GI Innovation is set to reveal the results of its clinical trial for the next-generation immuno-oncology drug GI-102 in a subcutaneous (SC) injection formulation at an international conference this December. Building on the success of intravenous (IV) administration, the company has now confirmed anti-cancer activity and immune cell activation effects with the subcutaneous method, opening doors for diverse administration routes and accelerating combination therapy development.
GI Innovation announced on Wednesday that it will present the clinical results of the GI-102 subcutaneous injection formulation at the 2026 European Society for Medical Oncology Immuno-Oncology and Advanced Therapies Congress (ESMO IO 2026), scheduled to take place in London from December 14 to 16.
ESMO IO, a specialized international conference organized by the European Society for Medical Oncology (ESMO), serves as a platform for discussing cutting-edge clinical research in immuno-oncology, next-generation immunotherapy technologies, and innovative combination treatment strategies.
At this conference, GI Innovation will showcase a poster presentation detailing the clinical trial results that evaluate the safety, tolerability, anti-cancer activity, and immune cell activation effects of the GI-102 subcutaneous injection formulation.
The company has successfully completed a dose escalation study involving four dosage groups (ranging from 0.12 to 0.65 mg/kg) in 34 patients with advanced solid tumors who had not responded to standard treatments. Encouraged by the favorable safety and tolerability profile, researchers are now pushing the dosage up to 1.2 mg/kg.
GI-102 is an immuno-oncology candidate drug being developed by GI Innovation. The company has applied its proprietary technology that enables both intravenous and subcutaneous administration without altering the formulation.
Subcutaneous injection, which involves administering the drug into the tissue beneath the skin, offers a simpler process compared to intravenous injection. This method reduces patient discomfort by eliminating the need for venous access and improves convenience for healthcare providers, making it an increasingly popular option in cancer drug development.
In this clinical trial, researchers observed not only good safety and anti-cancer activity with subcutaneous administration but also sustained immune cell activation. Based on these promising findings, the company plans to expand clinical development of the subcutaneous formulation and explore various combination treatment strategies.
Yoon Na-ri, Vice President of GI Innovation, stated that it plans to unveil the results of GI-102’s intravenous administration phase II clinical trial at major international conferences, starting with the American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO GU) in February next year.
She added that this clinical trial has confirmed that GI-102 can be developed for both intravenous and subcutaneous administration. Notably, it observed anti-cancer activity and sustained immune cell activation with subcutaneous administration, which will allow them to broaden the scope for various treatment strategies and combination therapies.
