VBI Vaccines Inc. (NASDAQ: VBIV) (“VBI”), a commercial-stage biopharmaceutical company developing next-generation infectious disease and immuno-oncology vaccines, today announced its plans for a Phase 2 clinical study evaluating VBI-1501, the company’s prophylactic cytomegalovirus (CMV) vaccine candidate, following positive discussions with Health Canada.
The Phase 2 study is expected to be a formal dose-ranging study designed to assess the safety and immunogenicity of three different dosages of VBI-1501: 5μg, 10μg, and 20μg. The program will be an observer-blind, four-arm, placebo-controlled study in both men and women, aged 18 – 40, and is expected to enroll approximately 110 subjects. Following discussions with Health Canada, toxicology studies are underway, the results of which are required prior to the start of the clinical study, which is expected to initiate enrollment around the end of 2019.
“Building from the encouraging Phase 1 study data – data that included a clean safety profile, and induction of functional neutralizing antibody responses against both fibroblast and epithelial cell CMV infection – we are eager to see how higher doses of VBI-1501, which at 20μg will be 10-times higher than the highest dose tested in the Phase 1 study, may improve immune responses against CMV,” said Francisco Diaz-Mitoma, M.D., Ph.D., VBI’s Chief Medical Officer. “We are very pleased that Health Canada has expressed its support of the VBI-1501 Phase 2 study design, which will enable us to further develop our candidate to prevent cytomegalovirus infection, a key public health priority.”
CMV is a significant unmet public health need in both the Congenital infection setting and in the organ transplant setting. Congenital CMV is a leading cause of birth defects worldwide. In the U.S., approximately 30,000 infants are born infected with CMV each year, of which more than 5,000 will develop permanent problems including deafness, blindness, and developmental delays. In the organ transplant setting, CMV status of recipient and donor have a major impact on organ and recipient survival and morbidity. Over 100,000 individuals in the U.S. are on the waiting list to receive a solid-organ transplant. Matching recipient and donor based on CMV serology is not practical given the limited supply of organs.
To learn more about CMV, visit: https://www.vbivaccines.com/cmv/