Helocyte’s Pentamer program is a universal (non-HLA restricted) vaccine, which is designed to induce a robust and durable neutralizing antibody response to prevent transmission of CMV in utero. Pentamer is the first recombinant viral vector vaccine in development for congenital CMV incorporating all five gH/gL-pentamer complex subunits from human CMV (e.g., gH/gL/UL128/UL130/UL131A). The vaccine is comprised of the Modified Vaccinia Ankara (MVA) vector, which has been dosed safely in over 120,000 patients (young and old) and has been shown to be prolifically expressed and highly immunogenic. The Pentamer program is currently undergoing nonclinical development. Nonclinical studies of Pentamer completed to-date have demonstrated (among other important findings): (1) prevention of CMV infection of epithelial cells using the neutralizing antibody response induced in mice vaccinated with Pentamer; (2) durability of neutralizing antibodies induced in mice vaccinated with Pentamer, with NAbs stably detected for a period of at least 50 weeks following initial vaccination; and (3) prevention of CMV infection of epithelial cells and fibroblasts using neutralizing antibodies induced in rhesus macaques vaccinated with Pentamer. For more information regarding non-clinical data generated to-date with Pentamer, see
Helocyte plans to continue nonclinical development of Pentamer, and to file an Investigational New Drug Application to the FDA in 2017. Helocyte secured an option to take an exclusive worldwide license to the Pentamer program in April 2015, and Helocyte exercised its option and secured such rights in June of 2015.