Vical completes enrollment in Phase II trial of investigational CMV vaccine

ASP0113 is an investigational vaccine candidate under development for the prevention of CMV disease and associated complications in transplant recipients. Vical licensed the vaccine, ASP0113, to Astellas Pharma Inc. (TOKYO:4503), which is conducting the Phase 2 trial and an ongoing pivotal Phase 3 trial in hematopoietic stem cell transplant recipients.

Enrollment in the Phase 2 trial was completed almost a year ahead of schedule. A total of 150 kidney transplant recipients were enrolled, exceeding the original enrollment target of 140. The trial has enrolled subjects at approximately 80 centers in North America, Europe and Australia.

The randomized, double-blind, placebo-controlled trial will evaluate safety, tolerability and efficacy of ASP0113 in CMV-seronegative kidney transplant recipients receiving an organ from a CMV-seropositive donor (D+/R-).

The primary endpoint will evaluate efficacy of ASP0113 with 100 days of valganciclovir — compared to placebo with 100 days of valganciclovir — in reducing the incidence of CMV viremia over a period of one year following the first vaccination. Secondary endpoints include incidence of CMV disease, overall survival, and others. Topline trial results are expected in the second half of 2016.

"Under the current standard of care, approximately 50 percent of D+/R- kidney transplant recipients experience CMV viremia and approximately 35 percent experience CMV disease within one year after transplantation. The completion of enrollment of this Phase 2 trial is an important step toward expanding the development of ASP0113," said Dr. Larry Smith, Vical’s Vice President of Vaccine Research.

Vical has an agreement with Astellas, who has more than 20 years of experience in supporting the transplant community, to develop and commercialize ASP0113.

ASP0113 is an investigational vaccine candidate designed to prevent CMV disease and associated complications in transplant recipients, including hematopoietic stem cell transplant recipients and solid organ transplant recipients. ASP0113 is a bivalent DNA vaccine encoding CMV phosphoprotein 65 and glycoprotein B antigens for induction of both cellular and humoral immune responses, formulated with a proprietary poloxamer-based delivery system.

ASP0113 was discovered and initially developed by Vical and has been partnered with Astellas for further development and commercialization. ASP0113 has Orphan Drug designations in the U.S. and Europe.

It is the first CMV vaccine to enter Phase 3 clinical testing and the first DNA vaccine to enter Phase 3 clinical testing. This is the first trial to test ASP0113 in solid organ transplant recipients.