Cell Biotech begins clinical trials for new microbiome colon cancer drug ‘PP-P8’

Cell Biotech is starting clinical trials for its new colon cancer drug ‘PP-P8’ utilizing the microbiome, and is taking a full-fledged leap forward as a biopharmaceutical company. Cell Biotech is starting the first patient administration of ‘PP-P8’ in collaboration with Seoul National University Hospital and is starting the clinical trial in earnest.

Cell Biotech received approval for the Phase 1 clinical trial plan (IND) for ‘PP-P8’ from the Ministry of Food and Drug Safety in March 2024. Afterwards, in cooperation with Seoul National University Hospital, it changed the protocol by specifying the patient selection criteria and adjusting the contraindicated drugs. The changed clinical trial plan was approved by the Seoul National University Hospital Medical Research Ethics Review Committee (IRB) and the Ministry of Food and Drug Safety, and full-scale patient administration began. Although it took longer than expected, the company explained that it was a thorough preparation and review process that prioritized patient safety.

The clinical trial will evaluate ▲tolerance ▲safety ▲efficacy in a total of 32 patients with metastatic colorectal cancer (rectal cancer) at Seoul National University Hospital. In the dose escalation phase (Part 1), the safety will be confirmed by gradually increasing the dosage, and in the dose expansion phase (Part 2), the appropriate dosage will be selected to explore the efficacy.

PP-P8 is Korea's first innovative new drug (First-in-Class) developed as an anticancer agent by recombining lactic acid bacteria genes. Specifically, it is a transformed lactic acid bacteria based on 'CBT-SL4 (Pediococcus Pentosaceus CBT-SL4, KCTC 10297BP)' developed to mass-produce the anticancer protein 'P8' derived from Duolac's patented strain 'CBT-LR5 (Lactobacillus Rhamnosus CBT-LR5, KCTC 12202BP)'. The technology is designed as a mechanism that can produce 100 times more of the anti-cancer protein ‘P8’ that kills colon cancer cells than in its natural state by utilizing innovative genetic engineering technology.

All reagents required for clinical trials are produced directly at the ‘Biological Preparation Pharmaceutical Factory’ in the Gimpo headquarters of Cell Biotech. Currently, microbiome-based new drug development using microorganisms is actively taking place worldwide, but CDMO companies capable of producing new drugs and clinical reagents are extremely rare. Cell Biotech aims to lead the global CDMO market for microbiome-related pharmaceutical strains based on the lactic acid bacteria fermentation technology and know-how accumulated through the Duolac business over the past 30 years.

Cell Biotech’s Clinical Development Team Leader Byun Jong-sun said, “We are expanding our business area to develop new drugs for various diseases such as diabetes, obesity, and vaginitis as well as colon cancer using the lactic acid bacteria drug delivery system (DDS) platform technology,” and added, “Based on our accumulated know-how and experience, Cell Biotech will shorten the new drug development period, reduce trial and error, and transform into a biopharmaceutical company.”

Meanwhile, Cell Biotech, which is leading the innovation of ‘K-lactic acid bacteria’ colon cancer treatment with CBT lactic acid bacteria, has been selected as a ‘2024 World-Class Product’ in recognition of its position and competitiveness in the global lactic acid bacteria market, following its ranking as the world’s number one exporter for 11 consecutive years. Cell Biotech is currently exporting CBT lactic acid bacteria to 55 countries around the world, led by the lactic acid bacteria brand Duolac, and is recording the second largest market share in Denmark, the home of lactic acid bacteria.