VBI provided an update on the progress of its cytomegalovirus ("CMV") vaccine development program yesterday at the World Vaccine Congress 2015 in Washington, D.C.
Dr. David E. Anderson, VBI’s Senior Vice President of Research, presented new data from interim yield and purity testing of VBI-1501A, VBI’s prophylactic CMV vaccine candidate, which is now being manufactured in quantities needed for planned toxicology, stability, and clinical studies.
"The manufacture of VBI-1501A at a 50L production scale will allow us to initiate formal toxicology studies – this is a key next step in advancing towards IND approval and clinical trials," said Dr. Anderson. "We believe this positive interim data validates our eVLP vaccine platform and its potential utility in creating novel vaccine candidates for CMV and other indications." Download Presentation PDFVBI's eVLP vaccine platform allows for the design of enveloped (“e”) virus-like particle (“VLP”) vaccines. eVLPs are an innovative new class of vaccines that are designed to resemble the structure of viruses, but do not contain any potentially infectious viral material. Because of their structural similarity to viruses found in nature, eVLPs are capable of imparting greater immunity than immunization with the same recombinant target protein alone.
During recent testing, VBI employed electron microscopy to confirm the integrity of the eVLP particles (drug substance) used to create VBI-1501A. A separate in vivo potency assay assessed the consistency and potency of multiple batches of VBI-1501A, with positive interim results. Purity measurements are expected to meet regulatory requirements for clinical evaluation of the vaccine candidate. VBI plans to initiate formal toxicology studies in Q2 2015.