바이오스펙테이터

by Euna Lee

“Probiotics + IgE Trap Combo - ‘GI311’ with indication of allergic disease”..“Currently non-clinical stage, license out agreement and IPO in 2020”

“GI-Innovation has developed ‘μ+ Biologics (Mu plus biologics)’, a combo platform technology of microbiome and biologics, and with it is challenging new drug development. The leading pipeline ‘GI311’ targets allergic diseases with a combination of IgE Trap, which combines microbiome with the ‘hyFc’ technology of long acting API.”

▲장명호 지아이이노베이션 CSO

This explanation is from Myoung Ho Jang, CSO of GI Innovation, a company he founded in July 2017 that specializes in microbiome combo bio-drugs. He previously served as a professor at medical school of Osaka University, at the Green Cross Mogam Biotechnology Research Institute, IBS, and as Genexine scientific advisor and Progen CSO.

He said, “GI-Innovation is a new start-up company that has been in operation for less than a year, but experts in microbiology and biologics are gathering pace to develop new drugs. In recent years, Su Youn Nam, CEO of INTS BIO, who was previously global medical director of BMS, Roche, and the executive director R&D of Yuhan Corporation, joined as the CMO, and is planning a global clinical strategy.”

The present announcement introduces GI311, a new drug candidate for allergic disease. In the form of a combination of microbiome and IgE Trap proteins, which is a protein that combines the extracellular domain of IgE receptor with hyFc, a long acting API technology. This technology was developed by Progen.

“IgE Trap combines both allergenic IgE antibodies and IgG autoantibodies simultaneously to block the activation of mast cells, which can be effective in allergic diseases. The in vitro experiments showed IgE Trap confirmed 70 times higher IgE binding than omalizumab, an IgE antibody. As a result, we found that the activity of mast cells can be completely inhibited”, Jang said.

“Omalizumab is only available for patients over 12 years old in the United States, and in patients over 6 in Europe. Babies with high allergy tend to have few treatment options to choose. IgE Trap is expected to be superior in terms of safety. We have established clinical cell lines, and are in the process of testing for high purity tablets”, he added.

So what is the advantage of ‘GI311’? Microbiome reduces the number of mast cells that secrete histamine, an allergen, through exosome secretion. IgE Trap is added to block IgE and IgG, to maximize therapeutic efficacy by inhibiting the activation of mast cells. In the future, indications can be expanded to other diseases, such as atopic dermatitis, food allergy, and chronic idiopathic urticaria.

CSO Jang said, “GI311 was more effective in the in vivo than mono. The frequency of diarrhea, an allergic reaction, was reduced to 100 and 77% in allergic mouse models.” He added, “We filed a ‘conceptual patent’ for GI311. This is a patent for compositions including polypeptides that are capable of binding to all probiotics and IgE, and their uses.”

Finally, CSO Jang revealed the company’s ambition, saying, “Currently, GI311 is in the non-clinical stage, and aims to enter the clinical phase next year. GI311 and IgE Trap have filed patents in Korea and the US, and will maximize value through regional and global licsence out deal in the future. We are also committed to developing a pipeline that can cure cancer-related immune diseases, such as cancer and NASH.” He added, “In 2020, which is the third year of the establishment of the company, GI311 global license out deal, IPO, and M & A will be carried out at the same time.”