ISA Pharmaceuticals Commences Patient Treatment in Third Phase 2 Clinical Trial with the Combination of ISA101b and Libtayo® (cemiplimab)

- The phase 2 study enrols patients with advanced HPV16 positive oropharyngeal head and neck cancer that failed previous anti-PD1 treatment

- The trial is part of a clinical development plan that is aimed at a Biological License Application (BLA) for this combination immunotherapy

OEGSTGEEST, Netherlands, Sept. 8, 2021 /PRNewswire/ -- ISA Pharmaceuticals B.V., a clinical stage biotech company, announces the start of patient dosing in a pivotal clinical trial investigating the combination of ISA101b and Libtayo® (cemiplimab) in advanced HPV16 positive oropharyngeal cancer. This new study is the third with active recruitment under ISA Pharmaceuticals' strategic immuno-oncology collaboration with Regeneron.

The oropharyngeal cancer phase 2 study (NCT04398524) will include 86 patients with recurrent/metastatic HPV16 positive oropharyngeal cancer that progressed with prior anti-PD-1 therapy, a cancer with a high unmet medical need. The primary efficacy outcome parameter is Overall Response Rate (ORR) and the study expects top line data in the second half of 2023.

The other studies testing the combination of ISA101b and Libtayo are:

A cervical cancer phase 2 study (NCT04646005) that is being conducted by Regeneron. It will enrol 103 adult patients with recurrent/metastatic HPV16 positive cervical cancer who have experienced disease progression after first line chemotherapy. Primary endpoint of this study will be ORR.

A randomised, placebo controlled phase 2 study in first and second line HPV16 positive head-and-neck cancer (NCT03669718) that will include 194 patients also with ORR as primary endpoint. ISA Pharmaceuticals runs this study. Top line results for 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 (re-)establishes a powerful and targeted T-cell immune response against infected and/or cancerous cells and tissues. ISA101b is using ISA's proprietary Synthetic Long Peptide (SLP®) technology. Libtayo is an anti-PD-1 antibody that is being jointly developed by Regeneron and Sanofi.

Gerben Moolhuizen, Chief Executive Officer of ISA Pharmaceuticals, said: "We are pleased to announce that the first patient has been treated in this new study. It highlights the productive collaboration we have with Regeneron, with active operational involvement from both companies. This additional trial offers a potentially shortened path to first approval in a HPV16 positive cancer indication."

Head-and-neck and cervical cancers can be severe and life-threatening, often diagnosed in young to middle aged adults, with low overall survival rates once these cancers progress to advanced stages. HPV16 is a major cause of head & neck cancer with over 25,000 new cases and 11,000 deaths in Europe¹ and 46,000 new cases and 9,000 deaths in the US².

More information on the 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 developing treatments for various cancers and infectious diseases. ISA Pharma has best-in-class technology to stimulate and activate the human immune system, specifically T cells, to fight diseased or infected cells. Its lead asset ISA101b is in late-stage clinical trials for human papillomavirus type 16 (HPV16)-induced cancer in a collaboration with US pharmaceutical company Regeneron. Other assets are in preclinical stage development and include immunotherapies to treat patients that suffer from chronic hepatitis B infections, cancers that over-express PRAME, cancers caused by other HPV types than HPV16, or SARS-CoV2 infections. For more information, please visit www.isa-pharma.com.