Leiden, The Netherlands, April 26, 2018 – ISA Pharmaceuticals B.V., a clinical-stage immunotherapy company focusing on rationally designed immunotherapeutics against cancer and persistent viral infections, today announced the start of a Phase II combination trial of its lead compound ISA101b and Pfizer´s 4-1BB agonist Utomilumab, which will be sponsored and conducted by The University of Texas MD Anderson Cancer Center (Houston, TX).

The goal of the open-label Phase II study in patients with HPV16-positive, incurable oropharyngeal cancer is to investigate whether a combination of ISA101b with Utomilumab is able to shrink or slow the growth of tumors. The safety of the study drugs will also be evaluated. The study will enroll up to 27 patients, who will receive three subcutaneous administrations of ISA101b at four-week intervals and Utomilumab intravenously every 4 weeks for up to 12 doses. Primary endpoint of the study will be Overall Response Rate (ORR) assessed by RECIST 1.1 criteria. Secondary endpoints include adverse events, response rates monitored by radiographic assessment and immune-related progression-free survival monitored by radiographic assessment.

ISA Pharmaceuticals´ lead compound ISA101 is a clinical-stage SLP® immunotherapy targeting HPV16-induced diseases such as cervical cancer and head and neck cancer. Utomilumab, a 4-1BB agonist, is under investigation by Pfizer for the treatment of various cancers

“We are very excited to launch this second trial in our collaboration with ISA and Dr. Melief. The study has the potential to demonstrate Utomilumab’s specific effect on vaccine-induced T cells with enhanced tumoricidal activity,” said Bonnie Glisson, MD, Professor in the Department of Thoracic/Head and Neck Medical Oncology at MD Anderson and principle investigator of the study. “The ISA101b plus Utomilumab trial represents the clinical translation of research at MD Anderson by Drs. Curran and Sastry which showed that an HPV peptide vaccine and 4-1BB agonist antibody was the most effective vaccine I/O combination in mouse models of HPV-driven cancer.”

“We are delighted to expand our collaboration with MD Anderson by this second Phase II trial,” said Prof. Cornelis Melief, CSO of ISA Pharmaceuticals. “ISA101 has so far demonstrated great potential for the treatment of patients with HPV16-positive solid tumors and our goal is to provide novel, advanced therapeutic options for these patients. Combining our vaccine with Utomilumab is an exquisite opportunity to explore a promising new option, because Utolimumab is likely to expand vaccine-induced tumor-specific T cells.”

Oropharyngeal cancer, a subtype of head and neck cancer, affects tissues of the throat (oropharynx), e.g. the base of the tongue, the tonsils, the soft palate, and the walls of the pharynx. Oropharyngeal cancers can be divided into two types: HPV-positive, which are related to human papillomavirus infection, and HPV-negative cancers, which are usually linked to alcohol or tobacco use.

###

About ISA Pharmaceuticals

ISA Pharmaceuticals B.V. is an immunotherapy company developing rationally designed, fully synthetic immunotherapeutics against cancer and persistent viral infections. The company has built a proprietary immunotherapy platform based on the Synthetic Long Peptide (SLP^®) concept and AMPLIVANT^® technology. SLP^® immunotherapies are designed to fully harness and direct the body’s own defenses towards fighting the disease. In December 2017, ISA Pharmaceuticals closed a clinical immuno-oncology collaboration with Regeneron to advance its SLP^® lead compound ISA101, an immunotherapy targeting human papillomavirus type 16 (HPV16)-induced cancer, in combination with cemiplimab (REGN2810), a PD-1 (programmed cell death protein 1) antibody. In addition, ISA develops MyISA^®, a personalized SLP^® immunotherapy, targeting tumor-specific, mutation-derived neo-antigens.

For more information, please visit www.isa-pharma.com.

SLP^®, AMPLIVANT^® and MyISA^® are registered trademarks in Europe.

Contact & Media Inquiries:

akampion

Dr. Ludger Wess, Ines-Regina Buth

Managing Partners

Tel. +49 40 88 16 59 64  +49 30 23 63 27 68

info(at)akampion.com