Archive: Company News
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.
Company News: Curetis AG Chooses Mediphos as Exclusive Distribution Partner for the Netherlands
– Partners prepare market launch and clinical evaluation project –
Holzgerlingen, Germany, September 26, 2012 — Curetis AG today announced that Curetis and Mediphos have closed an exclusive distribution agreement for the Netherlands. Mediphos is an experienced independent distributor with a clear focus on molecular diagnostics and an emphasis on microbiology-based applications.
Under the agreement, both companies will prepare the market roll-out of Curetis´ Unyvero™ Solution and the Unyvero™ P50 Pneumonia Application. Moreover, Mediphos will be responsible for a clinical evaluation project in the Netherlands and will present the Unyvero Solution™ at the autumn meeting of the National Microbiology Association (NVVM) on November 15, 2012.
The Dutch target market for the Unyvero™ Solution covers approximately 40 hospitals (both university and large general hospitals). Significant market research has been jointly conducted by the partners to define a clear-cut execution strategy. Positive feedback from clinical opinion leaders and major hospitals has led to a two-pronged approach: while all target hospitals will be approached in parallel, the first Unyvero™ instrument system will be placed at one of the country’s leading university hospitals where a clinical evaluation by clinical opinion leaders will be initiated right away.
Company News: Curetis and Heraeus Medical Collaborate on the Development of New Unyvero™ Diagnostic Cartridge
– Joint development of cartridge for orthopaedics, wound and surgery infections –
Curetis AG and Heraeus Medical GmbH have signed a collaboration agreement to jointly develop a novel Unyvero™ cartridge for the detection of pathogens and antibiotic resistances in implant & tissue infections (ITI). One key application area will be in orthopaedics, e.g. to diagnose infections after knee and hip replacement surgeries.
Under the terms of the agreement, Heraeus and Curetis will co-fund product development in the respective indication areas. Heraeus’ customers will be given access to the Unyvero™ solution, while Curetis will pay a sales commission for any customer referrals by Heraeus to Curetis. No licenses are involved and further financial details were not disclosed.
Curetis will retain full control over its commercialization strategy and execution both directly in the DACH region as well as via its international distributor network. The resulting Unyvero cartridge and application will be a Curetis-labeled IVD.
The collaboration will provide Heraeus with access to leading-edge, innovative and easy-to-use in vitro diagnostics and molecular diagnostic solutions for its customers. The new ITI cartridge will be of interest not only in general surgery, but also in infections caused by biofilms (e.g. on knee and hip implants or catheters), in abdominal surgery infections, diabetic foot, burn wounds etc.
Today, wound and surgical site infections are increasingly caused by bacteria carrying multiple antibiotic resistances. In orthopaedic indications, infections often involve biofilms, communities of microorganisms very hard to open up and cultivate. At present, it may take 7-15 days to obtain results from biofilm samples. This scenario often leads to prolonged empiric treatment, follow-on surgeries and increased morbidity and healthcare costs.
For the development of the new cartridge, the partners have jointly conducted market research in orthopaedic applications throughout Europe. They have also teamed up with clinical key opinion leaders in Germany, Switzerland, France, the UK, and Scandinavia to determine the pathogens and antibiotic resistances that need to be included in the diagnostic panel of the new cartridge. The partners expect assay development for the new cartridge to be completed by early 2013, with clinical validation and CE marking throughout 2013 and an expected launch in the EU by the end of 2013. The product is likely to include more than 40 and possibly up to 50 analytes.
Curetis will present its Unyvero™ solution at the 64th Annual Meeting of the German Society for Hygiene and Microbiology (DGHM) in Hamburg (September 30 – October 3, 2012).