"GI Innovation challenges melanoma"

"...overcoming resistance to PD-1 antibodies" says Myoung Ho Jang, CEO of GI Innovation

Unveiled results of clinical trial data at the ESMO Congress 2025, the competitiveness of its drug candiate has been confirmed

Significant anti-cancer response was observed in patients who were refractory to PD-1 antibody monotherapy

Early-stage melanoma combination trial confirmed significant anti-cancer activity…GI Innovation has refiend its clinical trial strategy

GI Innovation is accelerating its entry into the global market.

 

The company unveiled clinical data for its new immunotherapy drug candidate, 'GI-102,' at the ESMO Congress 2025 (European Society for Medical Oncology).

 

GI-102 is drawing attention for its potential to overcome resistance, as it showed clinical improvement, including tumor shrinkage of more than half, even in melanoma patients who did not respond to PD-1 antibody monotherapy.

 

Based on the latest results, the company has strategized to expand collaboration with global pharmaceutical companies for joint clinical trials and aims for first-line treatment for melanoma.

 

DailyPharm met with Myoung Ho Jang, CEO of GI Innovation, and Nari Yun, Director, at the ESMO Congress 2025 to hear about the significance of the GI-102 poster presentation and the company's future strategy.

 

(from left) Na Ri Yun, Executive Vice President (Clinical Dev & Strategy) and Myoung Ho Jang, CEO of GI Innovation

"Demonstrated activity in patients refractory or resistant to immunotherapies…potential to overcome Keytruda resistance" The new drug candidate GI-102 is a fusion protein developed using the company's proprietary "Immune-cytokine" platform.

 

It is structured to maintain the anti-cancer immune activation function of IL-2 (Interleukin-2) while reducing toxicity by combining it with the immunomodulatory protein CD80.

 

It works by a differentiated mechanism that directly activates immune cells and suppresses regulatory T-cells (immunosuppressive cells), thus being assessed as an innovative candidate that can compensate for the limitations of existing PD-1 antibodies.

 

According to the GI-102 poster presentation at ESMO Congress 2025, the drug showed significant anti-cancer activity in a combination trial targeting patients refractory or resistant to PD-1 antibodies.

 

In the initial combination trial, 10 melanoma patients who were refractory to PD-1 antibodies, the combination of GI-102 and Keytruda (pembrolizumab) recorded an objective response rate (ORR) of 40% and a disease control rate (DCR) of 70%.

 

Notably, a case was presented where a patient whose disease had progressed just two months after initial Keytruda treatment achieved a partial response (PR), with the tumor shrinking by approximately 59%, after the GI-102 combination therapy.

 

In this case, the tumor reduction (cPR, -59%) and progression-free survival (PFS) of 3.9 months were observed when GI-102 was combined with the same drug backbone.

 

Na Ri Yun, Executive Vice President of GI Innovation (Clinical Dev & Strategy), explained, "The fact that the tumor shrank by more than half in a patient who did not respond to PD-1 antibody monotherapy signifies the potential to overcome refractoriness," and added, "The key finding is that GI-102 dramatically increases the number of immune cells (lymphocytes) that determine the response rate of immunotherapies." The GI-102 combination group also showed an increasing trend in anti-cancer immune cells, such as CD8⁺ and CD4⁺ T-cells, as treatment progressed.

 

Yun mentioned, "We confirmed a clear increase in anti-cancer immune cells, such as CD8⁺ and CD4⁺ T-cells, following the GI-102 combination," and added, "When the number of immune cells increases, there are more targets for the PD-1 antibody to bind to, which ultimately strengthens the anti-cancer effect." Notably, no dose-limiting toxicities (DLT) were observed in this combination trial.

 

Most adverse events, such as fever and chills, were mild (Grade 1-2).

 

Although elevated liver enzymes occurred transiently in some patients during the first treatment cycle, they recovered to the normal range.

 

The company explained that "global pharmaceutical companies also assessed these to be manageable through meetings." Yun said, "The frequency of side effects was significantly low compared to conventional IL-2 class drugs, and patients tolerated the treatment well." She added, "We have obtained very positive data in terms of safety." Myoung Ho Jang, CEO of GI Innovation, said, "This data confirmed that GI-102 monotherapy shows activity comparable to global blockbuster immunotherapies," and assed that "The combination therapy was confirmed to induce a response even in patient populations that existing PD-1 antibodies could not reach." Jang added, "GI-102 is garnering high interest from global pharmaceutical companies because it is an IL-2-based immunocytokine that suppresses regulatory T-cells." Active discussions with global pharma..."A head-to-head challenge in first-line melanoma treatments" GI Innovation engaged in discussions with global pharmaceutical companies at the conference regarding collaborative clinical trials for first-line melanoma treatment.

 

Currently, PD-1 antibodies like Keytruda and Opdivo (nivolumab) are approved as first-line monotherapies for melanoma.

 

Jang said, "We are having positive discussions with global pharmaceutical companies here at ESMO 2025," and added, "We are reviewing a randomized clinical design to 'head-to-head' compare the efficacy of the GI-102 combination effect against PD-1 monotherapy." Yun added, "Melanoma is the only cancer type where PD-1 monotherapy is the standard of care.

 

Proving the superiority of GI-102 here will increase its potential for expansion into other solid tumors." The fact that the company is considering a direct comparison clinical trial against a first-line monotherapy is evidence of its confidence in the results.

 

Notably, GI Innovation stated that it is considering developing GI-102 not merely as a technology transfer (L/O) but as a co-clinical/co-commercialization model with global pharmaceutical companies.

 

Jang stressed, "While we are in discussions for the technology transfer of GI-101A, we prefer a model where the company retains certain rights and co-develops GI-102 with a global pharmaceutical company," and stressed, "Our goal is to increase long-term value through a direct commercialization structure, creating direct revenue rather than just royalty income." Yun added, "We favor a partnership structure where the company proactively secures rights so as not to be swayed even if a global pharmaceutical company's internal priorities change." In conclusion, the analysis suggests that the discussions held at ESMO Congress 2025 confirmed GI-102's competitiveness in the global market.

 

Finally, Jang said, "Although we are starting with melanoma, we expect a rapid expansion into other solid tumors through off-label use as clinical evidence accumulates," and added, "The conference provided us with confidence that GI-102 possesses genuine competitiveness in the global market."