바이오스펙테이터

by Jongwon Jang

KB Biomed is currently developing an oral formulation for injection based on biomaterials-based oral drug delivery transporter with decreased risk of side effect and increased administration efficiency. KB Biomed was founded by Lee Yong-gyu, a Professor of the Department of Chemical & Bioengineering, Korea National University of Transportation. The company was also selected by TIPS, the Private Business Incubation Support Program, through the Chungbuk Center for Creative Economy Innovation.

The platform technology of drug delivery system allows absorbance of drug in the small intestine, thereby delivering the drug to cells by an oral administration. Genes, hormone, and peptide, etc. are mounted on the transporter (carrier) attached with a material targeting apical sodium dependent bile acid transporter (ASBT) among in vivo bile acid receptors.

President Lee Yong-gyu of KB Biomed stated in the meeting with reporters from Biospectator, “… the leading pipeline is the mechanism of GLP-1 Oral Gene Therapeutic Agent targeting Type II Diabetes Mellitus through which natural GLP-1 is produced by genes of GLP-1 delivered into cell nucleus which is absorbed in the small intestine to control the level of blood sugar…”, “… we have confirmed that the level of blood sugar is controlled normally after administration of 100 μg once a week through animal test ...”.

KB Biomed intends to expand the field of development of drugs based on the platform of drug delivery system of oral drugs for rare diseases, anticancer agent, and therapeutic agent for diabetes mellitus.

◇ Development of Drug Delivery Transporter using Bile Acid Receptor … Natural GLP-1 is Produced through Manifestation of Genes Inside Cells after Absorbance in Small Intestines

KB Biomed focuses on bile acid that works on the absorbance of protein in small intestines, and exploits it for the development of drug delivery transporter. Bile acid is produced from liver, stored in gall bladder, and secreted in small intestine upon uptake of foods for the digestion and absorbance of foods.

President Lee explained, “… an average 12~18 g of bile acid is produced daily by an adult with body weight of 70 kg. The produced bile acid is absorbed by apical sodium dependent bile acid transporter (ASBT) and then reused via circulation between small intestine and liver…”.

KB Biomed has developed a platform technology that enables the absorbance of drugs through receptors in small intestines upon administration of drug by applying characteristics of bile acid to drug delivery transporter.

The ASBT targeted by KB Biomed was spotlighted as a potential target enhancing absorbance of orally administered drugs in small intestines. KB Biomed has developed a coating technology of ‘Bile Acid Heparin Carrier’ that enables intracellular absorption of drugs through a mechanism wherein bile acid combined with ASBT receptor on the polysaccharide layer is attached to the carrier. The company has secured domestic patent right of the platform technology and filed a patent application to PCT.

President Lee emphasized, “… GLP-1 analogues are mostly in the form of chemical peptides in formulations for an injection. KB Biomed enables the control of blood sugar by producing natural GLP-1 through delivery of GLP-1 genes to cells by an oral administration which is enabled by the platform technology of drug delivery system…”

KB Biomed expresses that the company has ascertained an even higher efficiency of delivery of GLP-1 genes to ileal cells by the transporter of the company compared to drug transporters from other companies. Besides, using an animal model of diabetes mellitus induced by high-fat diet manifested the effect of control of blood sugar level for 7 days upon administration of the drug with an observation of maximum decrease in body weight of 20%.

President Lee stated, “… the development of oral drug that enables the administration of drug for patients once a week is expected to be playing an important role in improving the quality of life of patients…”. KB Biomed currently manages the experiment employing animal model of monkey to identify toxicity etc. of the drug upon completion of an ascertainment of safety and efficacy through experiments using animal model of mice.

◇ “Gene, Hormone, and Peptide can be applied. Thus, the Field of Development of Drugs will be Expanded from Diabetes Mellitus to Rare Diseases”

The platform technology of KB Biomed enables the mounting of diverse materials such as genes, hormones, and peptides etc. on a transporter. It is able to deliver drugs to targets by employing fatty acid and antibody etc. Therefore, the technology is applicable to diverse fields, including those of anticancer agent and therapeutic agent for osteoporosis as well as rare diseases.

The company states that the pipeline targeting osteoporosis and hepatoma including rare disease such as Gaucher’s disease and Fabry's disease is being developed.

KB Biomed also develops oral therapeutic agents for hepatoma which is mounted with siRNA of lower stability due to lyase in blood on the drug transporter. The company ascertained that the growth of tumor in liver of mouse remained almost standstill with the application of a drug (100 μg/kg) based on observation of the size of tumor in liver upon application of candidate material in the test employing mice wherein hepatoma was induced and metastasized.

KB Biomes heads for the Phase 1 Clinical Trial at the second half of 2020 on completion of the Preclinical Trial of oral GLP-1 gene therapeutic agent. President Lee stated, “… we are also planning global Phase 1 Clinical Trials in countries such as Australia and China besides Korea …”. The company intends for the invitation of investment for Series A to provide expenses for Preclinical Trial and R&D in Clinics.

President Lee Yong-gyu also emphasized, “… KB Biomed is growing rapidly in recent three years with technologies matured through stages of accomplishment after foundation. The platform technology of our company has a potential of infinite expandability including cosmetic products, foods, as well as therapeutic agents. Based on the technology, we intend to grow to become a company that develops the first oral gene therapeutic agent for the first time in the world … “.