News
Company News: ISA Pharmaceuticals Initiates Phase I/II Clinical Trial With ISA101 in Women with Cervical Cancer
– Therapeutic vaccine against Human Papilloma Virus type 16 (HPV16) tested together with chemotherapy in women with HPV16-positive advanced or recurrent cervical cancer –
ISA Pharmaceuticals B.V., a clinical-stage biopharmaceutical company focusing on rationally designed therapeutic vaccines against cancer and persistent viral infections, today announced the initiation of a Phase I/II clinical study of its lead candidate ISA101 in women with HPV16-positive advanced or recurrent cervical cancer, eligible for standard chemotherapy with carboplatin and paclitaxel (CervISA study). The first patient was vaccinated this month.
ISA101 is a synthetic long peptide (SLP®) vaccine for the treatment of diseases induced by human papilloma virus (HPV) type 16, such as cervical cancer, ano-genital premalignant and malignant lesions, and head and neck cancer.
The open-label, multicenter CervISA study is designed to determine the safety and immune-modulating effects of ISA101 at different doses with or without pegylated interferon alpha in combination with carboplatin and paclitaxel.
Patients will receive up to six standard chemotherapy cycles (paclitaxel 175 mg/m2 and carboplatin AUC 6 every three weeks) and three vaccinations at different dose levels during the same period. Half the women at each dose level will also receive pegylated interferon alpha. Primary endpoints of the trial are safety and HPV-specific immune responses. The secondary endpoint is antitumor efficacy according to RECIST 1.1.
Virtually all cervical cancers are caused by HPV infections, with HPV16 being responsible for about 50-60% percent of all cases.
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.