GI Innovation's 'GI-102' Designated as FDA Orphan Drug

GI Innovation announced on the 11th that it has received Orphan Drug Designation (ODD) from the U.S. Food and Drug Administration (FDA) for GI-102, a next-generation immuno-oncology drug under development, for the treatment of advanced or metastatic sarcoma. This is the second time GI Innovation's pipeline has been designated as an orphan drug, following the designation related to GI-101 for Merkel cell carcinoma.

GI Innovation logo [Photo by GI Innovation]

Orphan drugs are part of an incentive system aimed at developing treatments for rare diseases with an annual prevalence of less than 100,000 people. Designation as an orphan drug provides benefits such as tax credits, waiver of application fees, and seven years of market exclusivity after approval.

The sarcoma for which GI-102 received orphan drug designation is a tumor formed in soft tissues such as fat, muscle, nerves, fibrous tissue, and blood vessels, accounting for about 1% of adult malignant tumors. Notably, 40-60% of all patients experience local recurrence or systemic metastasis after tumor removal. These sarcomas have a poor prognosis, creating an urgent medical need. Therefore, it is one of the cancer types with a high possibility of accelerated approval.

The company expects that this approval will further accelerate the global expansion of GI-102. Myungho Jang, Chief Strategy Officer (CSO), said, “We are pleased to have received orphan drug designation from the FDA while continuing discussions on rare diseases with the U.S. Memorial Sloan Kettering Cancer Center and key U.S. opinion leaders,” adding, “We hope this will help patients with advanced or metastatic sarcoma who have no treatment options.”

In particular, it is anticipated that this designation will expand compassionate use within the U.S. medical field. CSO Jang explained, "GI-102 has been recognized in the domestic medical field through approval for therapeutic use in bladder cancer and cervical cancer, so there is an opportunity for compassionate use before approval in the U.S. as well,” adding, “In the U.S., compassionate use can also involve charging patients, enabling early commercialization."