Inovio Product Pipeline: Cytomegalovirus
Product & Indication
This experimental plasmid-based DNA vaccine encodes the cytomegalovirus (CMV) antigens pp65 and gB and is delivered intramuscularly using Inovio's Medpulser DNA Delivery System to patients undergoing hematopoietic stem cell transplantation (bone marrow transplant).
Market Potential
The Institute of Medicine, or IOM, of the National Academy of Sciences estimated the cost of treating the consequences of CMV infection in the United States at more than $4 billion per year in a 1999 report, and placed a CMV vaccine in its first priority category on the basis of cost-effectiveness. Vical's initial focus is on the transplantation indication, and should allow proof-of-concept that could then lead to the opportunity to develop a CMV vaccine for other groups such as immuno-compromised individuals and at-risk women of reproductive age.
Technical
Vical initiated a Phase 1 clinical trial with a non-electroporated version of the CMV immunotherapeutic vaccine in March 2004. Subjects in the trial were healthy adults who were monitored primarily for safety, with secondary endpoints of immunogenicity. The trial tested two dosing levels and two dosing schedules, with approximately half of the subjects in the trial having prior exposure to CMV (seropositive) and half with no evidence of prior exposure (seronegative).
Results from the Phase 1 trial indicated that the CMV immunotherapeutic vaccine was safe and well-tolerated by a majority of subjects, with temporary injection site pain being the most common side effect. The vaccine induced antibody and T-cell immune responses, at both dose levels and both dosing schedules tested. Based on these results, Vical designed a Phase 2 study in hematopoietic cell transplant, or HCT, patients. The Phase 2 human trials began enrolling HCT donor-recipient related pairs in February 2006. Subsequent amendments included the addition of a second arm to the trial to enroll recipients of HCTs from unrelated donors.
Stage of Development
Phase: IND filed and approved
Purpose: To enhance the immune response to Vical's pp65/gB CMV vaccine in HCT patients.
Study Type: Open label, Phase I dose escalation trial
Status: On hold, awaiting outcome of non-electroporated Phase II trial
Commercialization
Vaccine: owned by Vical.
Delivery technology: owned by Inovio.