Microbiome-Based Gene Therapy, First-in-Class Colorectal Cancer New Drug
Cell Biotech received approval from South Korea's Ministry of Food and Drug Safety (MFDS) for a phase 1 clinical trial of the colorectal cancer new drug 'PP-P8'.
PP-P8 is a microbiome-based oral gene therapy, a new first-in-class colorectal cancer drug. It is a therapeutic agent using genetic techniques based on safe probiotics. The phase 1 clinical trial of PP-P8 approved this time will be conducted in patients with severe stage colorectal cancer to evaluate ▲ tolerability ▲ safety ▲ effectiveness.
The new colorectal cancer drug PP-P8 is a gene recombinant drug of CBT-SL4 (KCTC 10297BP), which mass-replicates and produces the anticancer protein P8 derived from Cell Biotech's patented strain CBT-LR5 (KCTC 12202BP). It is designed to produce about 100 times more anticancer protein P8, which kills colorectal cancer cells, using genetic manipulation technology.
Using these technology platforms such as the probiotics Drug Delivery System (DDS) and recombinant probiotics for anticancer treatment, Cell Biotech plans to expand the development of new drugs through various research and development pipelines such as diabetes treatments and vaginitis treatments.
The probiotics drug delivery system is highly convenient to take, and it delivers drugs directly to the intestine, so treatment efficiency is high. Using natural proteins derived from lactic acid bacteria, it is expected to help overcome the shortcomings of chemical anticancer drugs, which have side effects caused by high concentration administration and long-term use.
Cell Biotech's CEO, Jung Myung-joon, stated, "As a key player in pioneering the path of microbiome drug development, Cell Biotech holds a sense of mission and pride, pouring all efforts into the day when the drugs we have developed contribute to improving the treatment and quality of life of numerous patients." He added, "Based on multifaceted microbiome businesses, including Korea's leading probiotic brands DUOLAC and DUOLAB, as well as novel drug development led by colorectal cancer treatments, we aspire to promote the excellence of Korean probiotics worldwide."