– Experiments to evaluate a novel nasal cervical cancer immunotherapeutic

Leiden, The Netherlands, March 3, 2015 – ISA Pharmaceuticals B.V., a clinical-stage immunotherapy company focusing on rationally designed immunotherapeutics against cancer and persistent viral infections, today announced that its fully-owned subsidiary ISA Therapeutics B.V. has closed an R&D agreement with Japan-based Shin Nippon Biomedical Laboratories, Ltd. (SNBL) to explore a novel nasal delivery for ISA’s cervical cancer immunotherapeutic. In the experiments, ISA Pharmaceuticals’ proprietary Synthetic Long Peptide (SLP^®) immunotherapeutic ISA101 will be administered via SNBL’s novel nasal drug delivery technology. SNBL´s patent-protected approach is designed to significantly enhance the absorption of powder-based nasal drugs from the nasal mucosa.

Both parties expect to obtain basic research data on a potential antigen-specific immune response.

ISA101 is ISA Pharmaceuticals´ most advanced pipeline program and designed to treat early-stage, advanced and recurrent cancers induced by HPV16 infections. ISA101 is currently administered via subcutaneous injections and has successfully completed several clinical studies in the Netherlands and Belgium for advanced and recurrent cervical cancer, as well as other early-stage HPV16-related cancers.

ISA101 consists of 13 synthetic long peptides (25-35 amino acids long) derived from the E6 and E7 oncogenic proteins of the HPV16 virus. This strain is responsible for 50% of human cervical cancers and cervical intra-epithelial neoplasias and for more than 85% of HPV-positive head and neck cancers, anal cancers and premalignant HPV-induced anal lesions (termed anal intra-epithelial neoplasia, or AIN).

In the United States, cervical cancer is the second most common cancer in women after breast cancer. In Japan, approximately 10,000 women are diagnosed for cervical cancer, and approximately 2,700 infected women die from the disease every year. Since HPV can remain persistent in the body for over a decade before cancer develops, there is a strong demand not only for prophylactic vaccines preventing HPV infections, but also for novel immunotherapeutics to treat already infected individuals.

“The R&D partnership with SNBL enables us to explore new and more convenient administration routes for ISA101,” said Ronald Loggers, CEO of ISA Pharmaceuticals. “ISA101 targets a significant global market, and a potential nasal delivery could further enhance the attractiveness of the compound.”

###

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.

About SNBL, Ltd.
For more than 55 years, SNBL has been a leader in helping biopharmaceutical companies generate high quality data with the exceptional precision needed to rapidly advance new medical therapies and innovations that improve patients’ lives. SNBL’s business consists of contract research in preclinical studies, clinical pharmacology studies, pharmacokinetics/bioanalysis, and clinical studies, as well as SMO business. In the recent years, SNBL is aggressively expanding the Translational Research business.

Contact & Media Inquiries:
akampion
Dr. Ludger Wess , Ines-Regina Buth
Managing Partner
Tel. +49 40 88 16 59 64, Tel. +49 30 23 63 27 68
info(at)akampion.com