Pennsylvania Bio Firm Announces COVID-19 DNA Vaccine Partnership in China
A Pennsylvania based biotechnology company and Advaccine Biopharmaceuticals Suzhou Co., Ltd. announced that they have entered into a collaboration and license agreement for the experimental COVID-19 DNA vaccine INO-4800.
INO-4800 is a DNA vaccine candidate matched to the SARS-CoV-2 coronavirus, which causes the COVID-19 disease in humans.
Under the collaboration and license agreement, INOVIO agreed that Advaccine would have the exclusive right to develop, manufacture, and commercialize INO-4800 within Greater China, inclusive of Mainland China, Hong Kong, Macao Taiwan.
Advaccine will license its plasmid manufacturing process for use with INO-4800 and other INOVIO pipeline product candidates to INOVIO with the right to sublicense to INOVIO's manufacturing partners.
Additionally, Advaccine will provide its clinical data to INOVIO to support INOVIO's global INO-4800 regulatory filings. INOVIO will provide its INO-4800 clinical data to be incorporated into Advaccine’s marketing applications in Greater China.
Dr. J. Joseph Kim, President and Chief Executive Officer of INOVIO, said in a press release, "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 says INO-4800 is the only nucleic-acid-based vaccine stable at room temperature for more than a year and does not require frozen in transport or for years of storage, which are essential factors when implementing mass immunizations to battle the current pandemic.
Dr. Bin Wang, Founder and Chairman of Advaccine, added, "Advaccine will leverage its innovative large-scale DNA plasmid manufacturing process developed over the years -- our GMP manufacturing facility in Suzhou can produce over one hundred million doses of DNA vaccine per year.”
“Given the strong safety profile and robust immune responses observed in the U.S. 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.”
“INO-4800 is projected to be stable at room temperature for over a year, at 37 Celsius for more than a month, and with a five-year projected shelf life at normal refrigeration temperature. INO-4800 does not need to be frozen during transport or storage – a critical element when considering the feasibility of distribution in Greater China and globally."
INOVIO and Advaccine stated they have been working together to advance the clinical development of INO-4800 in China, having all 640 subjects dosed for the first vaccination in Phase 2 clinical trial in China.
The Phase 2 clinical trial of INO-4800 in China has enrolled both adults who are 18-59 years old and older adults (60 years and older) with the primary endpoints of evaluating safety and immunogenicity within the Chinese population.
The dosing regimen involves two vaccinations at 0 and 28 days with either 1.0 mg or 2.0 mg dosing levels, similar to the independently run Phase 2 segment of INOVIO's Phase 2/3 clinical trial for INO-4800 in the U.S, called INNOVATE (INOVIO INO-4800 Vaccine Trial for Efficacy).
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