Shanghai, China, Jan 12th,2024 - IMPACT Therapeutics announced that the first patient in the United States has been treated with EIK1003 (formerly IMP1734), a PARP1 selective inhibitor which was discovered by IMPACT Therapeutics and undergoing global clinical development in collaboration with Eikon Therapeutics.
This is a first-in-human, Phase 1/2, open-label, multi-center, dose-escalation, dose-optimization, and dose-expansion study to evalsuate the safety, tolerability, pharmacokinetics, pharmacodynamics, and anti-tumor activity of the PARP1 selective inhibitor, EIK1003, in patients with advanced solid tumors. The study was approved by the U.S. FDA in Q3, 2023 and approved by NMPA in Q4, 2023.
“We are delighted to announce the successful global first-patient-dose of EIK1003 in the United States. This marks a significant milestone in our commitment to improving cancer care. Our collaboration with EIKON Therapeutics is pivotal in accelerating EIK1003’s global clinical development. Our joint endeavor aims to offer cancer patients a treatment option that is not only more effective but also safer. We are dedicated to making this innovative therapy available to patients at the earliest opportunity," stated Dr. Chih-Yi Hsieh, Chief Medical Officer and Executive Vice President of IMPACT Therapeutics.
About EIK1003
EIK1003 is a novel and 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 EIK1003 for PARP1 supports clinical study of this agent as monotherapy and potentially in combination with other treatment regimens.
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 Therapeutics has assembled one of the most comprehensive DNA damage responses (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), ATR inhibitor (IMP9064),and PARP1 selective inhibitor (IMP1734, in collaboration with Eikon Therapeutics), as well as other novel DDR pathway inhibitors. The lead clinical program, PARP inhibitor (Senaparib/IMP4297), has successfully completed Phase III pivotal trial in ovarian cancer first-line maintenance (FLAMES study) setting with best-in-class efficacy and safety profile. Based on the results of the FLAMES study, the Senaparib New Drug Application (NDA) has been accepted for review by the National Medical Products Administration (NMPA) of China. WEE1 inhibitor IMP7068 and ATR inhibitor IMP9064 is undergoing global Phase I clinical study. PARP1 selective inhibitor IMP1734 (EIK1003) has obtained IND clearance from U.S. FDA and National Medical Products Administration of China.
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