바이오스펙테이터

by Jongwon Jang

Joint Network of Domestic Clinical Experts + R&D Accomplishment in Oriental Medicine … Completed the Phase I Clinical Trial and Planned the Independent (Phase II) and Joint (Phase 1/2) Clinical Trials

Jaein R&P is a Bio-Venture, founded in 2017 by Professor Ko Seong-gyu of the College of Korean Medicine at Kyung Hee University. Based on the natural substances used as wonder drugs in Korean Medicine, Jaein R&P challenges the development of therapeutic agents, such as anticancer agents or therapeutics for atopic disorders, in collaboration with the network of domestic experts.

The anticancer agent 'SH003' leading the drug pipeline is currently in research & development along with an approval of the 4 domestic clinical trials (IND). In particular, the ‘SH003’ acquired the approval of “Phase 1/2 ‘Basket’ Clinical Trial” that enabled its exploitation as a combined therapeutic for diverse types of solid cancer, for which the clinical trial preparation is under way.

The herbal extract SH003 developed by Jaein R&P exhibits multiple mechanisms of action. President Ko Seong-gyu explained, “… cancer cells grow by interacting with peripheral micro-environment of cancer. Based on current studies and results of Phase I Clinical Trial, SH003 interrupts the interaction between cancer cells and peripheral environment, and acts as an anticancer immunotherapeutic and cytotoxic agent simultaneously, which enhances the quality of life and disease control as well as the life span of patients suffering from terminal stage cancer…”.

SH003 inhibits the activity of STAT3 by suppressing IL-6. It was also reported that SH003 suppresses the multidrug resistance gene (MDR1) that codes for P-glycoprotein. Besides, it inhibits angiogenesis by suppressing VEGFR2, the representative cancer target. Jaein R&P acquired IND approval based on 4 domestic clinical trials investigating SH003 and ongoing relevant studies.

Above all, the Phase I Clinical Trial involving patients above 19 years of age, who are suffering from solid cancers, was completed in September of last year. Jaein R&P administered SH003 to patients suffering from solid cancer in doses ranging from 1200 mg/kg to 4800 mg/kg in the domestic Phase I Clinical Trial, and established the safety of SH003. In addition, the rate of disease control in patients at the terminal stage of cancer (stage 4) was satisfactory and associated with a proportional increase in drug administration for 3 weeks. The stabilization of 2 out of 9 patients, who were treated with the drugs on request in the clinical trials approved by the Ministry of Food and Drug Safety, was identified. Based on these results, Jaein R&P acquired an additional approval of the domestic Phase I Clinical Trial from the Ministry of Food and Drug Safety last March, whereby the administration of drug was extended to a maximum of 9600 mg/kg.

Jaein R&P also received approval for ‘Independent Domestic Phase II Clinical Trial’ for SH003 last November. The open-label, multi-center, single-cohort ‘Phase II Clinical Trial’ involves patients diagnosed with ‘wild-type EGFR NSCLC’ to investigate the efficacy and safety of SH003. A total of 97 domestic patients are supposed to participate in the clinical trial. Together with the approval, the company also received an approval for ‘Phase 1/2 Clinical Trial (18 subjects, 101 subjects)’ last July, involving the co-administration of SH003 together with ‘Docetaxel’ for patients suffering from solid cancers, such as lung and breast cancers. The company explains that it would be the first approval of domestic ‘Basket Trial’ whereby SH003 will be co-administered to treat diverse types of solid cancers.

Jaein R&P resolved the difficulties in terms of CMC parameters (Chemistry, Manufacturing, and Control) of drugs derived from natural substances based on stability tests lasting 36 months, and progress toward production of SH003 by KGMP-certified pharmaceutical companies starting from the initial stage of development of SH003. Further, the company strives to develop PK methodology to investigate oriental medicine (herbs) and the interaction between oriental and western drugs, in addition to implementing quality control measures for export to the US market.

President Ko Seong-gyu stated, “… the ultimate goal of our challenge is to become a global market player alongside USA, Europe, Japan, Hong Kong, and China.” “We will employ scientific approaches to exploit the research advances of ‘Korean Medicine’ and its strength in toxicity-related issues for the development of new drugs…”.