Hinova Pharmaceuticals’ investigational drug HP518, utilizing PROTAC technology to target androgen receptor positive (AR+) triple-negative breast cancer, receives FDA Fast Track designation to accelerate development and review processes. The drug shows promising results in preclinical trials and offers new hope for patients with aggressive forms of breast cancer.
Hinova Pharmaceuticals Secures FDA Fast Track Designation for AR+ Triple-Negative Breast Cancer Drug
Chengdu, China, July 5, 2024 — The U.S. Food and Drug Administration (FDA) has granted Fast Track designation to Hinova Pharmaceuticals’ investigational drug HP518, aimed at treating androgen-receptor positive (AR+) triple-negative breast cancer (TNBC). This designation is intended to speed up the development and review process for drugs that target serious conditions and address unmet medical needs.
Details on HP518
HP518 is described as a potent protein degrader employing PROTAC technology to target the androgen receptor (AR). In preclinical trials, HP518 has shown promising results, including significant tumor reduction in animal models of AR+ TNBC. It also demonstrated a favorable safety profile.
TNBC, accounting for about 15-20% of all breast cancer cases, is an aggressive form of cancer that lacks receptors for estrogen, progesterone, and HER2, limiting the effectiveness of traditional breast cancer therapies. Up to 50% of TNBC cases express the androgen receptor, making them potential candidates for AR-targeted treatments like HP518.
The drug is described as an oral AR PROTAC protein degrader that targets both wild-type AR and clinically relevant AR ligand-binding domain mutants, including L702H. Early clinical testing in Australia has suggested HP518’s efficacy in patients with metastatic castration-resistant prostate cancer (mCRPC), showing long-term responses in some participants with an acceptable safety profile. Further Phase 1/2 clinical trials are ongoing in China.
FDA Fast Track Designation
The FDA’s Fast Track designation is designed to streamline the development and expedite the review of drugs that treat serious conditions and address unmet medical needs. This designation allows for more frequent meetings and communications with the FDA to discuss the drug’s development plan and makes the drug eligible for Accelerated Approval and Priority Review if it meets certain criteria.
“We are thrilled to receive Fast Track designation from the FDA for HP518,” said Dr. Yuanwei Chen, Chief Executive Officer of Hinova Pharmaceuticals. “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.”
Future Steps
Hinova Pharmaceuticals plans to update the Investigational New Drug (IND) application 164902 for TNBC development and expedite the clinical trial processes. The company aims to accelerate the development of HP518, in hopes of offering a new therapeutic option for those affected by this challenging form of breast cancer.
About Hinova Pharmaceuticals Inc.
Hinova Pharmaceuticals Inc. is a clinical-stage biopharmaceutical company based in Chengdu, China. The company focuses on developing and commercializing innovative therapies for cancer and metabolic diseases. Their pipeline includes numerous investigational drugs targeting a variety of conditions, all aimed at addressing significant unmet medical needs and improving patient outcomes.
Forward-Looking Statements
The announcement from Hinova includes forward-looking statements about the potential benefits and development of HP518. These are subject to risks and uncertainties, including those associated with clinical trials and regulatory approval processes.
Hinova’s developments and further information about their ongoing studies can be found on their website.
While the Fast Track designation is a crucial milestone, it’s important to note that it does not guarantee approval from the FDA. The approval of HP518 will depend on successful clinical trial results and compliance with regulatory requirements.
Conclusion
With the Fast Track designation for HP518, Hinova Pharmaceuticals aims to bring a potentially groundbreaking treatment to patients with AR+ TNBC more quickly. This move highlights ongoing efforts to address unmet medical needs in oncology and offers hope for improved treatment options for patients suffering from aggressive forms of breast cancer.
