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Shanghai, China, September 25, 2023—IMPACT Therapeutics, Inc. (“IMPACT Therapeutics”) announced that U.S. Food and Drug Administration (FDA) has granted Investigational New Drug (IND) clearance for IMP1734, a highly selective PARP1 inhibitor discovered by Impact Therapeutics and in co-development with Eikon Therapeutics. The Phase I study for IMP1734 will be initiated in the fourth quarter of 2023.

IMP1734 is a novel potent, PARP1 inhibitor that shows biochemical and cellular selectivity when compared to PARP2 which is a related enzyme that is thought to contribute disproportionately to the adverse effect profiles of currently marketed PARP 1/2 inhibitors. The selectivity of IMP1734 for PARP1 supports clinical study of this agent as monotherapy and potentially in combination with other treatment regimens. The initiation of Phase I clinical studies of IMP1734 in the United States and other jurisdictions is expected to begin in the fourth quarter of 2023. In addition, Eikon and Impact Therapeutics have together planned initiation of IND-enabling studies for a brain-penetrant PARP1 candidate that is expected to enter Phase I clinical trials once the IND-enabling studies are successfully completed and reviewed.

“We are very pleased that IMP1734 has received Investigational New Drug (IND) clearance for Phase I studies from the FDA and we will work closely with our partner Eikon Therapeutics to accelerate its clinical development globally,” commented Dr. Sui Xiong Cai, CEO of IMPACT Therapeutics. “We believe that IMP1734 has tremendous potential to be developed as an important treatment for cancer patients.”

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 pipelines 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), which has successfully completed Phase III pivotal trial in ovarian cancer first-line maintenance setting with best-in-class efficacy and safety profile. Senaparib/IMP4297 is currently under NMPA NDA review in China. In addition, Impact is also developing WEE1 inhibitor (IMP7068), ATR inhibitor (IMP9064) in the clinic, PARP1 selective inhibitor (IMP1734, in collaboration with Eikon Therapeutics) and other novel DDR pathway inhibitors.

IMPACT Therapeutics Contact Information:

http://www.getunderline.com

Email: info@getunderline.com