Archive: Company News
Company News: Curetis Announces Participation in Several Investor and Industry Conferences in Q2-2016
Curetis N.V. (the “Company” and, together with Curetis GmbH, “Curetis”), a developer of next-level molecular diagnostic solutions, today announced its participation in several major industry conferences in the second quarter of 2016. The respective investor presentations will be made available on the company’s website.
April:
26th European Congress of Clinical Microbiology and Infectious Diseases (ECCMID), April 9 – 12, 2016, in Amsterdam, The Netherlands: scientific meeting
Morgan Stanley Panel discussion and Meeting on Infectious Disease Diagnostics, April 14, 2016 in New York, NY, USA
May:
Bio€quity Europe 2016, May 10-11, 2016 in Copenhagen, Denmark: management presentation
35th Annual Conference of the Austrian Society for Hygiene, Microbiology and Prevention (ÖGHMP), May 30-June 2nd in Zell am See, Austria: scientific meeting
June:
Swiss MedLab, June 13-16, Berne, Switzerland: scientific meeting
Company News: Humabs BioMed Reports Regulatory Milestone in MedImmune Partnership
– MedImmune Receives U.S. Fast Track Designation for MEDI8852 Antibody Developed Under a Collaboration with Humabs for the Treatment of Influenza A
Humabs BioMed SA, a leading Swiss antibody therapeutics company, today announced that a novel antibody developed using its proprietary Cellclone technology has received Fast Track designation from the US Food and Drug Administration (FDA). The investigational human monoclonal antibody MEDI8852 is being clinically developed by MedImmune, the global biologics research and development arm of AstraZeneca, for the treatment of patients hospitalized with Type A strain influenza.
The antibody with broad influenza-neutralizing properties is a human IgG1 kappa monoclonal antibody administered via infusion. The precursor to MEDI8852 was isolated from human memory B cells by Humabs BioMed and further optimized for enhanced neutralization activity at MedImmune. MEDI8852 binds to a region within the stalk of the hemagglutinin protein that is highly conserved amongst all influenza A subtypes. MEDI8852 is being developed as a treatment for patients hospitalized with seasonal influenza caused by Type A strains in conjunction with local standard of care. It is anticipated that it could also be used in the pandemic setting.
MEDI8852 is currently being evaluated in a Phase Ib/IIa clinical trial to investigate the safety and 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. A recently completed Phase I study in healthy adult subjects demonstrated that MEDI8852 had an acceptable safety and pharmacokinetics profile, which supports continued development in patients with influenza.
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.
“We are very pleased that our partner MedImmune received Fast Track designation for the antibody we jointly identified only five years ago,” said Filippo Riva, CEO of Humabs BioMed. “This is a validation of our technology and also of our strategy to rapidly discover and develop human-derived antibodies in life-threatening infectious diseases.”
Company News: Curetis to Launch CE-IVD Unyvero Blood Culture Application Cartridge at ECCMID 2016
– Successful completion of CE Performance Evaluation Study
– Covers 103 diagnostic targets with 87 pathogens and 16 resistance markers
Curetis N.V. (the “Company” and, together with Curetis GmbH, “Curetis“), a developer of next-level molecular diagnostic solutions, today announced the successful completion of the CE Performance Evaluation study of the new Unyvero BCU Blood Culture Application Cartridge (Unyvero BCU). Unyvero BCU, which will be launched in early April as a CE-IVD-marked product, is designed for the diagnosis of infections spreading through the bloodstream. The cartridge is compatible with most standard blood culture systems. Its comprehensive assay panel covers a broad range of diagnostic targets including 87 of the the clinically most relevant pathogenic microorganisms, among them Gram positive and Gram negative bacteria, several fungi and atypical pathogens, as well as 16 related antibiotic resistance markers. Sold as a consumable for Curetis’ Unyvero System, the product analyzes samples from blood culture bottles inoculated with blood or punctates from patients with suspected bloodstream infections that were flagged positive for microbial growth during incubation in an automated blood culture system. It is the third Application Cartridge for the Unyvero System following the P55 Pneumonia Application launched in 2015 and the ITI Application for implant and tissue infections launched in 2014.
In the performance evaluation study, a total of 609 samples were tested with the BCU Cartridge. These include more than 200 samples from blood culture bottles flagged positive for microbial growth in the routine work-up of patients, blood cultures that were flagged negative in clinical routine as well as 59 additional blood culture bottles inoculated with one of the different microbial strains covered by the panel.
The results demonstrated
- an average sensitivity for all pathogens of 96.2%,
- an average specificity of 99.4%,
- a positive predictive value of 90.1% and
- a negative predictive value of 99.8%.
To ensure compatibility with commonly used blood culture systems, the two most common systems and bottle types in the industry by Becton Dickinson and bioMérieux were used in the study and performance has been uniformly positive across the range of systems and bottles tested. Moreover, Curetis has demonstrated that other blood culture systems and bottles such as products by Oxoid, Thermo and VersaTREK can also be used with the Unyvero BCU cartridge.
The Unyvero BCU Blood Culture Application Cartridge will be launched during the 26th European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) in Amsterdam, The Netherlands (April 8-12, 2016). Three customer sites at renowned hospitals in Austria and Germany have already agreed to further evaluate the CE-IVD-marked Unyvero BCU product in clinical routine. Following the launch, Curetis expects to roll out the product via its direct selling markets in Europe and its distribution partner network in other European countries, the Middle East and Asia.
“We are excited to start marketing the third Application Cartridge for our Unyvero Platform,” said Dr. Achim Plum, Chief Commercial Officer of Curetis. “With over 100 diagnostic targets covered by the Unyvero BCU cartridge, we believe to have the broadest available panel for suspected blood stream infections that can be used with a wide range of routine blood culture systems. The new Unyvero application will provide physicians with timely, comprehensive and actionable information in situations where every hour counts for the patient.”
Curetis´ CEO Oliver Schacht, PhD, added: “One of our key priorities after the IPO has been the expansion and acceleration of our product development pipeline. With the successful validation and launch of the BCU product, significant progress with a second generation ITI cartridge, the upcoming IAI Intra-Abdominal Application Cartridge and our Sepsis Host Response program, we continue to deliver on key aspects of our equity story outlined to the market at our IPO.”
Company News: Scientific Review Endorses ISA Pharmaceuticals’ Strategy to Overcome Immune Evasion in Cancer Immunotherapy
– Targeting and Activating Dendritic Cells is the Key to Success
ISA Pharmaceuticals B.V., a clinical-stage immunotherapy company, has announced the publication of a review of cancer immunotherapies in Nature Reviews Cancer[1] that outlines strategies to overcome immune evasion by tumors. The publication was co-authored by a team of researchers from Leiden University Medical Center (LUMC) and ISA Pharmaceutical’s’ CSO Kees Melief.
Cancer immunotherapies have a mixed track record. While challenging the immune system via tumor antigens by raising tumor-specific T cells is successful in most cases, this strategy often does not cause T cells to zero in on tumor cells and exert their function within the tumor. Such failures demonstrate the overwhelming ability of cancers to protect themselves by suppressing the immune system, escaping mechanisms via cell-intrinsic factors and controlling their microenvironment. Cancer immunotherapies have successfully eradicated tumor cells only in a setting where immunosuppression was less evident or counteracted by successful measures such as checkpoint blocking.
This review of nearly 250 peer-reviewed publications demonstrates that successful immunotherapies rely on a number of important factors:
– Selection of tumor-associated antigens (should be virus-related in virus-induced cancers or, in cancers of other origins, preferably neo-antigens arising from mutations)
– Induction of robust and balanced CD4/CD8+effector and memory T cell responses by a suitable immunotherapy platform
– Parallel targeting of the immunosuppressive cancer environment via selected co-treatments, e.g. chemotherapy or checkpoint blocking
“Optimal therapeutic activity relies on immunotherapeutics that simultaneously target and activate dendritic cells, thereby eliciting robust type I oriented CD4+ and CD8+ T cell responses,” said Kees Melief, CSO of ISA Pharmaceuticals and co-author of the review. “In settings of premalignant disease, carcinoma in situ or minimal residual disease, immunotherapeutic vaccines are clinically successful as a monotherapy. However, in progressive cancers, co-treatments are required to overcome immune evasion and to achieve full efficiency. In this setting, immunotherapeutic vaccines will become valuable by increasing the effects of standard chemotherapies, checkpoint blocking and other therapies.”
“The review clearly validates our strategy of addressing HPV-induced malignancies with an off-the-shelf monotherapy of synthetic long peptides (SLPs), and of targeting other cancers via personalized SLPs based on patient-derived neo-antigens”, said Ronald Loggers, CEO of ISA.
[1] Van der Burg SH et al. 2016. “Vaccines for established cancer: overcoming the challenges posed by immune evasion.” Nat Rev Cancer (in press; advance online publication: March 11, 2016); doi:10.1038/nrc.2016.16