September 26, 2019 12:00 PM Eastern Daylight Time
SEATTLE–(BUSINESS WIRE)–Curevo, Inc., a Seattle-based biotechnology company invested in by GC Pharma, one of the largest therapeutic protein manufacturers in the world, has announced encouraging preliminary Phase I safety and tolerability results of their Shingles vaccine candidate, CRV-101. Interim trial results demonstrating a promising safety and tolerability profile of the vaccine in 90 healthy adults ≥18 to <50 were presented in an oral presentation at the 44th annual International Herpesvirus Workshop in Knoxville, Tennessee.
“Immunologic analyses are ongoing, but we believe that CRV-101 may be an important addition to current vaccines for Shingles as the manufacturing process should allow it to be widely available and the components of the vaccine appear minimally toxic. We are eager to advance quickly to larger Phase II studies.”Tweet this
“The trial of CRV-101 is quite large for a Phase I study, and the findings were important in that the vaccine was extremely well-tolerated by healthy adults,” said Dr. Corey Casper, who led the study and serves as the President and Chief Executive Officer for IDRI. “Immunologic analyses are ongoing, but we believe that CRV-101 may be an important addition to current vaccines for Shingles as the manufacturing process should allow it to be widely available and the components of the vaccine appear minimally toxic. We are eager to advance quickly to larger Phase II studies.”
The reported interim data are from the Phase I randomized, placebo-controlled, observer-blind study evaluating the safety, tolerability and immunological profile of CRV-101 at different dose and adjuvant levels.
Key Findings of the Phase I Trial:
- The vaccine was safe and well tolerated
- No Grade 3 or Grade 4 local reactogenicity
- One Grade 3 systemic adverse event (fever) in the highest dose cohort
The vaccine was extremely safe and well-tolerated at all doses. No severe side effects (“Grade 3” or “Grade 4”) were attributed to the vaccine, and the proportion of participants experiencing soreness at the injection site was <10%.
The results demonstrate the potential impact Curevo’s vaccine can make in preventing Shingles virus. Clinical development plans include Phase II study of CRV-101 in adults to optimize dose selection and assess preliminary efficacy.
Curevo is working to provide excellence in protein science and adjuvant technology to speed safe and highly effective vaccines from the bench through clinical development. Curevo will focus on vaccine-preventable illnesses that are common in both the Asian and US markets. Curevo’s goal is to rapidly advance innovative new vaccine candidates from research laboratory to clinic by joining forces with South Korean Mogam Institute for Biomedical Research, GC Pharma, and the Infectious Disease Research Institute based in Seattle, Washington.