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INOVIO Expands Manufacturing of COVID-19 DNA Vaccine INO-4800 With New Funding from CEPI
INOVIO and Richter-Helm BioLogics will expand existing DNA manufacturing agreement to support large-scale manufacturing of INO-4800 INO-4800 Phase 2/3 U.S.
About this update from Inovio Pharmaceuticals, Inc.
[{"type":"text","content":"INOVIO and Richter-Helm BioLogics will expand existing DNA manufacturing agreement to support large-scale manufacturing of INO-4800\n INO-4800 Phase 2/3 U.S. clinical trial being prepared to start this summer\n\n\nPLYMOUTH MEETING, Pa., April 30, 2020 /PRNewswire/ -- INOVIO (NASDAQ:INO) today announced it has entered into an agreement to expand its manufacturing partnership with the German contract manufacturer Richter-Helm BioLogics GmbH & Co. KG, to support large-scale manufacturing of INOVIO's investigational DNA vaccine INO-4800, which currently is in Phase 1 clinical testing in the U.S. for COVID-19 and could potentially advance to Phase 2/3 efficacy trials this summer. The agreement is being partly funded by an initial grant of $1.3 million from the Coalition for Epidemic Preparedness Innovations (CEPI), which brings CEPI's total support to date for the development of INO-4800 to $17.2 million. \n\"We are grateful to CEPI for its continued generous funding and pleased to expand our work with Richter-Helm BioLogics to support large-scale manufacturing capacity for INO-4800,\" said INOVIO's President & CEO, Dr. J. Joseph Kim. \"Richter-Helm has deep experience working with our optimized DNA plasmids, which are the building blocks of our DNA vaccines, and have consistently produced DNA medicines of the highest quality under stringent GMP standards.\"\nINOVIO has been working with Richter-Helm BioLogics, which manufactures INOVIO's DNA medicine candidate VGX-3100, since 2014. Currently, VGX-3100 is in Phase 3 clinical trials for the treatment of precancerous cervical dysplasia caused by high-risk human papillomavirus (HPV). INOVIO has established commercial-scale plasmid production at Richter-Helm BioLogics for its DNA medicines platform, with successful technology transfer already demonstrated for VGX-3100 and an Advanced Therapy Medicinal Product (ATMP) certification granted by the European Medicines Agency (EMA) in May 2019.\n\"Richter-Helm BioLogics has a strong, long-standing relationship with INOVIO and is a leading manufacturer of DNA plasmids,\" said Richter-Helm BioLogics' Managing Director Dr. Kai Pohlmeyer. \"We will mobilize all our resources to ensure sufficient supply of late-stage clinical and commercial batches of INO-4800 and contribute to the fight against the deadly COVID-19 pandemic.\"\nINOVIO plans to prod...