Therapy Areas: Autoimmune
First Subject Dosed in Phase 2 Clinical Trial for COVID-19 DNA Vaccine Candidate INO-4800 in China
11 December 2020 - - China-based emerging biotech company Advaccine Biopharmaceuticals Suzhou Co., Ltd, has dosed the first subject in a Phase 2 clinical trial for COVID-19 DNA vaccine candidate, INO-4800, in China, the companies said.

The Phase 2 clinical trial being conducted in China is independent of the US-based biotechnology company Inovio's (NASDAQ: INO) Phase 2/3 clinical trial of INO-4800 being advanced in the US and will enroll approximately 640 participants who are 18 years or older.

Advaccine is conducting and funding the Phase 2 trial in China, which is expected to fully enroll by the end of this month.

Inovio and Advaccine have been working together to advance the clinical development of INO-4800 in China.

The Phase 2 clinical trial of INO-4800 in China will enroll both 18-59 years old adults 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 and is similar to the Phase 2 segment of Phase 2/3 clinical trial in US.

This trial in China will provide valuable insights on INO-4800 safety and immunogenicity profile to support further evaluation of this vaccine candidate.

Inovio recently announced it has dosed the first subjects in the Phase 2 segment of its Phase 2/3 clinical trial for INO-4800 in the US, called INNOVATE (INOVIO INO-4800 Vaccine Trial for Efficacy).

The lead Principal Investigator for INNOVATE is Dr. Pablo Tebas, Professor of Medicine at the Hospital of the University of Pennsylvania.

The Phase 2 segment of the clinical trial is designed to evaluate safety, tolerability and immunogenicity of INO-4800 in a 2-dose regimen (1.0 mg or 2.0 mg), in a three-to-one randomization (in a planned total of 400 subjects) to receive either INO-4800 or placebo, to confirm the more appropriate dosing level for each of three age groups (18-50 years, 51-64 years and 65 years and older) for the subsequent Phase 3 efficacy evaluation.

The company strives to ensure diversity in enrollment, targeting specific populations that are working or residing in environments with high risk of exposure to SARS-CoV-2, for whom exposure may be relatively prolonged or for whom personal protective equipment may be inconsistently used, especially in confined settings.

The INNOVATE trial is funded by the US Department of Defense Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) in coordination with the Office of the Assistant secretary of Defense for Health Affairs (OASD) and the Defense Health Agency.

In the Phase 3 segment of the trial, Inovio intends to enroll healthy men and non-pregnant women 18 years and older, to evaluate the efficacy of the proposed dosing level(s) for each age group based on the data from the Phase 2 evaluation.

Participants will be enrolled in a one-to-one randomization to receive either INO-4800 or a placebo.

The Phase 3 segment will be case-driven with the final number of enrollees to be determined by the incidence of COVID-19 during the Phase 3 segment.

The primary endpoint of the Phase 3 segment will be virologically confirmed COVID-19 disease.

Inovio has assembled a global coalition of collaborators, partners and funders to rapidly advance the development of INO-4800.

To date, the Coalition for Epidemic Preparedness Innovations, the Bill and Melinda Gates Foundation, and the US Department of Defense have contributed significant funding to the advancement and manufacturing of INO-4800.R and D collaborators to date include The Wistar Institute, the University of Pennsylvania, the University of Texas, Fudan University and Laval University.

Inovio has partnered with Advaccine and the International Vaccine Institute to conduct clinical trials of INO-4800 in China and South Korea, respectively.

Inovio is also assessing nonclinical efficacy of INO-4800 in several animal challenge models with Public Health England and Commonwealth Scientific and Industrial Research Organization (CSIRO) in Australia.

Inovio is working with a team of contract manufacturers including Kaneka Eurogentec S.A, Thermo Fisher Scientific, Richter-Helm BioLogics, and Ology Bioservices to manufacture INO-4800 on a commercial scale and is seeking additional external funding and partnerships to further scale up manufacturing capacities to satisfy the urgent global demand for safe and effective vaccines.

INO-4800 is Inovio's DNA vaccine candidate against SARS-CoV-2, the novel coronavirus that causes COVID-19.

Inovio has extensive experience working with coronaviruses and was the first company to initiate a Phase 2a trial for INO-4700, a DNA vaccine candidate for a related coronavirus that causes Middle East Respiratory Syndrome.

Composed of an optimized DNA plasmid, INO-4800 is delivered directly into cells in the body via a proprietary smart device to produce a robust, safe and tolerable immune response.

INO-4800 is the only nucleic-acid based vaccine that is stable at room temperature for more than a year, at 37o C for more than a month, has a five-year projected shelf life and does not need to be frozen during transport or storage which are important considerations when preparing for mass immunizations.

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, being developed under grants from the Coalition for Epidemic Preparedness Innovations and the US Department of Defense.

DNA medicines are composed of optimized DNA plasmids, which are small circles of double-stranded DNA that are synthesized or reorganized by a computer sequencing technology and designed to produce a specific immune response in the body.

Inovio's DNA medicines deliver optimized plasmids directly into cells intramuscularly or intradermally using Inovio's proprietary hand-held smart device called Cellectra.

The Cellectra device uses a brief electrical pulse to reversibly open small pores in the cell to allow the plasmids to enter, overcoming a key limitation of other DNA and other nucleic acid approaches, such as mRNA.

Once inside the cell, the DNA plasmids enable the cell to produce the targeted antigen.

The antigen is processed naturally in the cell and triggers the desired T cell and antibody-mediated immune responses. Administration with the Cellectra device ensures that the DNA medicine is efficiently delivered directly into the body's cells, where it can go to work to drive an immune response.

Inovio's DNA medicines do not interfere with or change in any way an individual's own DNA.

The advantages of Inovio's DNA medicine platform are how fast DNA medicines can be designed and manufactured; the stability of the products, which do not require freezing in storage and transport; and the robust immune response, safety profile, and tolerability that have been observed in clinical trials.

Advaccine Biopharmaceuticals Suzhou Co., Ltd. is an emerging clinical stage immunotherapy company pioneering novel preventive and therapeutic vaccines against infectious diseases, cancers and autoimmune diseases.

Inovio is a biotechnology company focused on rapidly bringing to market precisely designed DNA medicines to treat and protect people from infectious diseases, cancer, and diseases associated with HPV.
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