News
Company News: ISA Pharmaceuticals Granted European Patent for the Intradermal Administration of ISA101
– Intradermal administration provides significant benefits compared to subcutaneous application
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.
Company News: Curetis Initiates Clinical CE Performance Evaluation of Unyvero P55 Pneumonia Application
– Clinical study to test more than 400 patient samples
– Follows successful completion of analytical CE Performance Evaluation in more than 400 cartridge runs
– Expected results and product launch in spring 2015
Curetis AG, a developer of next-level molecular diagnostic solutions, today announced the start of the clinical CE performance evaluation of its next-generation Unyvero P55 Pneumonia Application. The new P55 Cartridge will replace the current P50 Pneumonia Application, which was launched in 2012. P55 will offer an even broader panel of pathogens and antibiotic resistance markers, reflecting global changes in the importance of microorganisms and certain critical resistance mechanisms responsible for pneumonia and other lower respiratory tract infections. Final study data and the P55 product will be presented at the upcoming 25th European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) April, 25 – 28 2015 in Copenhagen, Denmark.
The clinical study will evaluate more than 400 already collected native samples from patients suffering from pneumonia. Primary endpoint of the study will be assay performance defined as clinical sensitivity and specificity as compared to microbiology culture, today’s diagnostics standard of care. Analytical sensitivity has already been established for all panel analytes in more than 400 P55 cartridge runs.
The P55 Cartridge comes with a panel of up to 21 pathogens and up to 19 antibiotic resistance markers. Additions are expected to include e.g. Mycoplasma pneumoniae, Citrobacter freundii, Enterobacter aerogenes, and Klebsiella variicola as well as clinically relevant resistance genes coding for carbapenem (imp, ndm, vim and several oxa-markers) and oxacillin (mecC) resistance. These enhancements reflect input from clinical and epidemiological findings, key opinion leaders and customers over the past two years and will support Curetis’ global product launch activities.
The new cartridge will replace the P50 Application on the European market. Pricing will remain unchanged, with an international roll-out expected to start in the second quarter of 2015. Under the label LRT55, the P55 Cartridge will also be used as a Lower Respiratory Tract (LRT) Application in the U.S. FDA clearance trial, which is expected to be completed in 2016.
Company News: ISA Pharmaceuticals signs R&D agreement with Shin Nippon Biomedical Laboratories
– Experiments to evaluate a novel nasal cervical cancer immunotherapeutic
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.
Company News: ISA Pharmaceuticals Announces Start of First Phase I/II Clinical Trial of its SLP®-AMPLIVANT® Conjugates
– Leiden University Medical Center to study novel immunotherapeutic in HPV-positive head & neck cancer patients
ISA Pharmaceuticals B.V., a clinical-stage immunotherapy company focusing on rationally designed immunotherapeutics against cancer and persistent viral infections, has announced the start of an investigator-initiated Phase I/II clinical trial of a novel immunotherapeutic based on ISA Pharmaceuticals´ platform technology. The trial will be conducted by the Department of Clinical Oncology at Leiden University Medical Center in The Netherlands. The study will investigate the biological activity and safety of the compound in head and neck cancer patients who tested positive for human papilloma virus type 16 (HPV16). HPV infections, in particular HPV16, are one of the major causes of this type of cancer. The immunotherapeutic is a conjugate of two HPV16 E6 Synthetic Long Peptides (SLP®s) covalently linked to AMPLIVANT®, a synthetic Toll-like receptor (TLR) 1/2 ligand. The investigators have assigned the acronym HESPECTA to the conjugate (HPV E-Six Peptide Conjugated To AMPLIVANT®).
In the single-center, open-label dose escalation study, 24 HPV16-positive head and neck cancer patients will be grouped into four dose escalation groups. In each group, every patient will receive three intradermal doses of the immunotherapeutic. The primary endpoint is to assess its ability to induce HPV16 E6-specific T-cell immunity. The secondary endpoint is to evaluate the safety of the intervention.
The human papillomavirus is associated with several types of cancer, of which HPV16 is by far the most common high-risk HPV type detected. It encodes the two tumor-specific oncoproteins E6 and E7 which are known to also induce and maintain the malignant state of the transformed cells. This SLP®-AMPLIVANT® conjugate aims to induce a strong, lasting immune response against the tumor.
AMPLIVANT®, developed by ISA Pharmaceuticals, is based on a Toll-like receptor ligand (TLR1/2 ligand), one of the most powerful natural stimulants of the immune system. SLP®-AMPLIVANT® conjugates have demonstrated to be 100- to 1000-fold more potent in inducing an immune response compared to unconjugated SLP®s in preclinical and mouse tumor models.