Korea Kolmar Holdings Accelerates Microbiome New Drug Development

Contract with US Aranta Bio for Production of Clinical Trial Drugs for Intestinal Disease
Aiming for IND Approval of Global Phase 1 Clinical Trial Plan Next Year

A researcher at Kolmar Holdings Biome Research Institute is culturing and observing bacterial strains.

[Asia Economy Reporter Lim Hye-seon] Kolmar Holdings' Biome Research Institute is accelerating the development of microbiome new drugs. As the global microbiome pharmaceutical market is gaining attention as a blue ocean, the company aims to solidify its position as a leading company in this field through proactive research and development.

On the 25th, Kolmar Holdings announced that it signed a CDMO contract with Arranta Bio, a global contract development and manufacturing organization (CDMO) specializing in the United States, to produce clinical trial drugs for the inflammatory bowel disease treatment candidate strain ‘KBL382’.

Arranta Bio is a microbiome pharmaceutical specialized CDMO headquartered in Boston, USA. It has production facilities in the US that minimize cross-contamination risks during drug manufacturing in accordance with the US Food and Drug Administration (US FDA) LBP (Live Biotherapeutic Products) guidelines.

Through this contract, the two companies will collaborate on all aspects of clinical trial drug development and manufacturing, including cell line production of the KBL382 strain, raw material production, and finished drug production. The goal is to apply for the global Phase 1 clinical trial plan (IND) by the second half of next year.

The KBL382 strain is a microbiome new drug candidate transferred to Kolmar Holdings from Gobio Lab in December last year. It demonstrated superior efficacy compared to existing drugs in inflammatory bowel disease animal model efficacy tests. Derived from human resident bacteria, it is a strain that has secured safety with low side effects even with long-term use.

A Kolmar Holdings official said, "This contract signing is significant as it visualizes the development of drugs using microbiome materials, one of the main pipelines of the Biome Research Institute." He added, "Through collaboration with a global CDMO company, we will accelerate the clinical development of other microbiome pipelines we possess and aim to preoccupy the global microbiome pharmaceutical market."