CDMO Exothera selected for the development and GMP manufacturing of intranasal vaccine candidate for Phase III clinical trial is Europe and the U.S.
Vaccine company CyanVac has selected Exothera S.A., a full-service contract development and manufacturing organization (CDMO), for the development and manufacturing of their COVID-19 intranasal vaccine based on a proprietary parainfluenza virus 5 (PIV5) vector.
Exothera will be responsible for the fast-track development of a manufacturing process for CyanVac’s COVID-19 vaccine candidate, CVXGA1, using the unique scale-X platform. This cutting-edge platform and Exothera’s leadership in process development will enable CyanVac to produce GMP clinical trial material (CTM) in 2021 for planned phase 3 clinical studies.
CVXGA1 is a COVID-19 vaccine candidate based on CyanVac’s proprietary PIV5 vector that encodes the spike (S) protein of SARS-CoV-2. CyanVac is developing CVXGA1 as a single dose, intranasal vaccine to prevent SARS-CoV-2 infection and serious complications associated with COVID-19. Preclinical studies have demonstrated that CVXGA1 is immunogenic and prevents infection by SARS-CoV-2. CyanVac is planning to evaluate CVXGA1 in a Phase 1 clinical trial in the first half of 2021.
“We have selected Exothera as our CDMO to produce our Phase 3 clinical trial material because their experience with the scale-X fixed-bed bioreactor will enable us to rapidly produce millions of doses of our intranasal vaccine per batch to meet global demand,” said Biao He, CEO and founder of CyanVac.
CVXGA1 will be manufactured at Exothera’s Vega GMP plant, one of two new state-of-the-art GMP facilities located on the Univercells’ Jumet campus in Belgium. The Vega plant features the latest technology and will produce the vaccine for both the EU and U.S. markets.
Thibault Jonckheere, deputy CEO of Exothera, said, “We are delighted to partner with CyanVac to help them bring their product to the market as efficiently as possible, by utilizing our technological platforms and state-of-the-art GMP capabilities. Our goal is always to work hand in hand with our clients to deliver meaningful solutions together.”