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Inovio Initiates Phase II Study On Pipeline Drug VGX-3100

Published 05/22/2018, 12:01 AM
Updated 07/09/2023, 06:31 AM
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Inovio Pharmaceuticals, (NASDAQ:INO) has initiated a phase II study to evaluate the efficacy of its pipeline candidate VGX-3100 on adult men and women with human papilloma virus (HPV)-related anal dysplasia. This will be the third indication that VGX-3100 will be evaluated for. It is already being evaluated to treat HPV-related vulvar and anal precancers.

In the phase II study, VGX-3100 will be administered by intramuscular (IM) injection with CELLECTRAdelivery system in adult men and women who are human immunodeficiency virus (HIV) negative with histologically confirmed anal or perianal high-grade squamous intraepithelial lesions (HSIL) associated with HPV-16 and/or HPV-18. The study is expected to enroll 24 patients and will administer at least three doses of VGX-3100. In a phase II study for cervical dysplasia, VGX-3100 demonstrated a systemic response (versus localized surgery) and clearance of cervical lesions and eliminating the underlying HPV infection in many patients.

Anal HSIL or dysplasia is the precursor to anal cancer, which is estimated to cause more than 1,100 deaths in the United States in 2018. Currently the only treatments for anal dysplasia are surgical excision and electro-cautery or laser therapy. However, more than 50% treated with these current treatments experience recurrence of the disease. VGX-3100 has potential to be the first approved treatment for HPV infection of the cervix and the first non-surgical treatment for precancerous cervical lesions.

Year to date, shares of Inovio have rallied 16.5% against the industry’s decline of 9.8%.

VGX-3100 a DNA based immunotherapy, is the most advanced candidate in the company’s pipeline, and is currently being evaluated in a phase III study for the treatment of cervical dysplasia caused by HPV. The company is also conducting a phase II study to examine the efficacy of VGX-3100 in women with HPV-related vulvar neoplasia. Moreover, the company is evaluating MEDI0457 (a combination of VGX-3100 and its DNA-based IL-12 cytokine) in phase II studies in combination with the AstraZeneca’s (NYSE:AZN) PD-L1 checkpoint inhibitor, Imfinzi, for the treatment of HPV-caused cervical, and head and neck cancers.

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Zacks Rank & Stocks to Consider

Inovio has a Zacks Rank #4 (Sell)

Some better-ranked stocks from the same space are Illumina, Inc. (NASDAQ:ILMN) and Ligand Pharmaceuticals (NASDAQ:LGND) . While Illumina sports a Zacks Rank#1 (Strong Buy), Ligand carries a Zacks Rank #2 (Buy).You can see the complete list of today’s Zacks #1 Rank stocks here.

Illumina’s earnings per share estimates have moved up from $4.60 to $4.84 for 2018 and from $5.34 to $5.57 for 2019 over the last 30 days. The company delivered a positive earnings surprise in all the trailing four quarters with an average beat of 23.17%. The stock has gained 22.8% so far this year.

Ligand’s earnings per share estimates have been revised upward from $4.07 to $4.37 for 2018 over the past 60 days. The company came up with a positive earnings surprise in all the last four quarters with an average beat of 31.79%. Shares of the company have surged 35.4% year to date.

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Illumina, Inc. (ILMN): Free Stock Analysis Report

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Inovio Pharmaceuticals, Inc. (INO): Free Stock Analysis Report

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