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IMPACT Therapeutics announced today that the PRC National Medical Products Administration (NMPA) has approved the Investigational New Drug (IND) application of our Wee1 inhibitor IMP7068 to commence its clinical trial in China. This is a Phase 1, open-label, multi-center, dose escalation and expansion study to evalsuate the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of IMP7068 monotherapy in patients with advanced solid tumors. IMP7068 is in Phase 1 study in the United States.

“Wee1 kinase is a cell-cycle regulator that plays important role in DNA Damage Response (DDR) pathways and a scientifically validated anti-tumor target. There is a strong biological rationale supporting that Wee1 is a synthetic lethality target in p53-mutant tumors. Synthetic lethality arises when a combination of deficiencies in the expression of two genes leads to cell death, whereas a deficiency in only one gene does not. It can be exploited to develop targeted anticancer therapeutics using targeted agents, since cancer cells are more dependent on the targeted pathway when deficient in the alternative pathway. Synthetic lethal approach is becoming a new paradigm for targeted anti-cancer therapy.

IMP7068 is a novel Wee1 inhibitor internally discovered and developed by IMPACT Therapeutics, with worldwide intellectual property rights. In preclinical studies, IMP7068 exhibited satisfied safety, tolerability, and pharmacokinetic profiles in animal models. Additionally, IMP7068 has demonstrated in vitro and in vivo anti-cancer activities in a broad range of solid tumor cell lines and xenograft models. Based on the differentiated chemical structure, IMP7068 has showed better selectivity, longer half-life and higher drug exposure in preclinical studies, all of which would potentially lead to superior safety profile in clinical and more flexibility for single agent and combination therapy.“

Dr. Chih-Yi Hsieh, Senior Vice President and Chief Medical Officer said, “It is exciting that IMP7068 was approved by the NMPA to enter a Phase 1 study in China. It is a big step of IMPACT synthetic lethality pipeline progress, which means we have the opportunity to validate the advantages of IMP7068 in clinical based on what we have observed in preclinical studies. China is always one of the most important markets for our global development strategy. We will practice a seamless transition in clinical trial design and maintain frequent communication with regulatory authorities to expedite the development process and benefit the 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 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 a PARP inhibitor（Senaparib/ IMP4297）, a Wee1 inhibitor（IMP7068）, and other novel DDR pathway inhibitors. The lead clinical program, a PARP inhibitor, is in a Phase 3 study in China, and other global clinical trials for this PARP inhibitor have also started. Preliminary clinical data demonstrated better safety profile and wider therapeutic window of this PARP inhibitor. Wee1 inhibitor is in a Phase 1 study in the United States.