DM Bio said that it has made a contract development and manufacture organization (CDMO) agreement with GI Innovation concerning GI-301, an allergy treatment candidate, which is currently being developed by the latter.
Under the accord, DM Bio will be responsible for developing the process for making drug substance for GI-301, improving its productivity, developing a system to examine its stability, and producing about 2,500 liters of samples for phase 2 clinical trial,
GI Innovation plans to conduct clinical trials for GI-301 in Europe in September as a treatment for allergic diseases caused by immunoglobulin E (IgE), such as chronic idiopathic urticaria, atopic dermatitis, asthma, and food allergies.
According to GI Innovation, Xolair (component name: omalizumab), which is being developed jointly by Novartis and Roche, has indications similar to GI-301. However, GI Innovation claims GI-301 has a binding force 32 times stronger than Xolair.
DM Bio is a biopharmaceutical company founded by Dong-A Socio Group in collaboration with Meiji Seika Pharma.
The company has current good manufacturing practice (cGMP) level production facilities for antibody biopharmaceuticals and also has received GMP approval from the Japan Pharmaceuticals and Medical Devices Agency for its production facilities.
The company is focusing on the CDMO business as well as the production of a biosimilar jointly developed by Dong-A Socio Group and Meiji Seika Pharma.
Last year, the company received a consulting service from Lachman of the United States for its GMP system to match the U.S. Food and Drug Administration standards and expand its CDMO domain to include a contract research organization (CRO) business. To this end, the company has established a research center.
GI Innovation is a bio-venture company, which develops new drugs and strives to provide hope to patients through innovative fusion between basic science and broker research.
By establishing the GI SMART-based technology, the company is developing new drugs marked by high-quality, high-productivity and multi-target fusion protein for treating immune anti-cancer, inflammatory, and immune disorder diseases.
“Based on our excellent production facilities and production system that meets global standards, DM Bio has recently expanded its CDMO business for biopharmaceuticals and moving toward the CRO business,” a company official said. “We will serve as a forward base to help biopharmaceutical developers launch their products in the global market.”