Vical Releases Positive Preliminary Data From TransVax CMV Vaccine Phase 2 trial

Vical has reported that TransVax cytomegalovirus (CMV) vaccine elicited sustained increases in both cellular and antibody immune responses compared with placebo

TransVax is a bivalent DNA vaccine containing plasmids (closed loops of DNA) encoding CMV phosphoprotein 65 (pp65) and glycoprotein B (gB) for induction of cellular and humoral immune responses.

TransVax is formulated with a proprietary poloxamer-based delivery system. The Phase 2 trial is evaluating the potential for TransVax to prevent CMV reactivation in immunosuppressed CMV-seropositive hematopoietic stem cell transplant (HCT) recipients, which could reduce antiviral usage and CMV-associated disease.

Vical said that at the 12-month immunogenicity analysis by group, TransVax continued to provide increased cellular immunological responses to both encoded CMV antigens, and increased antibody responses to gB, compared with placebo. TransVax has received orphan drug designation for HCT and solid organ transplant patients.

Richard Kenney, vice president of clinical development at Vical, said: “We were excited to see that our TransVax vaccine was able to enhance both T-cell and antibody responses to the encoded CMV antigens through the final 12-month data point and we are excited to see how these responses impact viral control.

“We also saw an encouraging boost in both T-cell and antibody responses after the fourth injection, which could prove important in controlling late-onset CMV reactivation. We expect to complete our analysis of the final trial data and report on our full evaluation of viral load and clinical endpoints in the third quarter.”