OEGSTGEEST, Netherlands, September 8, 2021 / PRNewswire / – ISA Pharmaceuticals BV, a clinical-stage biotechnology company, announces the start of patient dosing in a pivotal clinical trial of the combination of ISA101b and Libtayo® (cemiplimab) in advanced cancer of the HPV16 positive oropharynx. This new study is the third with active recruitment as part of ISA Pharmaceuticals’ strategic collaboration in immuno-oncology with Regeneron.
The oropharyngeal cancer phase 2 study (NCT04398524) will include 86 patients with recurrent / metastatic HPV16 positive oropharyngeal cancer who progressed with previous anti-PD-1 therapy, a cancer with a high unmet medical need. The primary efficacy endpoint is the overall response rate (ORR) and the study predicts first-line data in the second half of 2023.
The other studies testing the combination of ISA101b and Libtayo are:
A phase 2 study in cervical cancer (NCT04646005) which is led by Regeneron. It will recruit 103 adult patients with recurrent / metastatic HPV16 positive cervical cancer who have experienced disease progression after first-line chemotherapy. The primary endpoint of this study will be ORR.
A randomized, placebo-controlled phase 2 study in first- and second-line HPV16 positive head and neck cancer (NCT03669718) which will include 194 patients also with an ORT as the primary endpoint. ISA Pharmaceuticals is leading this study. The main results of this study are expected in the second half of 2022.
ISA101b immunotherapy targets HPV16 positive cancers. It induces strong and specific immune responses to the HPV16 virus, and (restores) a powerful and targeted immune response of T lymphocytes against infected and / or cancerous cells and tissues. ISA101b uses proprietary ISA Synthetic Long Peptide (SLP®) technology. Libtayo is an anti-PD-1 antibody jointly developed by Regeneron and Sanofi.
Gerben Moolhuizen, CEO of ISA Pharmaceuticals, said: “We are happy to announce that the first patient has been treated in this new study. This highlights the productive collaboration we have with Regeneron, with active operational involvement of both companies. This additional trial offers a potentially shorter path to first approval in an HPV16 positive cancer indication. ”
Cancers of the head and neck and cervix can be serious and life-threatening, often diagnosed in young or middle-aged adults, with low overall survival rates once these cancers progress towards advanced stages. HPV16 is a major cause of head and neck cancer with more than 25,000 new cases and 11,000 deaths in Europe1 and 46,000 new cases and 9,000 deaths in the United States2.
More information on clinical trials can be found here.
1 Adapted from https://gco.iarc.fr/today/data/factsheets/cancers/3-Oropharynx-fact-sheet.pdf
2 Adapted from https://www.cancer.org/cancer/oral-cavity-and-oropharyngeal-cancer/about/key-statistics.html
About ISA Pharmaceuticals
ISA Pharmaceuticals is an immunotherapy company that develops treatments for various cancers and infectious diseases. ISA Pharma has the best technology in its class to stimulate and activate the human immune system, in particular T cells, to fight against sick or infected cells. Its main asset ISA101b is in advanced clinical trials for cancer induced by human papillomavirus type 16 (HPV16) in collaboration with the American pharmaceutical company Regeneron. Other actives are in preclinical development and include immunotherapies to treat patients with chronic hepatitis B infections, PRAME overexpressing cancers, cancers caused by HPV types other than HPV16 or infections by SARS-CoV2. For more information, please visit www.isa-pharma.com.
SOURCE ISA Pharmaceutical