Hinova Pharmaceuticals  a leading biopharmaceutical company dedicated to developing innovative cancer therapies, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for HP518, an investigational drug for the treatment of Androgen-receptor positive (AR+) triple-negative breast cancer (TNBC). This designation is intended to expedite the development and review process for drugs that address serious conditions and fill an unmet medical need.

 HP518

HP518 is a potent PROTAC AR degrader showing efficacy in AR+ TNBC. In preclinical IND-enabling studies, HP518 has demonstrated promising antitumor activity in AR+ TNBC animal models, showcasing significant tumor reduction and a favorable safety profile. The molecular subforms of TNBC are particularly aggressive forms of breast cancer that lack targeted treatment options, accounting for approximately 15-20% of all breast cancer cases, and are characterized by the absence of estrogen and progesterone receptors and HER2 expression. Notably, a significant proportion of TNBC cases (up to 50%) express the androgen receptor, highlighting the potential impact of AR-targeted therapies like HP518.

HP518 is an oral AR PROTAC protein degrader that degrades both wild-type AR and clinically relevant AR ligand-binding domain (LBD) mutants including L702H. Phase 1 clinical trial in Australia achieved several long term PSA50 and partial responses (PR), demonstrated HP518's promising efficacy and acceptable safety profile in mCRPC patients. The clinical Phase 1/2 trial of HP518 for patients with mCRPC in China is ongoing.

FDA Fast Track Designation

The FDA's Fast Track program is designed to facilitate the development and expedite the review of drugs that treat serious conditions and fill an unmet medical need. Fast Track designation enables more frequent communication with the FDA to discuss the drug's development plan and ensures 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."

Next Steps

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