Clinical Trial Application for VB10.NEO filed with PEI
Vaccibody AS today announced filing of a Clinical Trial Application (CTA) for cancer neoantigen vaccine VB10.NEO with German regulatory authority Paul Ehrlich Institute (PEI). VB10.NEO is a personalized vaccine designed specifically for each patient and the neoantigen mutations that are unique to that patient’s tumour DNA. The CTA is filed in order for Vaccibody to be able to initiate a multicenter phase I/IIa clinical trial evaluating the safety, feasibility and efficacy of VB10.NEO in combination with standard of care checkpoint inhibitor therapy. The clinical trial will enroll patients with locally advanced or metastatic non-small cell lung cancer, melanoma, renal cancer, bladder and head&neck cancer. A total of 40 patients is planned to be enrolled in the phase I part of the trial. The trial will evaluate immune responses in serial samples of peripheral blood and tumor tissue through a comprehensive immunomonitoring program.
Mads Buhl Axelsen appointed Chief Medical Officer
To secure optimal implementation of the VB10.NEO trial, and a strong clinical leadership in general, Dr. Mads Buhl Axelsen has joined Vaccibody to take up the position as Chief Medical Officer (CMO). Mads holds a MD from Medical School, University of Copenhagen and a Master of Medical Business Strategies from Copenhagen Business School. Mads has since 1990 worked in drug development with clinical research and regulatory affairs in varies pharma and biotech companies. Mads started his career in Leo Pharma followed by Novo Nordisk A/S, Novo Nordisk Pharmaceutical Inc., NatImmune A/S, Neurokey A/S and Hemofocus Aps. Mads has been involved in several late stage development programs, NDA filings, as well as in early clinical development e.g. first in man, translational research and clinical pharmacology mechanistic trials. Most recently Mads worked as an International Medical Director at Novo Nordisk A/S.
“We are very pleased to have to have Mads join the Vaccibody team” said Martin Bonde, Chief Executive Officer of Vaccibody. “Mads brings an enormous depth of drug development experience, having worked with many innovative drugs through early research into clinical development and commercialization. His profound knowledge and insights into drug development makes Mads an excellent addition to the Vaccibody team”.