Archive: Company News
Company News: Merus Presents Preclinical Data on its Novel Bispecific Antibody MCLA-117 at EHA 2013
– Clinical Candidate Designed for the Treatment of Acute Myeloid Leukemia (AML) –
Merus B.V., a biopharmaceutical company focusing on innovative human antibody therapeutics, has presented preclinical data on its antibody MCLA-117 at the Annual 18th Congress of the EHA 2013 (European Hematology Association) in Stockholm. The compound is being developed for the treatment of acute myeloid leukemia (AML), a disease with very poor long-term prognosis.
MCLA-117 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. CLEC12A is a myeloid differentiation antigen that is expressed on 90-95% of de novo and relapsed AML cases and is selectively expressed on leukemic stem cells.
Co-incubation of patients´ resting T cells and AML tumor cells via MCLA-117 resulted in efficient tumor cell lysis, i.e. the potent killing of cancerous AML cells. By introducing mutations in the heavy chain constant region CH2 domain, Merus was able to develop an antibody that in peripheral blood mononuclear cell (PBMC) assays prevented the release of non-specific, pro-inflammatory cytokines, while retaining its full capacity to induce T cell-mediated elimination of AML tumor cells.
The MCLA-117 antibody is based on Merus’ proprietary 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.
Company News: Anergis Files Provisional U.S. Patent on AllerDM Dust Mite Allergy Treatment
– Further expansion of the company’s product pipeline and patent estate –
Anergis, a company focusing on proprietary synthetic allergy vaccines designed to provide ultra-fast desensitization, has filed for provisional patent protection of its AllerDM dust mite allergy treatment in the U.S. The company plans to extend the patent application within the next 12 months to achieve world-wide protection under the Patent Cooperation Treaty.
AllerDM is an allergy vaccine for patients with house dust mite allergy and is based on Anergis’ proprietary Contiguous Overlapping Peptide (COP) technology, which allows for ultra-fast desensitization in only two months treatment. COP allergy vaccines are pharmaceutical quality products, which have proven to be safe and well tolerated and to induce a long-term immune effect. AllerDM is currently in pre-clinical development and is expected to enter clinical stage in 2015. Further details on the product are not being disclosed at present.
House dust mites are the most frequent cause of allergy and suspected to trigger severe consecutive disorders. Asthma may be caused by house dust mite allergy in 50 to 80% of patients. It is estimated that about 60 million patients in Europe, 30 million in the U.S., 20 million in Japan and 60 million in China suffer from dust mite allergies.
AllerT, the lead product of Anergis, is currently evaluated in a double-blind, randomized, placebo-controlled Phase IIb trial in 240 patients with moderate to severe birch pollen allergy, enrolled at 24 trial centers throughout Europe. Results are expected in Q3, 2013.
Earlier this year, Anergis presented preclinical data of its ragweed allergy vaccine candidate AllerR. A Phase I/IIa trial of AllerR is expected to start in 2015.
Company News: Aleva Neurotherapeutics Announces Promising Clinical Data on Directional Deep Brain Stimulation with directSTIM™
– Data Presented at the 2013 Quadrennial Meeting of the World Society for Stereotactic and Functional Neurosurgery (WSSFN) –
Tokyo, Japan, May 30, 2013 – Aleva Neurotherapeutics, a company developing next-generation implants for Deep Brain Stimulation (DBS) in major neurological indications such as Parkinson´s disease or depression, today announced interim clinical data of an interventional, intraoperative pilot study of its novel directSTIM™ electrode. Data were presented at the 2013 Quadrennial Meeting of the World Society for Stereotactic and Functional Neurosurgery (WSSFN) in Tokyo, Japan, on May 30.
In the ongoing pilot study, clinical investigators assessed the intraoperative clinical effect of directional stimulation using the directSTIM™ lead. It features two rings consisting of three independent electrodes each. The angular position of the electrodes allows stimulation at 0°, 120° and 240° directions. After assessment, directSTIM™ was removed and replaced by a classical, ring-shaped permanent DBS lead.
The data reported in Tokyo are based on 5 males with Parkinson Disease, which underwent Subthalamic Nucleus (STN) DBS, and 2 males with essential tremor, which underwent Ventral Intermediate Nucleus of the Thalamus (Vim) DBS. Directional stimulation was tested at the target determined for the permanent lead. The clinical investigators compared the therapeutic window (TW, defined as the electrical current threshold at which side effects occur minus the current threshold at which a significant therapeutic effect is observed) of directional and classical stimulation. Directional stimulation resulted in an improved therapeutic window in five of six patients (the ratio could not be measured in one of seven patients). No adverse event took place.
“This is a real breakthrough in the field of DBS. At present, DBS is carried out using ring-shaped electrodes,” said Claudio Pollo, MD, Head of Functional Neurosurgery at the University Hospital, Bern, Switzerland and Principal Investigator of the study. “This intraoperative study is the first to investigate the proof-of-concept of directional stimulation in humans. The increased therapeutic window demonstrated in the study suggests that directional stimulation is more selective for beneficial effects while avoiding side effects. Moreover, the observed side effects were consistent with what we expected given the anatomical structures surrounding the stimulated area.”
“We are very pleased with the data, as we have proof-of-concept in an intraoperative setting that directional stimulation is measurable and that it is different from classical stimulation,“ said Jean-Pierre Rosat, CEO of Aleva Neurotherapeutics. “This is very promising as it indicates that the effectiveness of DBS may be improved by our novel electrodes.”
Alain Dransart, Aleva’s Clinical and Regulatory Director, concluded: “We are delighted by the way the study is conducted and by the excellent collaboration with the investigators. The pilot study will be completed by the end of this year and we believe its results will pave the way for a future directSTIMTM chronic study.”
Company News: SUPPRESTEM Consortium Led by Merus Receives € 6 Million FP7 Grant from the European Union
– Development of Therapeutic Bispecific Antibodies (Biclonics™) Targeting Treatment-resistant Cancer Stem Cells Using Patient-Derived Organoid Screening Tools –
Utrecht, The Netherlands, May 27, 2013 – Merus B.V., a biopharmaceutical company focusing on innovative human antibody therapeutics, today announced that it has been granted funding from the European Union’s FP7 program. Merus is leading the SUPPRESSTEM consortium which was granted a total of about €6 million to develop novel antibody-based therapeutics targeting cancer stem cells for the treatment of colorectal cancer as well as patient-derived organoid-based screening tools to aid drug discovery. The consortium includes The Hubrecht Institute (The Netherlands), OcellO B.V. (The Netherlands), Fundacio Privada Institut de Recerca Biomedica (Spain), and The Wellcome Trust Sanger Institute (UK).
Specifically, the consortium is addressing mechanisms that lead to the development of treatment resistance and tumor escape in colon cancer, a problem that has hampered the development of efficient therapeutics in the past. Furthermore, it is pioneering the application of patient-derived tissue in drug discovery to address the high clinical failure rate in cancer drug research. It is hoped that the SUPPRESSTEM results will have broad application in cancer drug development.
In the SUPPRESSTEM consortium, Merus will develop Biclonics™ antibodies which will both modulate the Wnt pathway and address growth factor receptors to specifically inhibit cancer stem cells with minimal toxicity on healthy tissue. Functional screening of these stem cell-targeting bispecific antibodies for specific inhibitory activity and for selecting lead candidates will be done using organoids.