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Inovio Ends Enrollment in Vulvar Dysplasia Study on VGX-3100

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Inovio Pharmaceuticals, Inc. (INO - Free Report) announced that it has completed enrollment in a phase II study, evaluating its investigational HPV immunotherapy — VGX-3100 — for the treatment of vulvar dysplasia caused by human papillomavirus (HPV). The study will assess the efficacy, safety and tolerability of VGX-3100 in 33 women with high-grade HPV-related vulvar lesions.

The primary endpoint will measure the histologic clearance of high-grade lesions and virologic clearance of the HPV virus in vulvar tissue samples. Interim data from this study is expected before the end of 2019.

Notably, surgery is the most common form of treatment for women with HPV-related vulvar lesions as there are no FDA approved non-surgical options currently available. If granted a nod, Inovio will be able to address this unmet medical need by providing a non-surgical alternative as the disease often recurs in patients, who undergo surgery.

Shares of Inovio have lost 25.5% so far this year versus the industry’s increase of 3.9%.


VGX-3100 is the most advanced candidate in Inovio’s pipeline. Another phase II program is examining the efficacy of VGX-3100 in patients with anal dysplasia.

In late June, Inovio concluded enrollment in the pivotal phase III investigation of REVEAL 1, which is currently examining VGX-3100 for the treatment of cervical dysplasia caused by HPV. The study successfully achieved the recruitment target of 198 subjects. Earlier in March, Inovio started enrolling patients in the confirmatory REVEAL 2 probe. Based on the outcomes from this REVEAL 2 analysis, Inovio will submit a regulatory filing, seeking an approval for VGX-3100 in 2021.

We would like to remind investors that last August, Inovio entered into a partnership agreement with the AIDS Malignancy Consortium to evaluate VGX-3100 for treating HPV-associated precancerous conditions in patients, having tested positive for HIV.

Moreover, in May this year, Inovio formed a companion diagnostic alliance with the Dutch pharmaceutical company, Qiagen N.V. (QGEN - Free Report) . This collaboration is aimed at creating a liquid biopsy companion diagnostic test to guide the selection of patients, who would benefit from Inovio’s VGX-3100.

Zacks Rank & Stocks to Consider

Inovio currently carries a Zacks Rank #4 (Sell).

Better-ranked stocks in the healthcare sector include Merus N.V. (MRUS - Free Report) and Repligen Corporation (RGEN - Free Report) , both sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Merus’ loss per share estimates have been narrowed 24.6% for 2019 and 24% for 2020 over the past 60 days. The stock has gained 4.1% so far this year.

Repligen’s earnings estimates have been revised 8% upward for 2019 and 7.7% upward for 2020 over the past 60 days. The stock has soared 60.7% year to date.

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