INOVIO Announces Strategy to Address Omicron, Future SARS-CoV-2 Variants

INOVIO Pharmaceuticals

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.

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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:

  1. 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.
  2. 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.
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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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