Archive: Company News

Company News: Curetis Obtains Key Patent for Unyvero™ Technology

–      Australian patent office grants patent for integrated amplification and detection in Unyvero™ cartridges

–      Patent covers unique combination of end-point PCR with array-based detection

Curetis AG, a developer of next-level molecular diagnostic solutions, today announced that it has been granted a core technology patent by IP Australia, the Australian patent office, for its Unyvero™ platform technology. The patent, “Reaction Vessel For PCR Device and Method of Performing PCR,” is the first of several core technology patents filed by Curetis. Its claims cover PCR chamber vessels allowing the integrated amplification and detection of DNA sequences. Curetis has submitted patent applications covering this technology in other key regions, including Europe, the U.S. and Japan. The Company expects these additional patents to be granted in the near future.

Further patents covering additional aspects of the Unyvero™ Solution, e.g. the unique sample lysis technology, are pending.

Company News: New Clinical Data on Cancer Vaccine ISA101 to Be Presented at the AACR Annual Meeting 2014

ISA Pharmaceuticals B.V., a clinical-stage immunotherapy company focusing on rationally designed therapeutic vaccines against cancer and persistent viral infections, today announced that principal investigator Prof. Sjoerd van der Burg, Ph.D., will present new clinical data on ISA101 at this year’s American Association for Cancer Research (AACR) Annual Meeting. ISA101 is a therapeutic cancer vaccine for the treatment of high-risk, HPV16-induced diseases.

The presentation titled “Synergistic effects of properly timed HPV16 SLP vaccination during standard carboplatin-paclitaxel chemotherapy in animals and patients with metastatic cervical carcinoma“ will be given at the Minisymposium MS.IM02.01 “Immune-based Therapies: Responses, Biomarkers, and Mechanisms” on Monday, April 07, 2014, at 3:20 PM in Room 6CF at the San Diego Convention Center.

The abstract # 2938 is available at the AACR website www.aacr.org.

Company News: ProBioGen and Merus Sign Deal on GlymaxX® ADCC Enhancement Technology

– GlymaxX® Manufacturing Technology Improves Bispecific Antibody Activity for Solid Tumor Treatment

ProBioGen AG and Merus B.V. today announced that the companies have signed a non-exclusive commercial option and license agreement on ProBioGen’s GlymaxX® fucose-engineering technology. Under the terms of the agreement, ProBioGen is granting Merus the non-exclusive right to use the GlymaxX® technology to enhance the ADCC (Antibody-Dependent Cell-Mediated Cytotoxicity) activity of one of its lead products, a bispecific anti-cancer antibody. The license is covering clinical development and production. Financial details have not been disclosed.

The GlymaxX® technology for the production of afucosylated antibodies and proteins is based on the stable integration of a heterologous enzyme into any antibody producer cell line, leading to the interference with the cells’ intracellular fucose biosynthesis pathway. As a unique feature differentiating it from other approaches, the GlymaxX® technology can be applied to both novel and already existing antibody producer cell lines and entire antibody expression and discovery platforms without negatively affecting their productivity. Moreover, it is simple, rapid, potent and universally applicable.

Company News: Curetis Prepares Launch of Second Unyvero™ Application

–      Final clinical performance evaluation study for Unyvero™ i60 ITI application ongoing

–      Study data expected by the end of Q1/2014

Curetis AG, a developer of next-level molecular diagnostic solutions, today announced that it has completed development of its second Unyvero™ application. The new Unyvero™ i60 ITI cartridge rapidly identifies more than 90 pathogens and more than 20 resistance markers common in implant and tissue infections. After successfully manufacturing several lots and completing initial verification testing of the cartridge, the Company has initiated a pivotal study using approximately 500 cartridges to validate analytical, technical and clinical performance for CE marking.

Following the completion of the study scheduled for end of Q1/2014, commercialization of the Unyvero™ i60 ITI is expected to begin in Q2/2014. Curetis will jointly market the cartridge with Heraeus Medical GmbH, the development and commercialization partner for this cartridge. Both companies have already received pre-orders from key opinion leaders and hospitals across central Europe.

The study will use frozen patient specimens – watery/swabs, viscous/purulent, sonication and synovial fluids, and biopsy material –  for diagnosis. The study will compare the molecular test with conventional microbial culture techniques. Discrepant or unexpected results will be resolved by additional tests. The study will also test assay repeatability and reproducibility and establish limit of detection.

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