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FDB to support Tonix in clinical-stage manufacturing for COVID-19 vaccine

Gareth Carpenter — 3 Jun 2020

Development partners believe orthopoxvirus vaccines have potential for scalability to supply very large markets 

Clinical stage biopharmaceutical firm Tonix Pharmaceuticals has announced an agreement with Fujifilm Diosynth Biotechnologies (FDB) in which the CDMO will support the manufacturing of Tonix’s COVID-19 vaccine candidate, TNX-1800, for clinical trial supply.

Under the terms of the deal, FDB will develop a manufacturing process, manufacture, and stock a supply of TNX-1800 at its College Station, Texas site for Tonix’s clinical development.

“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,” said Tonix President and Chief Executive Officer, Seth Lederman.

Martin Meeson, President and Chief Executive Officer of FBD said his team’s expertise with vaccinia manufacturing may apply directly to manufacturing horsepox-based vaccines.

“FDB is capable of providing large scale production of viral vaccines to support the demands required in this pandemic,” he added.

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 COVID-19, based on Tonix’s proprietary horsepox vaccine platform.

Tonix is also developing TNX-801 (live horsepox virus vaccine for percutaneous administration) as a potential smallpox preventing vaccine for the US strategic national stockpile and as a monkeypox preventing vaccine.

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