DigmBio's Breakthrough Cancer Drug Clears Korean Regulatory Hurdle

26 March 2024 | Tuesday | News

In collaboration with BioDuro-Sundia, DigmBio's novel PARP1 inhibitor targeting triple-negative breast cancer gains IND approval from Korea's MFDS, paving the way for clinical trials
Image Source : Public Domain

Image Source : Public Domain

BioDuro-Sundia's partner, DigmBio, a South Korean biotechnology company, announced its selective PARP1 inhibitor for the treatment of triple-negative breast cancer has been approved by Korea Food and Drug Administration (MFDS) for Investigational New Drug (IND) application.

Founded in April 2020, DigmBio is a pioneering biotech company discovering and developing novel therapies to treat oncology, neurodegeneration, and fibrosis. The lead program DM5167 is the 2nd generation PARP1 selective inhibitor. According to preclinical study results, DM5167, a novel selective PARP1 inhibitor, exhibits superior in vivo safety, particularly in terms of hematotoxicity and demonstrates enhanced selectivity in enzyme assays, and possesses a more efficient DNA trapping capability. Notably, DM5167 showcases excellent brain permeability, rendering it suitable for treating brain metastasis and brain cancer. DigmBio CEO Kim Jung-min stated, "We are pleased to receive official approval from the Food and Drug Safety Department without the need for any special supplements to the clinical drug. Due to its demonstrated excellent anti-tumor efficacy in various animal models, we anticipate positive safety and effectiveness outcomes in phase 1 clinical trials compared to existing drugs."

As a global trusted Contract Research, Development and Manufacturing Organization (CRDMO) BioDuro-Sundia's integrated Chemistry, Manufacturing, and Controls (CMC) departments facilitated one-stop IND-Enabling services for DigmBio, encompassing process development, formulation, analysis, GMP production, and IND application document preparation. Its effective communication among departments facilitated rapid approval by the Korean MFDS. Dr. Jung-Ho Kim, Chief Strategy Officer of DigmBio said, "We are grateful to the BioDuro-Sundia team for their responsive and timely work on the DM5176 project, which accelerated our project's approval process."

"As a global partner of DigmBio, we sincerely congratulate the approval of the DM5167 project for the Korean IND," said Dr. Jim Li, Global CMC President of Asia Pacific at BioDuro-Sundia. "BioDuro-Sundia is committed to offering comprehensive new drug R&D solutions with high quality and efficiency. We are honored to collaborate with DigmBio and anticipate their differentiated drugs with unique advantages to benefit the patient at earliest."

BioDuro-Sundia is committed to providing a comprehensive, one-stop new drug R&D service platform and professional technical support to global biopharmaceutical companies. The integrated CMC department delivers integrated services from the IND to the New Drug Application (NDA) stage, encompassing Active Pharmaceutical Ingredient (API) development, formulation development, analysis support, Drug Metabolism and Pharmacokinetics (DMPK), pharmacology, toxicology, project management, and IND application support. Additionally, a robust Environmental, Health, and Safety (EHS) policy and Intellectual Property protection system establish a reliable foundation for collaboration. With team members boasting extensive experience in new drug R&D and registration applications, coupled with proficiency in regulations and policies across multiple regions, including China, US, EU, JapanSouth Korea, and Australia, BioDuro-Sundia is equipped with a professional project management system and a rigorous quality management system. Looking forward, BioDuro-Sundia will continue to invest in our CMC capabilities to support partners' new drug development programs with leading technical services.

Stay Connected

Sign up to our free newsletter and get the latest news sent direct to your inbox


Forgot your password?



Lost your password? Please enter your email address. You will receive a link to create a new password.

Back to log-in