CHENGDU,
China, July 5, 2024 /PRNewswire/ -- Hinova
Pharmaceuticals Inc. (688302.SH), 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.
About 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.
About Hinova Pharmaceuticals Inc.
Hinova is an international and clinical-stage biopharmaceutical
company focused on developing and commercializing innovative
therapies for treating cancer and metabolic diseases. The company's
pipeline includes multiple investigational drugs targeting a
variety of cancer types and metabolic disorders, all aimed at
addressing significant unmet medical needs and improving patient
outcomes.
Forward-Looking Statements
This press release contains forward-looking statements,
including statements regarding the development and potential
benefits of HP518 and the anticipated clinical trial plans. These
forward-looking statements are based on Hinova's current
expectations and are subject to risks and uncertainties that could
cause actual results to differ materially. Factors that could cause
actual results to differ include the risks associated with clinical
development, regulatory approval processes, and other risks.
Note to Editors:
For more information about HP518 and ongoing studies, please
visit Hinova's website at https://www.hinovapharma.com/en/
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SOURCE Hinova Pharmaceuticals Inc.