On the 23rd, GII Innovation announced that it had completed the first patient administration of the subcutaneous (SC) formulation of the immune anticancer drug candidate 'GI-102' in a phase 1 clinical trial conducted on the 17th.
The company noted, "GII Innovation is the first to start patient administration of an SC formulation of a domestic immune anticancer drug following the subcutaneous formulation of Keytruda by the global pharmaceutical company Merck (MSD) using the Alteogen platform."
According to the company, the GI-102 SC formulation clinical trial is being conducted at approximately 14 medical institutions in South Korea and the United States. Professor Kim Seung-tae, an oncologist at Samsung Seoul Hospital, who registered the first patient for GI-102 subcutaneous injection, said, "Patients injected with GI-102 show stable conditions up to one week post-injection," and added, "Patients largely prefer the SC formulation, so we expect rapid progress in the clinical trial."
GII Innovation began developing the SC formulation in 2021. The advantage of the SC formulation is its convenience in administration. Compared to the previous intravenous (IV) formulation, the SC formulation can reduce the administration time from half a day to 10 minutes, saving patient time and increasing hospital turnover.
There are also expectations for increased efficacy. The company stated, "In existing intravenous formulations, GI-102 has shown an objective response rate (ORR) of 30% as a monotherapy in metastatic melanoma patients who failed all standard therapies, demonstrating overwhelming anticancer activity." Last year, at the American Society of Clinical Oncology (ASCO), Johnson & Johnson's pharmaceutical company Janssen confirmed that changing the immune anticancer drug Librium's intravenous (IV) formulation to SC resulted in an increase in patients' survival rates from 51% to 65%.
Chang Myung-ho, Chief Strategy Officer (CSO) of GII Innovation, said, "The SC formulation clinical trial has two cohorts, and we expect to complete phase 1 by the end of February next year," and added, "As many global pharmaceutical companies are interested in the GI-102 SC formulation clinical data, the negotiation power for technology transfer will also increase."