Archive: Company News
Company News: Merus Selects Clinical Candidate for the Treatment of Acute Myeloid Leukemia (AML)
Merus B.V., a biopharmaceutical company focusing on innovative human antibody therapeutics, today announced that it has selected MCLA-117 as lead candidate for clinical studies in patients with acute myeloid leukemia (AML). MCLA-117 is a human, full-length IgG bispecific antibody, which activates the patient’s own immune system by simultaneously binding to the CLEC12A molecule expressed by AML tumor cells and the CD3 molecule expressed by T cells. MCLA-117-mediated co-engagement of CLEC12A and CD3 results in the potent killing of cancerous AML cells and their malignant precursors. Merus intends to start phase I clinical trials with MCLA-117 in 2014.
The antibody is based on Merus’ Biclonics™ ENGAGE platform. Human bispecific antibodies from this platform can be manufactured and administered like conventional, full-length IgG molecules, thereby providing for high yield, good stability and a long serum half life. In addition, bispecific antibodies from the Biclonics™ ENGAGE platform have a modified constant region to abrogate unwanted clinical cytokine release.
Prof. Gert Ossenkoppele from the department of hematology at the Free University Medical Centre in Amsterdam, The Netherlands, will be the lead investigator of the first MCLA-117 Phase I study.
Company News: Merus Appoints Setareh van Driel Shamsili as Chief Medical Officer
Merus B.V., a biopharmaceutical company focused on innovative human antibody therapeutics, today announced the appointment of Setareh van Driel Shamsili, MD, Ph.D., as Chief Medical Officer (CMO).
Setareh van Driel Shamsili has more than 22 years of experience in general medicine, internal medicine and medical oncology. For the past 13 years, she has focused on both translational and clinical cancer research. She has more than eight years of experience in the pharmaceutical industry, including drug development, R&D, medical affairs, drug safety and pharmacovigilance and holds a PhD in Neuro-Oncology from Erasmus University Rotterdam.
Prior to joining Merus, Setareh van Driel Shamsili was Global Medical Leader Oncology at Astellas Pharma Global Development.
Company News: Curetis AG Initiates Clinical Trial in the U.S. Towards FDA Clearance
– Prospective Multi-Center Trial to Enroll Over 2,000 Clinical Samples –
Curetis AG today announced the start of a clinical trial of its Unyvero™ System and the corresponding LRT (lower respiratory tract) application in the U.S. The company expects enrollment completion within the next 12-15 months, followed by a 510(k) submission to the FDA in 2014.
The prospective, multicenter trial will include samples collected from more than 2,000 hospitalized patients suspected to have a lower respiratory tract infection and several hundred retrospective samples with known microbiology culture results for rare pathogens. Samples will be processed by the Unyvero™ Lysator, transferred to the LRT cartridge, and tested by the Unyvero™ Analyzer.
Primary endpoint of the study will be assay performance defined as clinical sensitivity and specificity compared to microbiology culture (today’s diagnostics standard of care) and to a composite reference diagnosis that incorporates PCR and sequencing to determine clinical truth whenever microbiology culture results are negative.
Trial sites include Northwestern University (Chicago, IL) and North Shore-LIJ Health System (Lake Success, NY), among others. The Principal Investigator is Prof. Christine C. Ginocchio, Senior Medical Director and Chief, Division of Infectious Disease Diagnostics, North Shore-LIJ Health System. Curetis has contracted Aptiv Solutions as its CRO and Neil Mucci of GlobalBioclinical as project manager in the US.
The LRT application analyzes 39 DNA targets simultaneously from a single patient sample. Results are available within about 4 hours. The pathogen panel has been selected for clinical relevance based on current international clinical guidelines and has been reviewed by clinical experts in Europe and the USA. Resistance genes were chosen by frequency and clinical significance. A similar product, the Unyvero™ P50 pneumonia cartridge is CE-marked and currently marketed in Europe and the Middle East.