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Hinova Receives FDA Proceed Authorization for its IND Application for HP518, an Orally Bioavailable Chimeric Degrader Targeting Androgen Receptor for Prostate Cancer Treatment

Time:2023-02-01 Source:海创药业 Hits:2039

Hinova Pharmaceuticals Inc., a clinical-stage biopharmaceutical company focusing on developing novel therapeutics for cancers and metabolic diseases, recently announced that the U.S. Food and Drug Administration (FDA) has cleared the company’s investigational new drug application (IND) for its innovative drug HP518, an oral chimeric degrader targeting androgen receptor (AR) for the treatment of metastatic castration-resistant prostate cancer (mCRPC). 

HP518 is currently in Phase I clinical trials in Australia. The open-label study approved by FDA will assess the safety, pharmacokinetics, and anti-tumor activity of HP518.

"HP518 is a novel drug expected to address the unmet clinical needs of prostate cancer treatment," said Yuanwei Chen, Ph.D., President and CEO of Hinova. "The available study results of HP518 strengthen our confidence that HP518 is a potentially new treatment for drug resistant prostate cancer. We are making full efforts to advance the clinical study, hoping HP518 will provide more clinical benefits to patients worldwide in the future."

HP518 has been discovered and developed through Hinova's targeted protein degradation drug discovery platform. It has the potential to overcome the drug resistance of prostate cancer that is due to some specific AR mutations. AR is a validated therapeutic target to treat prostate cancer. During the treatment of prostate cancer, drug resistance becomes inevitable due to multiple mechanisms, including AR amplification or mutations, etc. In preclinical studies, HP518 showed excellent selectivity and degradation activity against wild type AR and some specific AR mutants that are resistant to enzalutamide. HP518 also demonstrated excellent antitumor efficacy in xenograft mouse models. 

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About Hinova

Hinova is an international and clinical-stage biopharmaceutical company engaged in the development of innovative deuterated and chimeric degraders for cancers and metabolic diseases. The company has established a targeted protein degradation drug discovery platform, which allows Hinova to screen for protein degradation activity rapidly and to accomplish efficient design and optimization of chimeric degraders. Furthermore, Hinova has profound experience in chemical manufacturing control (CMC) of Chimeric degrader compounds. For more information, please visit http://www.hinovapharma.com/en/.