News
Company News: Agena Bioscience Expands ISO Accreditation for Genetic Testing
Agena Bioscience today announced accreditation of its Assays by Agena facility in Brisbane, Australia, under ISO/IEC 17025 in the field of biological testing for determinations of SNP Genotyping, somatic mutation detection, and quantitative methylation analysis using its MassARRAY® System.
The accreditation comes from the National Association of Testing Authorities, or NATA, and ensures that member facilities comply with standards and provide accurate data generation, controlled test methods and procedures, and properly trained personnel.
Agena Bioscience CEO Peter Dansky commented, “Accreditation of our facility in Brisbane demonstrates the company’s commitment to advance the MassARRAY System into the clinical market, and ensure consistent, valid, and robust results under documented quality management systems.”
The Assays by Agena facility in Brisbane offers highly cost-effective and adaptive testing services and custom panel development. In particular, the facility will offer a multiplexed solution for detecting rare variants in liquid biopsies as low as 0.1% frequency. “Detection of rare variants in tissue biopsies and minimally invasive liquid biopsies is a rapidly emerging field, well suited to the accuracy, sensitivity, flexibility and short turnaround time of the MassARRAY System. This enables valuable insight into genetic changes that may occur during the course of diseases such as cancer,” Dansky elaborated.
The ISO/IEC 17025 accreditation follows the company’s success in achieving significant milestones to enter the clinical diagnostics market. Earlier this year, Agena Bioscience launched two CE-IVD marked MassARRAY diagnostic products for in vitro testing of colon and lung tumors. The company previously received ISO/IEC 13485 certification of its San Diego facilities to develop, manufacture, and distribute its MassARRAY System, software, and reagents for life sciences.
Company News: Curetis to Report its Half-Year Results 2016 on August 19, 2016
– Company will host earnings conference call and webcast
Curetis N.V. (the “Company” and, together with Curetis GmbH, “Curetis“), a developer of next-level molecular diagnostic solutions, today announced that it will publish its financial results for the first six months ended on June 30, 2016, on August 19, 2016. In addition, the Company will host a public earnings conference call and webcast on August 19, 2016, at 03:00 pm CET / 09:00 am EST to present the H1 2016 financial results, highlight the most important events and provide an outlook for the second half of 2016 and beyond.
The conference call will be supplemented by a presentation, which can be accessed during the call at http://www.curetis.com/en/investors/financial-reports-and-conferences/financial-reports.html through the participants’ passcode curetis0816. The live webcast and a replay will be available at http://curetis190816-live.audio-webcast.com.
To access the call, please dial the following numbers using the passcode 93120684#
Germany: +49 692 222 290 43
UK: +44 203 009 2452
US: +1 855 402 7766
For further international dial-in numbers, please open the following link: http://events.arkadin.com/ev/docs/International Access Numbers_ UKFELBRI1_SU7.pdf
The full half-year financial report 2016 will be available as of August 19, 2016, at http://www.curetis.com/en/investors/financial-reports-and-conferences/financial-reports.html
Company News: New CELL Study presents groundbreaking pre-clinical work: developing immune therapy to potentially treat serious influenza A
– MEDI8852 blocked all influenza A with unique binding properties
A paper published today by Cell presents pre-clinical work to develop a promising new antibody, MEDI8852, as a potential therapy to treat influenza caused by numerous type A strains – the source of seasonal and pandemic outbreaks. The findings also highlight the mechanisms of action of MEDI8852, which along with its unique binding properties, point to valuable implications for the design of a universal influenza vaccine that can address the unpredictable nature of the flu virus.
“The results of this study confirm how MEDI8852’s unique molecular features have the potential to differentiate it from current treatment options for influenza, with the potential to become an important anti-influenza candidate during pandemic periods,” said JoAnn Suzich, Vice President, R&D, MedImmune.
The paper results from international collaboration among researchers at MedImmune, the global biologics research and development arm of AstraZeneca; Humabs BioMed; the Institute for Research in Biomedicine (Università della Svizzera italiana); and, the Francis Crick Institute in London.
Study highlights include:
- MEDI8852 exhibits multiple mechanisms of action, including blocking essential steps of the viral lifecycle; it also engages the immune system to eliminate virus-infected cells.
- MEDI8852 provides an extended therapeutic window in animal models when compared to the standard of care.
- Structural analyses reveal that MEDI8852 targets a unique and highly conserved epitope in the stem region of influenza in two distinct hemagglutinin (HA) subtypes, H5 and H7, distinguishing it from other structurally characterized cross-reactive antibodies.
“We compared the binding activity of MEDI8852 with other antibodies, as well as its precursor, and found it has the highest activity and the widest breadth of coverage,” said co-author Davide Corti, Chief Scientific Officer, Humabs BioMed. “This antibody targets a unique epitope in the stem of the influenza HA and can attack the virus’ entry and exit by blocking multiple mechanisms.”
John Skehel, one of the lead authors from the Francis Crick Institute, said: “This new antibody binds to numerous different influenza viruses to block their infectivity. Our studies show how this is achieved and highlight differences between this and other antibodies to explain its potential as an anti-influenza therapeutic.”
MEDI8852: Potential for high unmet medical need for influenza treatment
Despite advances in vaccines and antiviral therapeutics, a high unmet medical need remains for additional treatment options of influenza in populations at high risk for morbidity and mortality. In these patients, influenza infection can lead to severe complications and causes a significant burden to the overall healthcare system. The current standard of care for the treatment of influenza, the neuraminidase inhibitors (NAIs) oseltamivir and zanamivir, have many limitations, including a limited therapeutic window and the potential for resistance.
MEDI8852 received Fast Track designation from the US Food and Drug Administration (FDA) in March 2016. The FDA’s Fast Track program is designed to expedite the development and review of drugs to treat serious conditions and fill an unmet medical need.
MEDI8852 is currently being evaluated in a Phase Ib/IIa clinical trial to investigate the safety and preliminary efficacy of a single intravenous dose in combination with oseltamivir, and as a monotherapy in adult patients with confirmed acute, uncomplicated influenza caused by Type A strains prior to studying it in hospitalized patients. A recently completed Phase I study in healthy adult subjects demonstrated that MEDI8852 had an acceptable safety and pharmacokinetics profile, which supported continued development in patients with influenza.
Company News: Molecular Health Strengthens U.S. Based Executive Management Team
– Appoints Gerry Sheridan as Chief Financial Officer
– Appoints Dr. Les Paul as Chief Medical Officer
Molecular Health, a leader in precision medicine technology focused on commercializing products utilizing its proprietary Dataome™ technology platform, today announced it has strengthened its leadership team with the appointment of two U.S.-based executives. Gerry Sheridan will serve as Chief Financial Officer and Dr. Les Paul as Chief Medical Officer. Mr. Sheridan and Dr. Paul will be based in the Company’s U.S. headquarters in Boston to facilitate the Company’s expansion into the U.S. commercial markets and building of an expanded U.S. operational infrastructure.
Molecular Health Executive Chairman Friedrich von Bohlen commented, “The addition of Gerry and Les to our executive team is an exciting and critical step in building our U.S. commercial and operational infrastructure to support the continued commercial ramp of the GUIDE platform. Both bring substantial experience from commercial stage healthcare and oncology-focused companies. Their combined financial, medical and operational expertise together with their longstanding relationships with stakeholders across the U.S., make both Gerry and Les the optimal candidates to help deliver GUIDE, our fully automated cloud-based clinical decision support software, to the growing U.S. market.”
Mr. Sheridan said, “It is a tremendous opportunity to join Molecular Health at this juncture in their corporate development. Their existing global footprint, growth potential and commitment to bringing their revolutionary technology to such a large healthcare constituency make it an exciting time to join such a dynamic team. ”
Dr. Paul added, “GUIDE is uniquely positioned to systematically lead physicians and their patients to the best possible treatment outcomes. Information sciences as a support tool to help drive informed treatment decisions based upon the latest and most relevant literature, discoveries and knowledge is a tremendous offering to the medical community. I feel privileged to join the Molecular Health team and am excited to help broaden the market adoption of this technology. I am confident it will make a lasting impact on patients’ lives.”
Mr. Sheridan brings to Molecular Health over 25 years of international financial, operating and consulting experience and extensive knowledge of U.S. and European markets. Most recently, Gerry served as CFO of Seno Medical Instruments, an oncologic medical device company, where he led their most recent Series C funding round of $80 Million as the company began marketing and commercializing its device. Prior to his experience at Seno, Gerry was CFO of GDC Technics, an aerospace design firm. Mr. Sheridan graduated from University College Dublin in Ireland, is a qualified Chartered Accountant, a Certified Public Accountant and a member of the American Institute of Certified Public Accountants.
Dr. Paul joins Molecular Health following a lengthy career in medicine and in business. He has served as Chief Medical Officer at Caris Life Sciences; SVP, Global Medical Affairs at Intermune, VP, U.S. Medical Affairs at Novartis, VP, U.S. Medical Affairs at AstraZeneca R&D, VP, Medical Policy / Programs and Medical Affairs at MedCo Health Solutions before it was acquired by Express Scripts in 2012, and most recently he served as Principal at Tradewind Life Science Advisors. He has extensive experience in the pharmaceutical industry and in leading integrated U.S. and Global Medical Affairs teams in multiple therapeutic areas including precision cancer therapy and diagnostics. He has also been responsible for the medical aspects of product commercialization, medical policy, publications and scientific communication, and research. Dr. Paul received his Doctor of Medicine Degree from the University of Illinois and his Masters in Preventative Medicine and Administrative Medicine from the University of Wisconsin-Madison. He is also Board Certified in Internal Medicine & Pulmonary Disease from the American Board of Internal Medicine.