– Chemotherapy improves immune response to therapeutic vaccine against Human Papilloma Virus type 16 (HPV16)

Leiden, The Netherlands, September 30, 2013 – ISA Pharmaceuticals B.V., a clinical-stage biopharmaceutical company focusing on rationally designed therapeutic vaccines against cancer and persistent viral infections, today announced that it had presented novel data on its lead compound ISA101 at this year´s European Cancer Congress (ECCO-ESMO-ESTRO) in Amsterdam, The Netherlands.

In a preclinical mouse model of cancer, chemotherapy with cisplatin increased the therapeutic response to subsequent vaccination with an HPV16 synthetic long peptide (SLP®). While cisplatin or HPV-SLP® treatment alone increased survival, long-term survival was only achieved by combining chemotherapy with the vaccine.

These findings are further supported by a Phase I toxicity / immunogenicity study in 18 women with advanced or recurrent cervical cancer eligible for chemotherapy. Concurrent with standard chemotherapy (including carboplatin and paclitaxel), 12 patients received ISA101, a therapeutic cancer vaccine consisting of 13 synthetic long peptides from the E6 and E7 oncoproteins of HPV16. The control group (n=6) did not receive vaccination. The study demonstrates that chemotherapy does not cause lymphodepletion or suppression of cellular immune responses in patients. Patients showed shifts in leukocyte composition associated with increased dendritic cell function and improved memory T cell responses to common recall antigens. Patients treated with chemotherapy and ISA101 exhibited robust and sustained HPV16-specific proliferative T cell responses.

“We are pleasantly surprised that standard chemotherapy for late-stage cervical cancer is not immunosuppressive for T cells, and that it permits robust proliferative T cell responses to ISA101,” said Cornelis Melief, Chief Scientific Officer of ISA Pharmaceuticals. “Contrary to long-held beliefs, these results demonstrate that chemotherapy combines well with therapeutic cancer vaccines.”

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About ISA Pharmaceuticals

ISA Pharmaceuticals B.V. is a biopharmaceutical company developing rationally designed, fully synthetic therapeutic vaccines against cancer and persistent viral infections. The company has built a proprietary vaccine platform based on the Synthetic Long Peptide (SLP®) and AMPLIVANT technologies, which permit the generation of safe and effective vaccines with a known mechanism of action. SLP® vaccines are broadly applicable to multiple targets and ideally suited as monotherapy or as essential components in combination with conventional cancer treatments.

Two SLP® vaccines are currently in clinical development: ISA101, targeting human papilloma virus (HPV) induced diseases, and ISA102, targeting p53-overexpressing tumors. 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

About ISA101

ISA101, the lead product of ISA Pharmaceuticals, is a synthetic long peptide vaccine for the treatment of human papilloma virus (HPV) type 16 induced diseases, including cervical cancer, most ano-genital premalignant and malignant lesions, and head and neck cancer. Among others, it has been tested in women with vulvar intraepithelial neoplasia (VIN). In this study, ISA101 was well tolerated, and proved to be clinically effective with complete or partial regression of lesions in women with high-grade VIN. Clinical response was strongly associated with the induction of a robust and broad HPV-16-specific immune response. At present, ISA101 is evaluated in a Phase I/II Clinical Trial of ISA101 in patients with anal intraepithelial neoplasia (AIN).

The vaccine has been granted Orphan Drug Designation by the EMA (2007) and the FDA (2011) for the treatment of HPV-positive VIN.

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