GI Innovation, Joint Clinical Trial of Immuno-Oncology Drug with US Merck... FDA Designates as Orphan Drug

FDA Designates Immuno-Oncology Drug GI-101 as Orphan Drug
Merck Highly Rates GI-101's Potential and Provides Drug Free of Charge

On the 3rd of this month (local time), the U.S. Department of Health and Human Services unveiled a draft of the detailed plan for the Biden administration's cancer conquest project, "Cancer Moonshot." Cancer Moonshot is a policy goal announced to reduce the cancer mortality rate among Americans by 50% within the next 25 years.

Cancer ranks as the second leading cause of death among Americans. Every year, 600,000 people die from cancer in the United States. Early detection and appropriate treatment are crucial for cancer care, but inequalities exist in cancer treatment due to disparities in personal income, types of health insurance, race, and region.

The Biden administration has called for efforts to provide cutting-edge research to cancer patients and communities and to support patients and caregivers. The National Cancer Institute (NCI) has decided to launch a public-private partnership to enable cancer patients to enroll in clinical trials of the latest anticancer drugs and receive treatment.

Meanwhile, recently, Merck's "Keytruda" (active ingredient pembrolizumab) received formal approval from the U.S. Food and Drug Administration (FDA) for use in solid tumor patients with high-frequency microsatellite instability (MSI-H) or mismatch repair deficiency (dMMR), becoming the first immune checkpoint inhibitor approved for cancer treatment regardless of cancer type. Dr. Luis Diaz Jr. of Memorial Sloan Kettering Cancer Center said, "This approval reinforces the important role of Keytruda in certain MSI-H or dMMR solid tumor patients facing various cancers."

Domestically, GI Innovation, an immuno-oncology drug developer, has attracted attention by partnering with Merck. GI Innovation has nine pipelines, with immuno-oncology drugs GI-101 and GI-102, and allergy treatment GI-301 currently in clinical stages. Among these, GI-101 and GI-301 have completed technology transfers.

GI-101 was licensed to the Chinese pharmaceutical company Simcere in November 2019 for $790 million (approximately 1.027 trillion KRW). The contract with Simcere applies only to the Greater China region, including China, Hong Kong, and Taiwan. For other regions, combination therapy clinical trials are being prepared with AstraZeneca in the UK and Merck in the US. AstraZeneca is providing 160 doses of the drug (Imfinzi) worth about 117 billion KRW free of charge, and Merck is providing about 200 doses of the drug (Keytruda) worth approximately 63 billion KRW.

Regarding these companies’ high evaluation of GI-101’s potential and their provision of their drugs free of charge, Lee Byung-gun, CEO of GI Innovation, said, "It is rare for overseas pharmaceutical companies to provide their own drugs free of charge for combination clinical trials," adding, "In the case of GI-101, we paid close attention to quality even if it meant higher costs, such as entrusting process development and production to Samsung Biologics." He continued, "GI-102, a drug improved beyond GI-101, is scheduled to undergo Phase 1 clinical trials at the world’s top hospital, Mayo Clinic." Notably, GI Innovation’s GI-101 has already been designated as an orphan drug by the FDA, raising expectations for clinical success.

Founded in 2017, GI Innovation is a developer of bispecific fusion protein drugs. Using its proprietary platform technology, ‘GI-SMART,’ the company is efficiently discovering and developing various combinations of bispecific fusion proteins.