News
Company News: Curetis Completes Enrollment for its EU Trial As Planned
– Prospective multi-center trial enrolls 800 patient samples in 7 months-
Curetis AG today announced it has completed enrollment for the European clinical trial of its Unyvero™ Pneumonia Application on schedule. More than 800 patient samples were collected until September 30, 2012. Data analysis will be completed in early 2013. Subsequently, results will be published in a major, peer-reviewed journal.
The trial will compare the performance of the Unyvero™ P50 Pneumonia Cartridge with conventional microbiology culture, the current standard of care. Primary endpoint will be clinical sensitivity and specificity for the identification of 17 pathogens covered by the Unyvero™ P50 panel. Secondary endpoints include time to result and correlation of resistance marker detection with phenotypic antibiograms. Curetis will conduct systematic discrepant results resolution by PCR and sequencing to confirm the clinical truth in samples where Unyvero results differ from microbiology culture.
The study complements the previously completed CE performance evaluation study, in which the Unyvero P50 Cartridge identified a significant number of additional pathogens not detected by microbiology culture. These findings were confirmed by PCR analysis.
Company News: Merus Announces the Full Validation of Its MeMo® Transgenic Mouse for Common Light Chain Human Antibodies
Merus B.V., a biopharmaceutical company focused on innovative human antibody therapeutics, announced today the full validation of its transgenic MeMo® mouse for common light chain human antibodies. The MeMo® mouse creates human antibody diversity using a large repertoire of human heavy chains paired with a common human light chain.
“Over the last year, we have immunized MeMo® mice with half a dozen antigens and analyzed the immune response,” said Mark Throsby, COO at Merus. “We are extremely excited by the performance of the MeMo® technology; serum antibody titers as well as size, diversity, functionality and developability of antibody panels are comparable to those of wild type mice.”
“In MeMo®, a single human light chain drives the generation of a normal B cell compartment as well as supports a robust immune response,” said Ton Logtenberg, CEO and founder of Merus. “The large and diverse panels of high-quality human antibodies that we retrieve from MeMo® show that this platform is comparable to the best-in-class transgenic platforms using diversified heavy and light chains.”
Because of the common light chain, MeMo®-derived antibodies can be immediately used to rapidly generate thousands of bispecific antibodies (Biclonics™) and combinations of antibodies (Oligoclonics®) for functional screening. Merus has shown that the quality and diversity of common light chain antibodies drives the success of identifying Biclonics™ with unprecedented potencies for application in oncology. The MeMo® mouse is available for licensing.
Company News: VAXIMM Receives Grant to Expand Pipeline of Oral Cancer Vaccines
VAXIMM AG, a Swiss-German biotech company focusing on cancer vaccines, today announced that its German subsidiary VAXIMM GmbH has been awarded a grant from the leading-edge BioRN cluster “Cell-based and Molecular Medicine” to expand its oral T-cell vaccine technology platform. The cluster competition is a program of Germany´s Federal Ministry of Education and Research (BMBF) to promote top-notch innovation in Germany.
VAXIMM’s lead candidate VXM01 is an oral T-cell vaccine, which targets the tumor vasculature. It is currently in Phase I/II clinical evaluation in pancreatic cancer patients at the Heidelberg University Hospital. The funding from the leading-edge cluster program will be used to develop additional cancer vaccines complementary to VXM01, which are based on the same oral T-cell vaccine technology. A second candidate (VXM06), which targets an undisclosed, abundant, tumor-specific antigen, is already in preclinical development. Two further product candidates are at discovery stage.
VAXIMM’s oral T-cell vaccine technology has a number of advantages. The platform can easily and rapidly generate new vaccines, including multivalent vaccines. The resulting products combine oral efficacy with safety and excellent tolerability. Moreover, the vaccines do not require a complex manufacturing infrastructure.
Company News: Curetis AG Signs Up BioLine LLC as Exclusive Distribution Partner for Russia
– Partners to start registration process and market launch in Russia –
Curetis today announced that it has signed up BioLine LLC as an exclusive distribution partner for Russia, Ukraine, Kazakhstan and Belorus. BioLine is a major player in these markets and distributor for global companies such as Becton Dickinson, Leica Microsystems and many others.
BioLine is preparing the registration of the Unyvero™ Solution and the Unyvero™ P50 Pneumonia Application with the Russian Ministry of Health for regulatory clearance to sell the CE-marked IVD in Russia.
There is a huge unmet medical need for better pneumonia diagnostics in the region. According to the WHO, 1.5 million cases of pneumonia occur in Russia each year, of which only about 0.3 to 0.4 million are registered with the authorities. 25-33% of patients experience prolonged duration due to antibiotic resistances. Diagnosis is still poor: it is estimated that 20% of all patients diagnosed with severe flu in Russia are in fact suffering from pneumonia. Mortality from pneumonia is huge, reaching 14-20% in the elderly (≥ 60 years) and up to 25% in young children.