Impact Therapeutics announced today that the first patient was recently dosed in the first-in-human Phase 1 clinical study of Wee1 Inhibitor IMP7068 in the United States.

This is a Phase 1, open-label, multi-center, dose escalation and expansion study to evaluate the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of IMP7068 monotherapy in patients with advanced solid tumors.

IMP7068 is a 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 innovative chemical structure, IMP7068 has showed satisfied selectivity, longer half-life and higher drug exposure in preclinical studies, which could potentially lead to superior safety profile in clinical studies, providing more flexibility for IMP7068 as a single agent and in combination therapy. 

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.

Dr. Chih-Yi Hsieh, Senior Vice President and Chief Medical Officer said, "We really appreciate all the efforts and support from the investigators, clinical sites, CRO partners and team members that contribute to initiation of the IMP7068 Phase 1 study in the U.S. This is our first U.S. clinical study and a remarkable milestone of our synthetic lethality pipeline progress. It is exciting that IMP7068 has been approved by the TFDA  for Phase 1 study in Taiwan, China Region of China soon after the approval by the NMPA in mainland China in early February 2021. We will endeavor to advance the global clinical development of IMP7068 and to benefit more patients worldwide."

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, Senaparib, is in a Phase 3 study in China, and other global clinical trials for this PARP inhibitor have also being initiated. Preliminary clinical data of Senaparib demonstrated better safety profile and wider therapeutic window compared to marketed PARP inhibitors. Wee1 inhibitor completed the first patient dose in the United States and approved for clinical trials in China.