Zhiyi Biotech Finishes Series B Funding With $45 Million For Live Biotherapeutics
Guangzhou, China-based Zhiyi Biotech has raised $15 million in its B++ funding round, bringing the total amount of funds raised across B, B+, and B++ funding to $45 million. The latest round was joined by a syndicate of Chinese investors, including Qingkong SinoKing Capital, SDIC Venture Capital, and KIP.
Zhiyi works to isolate and identify new functional strains of microorganisms and turn them into live biotherapeutic products, or LBPs. Its lead product, SK08, is undergoing a Phase 2 study in irritable bowel syndrome (IBS-D) that is expected to be completed this year. The company has also begun another Phase 1b/2 trial of SK08 combined with a PD-1 inhibitor for advanced solid tumors. Other pipeline products are undergoing IND filing to both the US FDA and China’s NMPA.
LBPs as Potential Cancer Treatments
The active substance of SK08 is from a bacterial strain of Bacteroides fragilis, a common gut bacteria. Notably in 2019, SK08 became the first LBP in oncology to reach the clinic in China. Preclinical studies on SK08 suggest that the LBP may promote T-cell migration and proliferation, dendritic cell maturation and inflammation such as cytokine secretion in the tumor microenvironment.
While LBPs are slowly gaining interest as a cancer treatment, drug developers must pay attention to the quality, safety and efficacy of their candidate. A concern is how the strain reaches the tumor, and the possibility of unwanted sepsis, infection, or inflammation. The strain must also be designed to be unable to transfer antibiotic resistance to other microbes.
To ensure the purity of their LBPs, Zhiyi has established a platform system for strain selection, drug ability study, CMC study, and owns two commercial-scale plants for production.
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