COLLEGE STATION, TX — A College Station company will manufacture and stock supply of a COVID-19 vaccine candidate.
Tonix Pharmaceuticals Holding Corp., a clinical-stage biopharmaceutical company, announced an agreement where FUJIFILM Diosynth Biotechnologies (FDB) will provide contract manufacturing and development services to support the manufacturing of Tonix’s COVID-19 vaccine candidate, TNX-1800, for clinical trial supply.
Under the agreement, FUJIFILM Diosynth Biotechnologies will develop a manufacturing process, manufacture, and stock a supply of TNX-1800 at FDB’s College Station, Texas site for Tonix’s clinical development.
FDB’s manufacturing site in College Station, Texas is a state-of-the-art facility designed to operate as a flexible, responsive contract manufacturing facility to support production on multiple scales as candidates move through the clinical process from clinical stages into commercialization.
“Tonix is proud to partner with FUJIFILM Diosynth Biotechnologies, a leader in pharmaceutical manufacturing and development,” said Seth Lederman, M.D., President and Chief Executive Officer. “Live replicating orthopoxvirus vaccines have the potential for scalability to supply very large markets because the projected dose of vaccine (2.5-12.5 x 105 PFU) is relatively low and it is typical to provide the vaccines with 100 doses in each glass vial as is the case for licensed smallpox vaccine. This collaboration allows Tonix to benefit from FUJIFILM Diosynth Biotechnologies’ leading technical expertise in process development and commercial cGMP production to have a meaningful impact in the fight against this pandemic.”
“FUJIFILM Diosynth Biotechnologies is excited to be Tonix’s manufacturing partner for TNX-1800, their potential vaccine for COVID-19,” said Martin Meeson, President and Chief Executive Officer. “We believe that our team’s expertise with vaccinia manufacturing may apply directly to manufacturing horsepox-based vaccines. FUJIFILM Diosynth Biotechnologies is capable of providing large scale production of viral vaccines to support the demands required in this pandemic.”
In February, Tonix announced a strategic collaboration with Southern Research to support the development of TNX-1800* (live modified horsepox virus vaccine for percutaneous administration) to protect against the new coronavirus disease, COVID-19, based on Tonix’s proprietary horsepox vaccine platform.
Tonix is developing TNX-801 (live horsepox virus vaccine for percutaneous administration) as a potential smallpox preventing vaccine for the U.S. strategic national stockpile and as a monkeypox preventing vaccine.
The Company believes that its proprietary horsepox virus has the potential to serve as a vector for vaccines to protect against other infectious agents.