MEDSIR and Debiopharm Launch Study on Debio 0123 and Sacituzumab Govitecan for Advanced Breast Cancer

Debiopharm, a Swiss biopharmaceutical company, has announced a new clinical collaboration with MEDSIR, an international oncology research organization. The focus of this partnership is a Phase Ib/II investigator-sponsored trial (IST) known as the WIN-B study. This trial aims to evaluate the safety and preliminary efficacy of Debiopharm's WEE1 inhibitor, Debio 0123, in combination with Gilead's antibody-drug conjugate (ADC), sacituzumab govitecan (Trodelvy®), for patients suffering from advanced breast cancer, including both triple-negative and hormone receptor-positive (HR+)/HER2- subtypes.

Debiopharm's Debio 0123 is a selective WEE1 kinase inhibitor that has shown potential in preclinical studies to enhance the anti-tumor effects when combined with DNA-damaging agents. The WEE1 kinase plays a critical role in regulating DNA damage checkpoints, allowing cells to repair before division. Inhibiting WEE1 disrupts this repair mechanism, leading to increased DNA damage and cancer cell death. Sacituzumab govitecan, marketed by Gilead, targets Trop-2 and is already approved for treating metastatic triple-negative breast cancer (TNBC) and HR+/HER2- metastatic breast cancer.

Phase 1b/2 of the WIN-B trial will be conducted across multiple locations in Europe, the UK, and the USA, targeting patients who have previously received treatment for advanced breast cancer. Debiopharm will fund this trial fully, while Gilead will supply the sacituzumab govitecan. The trial's main aim is to discover new treatment approaches that could improve outcomes for these patients, who traditionally face poor prognoses due to limited treatment options.

HR+/HER2- breast cancer constitutes the majority of breast cancer cases, affecting about 70% of patients. This subtype is characterized by the presence of estrogen or progesterone receptors and has a 30% five-year relative survival rate once it becomes metastatic. Treatment often involves chemotherapy, to which many patients eventually develop resistance, leading to significant relapse rates. TNBC, on the other hand, represents 10-15% of breast cancer cases and is known for its aggressive nature and high relapse and mortality rates within five years of diagnosis.

Esteban Rodrigo Imedio, Executive Medical Director of Oncology at Debiopharm, expressed enthusiasm for the study, highlighting the potential benefits of the combination therapy for breast cancer patients. Similarly, Dr. Tim Robinson from the University of Bristol emphasized the importance of exploring novel combination strategies in the fight against breast cancer.

Dr. Javier Cortés, Senior Scientific Lead at MEDSIR, articulated the organization's dedication to advancing patient care through innovative oncology research. He noted that the trial builds on promising preclinical data showcasing the synergistic anti-tumor effects of combining Debio 0123 with sacituzumab govitecan. These findings are set to be presented at the American Association for Cancer Research (AACR) annual meeting in 2024.

Debiopharm is committed to bridging the gap between innovative discoveries and real-world patient applications. The company specializes in identifying promising compounds and technologies, demonstrating their clinical efficacy, and partnering with larger pharmaceutical companies for global commercialization.

MEDSIR, founded in 2012, manages all aspects of clinical trials from design to publication. The organization collaborates closely with partners to drive innovation in oncology research. With a global network of experts, MEDSIR leverages integrated technology to streamline the clinical trial process and advance independent cancer research.

This collaboration between Debiopharm, MEDSIR, and Gilead represents a significant step forward in exploring new, potentially more effective treatments for advanced breast cancer, aiming to meet the high unmet medical needs of this patient population.