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Inovio Gets FDA Go-Ahead To Initiate Covid-19 Vaccine Trial; Shares Rise 11%
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Inovio Gets FDA Go-Ahead To Initiate Covid-19 Vaccine Trial; Shares Rise 11%

Shares of Inovio Pharmaceuticals jumped 11% after the US Food & Drug Administration (FDA) cleared the way for the biotech company to launch the Phase 2 segment of its planned Phase 2/3 clinical trial for INO-4800, its COVID-19 vaccine candidate.

The Phase 2/3 clinical trial is a randomized, blinded, placebo-controlled safety and efficacy trial of INO-4800, which will be assessed among adults in the US, Inovio (INO) said. The Phase 2 segment of the trial will evaluate the safety, tolerability and immunogenicity of INO-4800 in a two-dose regimen (1 mg or 2 mg), in a three-to-one randomization to receive either INO-4800 or placebo for each dose depending on each of three age groups with high risks of infection (18-50 years, 51-64 years and 65 years and older).

“Initiation of our Phase 2 trial marks a pivotal milestone for INO-4800,” said Inovio’s CEO Joseph Kim. “INO-4800’s key differentiators are the safety and tolerability data we have observed thus far, as well as its excellent thermostability profile – making it possible to manufacture at scale and transport without frozen cold chain requirements. INO-4800 also maintains the ability to be safely re-administered and is differentiated by its ability to stimulate both CD4+ and CD8+ T cell responses.”

The Phase 2 segment of the trial plans to enroll about 400 participants at up to 17 US sites to test the safety and immunogenicity in order to determine the dosage for the subsequent efficacy evaluation planned for the Phase 3 segment.

For now, the Phase 3 segment of the trial remains on partial clinical hold until Inovio satisfactorily resolves the FDA’s remaining questions related to its Cellectra 2000 device that will be used to deploy INO-4800 directly into the skin. The company said that it seeks to resolve the remaining device questions during the Phase 2 segment, prior to the start of the Phase 3 segment of the trial.

The US Department of Defense (DoD) has agreed to provide funding for both the Phase 2 and Phase 3 segments of the clinical trial.

Inovio shares have spiked 276% so far this year, while analysts have a cautiously optimistic outlook on the stock with a Moderate Buy consensus. Looking ahead, the average analyst price target stands at $13.57, implying another almost 10% upside potential lies ahead.

Maxim Group analyst Jason McCarthy last week reiterated a Buy rating on the stock with a $20 price target saying that he was expecting the Phase 2/3 trial to get cleared by the FDA to proceed.

“We expect INO shares, which have pulled back since reaching a 52- week high in late June, to once again rise in value on the announcement,” McCarthy commented in a note to investors. “The timing is also critical as the COVID vaccine space is once again busy, as the late-stage players are beginning to report P2/3 and/or P3 data.” (See Inovio stock analysis on TipRanks).

Related News:
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