ISA Pharmaceuticals BV, a clinical stage biotech company, announced on Tuesday that it has received Fast Track designation from the United States Food and Drug Administration for its lead product ISA101b, a product aimed to treat recurrent and metastatic Human Papilloma Virus 16 positive oropharyngeal cancer.
The product stimulates immune responses to HPV16 virus proteins, providing a powerful T-cell immune response against virus infected and/or cancerous cells and tissues. It is using ISA Pharmaceuticals BV's proprietary Synthetic Long Peptide technology and is studied in HPV16 positive cancers in combination with Libtayo (cemiplimab) in three phase two clinical trials under a strategic collaboration with Regeneron.
Regeneron and Sanofi are jointly producing Libtayo, an anti-PD-1 antibody.
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