Policy & Regulation
ISA Pharmaceuticals wins FDA's FTD for ISA101b for oropharyngeal cancer
14 September 2021 -

Biotech company ISA Pharmaceuticals B.V. reported on Tuesday the receipt of US Food and Drug Administration (FDA) Fast Track Designation (FTD) to facilitate the development of its lead product ISA101b for the treatment of oropharyngeal cancer (OPC).

The company received the US FDA's FTD for ISA101b to improve the survival and delay progression of recurrent and metastatic Human Papilloma Virus (HPV) 16 positive oropharyngeal cancer (OPC). Head-and-neck cancer is a severe and life-threatening disease.

Using the company's proprietary Synthetic Long Peptide (SLP) technology, 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.

According to the company, ISA101b is studied in HPV16 positive cancers in combination with Libtayo (cemiplimab) in three phase two clinical trials under a strategic collaboration with Regeneron. Libtayo is an anti-PD-1 antibody that is being jointly developed by Regeneron and Sanofi.