[Seoul, May 27,2024] GI Innovation, a new innovative drug development company announced today that amending IND for next generation Immuno-oncology, GI-102, was approved by US FDA with applying combination therapy on subcutaneous injection (SC). 

GI leans into clinical trials with the top tier hospitals such as Mayo Clinic, Cleveland Clinic and Memorial Sloan Kettering Cancer Center in U.S. as it changed IND. 

Through the monotherapy clinical trial of GI-102, GI will tap into 50 trillion won blockbuster immuno-oncology market, including Roche, MSD, and BMS, with GI-102 that doesn’t need to alter SC, based on GI’s manufacturing process know-how. 

In addition, GI-102 progressing with Intravenous (IV) clinical trial will be combo clinical trials with chemotherapy, Keytruda and monotherapy phase 2.

GI confirmed that GI-102 showed 5 confirmed PR by strong immune therapy proliferation, increasing five times on average in mono dose escalation.

“IL-2 and Chemotherapy couldn’t utilize combination therapy due to toxicity even though the therapy demonstrated strong anti-cancer activation. But GI-102 would enable the combination with chemotherapy based on excellent tolerability” said Nari Yun, a clinical strategy leader of GI Innovation. “GI has discussed strong anti-cancer activation of GI-102 on chemotherapy and ADC based chemotherapy with global pharmaceuticals several times and we expect positive results through the collaboration. We will do our best for giving excellent treatment chances to many patients.”

Meanwhile, GI will attend ASCO 2024. GI will release data of GI-102 and have meetings with global pharmaceuticals there.