Cell Biotech Starts Clinical Trial for Microbiome-Based Colon Cancer New Drug

Targeting 32 Patients with Metastatic Colorectal (Rectal) Cancer

Cell Biotech is commencing the first clinical trial of its colorectal cancer new drug candidate, 'PP-P8.'

Cell Biotech, Biologics Pharmaceutical Factory. Cell Biotech

On the 19th, Cell Biotech announced that patient dosing has begun in collaboration with Seoul National University Hospital.

Previously, the Ministry of Food and Drug Safety of Korea approved the Phase 1 clinical trial plan (IND) for PP-P8 in March of last year. Since then, Cell Biotech has worked with Seoul National University Hospital to specify patient selection criteria and adjust contraindicated concomitant medications, among other protocol modifications.

The revised clinical trial plan was approved by the Institutional Review Board (IRB) of Seoul National University Hospital and the Ministry of Food and Drug Safety, leading to the official start of patient dosing.

The clinical trial is being conducted at Seoul National University Hospital with a total of 32 patients with metastatic colorectal cancer (including rectal cancer) to evaluate ▲tolerability ▲safety ▲efficacy. In the dose-escalation phase (Part 1), the dosing amount will be gradually increased to confirm safety, and in the dose-expansion phase (Part 2), an appropriate dose will be selected to explore efficacy.

PP-P8 is a new drug substance developed as an anticancer agent by genetically recombining probiotic bacteria. It is a genetically modified probiotic based on 'CBT-SL4,' developed to mass-produce the anticancer protein P8 derived from Duolac's patented strain 'CBT-LR5.'

This content was produced with the assistance of AI translation services.