EOC Pharma, a biotech company operating in the US and China, has announced that its New Drug Application (NDA) filing for entinostat has been accepted for review by the National Medical Products Administration (NMPA). The targeted indication is hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer with recurrence or progression after endocrine therapy combined with an aromatase inhibitor.
Clinical Study and Efficacy
The NDA filing is based on the Phase III clinical study of entinostat in combination with exemestane for HR-positive, HER2-negative advanced breast cancer patients. The results demonstrated that the combination significantly improved progression-free survival (PFS) compared to a placebo, with statistically significant differences and a good safety profile. These findings underscore the potential of entinostat to address significant unmet needs in the treatment of advanced breast cancer.
Mechanism and Development
Entinostat is a novel, oral, selective histone deacetylase (HDAC) inhibitor and represents EOC Pharma’s first Category 1 drug filed for NDA status. The drug improves and regulates histone hyperacetylation, promoting transcription activation of specific genes by selectively inhibiting HDAC type I, particularly the subtypes 1, 2, and 3. This mechanism ultimately inhibits cell proliferation and accelerates terminal differentiation and/or induces apoptosis. Administered once per week, entinostat has demonstrated safety and efficacy in over 2,000 patients across more than 50 clinical studies.
Licensing and Technology Transfer
EOC Pharma entered into a licensing deal with US-based Syndax Pharmaceuticals, Inc. in 2013, securing research and development, manufacturing, and commercialization rights for entinostat in mainland China, Hong Kong, Macau, Malaysia, Singapore, and Thailand. All technology transfers related to the drug have been completed, positioning EOC Pharma to advance the development and commercialization of entinostat in these regions.
Future Outlook
The acceptance of the NDA filing for entinostat by the NMPA highlights EOC Pharma’s commitment to advancing innovative treatments for advanced breast cancer. With demonstrated efficacy and safety in clinical studies, entinostat has the potential to improve patient outcomes and address significant unmet needs. EOC Pharma’s ongoing efforts in clinical development and strategic partnerships underscore its dedication to bringing novel therapies to patients in need.-Fineline Info & Tech
