News
Company News: Curetis Prepares Launch of Second Unyvero™ Application
– Final clinical performance evaluation study for Unyvero™ i60 ITI application ongoing
– Study data expected by the end of Q1/2014
Curetis AG, a developer of next-level molecular diagnostic solutions, today announced that it has completed development of its second Unyvero™ application. The new Unyvero™ i60 ITI cartridge rapidly identifies more than 90 pathogens and more than 20 resistance markers common in implant and tissue infections. After successfully manufacturing several lots and completing initial verification testing of the cartridge, the Company has initiated a pivotal study using approximately 500 cartridges to validate analytical, technical and clinical performance for CE marking.
Following the completion of the study scheduled for end of Q1/2014, commercialization of the Unyvero™ i60 ITI is expected to begin in Q2/2014. Curetis will jointly market the cartridge with Heraeus Medical GmbH, the development and commercialization partner for this cartridge. Both companies have already received pre-orders from key opinion leaders and hospitals across central Europe.
The study will use frozen patient specimens – watery/swabs, viscous/purulent, sonication and synovial fluids, and biopsy material – for diagnosis. The study will compare the molecular test with conventional microbial culture techniques. Discrepant or unexpected results will be resolved by additional tests. The study will also test assay repeatability and reproducibility and establish limit of detection.
Company News: Phase IIb Results of Anergis´ Lead Compound AllerT to be Presented at 2014 AAAAI Annual Meeting in San Diego
– Oral presentation scheduled for March 4, 2014 –
Anergis, a company discovering and developing proprietary allergy vaccines, today announced that the detailed Phase IIb results of its allergy vaccine AllerT will be presented during this year’s annual meeting of the American Academy of Allergy, Asthma & Immunology (AAAAI) in San Diego, CA. The oral presentation will be given by Prof. Francois Spertini, MD, Principal Investigator of the trial.
Presentation Title: “Ultra-Fast Hypoallergenic Birch Pollen Allergy Vaccine AllerT Is Efficient and Safe: Results Of a Phase IIb Study”
Time and Date: Tuesday, March 4, 2014, at 02:45pm PST.
Session: New Forms of Immunotherapy (session no. 5606)
Location: Convention Center, Mezzanine Level, Room 14AB
AllerT is a pharmaceutical-grade vaccine to treat birch pollen allergies via ultra-fast desensitization. The vaccine is based on the IP-protected Contiguous Overlapping Peptides (COP) technology.
Company News: InDex Pharmaceuticals Closes $20 m Financing Round, Welcomes NeoMed as New Shareholder
InDex Pharmaceuticals today announced the successful closing of a USD 20 million / EUR 15 million new rights issue. NeoMed led the oversubscribed financing round while current shareholders participated with 75% of the invested capital.
In summer 2014, InDex Pharmaceuticals expects to report data from a Phase III study with its lead product candidate Kappaproct®, which is being developed for the treatment of severe Ulcerative Colitis (UC) – a debilitating, chronic inflammation of the large intestine.
In conjunction with the investment, Dr. Erik Amble, Managing Partner and founder of NeoMed Management, has been appointed as a new member of the company’s Board of Directors. Dr. Amble has over 25 years of experience with venture capital investments in Europe and the U.S.
Since 2012, Kappaproct® has been investigated in the COLLECT trial, a European multicenter Phase III study to evaluate the effectiveness and safety for the treatment of chronic active, refractive ulcerative colitis (UC) patients. Kappaproct® is a DNA-based immunomodulatory sequence (DIMS) targeting the toll-like receptor 9 (TLR9). Primary endpoint of the COLLECT study is induction of clinical remission in severe UC patients, who have failed all other medical treatments and whose only remaining treatment option is colectomy.
Company News: ISA Pharmaceuticals Strengthens Patent Protection for its Lead Product ISA101
– Granted EU patent provides market exclusivity until 2028 –
ISA Pharmaceuticals B.V., a clinical-stage immunotherapy company focusing on rationally designed therapeutic vaccines against cancer and persistent viral infections, today announced it has been granted a European patent on its lead compound ISA101. The patent ensures market protection of ISA101’s active ingredient in Europe until 2028.
ISA101 is a therapeutic vaccine for the treatment of high-risk, HPV16-induced diseases. The vaccine consists of synthetic long peptides derived from the E6 and E7 oncogenic proteins of the HPV16 virus. This HPV strain is responsible, among others, for over 50% of human cervical cancers, more than 85% of HPV-positive head and neck cancers, and a variety of premalignant disorders.
The patent covers long peptides of the HPV-E6 protein, including a novel CD4+ epitope and provides exclusivity for the treatment of HPV-related diseases.
ISA101 is currently studied in the CervISA trial, a company-sponsored Phase I/II trial in cervical cancer and anal intra-epithelial neoplasia (AIN). Moreover, the vaccine has established clinical proof-of-concept by successfully completing a Phase II trial in vulvar intraepithelial neoplasia (VIN).