Liveome, a subsidiary of Medytox, has signed contract development and manufacturing organization (CDMO) contracts with Australia’s Luina Bio and U.K.’s Quay Pharma to develop an inflammatory bowel disease candidate, LIV001.

Liveome, a subsidiary of Medytox, has signed CDMO contracts with two foreign companies to develop LIV001, an inflammatory bowel disease candidate.
Liveome, a subsidiary of Medytox, has signed CDMO contracts with two foreign companies to develop LIV001, an inflammatory bowel disease candidate.

Luina Bio will provide raw materials, and Quay Pharma will make finished products, a company official said.

With the contract, Liveome will begin full-fledged efforts to commercialize LIV001.

“Starting with these CDMO contracts for LIV001, we plan to build a cell bank, develop a production process, and produce clinical samples,” Liveome CEO Song Ji-yoon said. “The company aims to complete a nonclinical toxicity test this year and start a global clinical trial by 2023.”

Liveome also prepares to start global clinical trials for LIV002, an anticancer drug candidate, from 2023, Song added. Liveome is a company specializing in the development of next-generation new drugs. The company, established last year, has received live biotherapeutic product (LBP) candidates and other technologies from Medytox.

Liveome has two LBP-related technologies -- N-LBP, a natural microbiome-based platform technology, and E-LBP, which maximizes gene-editing treatment efficacy. The company is rapidly expanding its new drug pipeline for intractable diseases based on the two platforms.

LIV001 is a candidate for the treatment of inflammatory bowel disease, which has applied the company’s E-LBP platform technology. The company has designed the drug to have maximized therapeutic efficacy by regulating immune function to ensure safety as a therapeutic agent.

Liveome has recently confirmed the therapeutic efficacy of LIV001 for acute and chronic enteritis through a preclinical trial.

Luina Bio and Quay Pharma are global pharmaceutical companies specializing in CDMO. Both companies have current good manufacturing practice (cGMP) production facilities for microbial therapeutics.

The two companies collaborate with several microbiome companies to produce raw materials and finished drugs necessary for clinical trials of microbiome treatments

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