CyanVac expects its Phase I parainfluenza virus-vectored Covid-19 vaccine trial to have early data in December, which could be the impetus for a $30m fundraise.
“The [December read] will be our first immunogenicity data in humans, and it is an important card to turn over,” chief business officer Samuel Wu told this news service.
The nasally administered vaccine candidate, called CVXGA1, features parainfluenza virus 5 (PIV5) vectors that contain the genetic code for the SARS-CoV-2 spike protein. Its ongoing 80-volunteer Phase I trial (NCT04954287) recently resumed enrolling after a built-in pause to confirm safety in the first four participants, Wu said.
Though not yet finalised, CyanVac’s fundraise will go in part toward funding a subsequent CVXGA1 trial, Wu said. This trial would be either a Phase I or Phase I/II design, likely enrolling 100–300 participants and investigating safety and immunogenicity, he added.
The fundraise will also go toward a Phase I trial for a respiratory syncytial virus (RSV) vaccine candidate and additional early pipeline development, Wu said. CyanVac aims to initiate a Phase I trial for the RSV vaccine in the first half of next year, he added.
As for other 2022 plans, CyanVac has a commitment from the US National Institutes of Health (NIH) to fund a Phase I trial of CVXGA1 as a Covid-19 vaccine booster, Wu said. This study would be run by the Infectious Disease Clinical Research Consortium (IDCRC), which has run several major government Covid-19 vaccine trials, he noted.
Previously, the majority of CyanVac’s funding had come from licensing agreements and partnerships, Wu said. Moving forward, CyanVac will also target public funding, including from the NIH, to fund its Covid-19 vaccine development program, he added. But until the initial Phase I data reads out, the exact timeline and target investors will not be finalised.