– Next-generation immunotherapy called MyISA^® for individual cancer patients

Leiden, The Netherlands, December 7, 2016 – ISA Pharmaceuticals B.V., a clinical-stage immunotherapy company, has joined the recently established Tumor neoantigEn SeLection Alliance (TESLA), a global cancer neoantigen alliance forged by the Parker Institute for Cancer Immunotherapy and the Cancer Research Institute, which was announced on December 1st, 2016. Consisting of 30 of the world’s leading research organizations and corporations, the group’s focus will be on developing better predictive models for identifying neoantigens. The initiative will support tests carried out by its members and the consistent improvement of algorithms to analyze tumor DNA and RNA sequences in order to predict the immunogenic capacity of neoantigens.

This initiative will support ISA’s strategy to expand its innovative portfolio of cancer immunotherapies by developing personalized therapeutic SLP^® vaccines directed against neoantigens under the MyISA^® program.

Neoantigens are mutation-derived antigens and tumor-specific for each individual patient. ISA, an early adopter in this field, has been on the forefront of T cell-mediated immunotherapy for many years. In 2014, scientists from Washington University St. Louis and ISA Pharmaceuticals demonstrated that SLP^®-based, neoantigen-directed immunotherapy was able to eradicate the tumor as effectively as checkpoint immunotherapy in pre-clinical models. The effort was led by Prof. Robert Schreiber, one of the opinion leaders in neoantigen-targeting cancer vaccines and the driving force behind the TESLA consortium.

MyISA^® therapeutic cancer vaccines will be based on translating the mutanome into a set of Synthetic Long Peptides (SLP^®) that bear the capacity to elicit tumor-specific T cell responses. Vaccines based on ISA’s proprietary SLP^® platform have demonstrated clinical efficacy, and in-house facilities are already in place for developing immunotherapeutics to treat HPV-induced cancers. ISA is expanding existing design and manufacturing capabilities necessary to deliver such personalized SLP^® vaccines. The company has established a dedicated in-house manufacturing process, and is transferring this to cGMP in order to produce personalized MyISA^® vaccine products by mid-2017.

SLP^®-based immunotherapies have been clinically validated in virus-induced cancers (e.g. in HPV16-induced diseases). They have been shown to trigger superior DC processing and durable targeted immune responses, which translate into clinical benefits. In terms of applicability, affordability, safety and quality of T cell responses, SLP^® immunotherapeutics can be considered to be “best in class”.

“Given the promising data on targeting neoantigens gained from our collaboration with Bob Schreiber and from several other teams around the world, MyISA is a logical extension of our approach,” said Ronald Loggers, CEO of ISA Pharmaceuticals. “With MyISA, we are building on extensive expertise and on sound clinical data generated with SLPs in HPV-induced malignancies and cancers – which puts us in a unique and leading-edge position.”

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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 personalized SLP^® immunotherapies targeting tumor-specific, mutation-derived neo-antigens. These SLP^®s are based on the analysis of specific 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). Moreover, a clinical Phase II combination trial with ISA101 and Nivolumab is being conducted at 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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