IMPACT announced Wee1 inhibitor IMP7068 IND clearance by US FDA
Impact Therapeutics recently announced that the U.S. FDA approved the Investigational New Drug (IND) application of Wee1 inhibitor IMP7068 for the first-in-human clinical study on October 29th, 2020. This is a Phase 1, open-label, multi-center, dose escalation and expansion study to evaluate safety, tolerability, pharmacokinetics, and anti-tumor activity of IMP7068 monotherapy in patients with advanced solid tumors.
Wee1 kinase is a cell-cycle regulator that is important in DNA Damage Response (DDR) pathways and a validated anti-tumor target. Inhibition of Wee1 prevents G2/M checkpoint initiation, leading to unscheduled mitotic entry with less precisely repaired DNA damage, subsequent loss of genomic integrity. Given the key role of TP53 in the regulation of G1/S checkpoint and the increased reliance on the G2/M checkpoint in p53-deficient cells, there is a strong biological rationale supporting that Wee1 is a synthetic lethality target of p53-deficient tumors. AstraZeneca's Wee1 inhibitor AZD1775 has demonstrated proof-of-concept clinical data in several tumors, especially in those with TP53 mutations. However, the key limitation of AZD1775 is its unignorable toxicity.
IMP7068 is a new chemical entity discovered and developed by Impact Therapeutics, with worldwide intellectual property, part of in-house DDR franchise. In preclinical studies, IMP7068 exhibited satisfied safety, tolerability, and pharmacokinetic profiles in animal models. Additionally, IMP7068 has demonstrated strong in vitro anti-cancer activities in a broad range of solid tumor cell lines and strong in vivo anti-cancer activities in tumor xenograft models. Compared to AZD1775, IMP7068 has better selectivity, longer half-life, and higher drug exposure, all of which would potentially lead to superior therapeutic window in treating patients.
Dr. Chih-Yi Hsieh, Senior Vice President and Chief Medical Officer said, “It is exciting that IMP7068 was approved by the U.S. FDA to enter First-in-human study. Meanwhile, Impact is filing an IND to NMPA as the first Wee1 inhibitor program in China. As our first US IND approval, this is not only a big step of Impact pipeline progress, but also a remarkable milestone of Impact globalization strategy. We are confident and eager to validate the pharmacological advantages of IMP7068 in clinical based on what we have discovered in pre-clinical studies. Meanwhile, we will integrate biomarker strategy throughout the development to select patients who will benefit the most from the treatment. Furthermore, we will practice seamless transition in clinical trial design and maintain frequent communication with regulatory authorities to expedite the development process and bring better treatment to cancer patients around the world.”
Impact Therapeutics is a privately held, clinical-stage biopharmaceutical company and dedicates to the discovery and development of targeted anti-cancer therapeutics based on synthetic lethality. Impact has assembled the most comprehensive global DNA damage response (DDR) 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 has been funded by recognized venture capital firms such as Lilly Asia Ventures.