GI Innovation's 'GI-101' Designated as FDA Orphan Drug

[Asia Economy Reporter Chunhee Lee] GI Innovation announced on the 20th that its immuno-oncology drug 'GI-101' has received Orphan Drug Designation (ODD) from the U.S. Food and Drug Administration (FDA) for Merkel Cell Carcinoma (MCC).

ODD is an incentive program for therapies targeting rare diseases with an annual prevalence of fewer than 100,000 people. Treatments aimed at rare diseases are granted benefits such as tax credits, waiver of application fees, and seven years of market exclusivity after approval.

Currently, GI-101 is undergoing global Phase 1 and 2 clinical trials. In 2019, the technology was licensed to Chinese company Simcere Pharmaceutical for the Chinese market in a deal worth approximately 950 billion KRW.

GI Innovation plans to accelerate clinical trials for MCC following this ODD designation. MCC is a rare disease originating from Merkel cells located at the boundary between the dermis and epidermis of the skin. Ninety percent of patients are elderly, aged 50 or older, and about 5-12% of these are diagnosed with metastatic MCC. The five-year survival rate is known to be less than 20%.

Pfizer’s immuno-oncology drug 'Bavencio' (generic name: avelumab), the first approved treatment for MCC, received accelerated approval following ODD and successfully entered the market within just three years of development. However, currently approved immuno-oncology drugs such as Bavencio and Merck (MSD)’s 'Keytruda' (generic name: pembrolizumab) are ineffective in more than half of patients, and there are no treatment options after failure of immuno-oncology therapy.

Jang Myung-ho, Chief Strategy Officer (CSO) at GI Innovation, who oversees new drug development clinical strategies, stated, “We have been in discussions for over a year with the Memorial Sloan Kettering Cancer Center and key opinion leaders (KOLs) across the U.S. specializing in rare diseases to provide treatment options for patients with rare diseases lacking appropriate therapies. We expect MCC clinical development to gain momentum through this ODD.”

Lee Byung-geon, Chairman of GI Innovation, also said, “With the rapid growth of the orphan drug market, fierce competition among global pharmaceutical and biotech companies for ODD is underway. Through the ODD designation of GI-101 for MCC, we will focus more on unmet medical needs and take the lead in new drug development.”

This content was produced with the assistance of AI translation services.