INOVIO 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.
"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."
INOVIO 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.
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"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."
INOVIO plans to produce one million doses of INO-4800 by the end of 2020. Additional capacity provided by Richter-Helm will significantly expand manufacturing of this DNA vaccine candidate to meet urgent needs in the midst of the pandemic.
"Having a trusted and proven partner with extensive experience manufacturing INOVIO's DNA medicines is critical as we scale up our INO-4800 production," said Robert Juba, INOVIO's vice president of Biological Manufacturing and Clinical Supply Management. "We look forward to continue to work closely together in our efforts to reduce the worldwide impact of COVID-19."