“GI Innovation, armed with both basic science and development strategy, will become the ‘small but strong company,” which develops globally innovative new drugs and transfers their technologies, in the fastest time in Korea.”
GI Innovation CEO Nam Su-youn made these and other points at a news conference on Monday, during which she introduced her company’s core values, new drug pipelines and significant technologies.
|GI Innovation CEO Nam Su-youn listens to reporters' questions at a news conference in Seoul on Monday.|
GI Innovation seeks to become the global leader of microbiome combination drug development. Dr. Jang Myoung-ho, a professor of immunology at Osaka University in Japan, founded the company.
CEO Nam Su-youn, former head of the Central Research Institute at Yuhan, is now leading the company. Nam was one of the key players who successfully concluded a billion-dollar export contract for “Lazertinib,” a new treatment of lung cancer, with global pharmaceutical giant Janssen when she worked for Yuhan.
During the news conference, CEO Nam said, “Two things determine the value of new drugs. One is excellence in science and technology, and the other is commercial competitiveness.”
It is difficult to win recognition for new drug’ value by fulfilling only one of the two requirements, she added.
“Recently, some companies are advocating NRDO (No Research, Development Only), but these firms run into limitations soon – they have to buy new drugs somewhere because they do not have in-house units that do basic science and make new drugs,” Nam said.
On the other hand, companies set up by researchers have only intellectual assets and are often lacking in development strategy, Nam pointed out, adding that both types of firms have limitations in creating the values of new drugs in some ways.
“GI Innovation has ushered in experts of basic science, led by its founder Dr. Jang Myoung-ho, and is making new drugs in itself,” Nam said. “In the process, these basic scientists and new drug developers produce data by exchanging feedbacks, creating synergic effects.”
‘Frontrunner in developing double-fusion protein and immune disorder new drugs’
GI Innovation has “GI-SMART” platform technology, used for developing double-fusion protein.
“The combinations of connecting parts are essential to the excellent production of double-fusion proteins,” CEO Nam said. “GI Innovation has numerous libraries on that, and can produce more than 24,000 proteins by combining them.”
She added that her company also has the technology to develop candidate proteins into cell lines as well as to express and screen them. “Based on that technology, we have come to conclude a memorandum of understanding with Yuhan to develop double-fusion protein jointly,” Nam said.
Earlier in the day, Yuhan and GI Innovation signed the MOU for their joint development of new drugs.
At the signing ceremony, Yuhan CEO Lee Jung-hee said, “Through this MOU with GI Innovation, Yuhan will be able to jump into the development of competitive new bio drugs by supplementing its platform capacity.”
CEO Nam for her part emphasized that GI Innovations has various pipelines, including “GI-101,” a biologics candidate for cancer therapy, “GI-301” candidate for atopic dermatitis and CIU, and “GI-210,” candidate for non-alcoholic steatohepatitis (NASH) therapy.
According to Nam, GI-101 is an immune-oncology made by using GI-SMART platform, which has the effect of immune checkpoint inhibitor through the double fusion of CD80 and IL2 as well as spreads immune cells.
The Ministry of Health and Welfare has recently selected research related to GI-101, which is underway in collaboration with Professor Cho Byung-cheol of Yonsei University College, as a national project, providing 2.3 billion won ($1.9 million) in subsidies for two years.
“Samsung BioLogics is now manufacturing GI-101, aiming to conduct pre-clinical toxicity test this year, and start clinical trials by next June,” Nam said. “The European Society of Medical Oncology (ESMO) has also selected our research results related to GI-101 for presentation at ESMO 2019 in September.”
Nam went on to say that the European Academy of Allergy and Clinical Immunology (EAACI) selected “GI-301,” being developed as an allergy treatment, and researchers made verbal representation on food-related allergy, at the academy’s conference in June.
“It is not well known in Korea, but food allergy market is estimated to be worth about 4 trillion won worldwide,” Nam said. “It is a large market and has a high incidence. Currently, however, basic treatment remains at desensitization therapy, which continually exposes people to a small amount of foods that trigger allergies.”
Nam went on to say, “Omalizumab has been designated globally as an innovative new drug that treats food allergy, and is conducting phase 3 clinical trials. GI-301 has also shown the effect of completely stopping diarrhea by a single administration on same patient groups, and is expected to have a competitive edge. Unlike omalizumab that cannot be used on children because of anaphylaxis risks, GI-301 has no such risks at all by its mechanism, and can be used on children.”
GI Innovation is conducting the pre-clinical toxicity test of GI-301 and aims to begin clinical trials in next March. It plans to research GI-301 as a treatment of chronic idiopathic allergy, food allergy and atopic dermatitis.
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