Archive: Company News
Company News: ProBioGen and Merus Sign Deal on GlymaxX® ADCC Enhancement Technology
– GlymaxX® Manufacturing Technology Improves Bispecific Antibody Activity for Solid Tumor Treatment –
ProBioGen AG and Merus B.V. today announced that the companies have signed a non-exclusive commercial option and license agreement on ProBioGen’s GlymaxX® fucose-engineering technology. Under the terms of the agreement, ProBioGen is granting Merus the non-exclusive right to use the GlymaxX® technology to enhance the ADCC (Antibody-Dependent Cell-Mediated Cytotoxicity) activity of one of its lead products, a bispecific anti-cancer antibody. The license is covering clinical development and production. Financial details have not been disclosed.
The GlymaxX® technology for the production of afucosylated antibodies and proteins is based on the stable integration of a heterologous enzyme into any antibody producer cell line, leading to the interference with the cells’ intracellular fucose biosynthesis pathway. As a unique feature differentiating it from other approaches, the GlymaxX® technology can be applied to both novel and already existing antibody producer cell lines and entire antibody expression and discovery platforms without negatively affecting their productivity. Moreover, it is simple, rapid, potent and universally applicable.
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.