– Intradermal administration provides significant benefits compared to subcutaneous application

Leiden, The Netherlands, March 24, 2015 – ISA Pharmaceuticals B.V., a clinical-stage immunotherapy company focusing on rationally designed immunotherapeutics against cancer and persistent viral infections, today announced it has been granted a European patent (patent no. EP 2 155 240) for the intradermal administration of synthetic long peptides (SLP®s) based on HPV oncogenes, including its lead compound ISA101.

Specifically, the patent was granted for the therapeutic use of intradermally delivered long peptides derived from the E2, E6 and/or E7 proteins of the human papillomavirus (HPV) to treat or prevent HPV-related diseases.

ISA101 is a clinical-stage immunotherapeutic for the treatment of early-stage, advanced and recurrent cancers induced by HPV16 infections and is based on ISA Pharmaceuticals´ proprietary SLP^® platform. The compound is currently in clinical Phase I/II trials in cervical cancer and anal intraepithelial neoplasia (AIN).

As shown in healthy volunteers, intradermal administration of low doses of the HPV16 E6 and E7 SLP® without any adjuvant resulted in an effective, long-lasting systemic T cell response. This shows that, compared to subcutaneous delivery, the new epidermal routing with lower doses and absence of a concomitant adjuvant is also capable of eliciting a robust immune response in naïve individuals.

“Intradermal vaccination differs from subcutaneous vaccination,” said Kees Melief, CSO of ISA Therapeutics. “It is targeting a specialized subset of dendritic cells and simultaneously serving as a drug depot. These so-called Langerhans cells are capable of homing to draining lymph nodes and elicit a systemic immune response, which can be easily demonstrated in blood samples.“

“ISA101 has already demonstrated safety and efficacy in several clinical studies,” said Ronald Loggers, CEO of ISA Pharmaceuticals. “The new patent will further strengthen our IP portfolio and the administration routes of ISA101 as we progress towards pivotal studies.”

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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 enable the generation of safe and effective drugs 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 as novel immunomodulators. SLP^® immunotherapies are capable of fully harnessing and directing the body‘s own defenses towards fighting the disease.

ISA101, an SLP^® immunotherapy targeting human papillomavirus (HPV)-induced diseases, is currently in clinical development in cervical cancer and anal intraepithelial neoplasia (AIN). Clinical proof-of-concept has been established with ISA101 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^® and AMPLIVANT^® are registered trademarks in Europe.

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