Vical Incorporated (NASDAQ:VICL) announced 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.
On the ratings front, H.C. Wainwright analyst Ram Selvaraju reiterated a Buy rating on VICL, with a price target of $9, in a report issued on August 9. The current price target represents a potential upside of 225% from where the stock is currently trading. According to TipRanks.com, Selvaraju has a yearly average loss of 7.3%, a 37% success rate, and is ranked #4632 out of 4693 analysts.
Vical is a biopharmaceutical company. The company engages in the research and development of biopharmaceutical products based on patented DNA delivery technologies for the prevention and treatment of serious or life-threatening diseases. Its core technology involves the insertion of DNA into plasmids designed to deliver the desired genes into cells in the body.