​GI Innovation to adopt new manufacturing process for immunotherapy agent GI-101

By Park Sae-jin Posted : April 10, 2023, 16:58 Updated : April 10, 2023, 16:58

[Courtesy of GI Innovation]

SEOUL -- South Korea's bio-venture company GI Innovation will adopt a new production process for the company's immune-oncology candidate substance called "GI-101."
GI-101 is a dual fusion protein with the functions of CD80 and IL-2, proteins that play important roles in the immune system. Through a joint clinical trial with global pharmaceutical companies including America's MSD and Britain's AstraZeneca, the first patient treatment was launched in February 2023.
According to the bio-venture on April 10, GI-101 produced through the new production process can increase the proliferation of anti-cancer immune cells in monkey models by about three times compared to the agent created through the existing process.
Based on the findings, GI Innovation has decided to conduct new clinical trials after discussing with key clinical professors and global pharmaceutical companies which conduct joint clinical trials, including Seoul Asan Hospital and Severance Hospital. GI Innovation said that the company received approval from the U.S. Food and Drug Administration and partner biotechnology companies for the change in the production process of GI-101.
Pointing out immune-oncology drugs have a limited effect on terminal cancer patients with reduced immune cells due to chemotherapy and radiation therapy, Jang Myung-ho, GI Innovation's head of clinical trials, said: "While the existing GI-101 protein has increased immune cells by about 2-3 times, the newly produced GI-101 through the new process showed a 7-fold increase in lymphocytes in the bloodstream of monkeys without toxicity." 
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