Archive: Company News

Company News: Curetis to Launch Next-Generation Pneumonia Application at ECCMID 2015

Company Successfully Completes Clinical CE Performance Evaluation of Unyvero P55 Pneumonia Application

Clinical sensitivity across 40-marker panel averages 94% at 99.4% specificity

Curetis AG, a developer of next-level molecular diagnostic solutions, today announced the successful completion of the clinical and analytical CE performance evaluation of its next-generation Unyvero P55 Pneumonia Application. The upgraded cartridge will launch at the 25th European Congress of Clinical Microbiology and Infectious Diseases (ECCMID, April 25 – 28, 2015 in Copenhagen, Denmark) and is supported by more than 800 cartridge runs and over 400 patient samples.

Unyvero P55, which is replacing the current P50 cartridge, identified a total of 127 additional pathogens compared to microbiology culture. Discrepant results have been resolved by independent PCR and sequencing and validated 93 cases as true positives, e.g. cases where traditional microbiology culture missed the pathogen.

The Unyvero P55 Pneumonia Application demonstrates superiority over culture and key enhancements compared to the P50 cartridge, evidenced by pathogen and resistance expansions and improved sensitivity proven in the CE clinical performance study. Specific upgrades include:

  • Expansion to detect 21 pathogens, including new targets Mycoplasma pneumoniae, Citrobacter freundii, Enterobacter aerogenes and Klebsiella variicola
  • Addition of critical antibiotic resistance markers (now a total of 19), including genes coding for carbapenem (imp, ndm, vim, oxa-23, oxa-24, oxa-48, and oxa-58 markers) and oxacillin (mecC) resistance
  • Improvements to sensitivity for several analytes, i.e.
    • Greater than 90% for most pathogens on the P55 panel, including Pseudomonas aeruginosa
    • Greater than 92% for Staphylococcus aureus
    • Near 100% for Pneumocystis, E. coli and Moraxella catharralis.

Comprehensive data supporting the next-generation Pneumonia Application will be presented at ECCMID.

The European and international roll out (excluding North America) commences in April 2015. Pricing for the P55 Pneumonia Application remains unchanged from the P50 cartridge. In the U.S., the P55 is being used under the label LRT55 as a Lower Respiratory Tract (LRT) Application in a U.S. FDA clearance trial, which is expected to be completed in 2016.

Company News: Humabs BioMed Reports Clinical Milestone in MedImmune Partnership

– MedImmune Starts Phase I Clinical Trial to Investigate an 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 through its proprietary Cellclone technology will be investigated for the treatment of influenza A in a Phase I trial being conducted by MedImmune, the global biologics research and development arm of AstraZeneca.

The investigational antibody, which has broad influenza-neutralizing properties, was isolated by Humabs from human memory B cells and further optimized for higher potency by MedImmune. The resulting antibody, MEDI8852, is exclusively licensed to MedImmune. The Phase I trial (NCT02350751) is designed to evaluate the safety and pharmacokinetics of MEDI8852 in healthy adults.

MEDI8852 binds to a novel site in the hemagglutinin stem region that is shared in viruses from all 18 Influenza A subtypes. This region is highly conserved and is considered to be the “Achilles’ heel” of the virus.

Humabs discovers and develops antibodies directly derived from individuals whose immune systems have successfully responded to major diseases.  While the concept of isolating antibodies directly from recovered patients is not new, Humabs has developed a unique, comprehensive scheme for screening and selecting naturally occurring antibodies. Its proprietary technology platforms use immortalized donor B cells or cultured plasma cells with unmatched, stable secretion rates. This allows Humabs to perform sophisticated functional screens to rapidly discover antibodies able to opsonize or kill bacteria, block viral entry, or eliminate virus-infected and cancer cells. Instead of looking for binders to predefined targets, the Humabs functional approach is target-agnostic. Within weeks, it leads to ultra-potent antibodies, which can subsequently be developed for therapeutic, diagnostic, or research purposes, including the identification of novel targets or vaccines.

Company News: Merus reaches pivotal milestone in bispecific antibody collaboration with ONO PHARMACEUTICAL CO., LTD.

– Successful product lead identification underscores the strength of Merus’ platform in delivering human, full-length IgG bispecific antibodies –

Merus B.V., a leader in developing best-in-class bispecific antibody therapeutics, announced today that it has reached a preclinical milestone in a bispecific antibody research and license collaboration with ONO PHARMACEUTICAL CO., LTD. (Osaka, Japan, ”ONO”) triggering a payment. The milestone is for achieving preclinical proof-of-mechanism with a lead bispecific antibody directed against a target combination relevant in the treatment of autoimmune disease.

Company News: Anergis Announces Completion of Treatment in AllerT Phase II Dose-Ranging Trial

–      213 patients included in trial of novel ultra-fast allergy immunotherapeutic

Anergis, a company developing novel and proprietary ultra-fast allergy immunotherapeutics, today announced treatment completion of its Phase II clinical trial of AllerT, a novel long-peptide immunotherapeutic to treat birch pollen allergies. In the trial, 213 patients were randomized to receive target doses of 10, 25 or 50 µg of AllerT or placebo as 5 subcutaneous injections over 2 months. The last patient was treated at the end of March. No serious adverse events and no grade 3 or 4 allergic reactions were reported. The trial is being conducted in Canada and is still blinded. Results are expected in Q3 of 2015.

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