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Friday, 12/17/2021 5:08:33 PM

Friday, December 17, 2021 5:08:33 PM

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H.C. Wainwright’s Ram Selvaraju calls the developments “positive” and believes the company is making “solid progress” with its lead asset VGX-3100.

In the meantime, Inovio has been working on other, less headline grabbing candidates in its pipeline.

On Tuesday, Inovio provided an update from the development of the Phase 3 program for VGX-3100, indicated to treat HPV-associated cervical high-grade squamous intraepithelial lesions (HSIL).

In the REVEAL 1 study, the 52-week safety follow-up has been completed, and the drug’s safety profile showed it was well-tolerated between Week 36 and Week 88.

Furthermore, by Week 88, patients which met the primary endpoint at Week 36, stayed free of HPV-16 and/or HPV-18.

The company also said the second global Phase 3 clinical trial of VGX-3100 - The REVEAL 2 study - is now fully enrolled. Top-line efficacy and safety data is anticipated to be announced in 2H22.

Along with partner QIAGEN, progress is also being made in biomarker development. The two are collaborating on a pre-treatment biomarker which will raise the likelihood of a clinical response in biomarker-positive women with cervical HSIL. Next year should see additional updates for the progress of the liquid biopsy-based in vitro diagnostic (IVD).

Lastly, in the Chinese Phase 3 trial of VGX-3100 for cervical HSIL, the first participant has been dosed. The study is being overseen by Inovio’s Chinese partner ApolloBio, and its design follows the REVEAL 2 blueprint and will include 84 participants.

H.C. Wainwright’s Ram Selvaraju calls the developments “positive” and believes the company is making “solid progress” with its lead asset VGX-3100.

However, due to “market valuation and volatility," Selvaraju rates INO a Neutral (i.e. Hold without suggesting a price target.

In contrast, Selvaraju’s colleagues do have a target in mind, and a bullish one, at that. The figure comes in at $20.33, implying shares will be valued 234% higher in a year’s time. Overall, the stock has a Moderate Buy consensus rating, based on 2 Buys vs. 2 Holds.
https://www.nasdaq.com/articles/inovio%3A-making-progress-in-the-cervical-hsil-program
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