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Impact Therapeutics Begins US Study of Synthetic Lethality WEE1 Inhibitor IMP7068

NEW YORK – Impact Therapeutics said on Wednesday that it has dosed the first patient in a US-based Phase I clinical study of its WEE1 Inhibitor IMP7068.

The first-in-human trial, expected to enroll roughly 150 patients with advanced solid tumors, is designed to assess IMP7068's safety, pharmacokinetics, and preliminary anti-tumor activity as a monotherapy. The agent is designed to inhibit the WEE1 kinase, which plays a key role in DNA damage response pathways. According to Nanjing, China-based Impact, there is a strong biologic rationale supporting WEE1 as a synthetic lethality target specifically in tumors with p53 mutations. The agent has demonstrated preclinical activity across various solid tumor indications, including in cell lines and in xenograft models.

Impact has also received clearance from regulatory authorities to evaluate IMP7068 in Taiwan- and China-based clinical trials.

"This is our first US clinical study and a remarkable milestone of our synthetic lethality pipeline progress," Chih-Yi Hsieh, Impact's senior VP and chief medical officer, said in a statement. "We will endeavor to advance the global clinical development of IMP7068 and to benefit more patients worldwide."