GI Innovation holds an online meeting on the 30th. From left: Executive Director Na-ri Yoon, CEO Joon-ho Hong, and CEO Myung-ho Jang attend. /Courtesy of GI Innovation YouTube Capture

Jang Myung-ho, CEO of GI Innovation, said, "The goal is to receive accelerated approval and marketing authorization from the U.S. Food and Drug Administration (FDA) in the third quarter of 2028 as the first in Korea for immuno-oncology drugs."

During an online briefing on the 30th, CEO Jang noted that in a Phase 2 clinical trial using the immuno-oncology candidate 'GI-102' in combination with Merck's (MSD) immuno-oncology drug 'Keytruda' (active ingredient pembrolizumab), they confirmed a more than 30% reduction in cancer cells of four patients with immune-oncology resistant or refractory cancer (kidney cancer and melanoma) and announced this plan.

GI-102 is a treatment that increases the number of immune cells in cancer patients by an average of five times, maximizing the effect of immuno-oncology drugs. It works by activating interleukin (IL)-2, an immune signaling molecule, and blocking CD80, a surface protein on immune cells, to enhance the cancer attack capability of immune cells. IL-2 plays a role in the proliferation and activation of immune cells, while CD80 blocks proteins that inhibit immune cells from attacking cancer cells.

Earlier, in June of last year, GI Innovation received orphan drug designation from the FDA for patients with advanced or metastatic sarcoma, a musculoskeletal cancer. In this case, conditional approval can be applied based solely on Phase 2 results. The company plans to pursue conditional approval based on clinical indicators instead of final clinical efficacy and aims to demonstrate additional effects through follow-up tests.

The collaboration between GI Innovation and Merck for a joint clinical trial is the second since they signed a contract for the immuno-oncology candidate GI-101 in 2020. GI Innovation is the only domestic company conducting two joint clinical trials with global pharmaceutical companies for immuno-oncology drugs.

The company confirmed a disease control rate (DCR) of about 80% in Phase 1 clinical trials of GI-102 conducted on 12 patients with resistant and refractory melanoma. The disease control rate refers to the proportion of patients in whom disease progression has been delayed. This figure is twice as high when compared to the standard treatment Bristol Myers Squibb's (BMS) 'Opdualag (40%).'

'Opdualag' reported nearly 100% annual revenue growth, generating 1.3 trillion won in sales last year. GI Innovation believes that once GI-102 is commercialized, it could achieve sales in the trillion won range. Executive Director Yoon said, "By adding cohorts (clinical groups with the same conditions) to ongoing clinical trials and collaborating with Samsung Biologics to produce samples, we aim to receive FDA accelerated approval in the third quarter of 2028."

Executive Director Yoon also mentioned the allergy treatment 'GI-301', which is jointly developed with Yuhan Corporation. He stated, "GI-301 showed more than three times better efficacy compared to the existing treatment 'Xolair'." He added, "Yuhan Corporation is developing GI-301 not only for chronic spontaneous urticaria but also for atopic dermatitis, and if it shows good efficacy for atopic dermatitis, it is expected to become a global blockbuster."

GI Innovation introduced a new immuno-oncology candidate 'GI-128' on this day. GI-128 is a dual antibody substance that consolidates an antibody that inhibits the immune checkpoint PD-L1 with an antibody that inhibits specific macrophage regulatory factors. It was selected as a project by the National New Drug Development Project group last year and is currently seeking global technology transfer.