News: The application for the clinical trial of SK08 combined with anti-PD-1 / L1 monoclonal antibodies in treating advanced solid tumors was approved
Release Time: 2022-03-11
On March 10 2022, Zhiyi’s Class 1 biological drug treatment, SK08 live bacteria powder, was accepted by the state drug administration (NMPA) for the clinical trial application of a new indication – combined anti-PD-1 / L1 monoclonal antibodies in the treatment of advanced solid tumors
SK08 live bacteria powder is the first LBP drug developed from Bacteroides fragilis internationally. Clinical trials for SK08 began in November 2019 and it is currently undergoing Phase II clinical trials for IBS-D. As a new indication used in the treatment of advanced solid tumors, SK08 is the first LBP-based tumor treatment approved by the state drug administration (NMPA).
About Anti-PD-1 / L1 Monoclonal Antibodies in the Treatment of Advanced Solid Tumors
Anti-PD-1 / L1 monoclonal antibodies have been approved for being used in the first-line and second-line treatment of patients with advanced solid tumors. Due to the primary or secondary drug resistance and the safety risks of immunotherapy, it is important to seek effective alternatives. Recent research findings showing the association between intestinal microorganisms and tumor responses to immunotherapy sparked the development of LBP drugs within the past years. Non clinical studies have confirmed that SK08 promotes T lymphocyte migration, induces DCS maturation and cytokine secretion in the tumor microenvironment. It also enhances the body’s immune surveillance of tumors, promotes CD8 + and CD4 + T cell proliferation and differentiation, and ultimately, improving anti-tumor efficacy.