Beijing Scitop Bio-tech Co., Ltd (SHE: 300858) announced that the US Food and Drug Administration (FDA) has granted Investigational New Drug (IND) approval for its live bacteria therapeutic candidate KEX02, to be tested in combination with a PD-1 inhibitor for the treatment of non-small cell lung cancer (NSCLC).
About KEX02
KEX02 is a live biotherapeutic product (LBP) derived from bacteria sourced from the intestines of healthy children. The therapy is designed to activate dendritic cells, enhance the killing function of effector T cells, and significantly improve the response rate of immunotherapy.
Preclinical Results
Cell and animal studies have demonstrated that KEX02 live bacteria possess excellent immune activation capabilities. When combined with a PD-1 inhibitor, the therapy has shown a significant tumor inhibition effect and notably improved survival rates in tumor-bearing mice.
Clinical Trial Plans
The FDA’s approval allows Scitop Bio-tech to proceed with clinical trials in the US, evaluating the safety and efficacy of KEX02 in combination with PD-1 inhibitors for NSCLC patients.-Fineline Info & Tech
