Inovio’s COVID-19 Vaccine INO-4800 Accomplished the Following:
- Durable antibody and T cell responses in rhesus macaques for 4 months.
- Long-term protection in non-human primates challenged with SARS-CoV-2 virus 13 weeks from vaccination. No other vaccine has demonstrated it.
- Reduced viral loads and faster viral clearance in macaques’ lungs and nasal passages as a result of a good Memory T and B cell responses.
- INO-4800 vaccination generated antibodies neutralizing both the earlier strain of the virus as well as the mutant variant (D614G) that has emerged with greater infectivity and now accounts for >80% of newly circulating virus.
No antibody-dependent enhanced disease events were reported.
Inovio’s (INO) COVID-19 DNA vaccine INO-4800 targeting SARS-CoV-2 (novel coronavirus or COVID-19) was effective in protecting non-human primates. Specifically, rhesus macaques from live virus challenge 13 weeks after the last vaccination. The protection was mediated by memory T and B cell immune responses from the INO-4800 vaccine.
These results, which were submitted to a peer-reviewed journal, demonstrate that INO-4800 reduced viral load in both the lower lungs and nasal passages in macaques that received two doses of INO-4800 (1 mg) four weeks apart and then were challenged with live virus 13 weeks after the second dose (study week 17).
This is the first time vaccine protection in non-human primates was reported from memory immune responses. The INO-4800-treated animals demonstrated seroconversion after a single vaccination with protective neutralizing antibodies and T cells lasting in their blood more than four months after the initial dose. The antibody levels were similar to or greater than those seen in patients who have recovered from COVID-19 and the T cell responses were significantly higher than those from convalescent patients.
Dr. J. Joseph Kim, President and Chief Executive Officer of Inovio, said, “All other previously reported NHP vaccine protection studies actually challenged the animals at the peak of their immune response. Our study demonstrates that INO-4800 could provide protection in a more real-world setting, where vaccine-generated memory immune responses protected NHPs for more than 3 months from the last vaccination. Given the importance of protective antibody and T cell responses, this study gives us more confidence as we continue to advance INO-4800 in the clinic. We believe INO-4800 holds significant potential to help address this global public health crisis.”
B cells are responsible for producing the antibodies that recognize SARS-CoV-2.
T cells play a role in killing the virally infected cells as well as supporting the B cell response.
The published data support that immunization achieved the following:
- INO-4800 limits active viral replication.
- INO-4800 has the potential to reduce the severity of the disease.
- INO-4800 reduced viral shedding in the nasal cavity.
In the study, researchers assessed the ability of INO-4800 to induce acute and memory T cell and B cell immune responses, including neutralizing antibody responses against both early virus as well as now-dominant G614 mutant variants.
This is the first report of vaccine-induced responses driving immunity against G614 variants. A strong anamnestic or memory T and B cell responses were demonstrated following challenge with the live virus.
Dr. Kate Broderick, Ph.D., Inovio’s Senior Vice President, Research & Development, further explains: “As we eagerly anticipate initiating a Phase 2/3 efficacy trials this summer, an animal challenge is currently the closest thing we have to test a vaccine’s efficacy when confronting a live virus. We are very encouraged with the duration of protection that INO-4800 demonstrated in this NHP study and look forward to reassessing its impact on the durability of response at 12 months out from our other ongoing non-human primate and animal challenge studies. In addition to safety and efficacy, it is essential that any vaccine targeting SARS-CoV-2 generates relevant durability of response.” Dr. Broderick added. “A vaccine that only provides protection for a very short period of time is not going to realistically solve the problem of this pandemic.”
A Separate Durability Study
A separate NHP study evaluating the durability of INO-4800 at 12 months after vaccination is currently underway. INO-4800 has also been selected by U.S. Operation Warp Speed for its COVID-19 non-human primate challenge study.
INO-4800 is Inovio’s DNA vaccine candidate. It is created to protect against the novel coronavirus SARS-CoV-2, which causes COVID-19.
INO-4800 is currently in Phase 1 trials in the U.S.
A Phase 2/3 trial is planned for the summer. Interim Phase 1 results showed a favorable safety profile and strong immunogenicity, including antibody and T cell responses. The Phase 1 study recently expanded to include adults over the age of 65 with no age limit given the propensity for COVID-19 to severely impact the health of older people. INO-4800 also is in Phase 1/2 trials for COVID-19 in South Korea and China.
INO-4800 was designed using Inovio’s proprietary DNA medicine platform rapidly after the publication of the genetic sequence of SARS-CoV-2. Inovio has extensive experience working with coronaviruses and is the only company with a Phase 2 vaccine for a related coronavirus that causes Middle East Respiratory Syndrome (MERS).
INO-4800 is the only nucleic-acid based vaccine that is stable at room temperature for more than a year and does not need to be frozen in the transport of storage, which are important factors when implementing mass immunizations.
About Inovio’s Pipeline
Inovio has 15 DNA medicine clinical programs focused on, HPV-associated diseases, cancer and infectious diseases, including coronaviruses associated with MERS and COVID-19 diseases being developed under grants from the Coalition for Epidemic Preparedness Innovations (CEPI) and the U.S. Department of Defense. DNA medicines are composed of optimized DNA plasmids, which are small circles of double-stranded DNA reorganized by computer sequencing technology and designed to produce a specific immune response in the body. The firm’s DNA products deliver optimized plasmids directly into cells intramuscularly or intradermally using Inovio’s proprietary hand-held smart device called CELLECTRA®. The 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.
Why the CELLECTRA device?
To ensure that the DNA medicine is efficiently delivered directly into the body’s cells where it can go to work to drive an immune response. Once inside the cell, the DNA plasmids enable the cell to produce the targeted antigen. The antigen triggers the desired T cell and antibody-mediated immune responses.
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 demonstrated in clinical trials.
With more than 2,000 patients receiving Inovio’s investigational DNA medicines in more than 7,000 applications across a range of clinical trials, Inovio has a strong track record of rapidly generating DNA medicine candidates with the potential to meet urgent global health needs.
We keep hearing skepticism of the mRNA and DNA because they are made through novel technologies and have never been tested. This is not the truth. A lot of vaccines created by these novel technologies have been tested in clinical trials but have yet to be approved because the country was not suffering an emergency situation and clinical trials usually take a long to be completed in normal times.
Inovio has vaccines for other diseases, including infectious diseases and cancers in mid- and late-Phases of clinical trials.
Inovio is the first company to have clinically demonstrated that DNA medicine can be delivered directly into cells in the body via a proprietary smart device to produce a robust and tolerable immune response.
We are in the middle of an unprecedented biological revolution that is changing the way medicine is practiced and diseases are treated and cured.
We are optimistic about the outcome of Inovio’s INO-4800 vaccine against COVID-19 infection as well as about the outcome of Moderna’s (MRNA) and Pfizer’s (PFE) + BioNTech’s vaccines. We are optimistic about AstraZeneca’s (AZN) vaccine and Regeneron’s (REGN) antibodies vaccine against COVID-19.
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