Archive: Company News
Company News: ISA Pharmaceuticals’ CSO Prof. Cornelis Melief to Present at CRI-CIMT-EATI-AACR Meeting in New York City
– Prof. Melief co-chairs Plenary Session 1: Antigens and Vaccines
ISA Pharmaceuticals B.V., a clinical-stage immunotherapy company focusing on rationally designed immunotherapeutics against cancer and persistent viral infections, today announced that Prof. Cornelis Melief, M.D., and Robert D. Schreiber, Washington University School of Medicine, St. Louis, MO, will jointly chair “Plenary Session 1: Antigens and Vaccines” on September 25, 2016, 8:50 am – 12:00 pm EST at the upcoming CRI-CIMT-EATI-AACR Meeting in New York City.
During the session, Melief will give a presentation titled “Selection of cancer antigens and conditions for success of immunotherapy of cancer involving vaccination”, outlining recent progress in the field.
Company News: Curetis Acquires Patents and Rights to Genetic Antibiotic Resistance and Susceptibility (GEAR) Database and Know-How from Siemens
– Agreement gives Curetis worldwide rights to database and IP based on Next Generation Sequencing
– GEAR significantly enhances Curetis’ leading position in the area of genetic antimicrobial resistance biomarker testing
Curetis N.V. (the “Company” and, together with Curetis GmbH, “Curetis“), a developer of next-level molecular diagnostic solutions, today announced the signing of an asset acquisition agreement with the Siemens Technology Accelerator GmbH (STA). Under the terms of the agreement, Curetis has acquired sole commercial rights from STA to the GEAR GEnetic Antibiotic Resistance and Susceptibility platform and database with all its content, numerous GEAR-related patents and patent applications, as well as all corresponding know-how. The deal gives Curetis sole worldwide product development and commercial rights, including the right to sublicense in the fields of human and animal diagnostics as well as food safety testing. Furthermore, Curetis has secured the sole rights to leverage the GEAR assets in collaboration with pharmaceutical companies for the development of novel antimicrobial drugs for human and animal health.
As consideration for these assets, STA will receive an undisclosed upfront payment from Curetis. Furthermore, Curetis will make undisclosed milestone payments for products including GEAR biomarkers upon first CE IVD marking and first FDA approval (or similar regulatory clearance), respectively. Also, there will be royalty payments to STA in industry-typical percentage ranges on future products based on use of the GEAR platform or GEAR biomarkers. Further financial details were not disclosed.
The state-of-the-art GEAR bioinformatics platform and database was developed and compiled in collaboration with two academic partners: The Institute of Clinical Molecular Biology (IKMB) at Kiel University that carried out the next generation sequencing (NGS) of bacterial isolates and the Clinical Bioinformatics Group of Saarland University headed by Prof. Dr. Andreas Keller that developed the bioinformatics platform and performed the computational analysis of 30 Terabyte of data underlying the GEAR database. GEAR allows users to assemble and annotate bacterial genomes from NGS raw data, identify genetic variations in those genomes and correlate those with the response of the respective bacterial strain to antibiotics. Currently, the GEAR database contains the entire DNA sequences as well as sensitivity data for 21 antibiotics of more than 11,000 bacterial strains isolated from patient samples across the world over the last three decades. It will allow Curetis to rapidly identify potential novel biomarkers, biomarker combinations, and algorithms predicting antibiotic resistance, as well as potential novel targets for antimicrobial drugs.
The acquisition of the GEAR database and patent estate adds significantly to the leadership position that Curetis has established in the area of genetic antimicrobial resistance biomarker testing with its Unyvero Application Cartridges. Curetis will further expand and mine the GEAR database in collaboration with leading academic institutions as well as pharmaceutical and diagnostics companies and leverage those into commercial products on its Unyvero Molecular Diagnostics platform and beyond.
“We are thrilled to have won in the competitive bidding process for this unique and exciting asset,” said Dr. Achim Plum, Chief Commercial Officer of Curetis. “With this platform, we are planning to build a network of strong and collaborative relationships with academics, clinicians and companies in the fields of diagnostics and pharmaceuticals alike. We will develop this repository into a valuable resource of antibiotic resistance biomarkers available to the global research community, while leveraging the proprietary nature of GEAR into our own Unyvero products and platform in the future.”
Oliver Schacht, CEO of Curetis, added, “Since our IPO, we have diligently executed on our commercial and product development plans. At the same time, we have kept our eyes open for strategic opportunities such as the GEAR acquisition. GEAR allows us to significantly expand the scale and scope of the Unyvero platform and complement it with NGS-based knowledge. GEAR will become an engine for even more comprehensive and differentiated content of antibiotic resistance biomarkers in our Unyvero products and allow us to stay on top of the development of cutting-edge molecular diagnostic products for critical hospital infections.”
Prof. Keller, one of the initiators of the project, highlighted the broad and unique character of GEAR: “The more than 11,000 whole bacterial genomes collected over three decades and across many countries in combination with culture-based phenotypic resistance profiles against 21 drugs enabled us to investigate multivariate genetic resistance mechanisms in a very comprehensive manner”. Prof. Keller also underlined that Curetis is a perfect partner for commercialization of tests for antibiotic resistance derived from GEAR: “We are convinced of the success of genetic antibiotic resistance tests and committed to support Curetis in their endeavor to improve care for patients suffering from bacterial infections”
About the GEAR Database and Assets:
The GEAR database includes genomic data of mostly Gram negative bacteria causing pneumonia, bloodstream infections, urinary tract infections, and gastric and wound infections. Samples were carefully selected across multiple geographies (USA, EU, Asia) and have been collected over three decades to reflect resistance development and variability over time. Sample collection was done at over 200 sites on 5 continents, with over 150 US institutes contributing. In addition to many of the most troublesome Gram negative bacteria, GEAR also includes S. aureus, demonstrating feasibility also for Gram positive bacteria.
Sample collection was designed to achieve significant statistical power with over 10,000 Gram negative bacterial strains and ca. 1,000 S. aureus (both MSSA and MRSA) strains tested. Overall, 21 antibiotic drugs in 182 different concentrations with all modes of action for resistance were tested for. Most commonly used drugs have been chosen by the former Siemens Microbiology Department. Antibiotic susceptibility testing (AST) reference methods as per CLSI (Clinical and Laboratory Standards Institute) guidelines were used and results interpreted according to EUCAST (European Committee on Antimicrobial Susceptibility Testing) guidelines. Seven out of nine combinations of bacteria and antibiotics identified as being of international concern by the WHO were analyzed in detail. Individual patent filings have been made for each bacteria for all antibiotics as well as certain method and process patents.
Next generation sequencing (NGS) was performed at one of the leading German Sequencing Centers (IKMB Institute of Clinical Molecular Biology in Kiel) on HiSeq 2000 and HiSeq 2500 Sequencers with over 300 Mio bases sequenced per sample. Taken together, 4 billion reads with 0.4 trillion bases were sequenced. Advanced bioinformatics approaches developed by the group of Prof. Dr. Andreas Keller, Chair for Clinical Bioinformatics, Saarland University, were employed to combine NGS results with AST data to identify potential novel and proprietary antibiotic resistance biomarkers and biomarker combinations.
GEAR enables a wide range of valuable clinical applications such as better genetic resistance testing for specific drug classes, broader syndromic resistance biomarker panels, and, in the future, potentially fully genetic antibiograms. It therefore can provide unique content for high-, medium-, and low-plexed MDx platforms.
Curetis to host conference call and webcast on GEAR acquisition
Curetis will host a public conference call and webcast on September 8, 2016, at 03:00 pm CET / 09:00 am EST to present its asset acquisition agreement with Siemens Technology Accelerator GmbH (STA) announced earlier today. Under the terms of the agreement, Curetis has acquired sole commercial rights from STA to the GEAR GEnetic Antibiotic Resistance and Susceptibility platform and database with all its content, numerous GEAR-related patents and patent applications, as well as all corresponding know-how.
The conference call will be supplemented by a presentation, which can be accessed during the call at http://www.curetis.com/en/investors/background-information.html. The live webcast and a replay will be available at http://curetis080916-live.audio-webcast.com (participants’ passcode curetis0916).
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
Company News: Curetis to Launch Next Generation CE-IVD Unyvero Implant and Tissue Infection Application Cartridge
– Launch follows successful completion of CE Performance Evaluation Study
– ITI now covers 102 diagnostic targets, including 85 pathogens and 17 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 next generation of its Unyvero ITI Implant and Tissue Infection Application Cartridge (Unyvero ITI).
The new Unyvero ITI comes with an extended panel and increased sensitivity. It will be launched in the third quarter of 2016 as a CE-IVD-marked product in the European direct sales and international distribution markets. Unyvero ITI is designed for the diagnosis of many types of severe infections, including prosthetic joint infections, surgical site infections, catheter-associated infections and skin and soft tissue infections.
The next-generation cartridge now covers a total of 102 diagnostic targets: 85 of the most clinically relevant pathogenic microorganisms, including Gram positive and Gram negative bacteria, several fungi, and 17 related antibiotic resistance markers. Specifically, the next generation ITI cartridge has added a universal bacterial primer, several Candida species, various types of Streptococci, Klebsiella variicola, and other new diagnostic targets. In addition, clinical sensitivity has been significantly improved for many key pathogens. Unyvero ITI is the most comprehensive commercially available panel for this indication area in a cartridge-based sample-to-answer format. The first generation ITI Application Cartridge launched in 2014 covered a total of 80 diagnostic targets.
Sold as a consumable running on the Curetis Unyvero System, the product analyzes many challenging and heterogeneous sample types such as fluids, tissues, swabs and others. It is the second Application Cartridge for the Unyvero System launched in 2016, following the recent launch of the BCU Blood Culture Application Cartridge.
In the performance evaluation study, a total of 1,100 samples were tested with the next generation ITI Cartridge. These included 700 samples positive for microbial growth in the routine work-up of patients.
Final validation results from patient samples demonstrated
- an overall sensitivity for all pathogens of 86.9% and
- an overall specificity for all pathogens of 99.2%.
Several customer sites at renowned hospitals in Europe have already agreed to further evaluate the second generation Unyvero ITI product in their clinical routine.
“We are excited to start marketing the new ITI Application Cartridge for our Unyvero Platform,” said Dr. Achim Plum, Chief Commercial Officer of Curetis. “Our development team has done a tremendous job and provided us with an improved, next generation product with higher clinical sensitivity overall, as well as an even broader panel. With more than 100 diagnostic targets covered by the new Unyvero ITI cartridge, we believe we have a solution with the broadest available panel for suspected implant and tissue infections and an unmatched versatility allowing the use of a wide range of routine clinical patient sample types.”
Curetis´ CEO Oliver Schacht, PhD, added, “A key priority for us since the IPO has been the expansion and acceleration of our product pipeline. With the successful validation and launch of the BCU product in Q2 and now the second generation ITI cartridge in Q3, we continue to deliver on key milestones of our equity story outlined at the time of our IPO.”
Company News: Agena Bioscience Names Genelex as Certified Service Provider for Targeted Genetic Analysis
Agena Bioscience today announced the successful certification of Genelex as a Certified Service Provider of the MassARRAY® technology.
The MassARRAY System is used to identify and validate SNPs, INDELs, CNV’s, translocations, somatic mutations, including rare variants, and methylation profiles across a variety of sample types. The flexibility and scalability of the platform facilitate easy development of custom panels and validation across large numbers of samples.
As a Certified Service Provider, Genelex will provide dedicated customer support, customizable assay design, test development and validation across multiple platforms. The laboratory has integrated robotics and secure Laboratory Information Systems to ensure high accuracy, low error, and rapid turnaround on results.
“Certified Service Providers like Genelex enable our customers to perform translational research in a CAP/CLIA environment and receive high quality support and data,” said Marisa Pearce, Sr. Director of Marketing at Agena Bioscience.
Genelex is accredited by the College of American Pathologists; certified under the Clinical Laboratory Improvement Amendments Act; is Washington State Medical Test Site; licensed by the New York Department of Health; compliant with Code of Federal Regulations (CFR) 21 and Health Insurance Portability and Accountability Act (HIPAA) and is licensed to perform high complexity clinical testing in all US states.
Genelex CSO and Lab Director, Tia Aulinskas commented, “From standard testing to customized assays, Genelex provides actionable data with >99% reportable tests. Our team has the knowledge and experience on the MassARRAY System, and the dedication to ensure the accurate and timely delivery of your data.”