– Incurable HPV16+ solid tumors treated with therapeutic cancer vaccine plus checkpoint inhibitor

Leiden, The Netherlands, September 4, 2017 – ISA Pharmaceuticals B.V., a clinical-stage immunotherapy company, today announced the presentation of the results of a clinical Phase II trial initiated by MD Anderson Cancer Center in collaboration with ISA and Bristol-Myers Squibb (NCT02426892) at ESMO 2017 (September 8-12, 2017, Madrid, Spain). In the trial, cancer patients with HPV16+ incurable solid tumors received a combination of ISA’s synthetic long-peptide (SLP) HPV-16 vaccine ISA101 and nivolumab, a monoclonal antibody acting as a PD-1 checkpoint inhibitor.

An oral presentation of the results will be held by Bonnie Glisson MD, the Principle Investigator of the study, on Monday, September 11, 2017:

Proffered paper session “Immunotherapy of cancer”

Madrid Auditorium

11:45-12:00 “Nivolumab and ISA 101 HPV vaccine in incurable HPV-16+ cancer”

The data will be based on abstract no. 1136O. The investigators intend to publish the data in a peer-reviewed journal later this year.

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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, which have the potential to generate safe and effective immunologic responses with a known mechanism of action. Synthetic long peptides are broadly applicable to multiple targets and ideally suited for monotherapy, as essential components in combination with conventional cancer treatments, and with novel immunomodulators such as Nivolumab. SLP^® immunotherapies are designed to fully harness and direct the body’s own defenses towards fighting the disease. In addition, ISA has begun to develop MyISA^®, a personalized SLP^® immunotherapy, targeting tumor-specific, mutation-derived neo-antigens. These SLP^®s are based on the analysis of immunogenic DNA mutations in a tumor sample, and designed and synthesized for each individual patient.

ISA´s most advanced clinical-stage immunotherapeutic is ISA101, an SLP^® immunotherapy targeting human papillomavirus (HPV)-induced diseases. It is currently in clinical development in advanced and recurrent cervical cancer, incurable HPV16-positive solid tumors (such as small cell carcinoma of head and neck SCCHN) and anal intraepithelial neoplasia (AIN). A clinical Phase II combination trial with ISA101 and Nivolumab is completed and will soon be reported by the MD Anderson Cancer Center in the US. Clinical proof-of-concept has been established in vulvar intraepithelial neoplasia (VIN), a pre-cancerous disease caused by HPV.

The company was founded in 2004 by Aglaia Oncology Fund and is based in Leiden, The Netherlands. For more information, please visit www.isa-pharma.com

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

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