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Inovio: Making Progress in the Cervical HSIL Program

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Inovio (INO) made a big splash last year with its Covid-19 DNA vaccine candidate INO-4800. Development, however, has been slow, and the vaccine is still a while away from entering the market, should it ever get that far.

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. (To watch Selvaraju’s track record, click here)

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. (See INO stock analysis on TipRanks)

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Disclaimer: The opinions expressed in this article are solely those of the featured analyst. The content is intended to be used for informational purposes only. It is very important to do your own analysis before making any investment.