GI Innovation announced on December 23 the successful completion of the first patient dosing in the Phase 1 clinical trial of the subcutaneous (SC) formulation of its immuno-oncology drug “GI-102”.
The GI-102 subcutaneous injection clinical trial is being conducted at 14 medical institutions, including the Mayo Clinic, Cleveland Clinic, Memorial Sloan Kettering Cancer Center, Samsung Medical Center, Asan Medical Center, Seoul National University Hospital, Yonsei University Severance Hospital, and St. Vincent’s Hospital.
The subcutaneous (SC) formulation of GI-102 offers a significant advantage by reducing the administration time from half a day to just 10 minutes, enhancing patient convenience and improving compliance. This aligns with a global trend of transitioning leading immuno-oncology drugs, such as Keytruda, Tecentriq, and Opdivo, to SC formulations.
In its intravenous (IV) formulation, GI-102 has shown promising anti-cancer activity, with an objective response rate (ORR) of 30% in patients with metastatic melanoma who had failed all standard treatments. The anti-cancer activity is expected to improve with SC injection, particularly in melanoma, offering hope for more effective treatment options for difficult-to-treat cancers.
The Phase 1 clinical trial of the SC formulation is being conducted at 14 leading medical institutions worldwide, including the Mayo Clinic, Cleveland Clinic, and Memorial Sloan Kettering Cancer Center. In South Korea, trials are taking place at Samsung Medical Center, Asan Medical Center, and Seoul National University Hospital. Jang Myung-ho, the Chief Strategy Officer (CSO) of GI Innovation, is optimistic about the trial’s progress, with completion expected by February next year. This trial’s results are of strategic importance, as global pharmaceutical companies are closely monitoring the data, which will strengthen GI Innovation’s negotiating power in future technology transfer discussions.
The SC formulation of GI-102 marks a significant leap forward in immuno-oncology, a field focused on using the body’s immune system to fight cancer. The SC injection method is easier and faster than intravenous administration, improving patient adherence to treatment regimens, which is crucial for cancer patients. This development not only offers clinical benefits but also positions GI Innovation for stronger global partnerships with pharmaceutical companies, advancing cancer treatment worldwide.
Kim Seung-tae, a professor of oncology at Samsung Medical Center who registered the first patient for the GI-102 subcutaneous injection, said:
“The patient who received the GI-102 subcutaneous injection has shown stable condition up to one week after administration. As patients highly prefer the SC formulation, the clinical trial is expected to progress rapidly.”
About GI Innovation
GI Innovation is a bio-venture company focused on researching and developing innovative protein-based drugs through well-structured translational research. The company’s main research and development efforts are centered around immuno-oncology drugs and allergy diseases, with a unique focus on creating fusion proteins using the GI-SMART platform.
Currently, GI Innovation is advancing research in several promising therapeutic areas, including non-alcoholic fatty liver disease (NASH), in addition to its ongoing work in immuno-oncology and allergy treatments. The company is committed to developing cutting-edge therapies that can offer hope for patients with incurable diseases worldwide, positioning itself at the forefront of medical innovation.