Research & Development
US FDA grants Orphan Drug Designation to ISA Pharmaceuticals' ISA101b
2 July 2020 -

The Food and Drug Administration (FDA) in the USA has granted Orphan Drug Designation to ISA Pharmaceuticals BV, an immunotherapy company, for its lead product ISA101b, intended for the treatment of Human Papilloma Virus type 16 (HPV16)-positive cervical cancer, it was reported on Wednesday.

The therapeutic is a clinical-stage immunotherapy targeting HPV16-induced diseases and induces specific immune responses to the oncogenic E6 and E7 proteins of HPV16 and is based on ISA Pharmaceuticals BV's proprietary Synthetic Long Peptide technology. It is designed to mount a highly specific, broad and durable, T-cell mediated attack by the immune system on tumours that are positive for human papilloma virus type 16

ISA101 has indicated that it is an effective monotherapy in patients with early stage, HPV16 positive, premalignant neoplasias.