Advaccine Biopharma Suzhou announced a $108 million agreement to acquire Greater China rights to a DNA vaccine for COVID-19 from Inovio (NSDQ: INO) of Pennsylvania. As part of the deal, Advaccine will out-license its plasmid manufacturing process to Innovio for use with INO-4800, the COVID vaccine, and its other candidates. Advaccine is already collaborating with Inovio in a China Phase II trial of INO-4800 that has enrolled 640 subjects. The endpoints of the test are safety and immunogenicity in a China population.

Inovio is testing INO-4800 in a Phase II 2-dose regimen that will evaluate 1.0 mg or 2.0 mg doses to determine the best level of administration for Phase III. The trial will enroll 400 subjects who will be randomized three-to-one to receive either INO-4800 or placebo.

Composed of an optimized DNA plasmid, INO-4800 is delivered directly into cells via a proprietary smart device that Inovio says produces a robust, safe and tolerable immune response. The Cellectra^® device uses a brief electrical pulse to reversibly open small pores in the cell that allows the plasmids to enter, overcoming a key limitation of other DNA and other nucleic acid approaches, the company believes.

Advaccine pointed out that INO-4800 is expected to be stable at room temperature for over a year, at 37^oC for more than a month, and a five-year projected shelf life at normal refrigeration temperature. It does not need to be frozen during transport or storage, which will be a plus in some areas of Southeast Asia.

Advaccine will make an upfront payment of $3 million to Inovio and pay up to $108 million in development and sales milestones for INO-4800 in Greater China, plus royalties. Advaccine will own the rights to develop, manufacture and commercialize INO-4800 within Mainland China, Hong Kong, Macao, and Taiwan. Both companies will share clinical data to support their regulatory filings.

Dr. Bin Wang, Founder and Chairman of Advaccine, said, "We are proud to build upon our current partnership with Inovio and join their global manufacturing consortium. Advaccine will leverage its innovative large-scale DNA plasmid manufacturing process developed over years -- our GMP manufacturing facility in Suzhou has the capacity to produce over one hundred million doses of DNA vaccine per year. Given the strong safety profile and robust immune responses observed in the US and China clinical trials of INO-4800, we are confident in the vaccine candidate and are fully committed to the manufacturing of INO-4800 for Greater China."

Dr. J. Joseph Kim, President and CEO of Inovio, said, "Inovio's partnership with Advaccine enables us to leverage their deep expertise, capabilities and network across the region – making it possible to rapidly produce and if and when approved, distribute our vaccine candidate to more people across Greater China. This agreement also provides Inovio with an Asian manufacturing partner with a near-term focus on INO-4800 and a long-term manufacturing resource potentially for other Inovio products."

Inovio said its global coalition of collaborators, partners and funders have helped speed up the development of INO-4800. To date, the Coalition for Epidemic Preparedness Innovations (CEPI), the Bill & Melinda Gates Foundation, and the U.S. Department of Defense have contributed funding to the advance and manufacture INO-4800.

Inovio has 15 DNA medicine clinical programs currently in development focused on HPV-associated diseases, cancer, and infectious diseases, including coronaviruses associated with MERS and COVID-19. Its vaccine candidates include a preventive vaccine based on a novel adjuvant for respiratory syncytial virus (RSV) infection in the elderly and infants, an immunotherapeutic vaccine against chronic hepatitis B (CHB), and immunotherapeutic vaccine candidates against autoimmune diseases and various cancers.

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Disclosure: none.