Vical Announces Completion of the Phase 3 ASP0113 CMV Vaccine Trial

SAN DIEGO, Oct. 10, 2017 -- Vical Incorporated (Nasdaq:VICL) announced today that the last patient completed their final assessment during the one year follow-up period in the multinational Phase 3 registration trial of ASP0113 in hematopoietic cell transplant (HCT) recipients. The trial completed enrollment in September 2016 with a total of 515 subjects. The primary endpoint of the trial is a composite of overall mortality and cytomegalovirus (CMV) end-organ disease which will be assessed one year after transplantation. Astellas Pharma Inc. (“Astellas”) expects top-line data to be available in the first quarter of 2018.

Vicals development partner Astellas conducted the trial and has an exclusive worldwide license from Vical to develop and commercialize ASP0113. Vical developed ASP0113 through Phase 2 and continues to provide Astellas with development, regulatory and manufacturing support for the program.

“This is yet another exciting milestone for ASP0113, the first CMV vaccine to complete a pivotal Phase 3 trial,” said Vijay Samant, Vical’s Chief Executive Officer. “This has been a highly productive partnership with Astellas and both companies look forward to sharing the results of this study with the HCT community in the first quarter of 2018. Furthermore, we look forward to potentially commercializing this first-in-class, vaccine-based preventative therapy for CMV in HCT recipients.”  

The Phase 3 trial enrolled patients at over 70 clinical trial sites in 11 countries throughout North America, Europe, Asia, and Australia and was designed to support full approval of ASP0113 for the prevention of CMV reactivation in CMV seropositive HCT recipients. Randomization of HCT recipients in this double-blind, placebo-controlled trial was stratified by donor-recipient relatedness and donor CMV serostatus. The trial’s primary endpoint is a composite of overall mortality and CMV end-organ disease, and secondary endpoints include time to first CMV viremia and time to CMV-specific antiviral therapy.  

About CMV 
CMV is a herpes virus that infects more than half of all adults in the United States by age 50, and is even more widespread in developing countries. A healthy immune system typically protects an infected person against CMV disease, but does not prevent or clear latent infection. Individuals whose immune systems are not fully functional are at high risk of CMV reactivation, potentially leading to severe illness or death. Those at greatest risk include HCT and solid organ transplant recipients, as well as infants born to mothers who first become infected during pregnancy.

About ASP0113
ASP0113 is an investigational vaccine candidate designed to prevent CMV disease and associated complications in CMV seropositive HCT 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 initially developed by Vical and has been partnered with Astellas for further development and commercialization. ASP0113 has received Orphan Drug Designation in the U.S. and Europe.

About Vical
Vical develops biopharmaceutical products for the prevention and treatment of chronic or life-threatening infectious diseases, based on its patented DNA delivery technologies and other therapeutic approaches. Additional information on Vical is available at www.vical.com.

Forward-Looking Statements
This press release contains forward-looking statements subject to risks and uncertainties that could cause actual results to differ materially from those projected. Forward-looking statements include statements about the potential uses and benefits of ASP0113, the parameters of the Phase 3 trial and timing regarding results from the Phase 3 trial. Risks and uncertainties include whether Vical's technology will be successfully applied;  whether ASP0113 or any product candidates will be shown to be safe and effective in clinical trials; whether the Phase 3 trial of ASP0113 will proceed on Astellas’ expected timing or be completed, and if so, whether results will support further development or commercialization; whether ASP0113 will be successfully developed and commercialized; whether Vical or its collaborative partners will seek or gain approval to market any product candidates; whether Vical or its collaborative partners will succeed in marketing any product candidates; and additional risks set forth in the company's filings with the Securities and Exchange Commission. These forward-looking statements represent the company's judgment as of the date of this release. The company disclaims, however, any intent or obligation to update these forward-looking statements.

Contact:
Andrew Hopkins
(858) 646-1127
Website:  www.vical.com