HONG KONG – Kobiolabs Inc., a microbiome-based venture from Seoul, South Korea, has secured a ₩26.6 billion (US$22.2 million) investment. Founded in 2014, the venture has achieved ₩193 billion of enterprise value.

The company will use the investment to proceed with global clinical studies of its three drug candidates indicated for atopic dermatitis (KBLP-001), severe asthma (KBLP-002) and Clostridium difficile infection (KBLP-003).

"The phase I clinical trial and the first human treatments with KBLP-001 have recently started in Australia. We have completed a pre-IND meeting with the FDA and plan for an IND application for phase II clinical trial in the second quarter of next year," Sungji Kim, head of pharmaceutical development at Kobiolabs, told BioWorld. The biotech will possibly conduct a phase I clinical trial of KBLP-002 in Australia and KBLP-003 in the U.S. next year, however, the countries have not been confirmed yet.

As it accelerates its clinical studies, Kobiolabs also aims for an IPO on KOSDAQ in the second half of next year. A consortium of Samsung Securities and Daishin Securities is going to manage the listing procedure.

Hyunki Kim, managing director at Stonebridge Ventures, said that Kobiolabs has a technological potential that exceeds that of its competitors.

"Kobiolabs has built a human microbiome database of about 3,000 healthy Koreans, including twins cohorts, which is the optimal design for studying the influences of microbiomes on hosts. The company secured around 5,000 bacterial isolates identified from human donor samples. Kobiolabs also identifies microbes that differentiate the disease state from the healthy state with clinical metadata, and we believe that this is the company's key factor in leading the microbiome R&D market in Korea," Kim told BioWorld.

"We also expect the company to license out in the early stages, as some domestic and foreign pharmaceutical firms are discussing the technology transfer of its pipelines," Kim added.

Eleven institutional investors including Stonebridge Ventures Inc., Atinum Investment Co. Ltd., Company K Partners Ltd., Timewise Investment Co. Ltd., Samsung Securities Co. Ltd., Daishin Securities Co. Ltd. and Quad Investment Management Corp. participated in the investment by acquiring redeemable convertible preference shares.

Based at Seoul National University (SNU), the company is led by CEO Gwangpyo Ko, a professor of the Graduate School of Public Health and the director of the Center for Human and Environmental Microbiome at SNU. The venture was founded as a spin-off of the center.

Kobiolabs develops platform technology, builds human microbiome databases, operates a microbiome biobank and identifies therapeutic candidates such as bacterial strains and bioactive molecules.

The platform identifies microbial candidates by interrogating the host microbiome and clinical metadata. Then it searches therapeutic candidates, elucidates a mechanism of action (MoA) and conducts an IND enabling study. In the process from microbiome database and biobank building to mining, the platform explores the causality between microbiome and target disease and quickly searches for therapeutic candidates such as bacterial strains or bioactive molecules.

In microbiome biobank, it optimizes culture conditions based on anaerobic chambers, selective media and bioreactors to secure more than 5,000 bacterial isolates and their relevant data. The isolates include various types of bacteria such as Lactobacillus, Bifidobacterium, Faecalibacterium, Roseburia, Clostridium cluster IV and XIVa and Akkermansia. Then, the platform discovers therapeutic candidates through cell line-based assay and nonclinical animal studies for in vitro and in vivo evaluations, respectively.

Based on live bacteria and microbiome-derived effector molecules, the company is developing several drugs in its pipeline: besides KBLP-001 and KBLP-002, there is KBLP-007, an inflammatory bowel disease (IBD) therapy for its autoimmune target area.

In the metabolic therapeutic area, it is developing KBLP-004 for diabetes therapy, obesity and nonalcoholic steatohepatitis (NASH), and KBLP-009 for NASH and nonalcoholic fatty liver disease (NAFLD). The company is also developing Clostridium difficile infection therapy (KBLP-003) for its infectious diseases project.

According to a report on human microbiome market released by Markets and Markets Research Private Ltd., a U.S. market research company based in Northbrook, Ill., the whole market including product (prebiotic, probiotic, food, drug), application (therapeutic), disease and research technology is expected to grow from $942 million in 2024 to $1.7 billion by 2027, with a compound annual growth rate (CAGR) of 22.5% during the forecast period. Microbiome is responsible for a variety of metabolic and development processes from digestion to vitamin synthesis and brain function.

Classed by disease, the human microbiome market is segmented into five categories: infectious diseases, endocrine and metabolic disorders, inflammatory diseases, cancer and others. The infectious diseases segment is expected to dominate the market in 2022, the report says.

This is due to the increasing research in microbiome-based products and their use in treating infectious diseases. Many smaller companies are investing in R&D, and their major focus is on infectious disease products development targeting microbiome modulators, according to the report.

No Comments