Debiopharm Expands WEE1 Inhibitor Monotherapy Study in Gynecological and Biomarker-selected Solid Tumors

As of May 16, 2024, a Swiss biopharmaceutical firm, Debiopharm, has initiated a Phase 1 study expansion to evaluate the safety, tolerability, and potential anti-tumor effects of Debio 0123, a potent WEE1 inhibitor, for monotherapy in patients with recurrent or progressive solid tumors. The study, NCT05109975, includes three expansion cohorts, with two utilizing biomarkers to select patients with various solid tumors, and the third focusing on recurrent serous endometrial carcinoma. The first patient has been dosed, and the study is open for enrollment in the United States, Spain, and Switzerland.
Debiopharm's strategy involves the use of OMICs technologies to identify biomarkers and patient populations likely to respond to Debio 0123 due to synthetic lethality, aiming for a precision medicine approach. Uterine serous carcinoma (USC) is a particularly aggressive subtype of endometrial cancer, accounting for a significant proportion of endometrial cancer-related deaths despite its lower incidence. Similarly, epithelial ovarian cancer (EOC), which represents approximately 90% of all ovarian cancers, is known for its poor prognosis and high metastatic potential.
Dr. Victor Rodriguez-Freixinos, Medical Director at Debiopharm, emphasized the company's commitment to precision medicine, while Dr. Manish R. Sharma, Principal Investigator at the START Midwest, highlighted the need for new treatment options for these hard-to-treat cancers. Debio 0123 is a brain-penetrant WEE1 kinase inhibitor that disrupts the DNA repair process in cancer cells, potentially leading to their self-destruction. The compound is currently in development for use in solid tumors, both as a monotherapy and in combination with other treatments.
Debiopharm is dedicated to developing innovative therapies for oncology and bacterial infections, focusing on high unmet medical needs. The company identifies promising compounds, demonstrates their safety and efficacy in clinical trials, and then partners with large pharmaceutical companies to ensure global patient access. The study of Debio 0123 is part of this commitment, as it aims to maximize treatment efficacy while maintaining patient safety.

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