The world’s first colorectal cancer drug made from probiotics is expected to emerge from a Korean company. Cell Biotech is set to begin Phase 1 clinical trials in October for its genetically engineered colorectal cancer treatment, which combines Korean gut probiotics with Kimchi-derived probiotics. If successful, this new drug could become the 'first-in-class' treatment, offering similar efficacy to existing anticancer drugs but with significantly reduced side effects.
According to industry sources on the 18th, Cell Biotech is preparing for the clinical trials of its oral colorectal cancer drug 'PP-P8.' The trials will commence in October at Seoul National University Hospital, involving 32 participants. PP-P8 is a candidate drug that combines an anticancer protein, 'P8,' derived from Korean probiotics with Kimchi probiotics (PP), aiming to enhance the therapeutic effects against colorectal cancer.
P8 is an anticancer protein derived from Cell Biotech’s patented strain 'CBT-LR5.' Although its anticancer properties, such as destroying proteins that promote colorectal cancer growth, have been proven, its natural efficacy is limited. To overcome this, Cell Biotech has developed a proprietary Drug Delivery System (DDS) platform to amplify the production of P8 by more than 100 times compared to its natural state. This process involves inserting P8 into a plasmid (a gene carrier) and then transforming the plasmid DNA into Kimchi probiotics. The Kimchi probiotics serve as a 'vehicle' that survives stomach acid, facilitating the drug's journey through bile acids, the small intestine, and ultimately to the colon. Cell Biotech is currently the only company developing a colorectal cancer drug through this method of genetic recombination.
In March 2021, Cell Biotech applied for Phase 1 clinical trial approval with the Korean Ministry of Food and Drug Safety (MFDS) and received approval in March 2024, after three years. The company had to address safety concerns, conducting extensive animal testing on mice and monkeys, which delayed the approval process.
Currently, most colorectal cancer treatments are synthetic compounds or immuno-oncology drugs, which are often associated with side effects like fatigue, nausea, hair loss, elevated liver enzymes, abdominal pain, and shortness of breath, in addition to high costs. In contrast, PP-P8, being based on probiotics extracted from the human body, is expected to have fewer side effects. It is also being developed as an oral medication, offering greater convenience than injections. Animal trials, including those on primates, have shown no significant side effects, according to the company.
A representative from Cell Biotech stated, "We believe PP-P8 can provide similar efficacy to the standard colorectal cancer treatment '5-FU (Fluorouracil)' while offering lower side effects, better convenience, and cost-effectiveness. If we can secure a stable strain, mass production will be feasible due to Cell Biotech’s established capabilities, ensuring economic viability."
Cell Biotech aims to use this new drug as a stepping stone to officially enter the bio industry and achieve significant growth, drawing confidence from its 29 years of expertise in native probiotics. The company successfully mass-produced probiotics just nine months after its founding, becoming the fifth in the world to do so after Denmark, the United States, Germany, and Japan. It exclusively uses Korean probiotics and has received GRAS (Generally Recognized As Safe) certification from the U.S. FDA for 11 strains, the highest number for a single company globally.
Cell Biotech’s goal is to develop this colorectal cancer drug independently, without technology transfer. The company plans to complete Phase 1 trials by December 2025 and Phase 2 by June 2028, with plans to apply for conditional approval as an orphan drug upon entering Phase 3. A company representative stated, "Our goal is to develop the colorectal cancer drug as independently as possible, rather than through technology transfer. We are also exploring and identifying candidate substances for treating diabetes, obesity, and vaginitis, and we plan to expand our pipeline using our proprietary technologies."