Tuesday, March 26, 2024
DigmBio, a leading biotechnology company headquartered in South Korea and a partner of BioDuro-Sundia, has achieved a significant milestone with the approval of its selective PARP1 inhibitor for the treatment of triple-negative breast cancer by the Korea Food and Drug Administration (MFDS) for Investigational New Drug (IND) application.
Founded in April 2020, DigmBio focuses on discovering and developing innovative therapies for oncology, neurodegenerative diseases, and fibrosis. Their flagship candidate, DM5167, is a second-generation PARP1 selective inhibitor. Preclinical studies have shown promising results for DM5167, indicating superior safety profiles, particularly in hematotoxicity, enhanced selectivity in enzyme assays, and improved DNA trapping capabilities. Notably, DM5167 exhibits excellent brain permeability, suggesting potential efficacy in treating brain metastasis and brain cancer. CEO Kim Jung-min expressed satisfaction with the approval process, highlighting the drug's efficacy in various animal models and anticipating positive outcomes in phase 1 clinical trials.
BioDuro-Sundia, a global Contract Research, Development, and Manufacturing Organization (CRDMO), played a pivotal role in facilitating the IND application process for DigmBio. Through its integrated Chemistry, Manufacturing, and Controls (CMC) departments, BioDuro-Sundia provided comprehensive services, including process development, formulation, analysis, GMP production, and IND application document preparation. Effective communication within BioDuro-Sundia expedited the approval process, earning praise from DigmBio's Chief Strategy Officer, Dr. Jung-Ho Kim, for their responsiveness and timely support.
Dr. Jim Li, Global CMC President of Asia Pacific at BioDuro-Sundia, extended congratulations to DigmBio on the approval of the DM5167 project, emphasizing BioDuro-Sundia's commitment to offering high-quality and efficient R&D solutions. As a global partner, BioDuro-Sundia looks forward to collaborating with DigmBio and anticipates the positive impact of their differentiated drugs on patient outcomes.
BioDuro-Sundia remains dedicated to providing comprehensive new drug R&D services and technical support to biopharmaceutical companies worldwide. Their integrated CMC department offers services from IND to New Drug Application (NDA) stages, including API development, formulation, analysis, DMPK, pharmacology, toxicology, project management, and IND application support. With a robust Environmental, Health, and Safety (EHS) policy and Intellectual Property protection system, BioDuro-Sundia ensures reliable collaboration. Equipped with extensive experience in new drug R&D and registration applications across multiple regions, BioDuro-Sundia is committed to investing in CMC capabilities to support partners' new drug development programs.
Source: prnewswire.com
