As the project partner, BLA congratulates GI Innovation on receiving FDA Fast Track Designation for GI-102 in immuno-oncology therapy
Gaithersburg, MD (October 6, 2025) – BLA Regulatory, LLC, a full-service biopharma regulatory consultancy, congratulates GI Innovation on receiving the Fast Track Designation (FTD) from the U.S. Food and Drug Administration (FDA) for its immuno-oncology candidate GI-102. This designation applies to patients with advanced or metastatic melanoma who have previously undergone immunotherapy.
About GI-102
GI-102 is a novel immunotherapy candidate designed to improve outcomes in patients with advanced or metastatic melanoma. The candidate demonstrated promising efficacy in a Phase 1 monotherapy study with 14 patients, achieving an objective response rate (ORR) of 25% and a disease control rate (DCR) of 83%, surpassing the outcomes of the currently approved standard of care. GI-102 is currently being evaluated in Phase 2 clinical trials in combination with Keytruda and other therapies, both in the United States and Korea.
About BLA Regulatory, LLC
BLA Regulatory, LLC, is a full-service drug regulatory consultancy focusing on the U.S., with global reach to other major markets. BLA provides comprehensive regulatory strategy and operational services from pre-IND strategic planning, IND preparation & submission, all the way to BLA/NDA submission and approval. With credits of 300+ INDs and 50+ NDAs/BLAs to our senior consultants, BLA brings clients extensive experience from Big Pharma, CROs, and the FDA. Our services cover regulatory, CMC, nonclinical, clinical, biostatistics, scientific writing, project management, eCTD publishing, and submission support. We have expertise across therapeutic areas including oncology, respiratory, autoimmune, inflammatory, metabolic, and cardiovascular diseases.
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Reference
GI Innovation. “GI Innovation’s immuno-oncology candidate ‘GI 102’ granted fast-track designation by U.S. FDA.” The Bio News, September 29, 2025