Microbio Co., Ltd. (4128) Announces Promising Results of "MS-20" in Combination with Keytruda for Stage IIIb/IV Non-Small Cell Lung Cancer

CUPERTINO,Calif.,Dec. 17,2024 -- Microbio Co.,Ltd. (4128) today revealed encouraging results from an exploratory clinical trial of MS-20 combined with Keytruda (pembrolizumab) in stage IIIb/IV non-small cell lung cancer (NSCLC). The trial showed a threefold increase in the objective response rate (ORR) for the MS-20-Keytruda group (75%) compared to Keytruda alone (25%). Additionally,the median progression-free survival (PFS) for MS-20 patients improved from 4.5 months to over 12 months,with a complete response (CR) rate of 12.5%.

Enhancing Immunotherapy with MS-20

MS-20,developed by Microbio,is a microbiome-based postbiotic designed to improve cancer immunotherapy by modulating the gut microbiome. "The results support MS-20's potential to reshape the microbiome and enhance Keytruda's effectiveness in treating advanced NSCLC," said Dr. Wan-Jiun Chen,Executive VP of Research & Development at Microbio. "Currently,hundreds of ongoing trials are aimed to find novel therapeutic agents for improving the efficacy of cancer immunotherapy,and this proof-of-concept trial supports the use of MS-20 in such application."

This randomized,double-blind,placebo-controlled trial involved 15 patients,with 12 analyzed in the modified intent-to-treat (mITT) population (ClinicalTrials.gov ID: NCT04909034). Of the 8 patients receiving MS-20 and Keytruda,6 (75% ORR) responded positively,including 1 with an ongoing CR lasting over 22 months and 5 with partial responses (PR). In contrast,only 1 of 4 patients in the placebo and Keytruda group showed a PR (25% ORR). The median PFS for the MS-20-Keytruda group was over 12 months,compared to 4.5 months in the placebo group.

Scientific Insights and Next Steps

Preclinical research published in Gut Microbes earlier this year supported these findings,showing that MS-20 enhances immune responses by increasing effector CD8 T cells in the tumor microenvironment. Microbio plans to use these results to pursue global collaborations and further its microbiome-based cancer immunotherapy platform.

About Microbio Co.,Ltd.

Microbio (MB,Est. 2000) is a company focused on immune,oncology and metabolic diseases. In addition,MB is specialized in research and development into microbiome via its unique microbial pharmaceutical technology platforms. Its proprietary library with hundreds of unique anaerobic commensal bacteria metabolites has obtained significant findings in treatment of immune,oncology and metabolic diseases which takes it a further step into next-generation microbiome-based therapeutics.

About MS-20

MS-20 is a postbiotic developed through Microbio's Symbiota™ fermentation technology involving symbiotic fermentation with multi-strain probiotics under an anaerobic condition. It is clinically proven to alleviate chemotherapy side effects and enhanceimmunotherapy efficacy. In 2024,MS-20 received an independent/self-affirmed GRAS status in the U.S. and is used in various food and beverages,including specialized medical nutrition products.

For more information,visitwww.twmicrobio.comor meet the team at the JPMorgan Healthcare Conference in San Francisco from January 13-16,2025.