Moving onto manufacturing

SAN FRANCISCO—Vaxart, Inc. has entered into an agreement with Kindred Biosciences, Inc. for the manufacture of Vaxart’s lead oral vaccine candidate for COVID-19. In January, Vaxart initiated a program to develop a COVID-19 vaccine based on its VAAST oral vaccines platform. Vaxart has chosen its lead candidate based on the magnitude and the breadth of the immune response. 

“All our COVID-19 vaccine constructs were highly immunogenic in preclinical testing, and we are taking the candidate forward that is expected to generate the broadest immune response in humans. In a Phase 2 efficacy study that was recently published in the Lancet Infectious Diseases, we have demonstrated that our oral H1 flu tablet vaccine protected against influenza infection after just one dose,” noted Sean Tucker, Ph.D., chief scientific officer of Vaxart. “Based on these results, we believe our vaccines are ideal to protect against mucosal respiratory viruses such as SARS-CoV-2, the virus that causes COVID-19.”

Vaxart has contracted both with Emergent BioSolutions and Kindred Biosciences to produce bulk vaccine under cGMP for upcoming clinical trials. The partnership with Kindred is meant to to complement the manufacturing capacity of Emergent.

“We are proud to be contributing toward the effort to develop a COVID-19 vaccine,” said Richard Chin, M.D., chief executive officer of KindredBio. “We look forward to working with Vaxart to bring this innovative technology to patients as quickly as possible. This marks an important step in the development of our contract manufacturing business, which has the potential to help fund our promising pipeline.”

Under the terms of the agreement, KindredBio will provide manufacturing services from its state-of-the-art biological development and cGMP manufacturing facility in Burlingame, California. KindredBio will produce the candidate vaccine bulk drug substance under GMP guidelines, and provide it to Vaxart to be formulated into an oral vaccine tablet.

“We are very pleased to have an experienced partner such as KindredBio to help us meet global demand for our COVID-19 vaccine,” added Wouter Latour, M.D., chief executive officer of Vaxart. “The program with Emergent BioSolutions is progressing very well, and we expect KindredBio will add additional capacity to help produce bulk vaccine. An important benefit of our platform is that our vaccines are produced in tablet form and we don’t need the sterile fill and finish that is required for the production of injectable vaccines. Manufacturing of our COVID-19 vaccine is on track to start a first Phase 1 study in the second half of this year, possibly as early as the summer.”