PLYMOUTH MEETING, PA — INOVIO (NASDAQ: INO) announced the company is rapidly moving to evaluate its COVID-19 DNA vaccine candidates INO-4800 and INO-4802 against the emerging B.1.1.529 (Omicron) variant of concern. Concurrently, INOVIO has initiated pre-clinical development of an Omicron-specific DNA vaccine candidate and will progress if needed.
The Omicron variant of SARS-CoV-2 is the latest variant to emerge, following previous variants of concern (VOCs), Alpha, Beta, Gamma and Delta. Notably, INO-4800 has maintained T cell responses against these previously identified VOCs as well as the ability to generate binding and neutralizing antibodies against them. Generally, T cell immune responses are less likely to be evaded by multiple mutations, and the ability to generate a strong T cell response is likely to play a crucial role in reducing mortality and the severity of symptoms in those infected. More specifically, Omicron mutations at the T cell level is predicted to be only 2%, supporting that majority of the T cell epitopes induced by T cell generating vaccines such as INO-4800 will likely remain capable of targeting this variant. INOVIO plans to test clinical samples from their INO-4800 vaccine candidate as well as the Company’s Pan-COVID-19 vaccine candidate INO-4802 against the Omicron variant to assess the generation of immune responses, with data expected in the coming weeks.
Dr. J. Joseph Kim, INOVIO’s President and CEO, said, “INOVIO is moving rapidly to test its COVID-19 vaccine candidates against the emerging Omicron variant. Both INO-4800, our lead candidate vaccine currently in Phase 3 testing) and INO-4802, our Pan-COVID-19 vaccine candidate, have maintained T cell responses and generated neutralizing antibodies against previous SARS-CoV-2 VOCs. In particular, we believe that INO-4800’s ability to generate durable T cell responses, which could be resilient to changes in the SARS-CoV-2 virus, positions INO-4800 as a potentially important tool in the U.S. and international arsenal against both current and future variants.”
Since late 2020, INOVIO has been advancing a comprehensive strategy to address both existing and new VOCs.
To address the Omicron variant, INOVIO is:
- Rapidly assessing INO-4800 samples from clinical trial participants against the Omicron variant using lab-based read-outs. INOVIO has generated clinical data demonstrating that immune responses following vaccination with INO-4800 are reactive to the Alpha, Beta, Gamma and Delta VOCs. INOVIO is working rapidly to assess the immune responses against the Omicron variant; data are expected in the coming weeks.
- Testing INO-4802, a Pan-COVID-19 vaccine candidate, against Omicron. INOVIO has been proactively developing INO-4802 as a second-generation Pan-COVID 19 vaccine to potentially address future variants. Published preclinical data with INO-4802 in multiple animal models revealed both broader and increased levels of neutralizing antibodies against a panel of variants over strain-matched vaccines. INOVIO will analyze the preclinical samples from INO-4802 to assess the immune responses against the Omicron variant and anticipates data in the coming weeks.
INO-4800 is undergoing Phase 3 evaluations as a 2-dose regimen. However, given its tolerability and immunologic profile to date, as well as lack of an anti-vector response, INO-4800 may also serve as a heterologous booster independent of the primary vaccination regimen. INO-4800 is composed of a precisely designed DNA plasmid that is administered intradermally followed by electroporation using a proprietary smart device, which delivers the DNA plasmid directly into cells in the dermis of the skin and is intended to produce a well-tolerated immune response. INO-4800 is stable at room temperature for more than a year, at 37°C for more than a month, has a five-year projected shelf life at normal refrigeration temperature and does not need to be frozen during transport or storage. The ability to distribute INO-4800, and to license to global manufacturers, without the burden and expense of frozen cold-chain logistics, indicate the suitability of this DNA vaccine for international deployment at scale.
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