Archive: Company News
Company News: Merus Granted European Patent on MeMo®, a Transgenic Mouse for Generating the Building Blocks of Therapeutic Human Bispecific Antibodies
– Invention provides unique technology base for therapeutic human bispecific antibodies
– Full-length IgG format of bispecific antibodies facilitates standard manufacturing processes
Merus B.V., a biopharmaceutical company focusing on innovative antibody therapeutics, today announced that it has been granted a European patent on its MeMo® transgenic mouse for the generation of common light chain human antibodies. Using standard industry processes, MeMo®-derived common light chain antibodies can be manufactured in clonal cell lines to efficiently obtain full-length IgG human bispecific antibodies (branded as Biclonics™) for therapy.
“We are very pleased about this important patent as it underlines our unique approach to creating improved antibody therapeutics,” said Ton Logtenberg, CEO of Merus. “MeMo® is distinct from other transgenic mice for human antibodies because the common light chain facilitates co-expression of two antibodies in a single cell to generate functional bispecific antibodies. By screening thousands of bispecific antibodies in cell-based assays, antibody therapeutics with truly superior functional activities are efficiently identified. The full-length IgG format provides for using established, ‘off-the-shelve’ analytical and manufacturing processes which are already in place for therapeutic monoclonal antibodies.”
“This is a major accomplishment of Merus,” said Jason Avery, CBO of Merus. “The company has built an exceptional product and technology base for superior therapeutics that combine the benefits of full-length IgG monoclonal antibodies with the ability of simultaneously addressing multiple disease targets. MeMo® is a source of large panels of high quality human antibodies that may be used to rapidly identify bispecific antibody leads. We are offering biopharmaceutical companies worldwide a non-exclusive license to MeMo®. There are no target restrictions and license terms are flexible.”
Company News: Curetis Presents First Data on Novel Unyvero™ i60 ITI Application for Implant and Tissue Infections
– New cartridge detects 114 targets
– Roll-out in collaboration with Heraeus Medical expected in early 2014
Curetis AG today announced first details on its new Unyvero™ i60 ITI application for the diagnosis of implant and tissue infections. The cartridge has been developed in close collaboration with Heraeus Medical GmbH, a company focused on orthopedic biomaterials. The data were presented at this year´s 65th Joint Annual Meeting of the German Society for Hygiene and Microbiology and the German Society for Infectious Diseases (DGHM/DGI 2013) in Rostock, Germany.
The new Unyvero™ System cartridge covers a broad range of infections common after abdominal as well as bone and joint surgery, trauma (e.g. burns) or skin and soft tissue infections, including diabetic foot disease. In combination with the unique Unyvero™ L4 Lysator it is also possible to process biofilm samples, an important prerequisite for the fast and reliable diagnosis of implant infections (catheters, joints etc.).
The multiplex panel of the novel i60 application covers a total of 114 targets – 91 pathogens (gram-negative & gram-positive bacteria and fungi) and 23 resistance markers – relevant for eight clinical indications. At the conference, Curetis presented data from first evaluation studies demonstrating that the panel is able to detect pathogens in orthopedic and surgically relevant fresh and frozen samples, such as synovial and sonication fluids, swabs, and tissue material. All results were confirmed by standard microbiology culture. Of note, the i60 application also detected additional pathogens not covered by standard methods, e.g. anaerobic bacteria known to be involved in biofilm-formation on orthopedic implants.
Following the successful completion of assay development, Curetis is now running validation and verification tests. The company aims to run a clinical CE performance evaluation study this fall with a goal of obtaining CE-IVD marking for the Unyvero™ i60 ITI cartridge by the end of 2013.
Company News: vasopharm Reports Endorsement of Phase III Trial Design in Traumatic Brain Injury by European Medicines Agency
– Company receives protocol assistance from the EMA
– Agreement on endpoint, dosing scheme, trial size and use of Phase II dataset
vasopharm GmbH, a privately held biopharmaceutical company focusing on novel therapeutics for the treatment of cerebro- and cardiovascular diseases, today announced the positive outcome of a scientific advice meeting with the European Medicines Agency (EMA). The EMA’s Committee for Medicinal Products for Human Use (CHMP) has agreed to all major items of vasopharm’s proposed protocol for the realisation of a European Phase III study of VAS203 in patients suffering from traumatic brain injury (TBI).
In essence, the CHMP agreed on the primary endpoint, the proposed dosing scheme and the trial size. For the final evaluation, the CHMP further agreed to include the available Phase II dataset as supportive information for a potential approval of VA203 in the treatment of TBI patients. VAS203, the company’s lead compound, is an allosteric nitric oxide synthase inhibitor and in development for the treatment of TBI patients. The compound met all clinical endpoints for safety and demonstrated strong evidence of clinical benefit in the explorative Phase IIa NOSTRA trial in TBI patients. The trial was completed in 2012.
The company is also seeking advice from the U.S. Food and Drug Administration (FDA) in order to include U.S.-based clinic trial centres in a single Phase III trial in patients with TBI.
Company News: Immunology Data Further Underline the Positive Outcome of a Phase IIb Trial of Anergis´ Birch Pollen Allergy Vaccine AllerT
– Treatment with AllerT increases allergen-specific IgG4 antibody levels by a factor of 20
– AllerT administration produces humoral immune responses similar to conventional desensitization
Anergis, a company focusing on proprietary allergy vaccines, today reported immunology data from the Phase IIb study of its lead compound AllerT. In the trial, AllerT induced a strong increase of allergen-specific IgG4, a key marker of immunological responses typically observed in successful, conventional allergy immunotherapy (AIT, previously known as allergen-specific immunotherapy, or SIT). In September 2013, Anergis had reported that the trial showed significant clinical effects of AllerT on multiple efficacy endpoints, including combined symptom and medication scores assessed daily throughout the natural birch pollen season 2013.
In the placebo-controlled, double-blind, multicenter trial, a total of 240 patients from 24 European trial centers were randomized to receive 5 pre-seasonal injections of AllerT 50 μg, AllerT 100 μg, or placebo over a period of 2 months between November 2012 and March 2013.
Allergen-specific IgG4 antibody blood levels were similar in all three groups before treatment. Four weeks after completion of treatment and prior to the birch pollen season, the IgG4 levels were markedly and similarly increased in both AllerT dose groups by a factor of about 20 compared to baseline and to placebo (all tests p < 0.0001). During the subsequent birch pollen season, the IgG4 levels remained similarly elevated in both dose groups, showing that a plateau of IgG4 had been reached. By contrast, IgG4 levels remained unchanged in the placebo group during treatment and during the pollen season.
Anergis’ COP (Contiguous Overlapping Peptide) technology can be applied to a broad spectrum of allergy indications. At present, Anergis is developing AllerT for the treatment of birch pollen allergy, AllerR for ragweed pollen allergies and AllerDM for dust mite allergies.