ISA Pharmaceuticals Receives Fast Track Designation for Lead Product ISA101b
September 14, 2021
Oegstgeest, September 14th, 2021 – ISA announces that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to its lead product ISA101b, for the treatment of recurrent and metastatic oropharyngeal cancer (OPC) that is positive for Human Papilloma Virus type 16 (HPV16).
The Fast Track process is designed to facilitate the development of investigational treatments that demonstrate the potential to address unmet medical needs in serious or life-threatening conditions. Programs with Fast Track designation can benefit from early and frequent communication with the FDA throughout the entire drug development and review process and marketing application.
Leon Hooftman, Chief Medical Officer of ISA Pharmaceuticals commented: “Recurrent and metastatic HPV16 positive OPC is a form of head-and-neck cancer with a high unmet medical need. The Fast Track designation for ISA101b underlines the potential benefit of this immunotherapy for patients suffering from this disease.” Last week ISA Pharmaceuticals announced that the first patient has been dosed in a new phase 2 study in this indication.
ISA101b induces strong and specific immune responses to HPV16 virus proteins, and (re-)establishes a powerful T-cell immune response against virus infected and/or cancerous cells and tissues. It is using ISA’s proprietary Synthetic Long Peptide (SLP®) technology. ISA101b is studied in HPV16 positive cancers in combination with Libtayo® (cemiplimab) in three phase 2 clinical trials under a strategic collaboration with Regeneron. Libtayo is an anti-PD-1 antibody that is being jointly developed by Regeneron and Sanofi.
HPV16 is a major cause of head-and-neck cancer. Head-and-neck cancer can be a severe and life-threatening disease. More often than not it is diagnosed in middle aged adults. Once these cancers progress to advanced stages median survival times are short.
About Fast Track designation
Fast Track is a process designed to facilitate the development, and expedite the review of, drugs to treat serious conditions that address an unmet medical need, by providing a therapy where none exists or providing a therapy which may be potentially better and shows some advantage over available therapy. Fast Track designation includes opportunities for more frequent meetings with the FDA to discuss trial design, development plans, data needed to support drug approval, submission of a New Drug Application (NDA) on a rolling basis, and eligibility for accelerated approval and priority review, if relevant criteria are met.
Visit the FDA’s website for more information.