As the COVID-19 strain of coronavirus continues to spread around the globe, companies are scrambling to develop effective diagnostics and vaccines to contain the outbreak and reduce future threats. Among those is Inovio Pharmaceuticals Inc., of Plymouth Meeting, Pa., which has been awarded a $5 million grant from the Bill & Melinda Gates Foundation to speed testing and scale of smart delivery device for its COVID-19 vaccine candidate.

On March 11, the World Health Organization declared COVID-19 a pandemic, with 118,322 confirmed cases and 4,292 deaths across 108 countries. In the U.S., the number of confirmed cases and deaths has reached 696 and 25, respectively.

Inovio’s Cellectra 3PSP is a small, portable, battery-powered intradermal device intended for use in administering the company’s vaccines and therapies. Development of the device began last summer with $8.1 million in funding from the U.S. Defense Threat Reduction Agency’s Medical CBRN Defense Consortium. The award was also earmarked for the evaluation of DNA vaccines developed by the U.S. Army Medical Research Institute of Infectious Diseases using the Cellectra 3PSP device.

Convenient and easy to use

Designed with pandemic scenarios in mind, the next-generation Cellectra 3PSP operates on AA batteries and can be stockpiled in large quantities without special maintenance. The device delivers a short electrical pulse to open small pores in the cell, enabling the plasmid to enter. Once inside, the cell uses the plasmid to produce coded antigens, which trigger an immune response. Inovio emphasized that its current device, which is CE marked, has been used more than 6,000 times, with a good safety record.

With the new funds from the Gates Foundation, Inovio plans to accelerate testing and scale up of Cellectra 3PSP for the intradermal dosing of its DNA vaccine for COVID-19. INO-4800 is presently in preclinical testing, but Inovio expects to move the vaccine into phase 1 clinical testing in the U.S. next month. The Coalition for Epidemic Preparedness Innovations has promised $9 million to help fund the development of the vaccine. The company is also partnering with Beijing Advaccine Biotechnology Co. to conduct phase 1 testing of INO-4800 in China.

In line with those efforts and the growing threat of COVID-19, Inovio said its goal is to produce enough Cellectra 3PSP devices to support large scale manufacturing of INO-4800 doses by the end of the year.

“Inovio is grateful to the Bill & Melinda Gates Foundation for their continued investment in Inovio’s DNA medicines platform and for their support for DNA vaccines to potentially protect those at risk globally, given the current COVID-19 outbreak,” said Joseph Kim, Inovio’s president and CEO. “Our team of vaccine experts are working around the clock to advance INO-4800, and we look forward to attracting additional partnerships to expedite its development to meet this urgent global health need.”

1 million doses by year end

To that end, Inovio plans to deliver 1 million doses of INO-4800 and sufficient Cellectra 3PSP to support them by the close of 2020, using its currently available resources. The company is also working on a scenario for scaling production of both products to deliver millions of doses of vaccine against COVID-19.

To meet demands for increased capacity, Inovio is looking to contract manufacturers. The company plans to produce initial supplies of Cellectra 3PSP at its San Diego plant and show how design and scale up of the manufacturing process should be done, setting the stage for contract manufacturers to step in and help shoulder the load if necessary.

Inovio has taken on epidemic-scale infections before with its DNA medicine platform. In July 2019, the company reported positive results from the first-in-human phase I study of its INO-4700 vaccine to protect against Middle East Respiratory Syndrome (MERS), a coronavirus that first emerged in 2017. Patients inoculated against MERS with INO-4700, delivered via Cellectra, showed strong antigen-specific antibody (94%) and T cell (88%) responses at week 14 – two weeks after the third dose – and immune response was sustained through 60 weeks.

A number of medical device companies are developing COVID-19 products, mostly in diagnostics.

One company looking to treat the disease is CHF Solutions Inc., of Eden Prairie, Minn. The company’s Aquadex console filters patients’ blood, taking out excess plasma water to reduce fluid overload. CHF initially targeted the device for heart failure, but has expanded its use to other several other conditions. Interest in using Aquadex to reduce fluid build-up in COVID-19 patients has CHF now targeting that problem.

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