SACRAMENTO, Calif.–(BUSINESS WIRE)–Verndari, Inc., a biopharmaceutical company in Napa, California, announced today it will begin preclinical testing this week of a potential COVID-19 coronavirus vaccine, which will be administered using its patented VaxiPatch™, a microneedle array dermal patch. The testing will be conducted in laboratories at the University of California, Davis.
“We are excited to work with Verndari, Inc. to move its vaccine candidate through preclinical, and potentially clinical, studies”
Verndari, Inc. founded in 2015 by recognized leaders in the biotechnology industry, developed the potential COVID-19 vaccine using single, purified protein antigens produced by genetic engineering in a process that has proven to be extremely reliable. The vaccine candidate uses the COVID-19 “spike” protein that enables the virus to infect human cells.
“Verndari, Inc. was founded to enable a rapid response to new viral threats as well as to produce more effective vaccinations for existing viruses, such as seasonal flu, while sharply reducing costs and making vaccine administration much simpler,” said Daniel R. Henderson, Ph.D., CEO, and chief scientific officer of Verndari, Inc. “Our new approach and previous vaccine work have enabled us to quickly develop a potential vaccine for COVID-19. UC Davis provides a world-class forum for testing with leading researchers and a full spectrum of supporting capabilities.”
Preclinical testing of immune response begins this week at UC Davis’ Mouse Biology Program. Verndari, Inc. is also in discussions with the California National Primate Research Center at UC Davis to conduct further testing in nonhuman primates. If the preclinical testing meets safety and efficacy goals, Phase 1 human clinical trials would begin. Verndari estimates that testing from inception through Phase 1 human clinical trials will take approximately six months. The company is in consultation with the U.S. Food and Drug Administration (FDA) on its Investigational New Drug (IND) submission.
“We are excited to work with Verndari, Inc. to move its vaccine candidate through preclinical, and potentially clinical, studies,” said Prasant Mohapatra, vice chancellor for research at UC Davis. “This collaboration illustrates one of many ways that UC Davis is leveraging our unique expertise and established platform built on previous research for HIV, Zika and human cytomegalovirus in order to advance knowledge and solutions specific to COVID-19.”
“When we founded Verndari, Inc. we set about to transform the entire vaccination process, from development through vaccination,” said John H. Brown, president, and co-founder of Verndari, Inc. “Our goal is to enable more rapid development of more effective vaccines for both existing and emerging diseases that can be delivered at lower cost to populations around the world.”
Verndari’s unique VaxiPatch™ is a complete single-dose vaccination kit that uses a dermal patch with a microneedle array to deliver vaccines to the arm. The technology eliminates the need for refrigeration, a major cost factor in vaccination, and facilitates high-volume, automated manufacturing of vaccines. The vaccine technology can be used for both existing vaccines and new vaccines developed to meet emerging threats.
The VaxiPatch™ kit reduces or eliminates the reliance on healthcare professionals to administer vaccines and the need for sterile use of a needle and syringe. The vaccination is accomplished with a painless microneedle patch applied to the arm, which can potentially be self-administered.
Vaccine delivery to the skin rather than an intramuscular injection has advantages including production of a stronger immune response. It also has the promise of requiring the use of a significantly smaller dose of vaccine as compared to the traditional injection.
