GI-101 is a dual fusion protein that combines functions of CD80 and IL-2, proteins that play crucial roles in the immune system. GI-102 showed a high level of lymphocyte proliferation after drugs were administered in the preclinical stage. Both substances were approved by the U.S. FDA to carry out clinical trials.
GI Innovation said in a statement that the company partnered with Medidata to accelerate clinical trials for the two agents. The South Korean company has adopted a basket and adaptive clinical trial for the project. Basket clinical trial is used to evaluate multiple cancers at once and prove the possibility of prescribing one particular drug for the same genetic mutation detected in various cancer types. Adaptive clinical trials incorporate a mid-term evaluation process to determine whether the trial method should be maintained or changed.
"As the AI-based drug development is emerging as a core future technology, we will try our best for early commercialization by working with Medidata specializing in AI and machine learning," GI Innovation CEO Rhee Byung-geon said in a statement on September 5.
Medidata, which provides clinical trial solutions for pharmaceutical and medical device companies, has 14 branches in seven countries including Japan and Britain. "We are very glad to foster cooperation with GI Innovation, which is recognized for its outstanding pipelines and potential for advancement," said Yoo Jae-gu, the head of the South Korean office of Medidata.
GI Innovation was listed on KOSDAQ, the South Korean version of the U.S. stock market NASDAQ, in March 2023. The pharmaceutical firm had 27 registered patents and completed 138 patent applications as of March 2023.
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