On Apr. 30, 2020, INOVIO announced 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.

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.

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.

Richter-Helm Biologics is using manufacturing technology developed by VGXI, a wholly owned subsidiary of GeneOne Life Science (KSE:011000} and INOVIO’s contract manufacturer for early-stage clinical trial supply, under a license agreement from VGXI. Richter-Helm BioLogics will transfer and rapidly scale up the current (400 L scale) production process for the INO-4800 DNA plasmid from VGXI. Richter-Helm BioLogics and VGXI already share a long-term partnership that has resulted in numerous joint projects and project transfers followed by plasmid DNA production for commercial supply at Richter-Helm BioLogics´ facilities, including the technology transfer and Phase 3 manufacturing for VGX-3100.

INO-4800 is INOVIO’s DNA vaccine candidate created to protect against the novel coronavirus SARS-CoV-2, which causes COVID-19. INO-4800 was designed using INOVIO’s proprietary DNA medicine platform rapidly after the publication of the genetic sequence of the coronavirus that causes COVID-19. INOVIO has deep experience working with coronaviruses and is the only company with a Phase 2a vaccine for a related coronavirus that causes Middle East Respiratory Syndrome (MERS).