10 September 2020 | News
INOVIO adds Thermo Fisher Scientific to global manufacturing consortium as it plans to have 100 Million doses of COVID-19 vaccine candidate INO-4800 manufactured in 2021
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INOVIO, a biotechnology company focused on bringing to market precisely designed DNA medicines to treat and protect people from infectious diseases and cancer in the US, has announced that Thermo Fisher Scientific, the world leader in serving science, has signed a letter of intent to manufacture INOVIO's DNA COVID-19 vaccine candidate INO-4800.
Thermo Fisher joins other contract development and manufacturing organizations in INOVIO's global manufacturing consortium, enabling INOVIO to potentially scale commercial production of INO-4800. With its consortium of third-party manufacturers, INOVIO plans to have 100 million doses of INO-4800 manufactured in 2021, subject to FDA approval of INO-4800 for use as a COVID-19 vaccine. Thermo Fisher plans to manufacture INO-4800 drug substance as well as perform fill and finish of INO-4800 drug product at its commercial facilities in the US. At peak capacity, Thermo Fisher projects that it could produce at least 100 million doses of INO-4800 annually.
Thermo Fisher Scientific will join existing partners Richter-Helm BioLogics and Ology Biosciences in INOVIO's global manufacturing consortium. INOVIO is in active discussions with additional manufacturers to join the consortium as INOVIO seeks to complement its existing members with additional manufacturing partnerships to meet global supply needs.
INOVIO is conducting a Phase 1 clinical trial of INO-4800 in the United States and has submitted the full trial results for the first 40 subjects for publication in a peer-reviewed journal. The company plans to initiate its Phase 2/3 COVID-19 vaccine trials in September, subject to FDA clearance to proceed.
INO-4800 is administered via INOVIO's proprietary CELLECTRA® smart delivery device, which delivers the vaccine locally into the patient's skin, a process that takes only a few seconds.