Archive: Company News

Company News: Curetis to Present Clinical Unyvero™ Data at ECCMID 2013 in Berlin

Company to host medical symposium on molecular antibiotic resistance testing in standard care

Curetis AG today announced the presentation of top-line clinical data from various European cohorts and performance evaluation studies of the Unyvero™ System and the Unyvero™ P50 pneumonia cartridge at the European Conference of Clinical Microbiology and Infectious Diseases (ECCMID) 2013 in Berlin. Data from the analysis of more than 1,000 patient samples and case reports will be presented in the poster session “Molecular diagnosis of bacterial pneumonia” on Monday, April 29, from 12:30-1:30pm.*

As an ECCMID silver sponsor, Curetis will also host a medical symposium on Saturday, April 27 (1:30-3:30pm) in Hall B (P.32). The symposium entitled “Does molecular antibiotic resistance testing improve diagnostics and standard of care?” will be chaired by Professors Carl-Erik Nord and Christian G. Giske (both Stockholm/Sweden). Featured presentations will be “Genotypes and phenotypes of emerging resistance” (Prof. David Livermore, Norwich/UK) and “Correlation between genotypes and phenotypes: clinical implications” (Prof. Gian Maria Rossolini, Siena/Italy). The session will conclude with the discussion of case studies in pneumonia (Prof. Antonio Torres, Barcelona/Spain, Prof. Eiman Mokaddas, Kuwait) and implant & tissue infection (Prof. Andrej Trampuz, Berlin/Germany and Prof. Olivier Borens, Lausanne/Switzerland).

Curetis will be exhibiting its CE-marked Unyvero™ System at booth no. 323 in hall 15. Several international distribution partners of Curetis will also attend ECCMID.

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*Abstract Nr. 2360: M. Klein et al., First clinical validation of a rapid molecular test (Unyvero™ P50 Pneumonia Application) detecting microorganisms and antibiotic resistances in patients suspected with severe pneumonia.

Company News: Novel AMPLIVANT™ Technology Introduced at AACR Annual Meeting 2013

– AMPLIVANT™ TLR-ligand adjuvant to improve immunotherapies –

ISA Pharmaceuticals B.V., a clinical-stage biopharmaceutical company focusing on rationally designed therapeutic vaccines against cancer and persistent viral infections, announces that Cornelis Melief, Professor at Leiden University and Chief Scientific Officer of ISA, presented details on the company’s novel AMPLIVANT™ technology at the American Association for Cancer Research (AACR) 2013 Annual Meeting. AMPLIVANT™ is based on a powerful, proprietary toll-like receptor (TLR) ligand designed to improve immunotherapies. This promotes direct dendritic cell targeting of the antigen as well as antigen processing, resulting in long-term activation of dendritic cells and antigen presentation.

Toll-like receptors (TLRs) expressed by immune cells such as dendritic cells (DCs) or macrophages, play a key role in innate immunity by recognizing characteristic molecular structures present on the surface of bacteria and other microorganisms. Once these TLR ligands bind to the receptors, a signaling cascade is triggered which, among other effects, activates cells initiating immune responses. Thereby, they have the capacity to generate a robust acquired immune response.

Together with other scientists at Leiden University, the ISA team had observed that adding known strong TLR ligands to a vaccine consisting of synthetic long peptides resulted in a greatly improved immune response.

“Our rationale then was to link the peptide antigen chemically to the TLR ligands in order to obtain an even more efficient antigen delivery into the dendritic cells and additional activation stimuli from the TLR ligand,” said Melief. “In addition, we found that the AMPLIVANTTM-SLP conjugate is ingested more efficiently and leads to the creation of an antigen depot in the dendritic cells. This in turn results in long-lived antigen processing and presentation at the cell surface of the DCs.”

In tumor mouse models, conjugates of TLR ligands and synthetic long peptides resulted in much greater anti-tumor activity, long-term tumor protection and increased survival as compared to vaccines consisting of mixtures of peptides or peptides plus free TLR ligands.

To improve the TLR ligand performance further and to maximize clinical benefit, a synthetic TLR2-activating ligand was modified by rational molecular design, following a crystal structure analysis of the interaction between the ligand and its receptor.

“These efforts led to the AMPLIVANT™ technology, which had already yielded a number of proprietary agonists with enhanced receptor activation and DC maturation,” Melief added. “Our AMPLIVANTTM adjuvants are 100-fold more effective in terms of receptor stimulation than existing reference adjuvants, and we have also shown that they result in enhanced priming of CD8 T-cells in vivo.”

ISA is now planning a Phase I/II study to demonstrate safety and immunogenicity. “In this study, we will validate the AMPLIVANT™-SLP conjugate concept along the lines of our ISA101 vaccine, which has demonstrated clinical efficacy against pre-malignant disease,” said Gerard Platenburg, Managing Director of ISA Pharmaceuticals. “AMPLIVANT™ conjugates are based on two synthetic long peptides chosen from the 13 SLPs of the ISA101 vaccine. The trial in patients with HPV16-positive head and neck cancer is expected to start in early 2014.”

A Phase II trial of ISA101 in vulvar intra-epithelial neoplasia has established clinical proof-of-concept. In cervical cancer, ISA101 has completed a phase I/II trial and will enter into a randomized phase II trial later this year. ISA is also about to enter a phase I/II study in anal intra-epithelial neoplasia (AIN) with ISA101.

Company News: InDex Pharmaceuticals Reports Completion of Patient Recruitment in Phase III Ulcerative Colitis Study (COLLECT) with Kappaproct®

InDex Pharmaceuticals today announced the completion of patient enrollment for its Phase III COLLECT study of Kappaproct. The multinational, randomized, double-blind, placebo-controlled study reached the recruitment goal of 120 patients with treatment-refractory Ulcerative Colitis (UC). InDex is expecting final study results in mid-2014.

The Phase III trial is designed to assess Kappaproct’s efficacy and safety in treatment-refractory UC patients. This cohort consists of chronic active UC patients who have failed all currently available pharmaceutical treatment and whose only remaining treatment option is surgical removal of the colon. This is a rare group of patients with a very high unmet medical need. Kappaproct has an Orphan Drug Designation in Europe.

The study is conducted in seven European countries. The primary endpoint of the study is the induction of clinical remission at week 12. Secondary endpoints, among others, are the rate of and time to colectomy. The patients will be followed for a total of 52 weeks.

Kappaproct is a DNA-based immunomodulatory sequence (DIMS) targeting the toll-like receptor 9 (TLR9). Kappaproct has shown positive effects on key symptoms of UC such as stool frequency, blood in stool and mucosal healing in a previous phase II proof-of-concept study. Kappaproct has also demonstrated a favorable safety and side effect profile in previous clinical trials.

Company News: Prof. Cornelis Melief to Present Novel AMPLIVANT™ Platform at AACR Annual Meeting 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 Prof. Cornelis Melief, M.D., will present details on the novel AMPLIVANTTM platform at this year’s American Association for Cancer Research (AACR) Annual Meeting. AMPLIVANTTM is based on a powerful, proprietary toll-like receptor (TLR) ligand improving immunotherapies.

 

Presentation title: “Synthetic vaccine for immunotherapy of high risk HPV infections“

Symposium: SY27 “New Cancer Vaccines“

Abstract number: SY27-01

Date: April 9, 2013, at 10:40 a.m.

Location: Room 202 at the Washington Convention Center.

 

The abstract is available at the AACR website www.aacr.org.

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