[BioUSA] GIEuno "GI-102, ADC Combination Enables Blockbuster Leap"

GI Innovation
Interview with CSO Jang Myung-ho and Division Head Yoon Nari
Expecting Additional Synergy through 'Subcutaneous Injection' Formulation

"We received evaluations from key overseas opinion leaders that combining the antibody-drug conjugate (ADC) drug Enhertu with GI-102 will place it on the podium as a blockbuster. We aim to complete the technology transfer of GI-102 within this year."

Yoon Nari, Head of Clinical Translational Strategy at GI Innovation, and Jang Myungho, Chief Strategy Officer (CSO), are being interviewed by Asia Economy in San Diego, California, USA, where the 2024 Bio International Convention (BioUSA) is being held.
[Photo by Lee Chunhee]

At the 2024 BIO International Convention (BIO USA) held in San Diego, California, USA, on the 4th (local time), Jang Myung-ho, Chief Strategy Officer (CSO) of GI Innovation, said, "With the goal of technology transfer for GI-102, we held meetings with many top 10 big pharma companies, including at the American Society of Clinical Oncology (ASCO) and BIO USA," adding, "We will definitely make a decision within this year." Yoon Nari, Head of Clinical Translational Strategy, who joined the interview, emphasized, "At the poster presentation held at ASCO, it was hard to count the number of visitors, including many global pharmaceutical companies and competitors. Especially at ASCO, clinical staff also attended to directly review and discuss clinical data, which made it even more meaningful."

GI-102, being developed as an immuno-oncology drug, is a medication that recently encompasses all the core trends in the cancer treatment market. In addition to confirming the potential for combination therapy with ADCs, which have shown high targeted therapeutic effects and attracted attention, it also has the advantage of a subcutaneous injection formulation, which big pharma companies are eagerly pursuing to improve dosing convenience.

Yoon said, "GI-102 showed definite synergy in animal models of combination therapy with ADCs." Based on data showing that when GI-102 was combined with the ADC drug Enhertu in a breast cancer mouse model, tumor growth was more suppressed than with each drug administered alone, GI Innovation filed a patent on the 11th.

The reason such effects are possible is due to GI-102's immune-enhancing efficacy. GI-102 fundamentally binds to the immune protein interleukin (IL)-2, boosting anti-cancer immune functions such as T cells and natural killer (NK) cells. Yoon explained, "Since ADCs are also chemotherapeutic agents, they have issues like cytopenia that kill immune cells as well as cancer cells. GI-102, when used in combination, increased immune cells more than sixfold, confirming the potential to extend patients' progression-free survival (PFS)."

Graph showing synergistic anticancer activity when GI-102 and the ADC drug Enhertu were combined in a breast cancer mouse model
[Photo by GI Innovation]

However, existing IL-2 acting drugs could also affect the lungs and blood vessels, causing side effects such as lung damage or bleeding from blood vessels. This is why big pharma companies that pursued IL-2 cancer drug development faced repeated setbacks. GI-102 solved this problem by introducing a 'radar' that targets only immune cells. By utilizing the 'CD80' protein, which binds to the CTLA-4 protein mainly found on immune cells, like a radar, it precisely binds only to cancer-related immune cells, not to other potentially problematic sites. Yoon emphasized, "In GI-102, CD80 plays the role that antibodies do in ADCs. Existing IL-2 drugs had toxicity issues requiring hospitalization in intensive care units, but ours can be administered in outpatient settings."

GI-102 is also being developed in a subcutaneous injection formulation, which has recently emerged as another trend in the cancer drug market. Unlike intravenous injections that must be administered at medical institutions, subcutaneous injections can be self-administered at home, and preference for this method has recently increased significantly. Clinical trials in humans are underway, aiming for additional synergy with existing blockbuster cancer drugs. CSO Jang said, "From the production stage, a 'co-formulation' model mixing GI-102 with existing antibody cancer therapies is also possible," adding, "This is a clever strategy for big pharma companies worried about patent expirations of blockbuster drugs, as it allows patent extensions." If synergy with Keytruda, with which GI-102 is undergoing combination clinical trials, is confirmed, the emergence of a new drug combining Keytruda and GI-102 is also possible.

Meanwhile, GI Innovation has been running deficits for five consecutive years. However, CSO Jang stated, "Through meetings with global companies this time, our scientific value has been highly recognized," and emphasized, "Just as large companies take loans for facility investments, we ask for consideration of our deficits as investment costs." He added, "Of course, since the deficits are accurate from an accounting perspective, we are working hard to recover them quickly," and concluded, "This year, we will achieve results through the technology transfer of GI-102."