CJ applies to FDA for trials of immuno-anticancer drug candidate

CJ Bioscience, an independent red bio (pharmaceutical and healthcare) subsidiary of CJ CheilJedang Corp., said on Monday it has submitted a phase 1 and 2 clinical trial protocol for CJRB-101, an immuno-anticancer drug candidate, to the US Food and Drug Administration (FDA). 

CJRB-101 is a microbiome-based substance developed by CJ CheilJedang through immunological studies based on the strain library it has built.

In clinical trials, CJ will administer both CJRB-101 and immune checkpoint inhibitor pembrolizumab (Keytruda) to patients with advanced or metastatic non-small cell lung cancer, head and neck squamous cell carcinoma, and melanoma, to evaluate safety and preliminary efficacy. 

To expand the utilization of candidate substances, CJ Bioscience decided to simultaneously evaluate its efficacy in lung cancer, head and neck cancer, and skin cancer.

In the first half of 2023, it will apply for clinical trials to the Korean Ministry of Food and Drug Safety to conduct clinical trials in both countries.

"Combined uses of CJRB-101 and immune checkpoint inhibitors will improve the low response rate of existing immuno-anticancer drugs and provide new treatment options for patients with intractable conditions for whom immuno-anticancer drugs hardly work," said a CJ Bioscience official.

CJ Bioscience was launched last January by integrating bio sector resources previously owned by CJ CheilJedang with microbiome company Cheonlab, which it took over in October last year.

Write to Jae-Young Han at jyhan@hankyung.com