Impact Therapeutics Announced IND Approval of Senaparib targeting Prostate Cancer in the U.S.
Impact Therapeutics recently announced that the clinical study of its PARP inhibitor Senaparib (IMP4297) for treating prostate cancer has been approved by the U.S. Food and Drug Administration (FDA), and the clinical trial will begin soon in multiple countries including the United States.
This is a randomized, double-blind, multicenter, and placebo-controlled multi-country and multi-center clinical study. The purpose of this study is to evaluate the efficacy and safety of senaparib in the maintenance treatment of metastatic castration-resistant prostate cancer (mCRPC) patients with homologous recombination repair (HRR) gene alterations, who have obtained a complete or partial response to docetaxel treatment.
Senaparib is a PARP inhibitor developed by Impact Therapeutics which has gone through multiple clinical studies around the world, including an ongoing Phase-3 clinical trial using senaparib as a first-line maintenance treatment, a third-line treatment for patients with ovarian cancer, a Phase-2 clinical trial of senaparib for patients with BRCA mutations, and Phase-1/Phase-2 clinical trials using senaparib in combination with TMZ for treating advanced solid tumors and small cell lung cancer. Clinical and preclinical data show that senaparib has a wider treatment window and a better safety profile than similar products, is more suitable for long-time use and for use in combination with other medicine and has the potential to become the best-in-class drug. Last year, Impact Therapeutics and Junshi Biosciences established a joint venture focusing on the development and commercialization of senaparib in China.
Dr. Bao Jun, CEO of IMPACT Therapeutics expressed, "I am very pleased that Senaparib has been approved by the FDA to carry out clinical study on prostate cancer. IMPACT Therapeutics has been committed to solving the global unmet clinical needs. We hope that the uniqueness and differences of Senaparib can fill the gap in the first-line maintenance treatment of prostate cancer and bring benefits to patients around the world."
About IMPACT Therapeutics
Impact Therapeutics is a biopharmaceutical company dedicated to the discovery and development of targeted anti-cancer therapeutics based on synthetic lethality. Impact has assembled one of the most comprehensive DNA damage response (DDR) global pipeline of novel drug candidates generated by in-house discovery efforts and is expanding to other novel synthetic lethality targets to broaden its pipeline.
Impact pipeline products include PARP inhibitor（Senaparib/ IMP4297）, Wee1 inhibitor（IMP7068）, and other novel DDR agents inhibitors. The lead program PARP inhibitor is in Phase 3 study in China, and other global clinical trials have also started. Preliminary clinical data demonstrated better safety profile and wider therapeutic window. Wee1 inhibitor is in Phase 1 study in the United States and approved to enter clinical in China. Established and operated by an experienced management team in the pharmaceutical industry at home and abroad, the company has established a complete domestic early stage R&D and clinical development team, and is expanding to the United States. The company has received investment from recognized venture capital firms, including strategic investor JunShi Biosciences and Lilly Asia Ventures.