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Inovio Ends Enrollment in Anal Dysplasia Study on VGX-3100

Zacks Equity Research

Inovio Pharmaceuticals, Inc. INO announced that it has completed enrollment in a phase II study evaluating its lead HPV immunotherapy — VGX-3100 — for the treatment of anal dysplasia caused by human papillomavirus (HPV). The study will assess the efficacy and safety of VGX-3100 in 24 adult men and women with anal high-grade squamous intraepithelial lesions (anal HSIL). Preliminary efficacy data from the study is expected to be announced later this year.

Anal HSIL can often lead to HPV-associated squamous cell carcinoma of the anus (SCCA).

Notably, surgical excision, electro-cautery or laser therapy are the only forms of treatment available for patients with HPV-related anal dysplasia. However, half of these patients experience recurrence of the disease within one year of treatment and approximately 70% within three years of treatment, thereby requiring multiple treatment and repeated surgeries.

If approved, Inovio will be able to address this unmet medical need, which could effectively eliminate or delay surgery for the given patient population.

Shares of Inovio were up 2.5% following this news on Monday. However, the stock has plunged 39.3% so far this year wider than the industry’s decline of 2.1%.

VGX-3100, an HPV immunotherapy, is the most advanced candidate in Inovio’s pipeline.

Last month, the company concluded enrollment in another phase II study on VGX-3100 for the treatment of vulvar dysplasia caused by HPV. Interim data from this study is also expected before the end of 2019.

Moreover, in June, Inovio completed enrolling patients in the pivotal phase III study REVEAL 1, which is currently evaluating VGX-3100 for the treatment of cervical dysplasia caused by HPV. In March this year, Inovio had started recruiting patients in the confirmatory REVEAL 2 study. Based on the outcomes from this REVEAL 2 analysis, Inovio plans to submit a regulatory filing, seeking approval for VGX-3100 in 2021.

We would like to remind investors that in July, Inovio announced a strategic restructuring to prioritize the development of its late-stage HPV assets and reallocate capital to develop the fast-to-market product candidates. Following this, the company reduced its annual burn rate by 25% and cut workforce by 28%. Inovio also decided to trim some early-stage R&D programs while terminating the phase I/II study evaluating INO-5401 for the treatment of advanced bladder cancer.

Notably, in April this year, Inovio closed patient enrollment in the phase I/II study on its immuno-oncology combo of INO-5401 plus INO-9012 in combination with Regeneron REGN / Sanofi’s SNY PD-1 inhibitor Libtayo (cemiplimab) for treating the newly-diagnosed patients with glioblastoma (GBM).

The company expects to provide the interim progression-free survival and safety data on the above study by this year-end and the overall survival data in 2020.

Zacks Rank & Key Pick

Inovio currently carries a Zacks Rank #3 (Hold). A better-ranked stock in the healthcare sector is Alexion Pharmaceuticals, Inc. ALXN, which has a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here .

Alexion’s earnings estimates have been revised 4.2% upward for 2019 and 2.1% for 2020 over the past 60 days. The stock has rallied 15.8% year to date.

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