Shares in Inovio Pharmaceuticals dropped as much as 31% Friday after the company said the US government stopped funding the Phase III portion of the INNOVATE trial testing its DNA vaccine candidate INO-4800 against COVID-19. Inovio said the decision was made due to the "broad availability" of COVID-19 vaccines in the US, and is not "a reflection of the data generated to date for INO-4800…[but] rather a fast-moving environment associated with the former Operation Warp Speed on decisions related to future products."
The US government will still continue to fund completion of the Phase II portion of INNOVATE, with results due in the second quarter. Meanwhile, Inovio is now planning a "predominantly ex-US" Phase III trial for INO-4800 to be conducted with its partner Advaccine based on an upcoming analysis of another mid-stage trial under way in China.
The company indicated that it continues to assess boosting capabilities for INO-4800, and is also evaluating its pan-COVID-19 variant vaccine candidate INO-4802, adding that with the two, it "remains well-positioned to support both pandemic and endemic vaccine needs." Earlier this month, study findings submitted for peer review showed that INO-4800 induced "broad cross-reactive immune responses" in humans against variants of concern, including "robust" T-cell responses against all SARS-CoV-2 spike protein variants tested.
The FDA has so far issued emergency-use authorisations (EUAs) for coronavirus vaccines from Pfizer and partner BioNTech, Moderna and Johnson & Johnson. AstraZeneca has said it plans to file its vaccine for an EUA in the first half of April, while Novavax has a vaccine candidate in late-stage testing and expects an EUA could come as early as May after soon-to-be-released data from its US trial are reviewed by regulators.
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