News
Company News: New Oncology to Present Data at the 16th World Conference on Lung Cancer
New Oncology today announced that an abstract highlighting the company’s progress in clinical cancer genome diagnostics will be presented at the 16th World Conference on Lung Cancer taking place September 6 – 9, 2015, in Denver, USA.
Date & Time: Wednesday 9th September 2015, 9.45am – 10.45am and 3.45pm – 4.45am
Title: Discrepancies between ALK FISH and Capture Based NEOplus Diagnostics
Abstract: # 2748
Presenter: Dr. Rafał Dziadziuszko
“We analyzed primary tumor samples for our network of clinical partners using our NEO platform to detect therapeutically relevant gene fusions,” commented Dr. Lukas C. Heukamp, Medical Director of New Oncology. “In the cohort published today, our findings showed discrepant results in all cases when compared with fluorescent in situ hybridization (FISH), the current gold standard of gene fusion diagnostics. Clinical response data were available for all patients, and tumor sensitivity was always in line with the results obtained by NEO. With gene fusions becoming more and more important as cancer drug targets, the need for reliable results will drastically increase. With our NEO technology, we are perfectly adapted to analyze tumor samples that do not match the quality requirements for FISH analysis or for which only limited material is available.”
Company News: Aleva Neurotherapeutics Appoints Dr. Philippe Dro to its Board of Directors
– Seasoned entrepreneur brings 20 years of Life Science industry experience –
Aleva Neurotherapeutics, a leading company developing next-generation implants for Deep Brain Stimulation (DBS) in major neurological indications such as Parkinson´s disease, today announced the appointment of Dr. Philippe Dro to its Board of Directors.
Dr. Dro brings 20 years of entrepreneurial experience in the life science industry, including a pivotal role in executing strategic transactions at several biotech and medtech companies. Until recently, he was Chief Executive Officer and a Member of the Supervisory Board of GlycoVaxyn AG, a vaccine company that was acquired by GSK earlier this year. Prior to this, he served as Chief Executive Officer and Chairman of the Board of Endoart S.A., a medtech company developing telemetry-driven implants for cardiac disease and obesity that was sold to Allergan, Inc. From 1999 to 2003, he was Chief Financial Officer and Head of Business Development at drug discovery company Axovan AG, which was acquired by Actelion in November 2003. Prior to that, he held various position at Novartis, Skyepharma, and Antares Pharma.
Dr. Dro received a doctorate in Pharmacy (Pharm D) from the School of Pharmacy of the University of Grenoble, France, and holds a joint MBA from Ecole Superieure de Commerce de Lyon, France, and Cranfield School of Management, United Kingdom.
Company News: Merus Prevails in Inequitable Conduct Case Against Regeneron
– Court ruling further strengthens Merus’ freedom to operate in using transgenic mice for therapeutic human antibodies
Merus, a leader in developing best-in-class bispecific antibody therapeutics to treat cancer patients, today announced that it won its inequitable conduct trial against Regeneron. In a decision issued on Thursday, August 6, Judge Katherine B. Forrest of the U.S. District Court for the Southern District of New York indicated that Regeneron engaged in inequitable conduct in connection with obtaining U.S. Patent No. 8,502,018. This marks the third counterclaim upon which Merus has prevailed in this litigation, initiated by Regeneron. In December 2014, Regeneron conceded that Merus does not infringe any claim of the ‘018 patent, and that the patent is invalid in view of the Court’s prior decision on claim construction. Given the Court’s ruling on August 6, Regeneron’s patent has now been adjudged to be not infringed, invalid and unenforceable for being procured by inequitable conduct.
In that decision, the Court noted that Regeneron’s agents had withheld material information from the United States Patent Office (USPTO) during prosecution of the ‘018 patent. The Court further concluded that an adverse inference that Regeneron’s employees intentionally mislead the U.S. Patent Office was appropriate and “that Regeneron engaged in inequitable conduct in connection with the prosecution of the ‘018 patent.”
Company News: PNAS Paper Details Efficacy of a Potent, Fully Human Antibody for the Treatment of MERS
– First human-derived antibody which is suitable for prophylaxis, post-exposure prophylaxis, and treatment of MERS
– Therapeutic compound under development by Humabs BioMed on a non-profit basis
Humabs BioMed SA, a leading Swiss antibody therapeutics company, today announced that Proceedings of the National Academy of Sciences (PNAS) has published a paper describing the isolation and characterization of a potent antibody from memory B-cells of a patient recovering from an infection with coronavirus (CoV) and the resulting Middle East Respiratory Syndrome (MERS). The antibody, which was isolated from the infected individual two years ago, is active against all three clinically relevant MERS-CoV strains and against a site that is conserved in all MERS strains, including the strain responsible for the latest outbreak in South Korea. Humabs has developed a production cell line allowing – depending on regulatory clearance – the antibody either to be made available on the basis of a compassionate use program or to enter Phase I trials within a few months.
The human monoclonal antibody, code-named LCA60, binds to a novel, evolutionary highly conserved site on the Coronavirus spike protein. Thereby, it interferes with the binding of the virus to the receptor CD26 on target cells of the respiratory tract. LCA60 is highly effective both in prophylaxis and therapy in relevant preclinical models.
The initial screening, discovery and isolation of the anti-MERS LCA60 antibody was a joint effort of Public Health England (PHE, London, UK), the Institute for Research in Biomedicine (IRB, Bellinzona, Switzerland) affiliated to the Università della Svizzera italiana, the Department of Critical Care of the St Thomas’ Hospital (London, UK) and Humabs BioMed. Using the Cellclone technology developed by Prof. Antonio Lanzavecchia, which Humabs has exclusively licensed from the IRB, it took only five weeks to functionally select, clone and sequence LCA60 from the initial screening of human B cells derived from a convalescent patient, and an additional three months to develop a stable CHO cell line for manufacturing.
For the further characterization and testing of LCA60, Humabs BioMed collaborated with the University of Iowa (Iowa City, IA, USA) and the University of North Carolina at Chapel Hill, (Chapel Hill, NC, USA). The antibody will be made available on a non-profit basis.
“Our antibody was tested against 3 relevant strains and, according to our analysis on the epitope, it is active against all MERS isolates, including the last ones from the South Korean outbreak,” said Davide Corti, CSO of Humabs. “This last outbreak highlighted the importance of the spread of the virus in the hospital settings followed by a quarantine of large number of people at risk of exposure, so it is important to note that our antibody can also be administered pre-exposure to protect clinical personnel and caregivers.”
“Our anti-MERS antibody provides a good example of the rapid pathway we have established for the generation of effective antiviral therapies against emerging viruses,” said Alcide Barberis, CEO of Humabs BioMed. “This is of great importance in combatting the outbreak of epidemics of life-threatening diseases within a short time frame. This anti-MERS antibody could be developed for compassionate use as well as for stockpiling and made available at no costs to patients in the case of an epidemic. We are currently seeking financial support for GMP manufacturing and early clinical development. We hope charities will step in for bringing this compound to MERS patients and individuals at risk of infections.”