GI Innovation Selected for Clinical Development Support Project by National New Drug Development Program

Support of up to 7 Billion KRW for Clinical Trials of Immuno-Oncology Drug 'GI-101'

[Asia Economy Reporter Lee Gwan-joo] GI Innovation announced on the 9th that its immuno-oncology drug development project 'GI-101' has been selected as a new drug clinical development project for the first phase of the 2022 National New Drug Development Project by the Korea Drug Development Fund (KDDF).

Through this project selection, GI Innovation will receive up to 7 billion KRW in research support over two years, aiming to select the optimal indication in phases 1 and 2 clinical trials of GI-101 and proceed to phase 2b and 3 clinical trials or technology transfer.

GI-101 is a bispecific fusion protein containing CD80 and an IL-2 mutant. The IL-2 mutant region induces proliferation and functional enhancement of T cells and NK cells, while the CD80 region targets immune cells and simultaneously controls the immunosuppressive function of regulatory T cells.

GI Innovation plans to establish the appropriate phase 2 dosage for GI-101 as a monotherapy and in combination therapies with Keytruda (pembrolizumab), Lenvima (lenvatinib), and local radiation therapy by February 2024, focusing on identifying effective combination therapies and indications. Additionally, in collaboration with Professor Cho Byung-chul's and Professor Chae Dong-woo's teams at Sinchon Severance Hospital, they plan to increase the likelihood of success in late phase 2b and 3 clinical trials by discovering biomarkers from blood and tumor tissue samples collected from various solid cancer patients.

Jang Myung-ho, Head of Clinical Strategy for New Drug Development, expressed his ambition, stating, “We will accelerate efforts to enable early technology transfer to global pharmaceutical companies through this clinical trial.”

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