– Granted US patent provides market exclusivity until 2032
Leiden, The Netherlands, April 19, 2016 – 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 US patent on its AMPLIVANT® technology and compounds (patent no. 9,314,521). The patent ensures market protection in the United States until 2032 and covers the compounds, either as a stand-alone substance or in combination with antigenic peptides, nucleic acids or antibodies. The patent also covers the process for preparing the compounds.
ISA’s AMPLIVANT® technology provides an adjuvant that has been demonstrated to improve the immunostimulatory potency of SLP® immunotherapeutics 100- to 1000-fold. It comprises a synthetic small molecule toll-like receptor 1/2 (TLR1/2) ligand with enhanced immunostimulatory activity that can be used as a stand-alone additive or chemically coupled to immunotherapeutic compounds like synthetic peptides during the SLP® manufacturing process. SLP®-AMPLIVANT® conjugate compounds allow for lower doses at higher efficacy through better dendritic cell antigen processing and presentation as well as enhanced T cell priming. At present, clinical researchers at Leiden University Medical Center are evaluating the safety and immunogenicity of two SLP®-AMPLIVANT® conjugates in patients affected by HPV16+ disease (HESPECTA trial).
“This patent is the first of a family of patents and highly significant for the future development and protection of our next-generation SLP products,” said Ronald Loggers, ISA Pharmaceutical’s Chief Executive Officer. “With market protection in the US until 2032, we have added another level of protection to our products and, potentially, other applications.”
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-postive solid tumors 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 of ISA101 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® and AMPLIVANT® are registered trademarks in Europe.