Archive: Company News
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
Company News: InDex Pharmaceuticals Receives FDA Clearance of IND for Cobitolimod (Kappaproct®) Phase IIb Trial
InDex Pharmaceuticals AB today announced that the U.S. Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug (IND) application to initiate a phase IIb study with its lead drug candidate cobitolimod (Kappaproct®) in patients with moderate to severe ulcerative colitis (UC).
“The clearance of the IND is a major milestone for InDex Pharmaceuticals in our efforts to develop cobitolimod as a new therapy for patients with ulcerative colitis, a disease with a high unmet medical need,” said Peter Zerhouni, CEO of InDex Pharmaceuticals. “We are very pleased about this validation by the FDA, which is based on the extensive preclinical and clinical data package available for cobitolimod, and we look forward to initiating the study later this year. Having clearance from the FDA is key for our on-going discussions with potential licensing partners and investors. We will continue to work with the FDA as the development of this product progresses.”
Cobitolimod (Kappaproct®) is InDex Pharmaceutical’s lead drug candidate in late-stage clinical development for moderate to severe ulcerative colitis, a debilitating, chronic inflammation of the large intestine. Cobitolimod is a first-in-class Toll-like receptor (TLR) 9 agonist that functions as an immunomodulatory agent by mimicking microbial DNA, the natural ligand of the receptor. Cobitolimod provides local anti-inflammatory effects, leading to healing of the colonic mucosa and improvement of clinical symptoms. In January 2016, WHO recommended the INN name cobitolimod. The substance is also known as Kappaproct® and DIMS0150.
The product has achieved clinical proof-of-concept in moderate to severe ulcerative colitis, with a very favorable safety profile. Data from four placebo-controlled clinical trials show that cobitolimod has statistically significant effects on those endpoints that are most relevant in this disease, both from a regulatory and clinical perspective. These endpoints include the key clinical symptoms such as blood in stool, number of stools, and mucosal healing, respectively.
The planned phase IIb study will be a randomized, double-blind, placebo-controlled trial to evaluate the safety and efficacy of cobitolimod in inducing clinical remission in patients with chronic active moderate to severe ulcerative colitis as compared to placebo. The study will evaluate higher doses and more frequent dosing than those used in previous studies with the goal to provide substantially higher efficacy, while maintaining the compound’s superior safety profile.
Company News: Humabs BioMed and the Institute for Research in Biomedicine announce the successful isolation and characterization of a protective, human-derived antibody against Ebola
– International collaboration publishes results in two Science papers
– Clinical development to start with support by DARPA
Humabs BioMed SA, a Swiss antibody therapeutics company, and the Institute for Research in Biomedicine (IRB) affiliated to the Università della Svizzera italiana today announced the identification, isolation and characterization of two Ebola virus neutralizing monoclonal antibodies from the blood of a survivor of an Ebola infection. The results were achieved through an international collaboration with leading research institutes. As published in this week’s Science, one of the fully human antibodies is completely protective against lethal Ebola infection – even when given as single treatment and as late as five days after infection. A second publication, also in this week’s Science, identifies novel sites of vulnerability on the Ebola virus glycoprotein and reveals the molecular bases of virus neutralization by the human antibodies, providing new clues for vaccine design.
The Ebola virus causes hemorrhagic fever with a mortality rate of up to 90%. There is currently no approved Ebola therapy or vaccination. However, it is known that Ebola infection survivors carry life-long immunity preventing further infections. In a joint effort with researchers from the U.S. National Institute of Health (NIH) and the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID), Humabs BioMed and IRB were able to isolate two human antibodies against Ebola from the blood of two survivors of a 1995 Ebola outbreak 11 years after infection. Two antibodies code-named mAb100 and mAb114 demonstrated high virus-neutralizing capacity even when mAb114 was given as a monotherapy five days after infection.
Subsequently, researchers from the U.S: National Institute for Allergic and Infectious Diseases (NIAID), the Geisel School of Medicine at Dartmouth (Hanover, USA) and the School of Medicine Tsinghua University (Beijing, China) in collaboration with Humabs and the IRB characterized the targets addressed by the two antibodies. Both interfere with a glycoprotein that is essential for the binding of the virus to its host cells. This protein contains a certain loop that is being removed before the virus can enter cells. While mAb100 prevents the removal of the loop, mAb114, which is effective as a monotherapy, remains attached to the protein even after the loop is cut out. This is an entirely novel site of Ebola virus vulnerability that has never been reported to date and may open up new possibilities for the development of further preventive and therapeutic measures.
The lead mAb114 antibody is now being manufactured and developed for clinical testing with the support of the Defense Advanced Research Projects Agency (DARPA, Arlington, USA).