Advancing Cardiovascular and Renal Health: The Collaboration between BioMe and Bacthera on BM109

BioMe, a prominent player in the field of Live Biotherapeutic Products (LBPs), has recently made significant strides with its latest drug development candidate, BM109, aimed at treating Cardiovascular Disease (CVD) and Chronic Kidney Disease (CKD) by targeting TMAO levels. In a strategic partnership, Bacthera has joined forces with BioMe to facilitate a proof-of-concept study that underscores the potential of microbiome-based therapies in addressing complex health issues.

TMAO, or Trimethylamine N-oxide, has been identified as a significant biomarker for CVD and CKD, with elevated levels linked to higher risks of these conditions. BM109 emerges as an innovative approach by targeting this compound, showcasing BioMe’s commitment to pioneering in the field of microbiome-based therapy.

In the development of BM109, Bacthera has played a pivotal role, leveraging its expertise in LBP production to achieve significant milestones, including the achievement of drug substance yield over 10¹² CFU/g and excellent stability data. This collaboration highlights the seamless integration of Bacthera’s manufacturing capabilities with BioMe’s innovative drug development approach.

Reflecting on the collaboration, BioMe’s CEO, Sang Sun Yoon, remarked,

“The partnership with Bacthera has been instrumental in propelling BM109 forward. Their proficiency in LBP manufacturing and Fast Track Development solutions have significantly contributed to our progress, enabling us to focus on the science and potential of BM109 as a novel therapeutic option for CVD and CKD.”

Bacthera’s Lead Scientist, Line Thorsen, also commented on the project’s significance,

“Working on BM109 has been an exciting opportunity to apply our expertise in a way that could genuinely impact public health. The science behind this candidate is promising, and its development highlights the robustness and scalability of the strain. This project illustrates the comprehensive development solutions Bacthera provides, aimed at accelerating LBP innovation.”

Beyond BM109, BioMe is developing a range of innovative LBPs, including BM107 and BM111, through its “Molecule-First Approach.” BM107 is a synbiotic designed to produce butyrate for the treatment of Inflammatory Bowel Disease (IBD) or Colon Cancer, offering a novel approach to managing these conditions. Meanwhile, BM111 targets antibiotic-resistant infections, addressing a critical need for new treatment options against resistant pathogens such as Vancomycin-Resistant Enterococcus (VRE) and Carbapenemase-Producing Enterobacterales (CPE).

The collaboration between BioMe and Bacthera on BM109 represents a key milestone in the development of microbiome-based therapeutics. Through their joint efforts, both companies are not only advancing a promising candidate for cardiorenal diseases but also demonstrating the potential of innovative partnerships in overcoming the challenges of drug development. As BioMe continues to explore and expand its therapeutic pipeline, the future holds promise for new and effective treatments emerging from the field of microbiome science.

About Bacthera:

Bacthera is a leading one-stop-shop European-based CDMO for Live Biotherapeutic Products, offers innovative end-to-end development, clinical and commercial manufacturing solutions to advance the industry. With sites in Denmark, Spain, and Switzerland, Bacthera can support customers with state-of-the-art process and analytical development services, clinical drug substance and drug product GMP manufacturing, and large-scale commercial manufacturing solutions.

Working on more than 11’000 m^2 of manufacturing and laboratory floors, producing and releasing 30 LBP batches annually and showing a strong track record of handling aerobes, strict and facultative anaerobes, BSL1/2 and GMO1/2 organisms, Bacthera’s 180 employees at their four sites combine the experience of decades in LBP manufacturing.

About BioMe:

BioMe Inc., an innovative biotech company originated from Prof. Sang Sun Yoon’s laboratory at Department of Microbiology and Immunology, Yonsei University College of Medicine, located in Seoul, Korea, specializes in the development of Live Biotherapeutic Products (LBPs) aimed at addressing a spectrum of intractable human diseases. With over 15 years of foundational research, BioMe Inc. has harnessed the therapeutic potential of fecal microbes, offering novel treatments with clearly defined mechanisms of action.