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Inovio's HPV Immunotherapy Moves to Phase III, Stock Rises
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Inovio Pharmaceuticals, Inc’s (INO - Free Report) shares rose over 10% after the company initiated a pivotal phase III REVEAL study to evaluate the safety and efficacy of immunotherapy, VGX-3100 to treat cervical dysplasia caused by human papillomavirus (HPV).
This phase III study initiation was delayed with the FDA placing clinical hold on the proposed program in Oct 2016. The regulatory agency had requested the company for additional data to support the shelf-life of newly designed and manufactured disposable parts of the Cellectra 5PSP immunotherapy delivery device.
Subsequently in Apr 2017, Inovio submitted a complete response to FDA for the study’s initiation. The issue was eventually resolved as FDA lifted the clinical hold after reviewing necessary testing and validation data submitted by the company.
Inovio’s shares have outperformed the Zacks classified Medical-Biomed/Genetics industry so far this year. The company’s shares have rallied 18.1% compared with the industry’s gain of 1.7%.
The phase III study will contain primary (REVEAL 1) and confirmatory trials (REVEAL 2). Both the studies will be conducted in parallel as per FDA’s guidance. The primary endpoint is regression of cervical HSIL and virologic clearance of HPV-16 and/or HPV-18 in the cervix. Each research will enroll around 198 patients in over 100 study centers globally. The company plans to start enrollment immediately.
In Apr 2017, Inovio also initiated a phase II study with VGX-3100 for treating patients with vulvar intraepithelial neoplasia (VIN).
Investors must remember that in Feb 2017, Inovio Pharma announced to divesting the exclusive rights to develop and commercialize Inovio's VGX-3100 in Greater China to Chinese biomedical firm, ApolloBio Corporation.
Per company’s sources, roughly 90% of HPV infections are cleared by a person’s immune system while persistent HPV infection can lead to cervical intraepithelial neoplasia (CIN) 2/3 and if untreated, eventually invasive cervical cancer. HPV 16/18 are the two most prevalent high-risk types of the disease across the world, causing vast majority of HPV-related cancers. There is an annual incidence rate of CIN 2/3 caused by HPV types 16 and 18 in over 400,000 pateints across the world. Currently, only two FDA approved preventive vaccines are available – Merck & Co., Inc.’s (MRK - Free Report) Gardasil and GlaxoSmithKline plc’s (GSK - Free Report) Cervarix.
However, preventive HPV vaccines cannot treat or protect those already infected with HPV, which is a large population. There is no viable immunotherapy or drug to fight the established HPV infection or treat cervical dysplasia and/or cancer caused by HPV either. In this scenario, we believe that the less invasive option, VGX-3100, will be well-received in the market, if approved.
Inovio currently carries a Zacks Rank #3 (Hold). A better-ranked stock in healthcare sector includes VIVUS, Inc. which sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
VIVUS’s loss per share estimates narrowed down from 50 cents to 39 cents for 2017 in the last 60 days. The company posted positive earnings surprises in all four trailing quarters with an average beat of 233.69%.
More Stock News: This Is Bigger than the iPhone!
It could become the mother of all technological revolutions. Apple sold a mere 1 billion iPhones in 10 years but a new breakthrough is expected to generate more than 27 billion devices in just 3 years, creating a $1.7 trillion market.
Zacks has just released a Special Report that spotlights this fast-emerging phenomenon and 6 tickers for taking advantage of it. If you don't buy now, you may kick yourself in 2020. Click here for the 6 trades >>
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Inovio's HPV Immunotherapy Moves to Phase III, Stock Rises
Inovio Pharmaceuticals, Inc’s (INO - Free Report) shares rose over 10% after the company initiated a pivotal phase III REVEAL study to evaluate the safety and efficacy of immunotherapy, VGX-3100 to treat cervical dysplasia caused by human papillomavirus (HPV).
This phase III study initiation was delayed with the FDA placing clinical hold on the proposed program in Oct 2016. The regulatory agency had requested the company for additional data to support the shelf-life of newly designed and manufactured disposable parts of the Cellectra 5PSP immunotherapy delivery device.
Subsequently in Apr 2017, Inovio submitted a complete response to FDA for the study’s initiation. The issue was eventually resolved as FDA lifted the clinical hold after reviewing necessary testing and validation data submitted by the company.
Inovio’s shares have outperformed the Zacks classified Medical-Biomed/Genetics industry so far this year. The company’s shares have rallied 18.1% compared with the industry’s gain of 1.7%.
The phase III study will contain primary (REVEAL 1) and confirmatory trials (REVEAL 2). Both the studies will be conducted in parallel as per FDA’s guidance. The primary endpoint is regression of cervical HSIL and virologic clearance of HPV-16 and/or HPV-18 in the cervix. Each research will enroll around 198 patients in over 100 study centers globally. The company plans to start enrollment immediately.
In Apr 2017, Inovio also initiated a phase II study with VGX-3100 for treating patients with vulvar intraepithelial neoplasia (VIN).
Investors must remember that in Feb 2017, Inovio Pharma announced to divesting the exclusive rights to develop and commercialize Inovio's VGX-3100 in Greater China to Chinese biomedical firm, ApolloBio Corporation.
Per company’s sources, roughly 90% of HPV infections are cleared by a person’s immune system while persistent HPV infection can lead to cervical intraepithelial neoplasia (CIN) 2/3 and if untreated, eventually invasive cervical cancer. HPV 16/18 are the two most prevalent high-risk types of the disease across the world, causing vast majority of HPV-related cancers. There is an annual incidence rate of CIN 2/3 caused by HPV types 16 and 18 in over 400,000 pateints across the world. Currently, only two FDA approved preventive vaccines are available – Merck & Co., Inc.’s (MRK - Free Report) Gardasil and GlaxoSmithKline plc’s (GSK - Free Report) Cervarix.
However, preventive HPV vaccines cannot treat or protect those already infected with HPV, which is a large population. There is no viable immunotherapy or drug to fight the established HPV infection or treat cervical dysplasia and/or cancer caused by HPV either. In this scenario, we believe that the less invasive option, VGX-3100, will be well-received in the market, if approved.
Inovio Pharmaceuticals, Inc. Price
Inovio Pharmaceuticals, Inc. Price | Inovio Pharmaceuticals, Inc. Quote
Zacks Rank & Key Picks
Inovio currently carries a Zacks Rank #3 (Hold). A better-ranked stock in healthcare sector includes VIVUS, Inc. which sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
VIVUS’s loss per share estimates narrowed down from 50 cents to 39 cents for 2017 in the last 60 days. The company posted positive earnings surprises in all four trailing quarters with an average beat of 233.69%.
More Stock News: This Is Bigger than the iPhone!
It could become the mother of all technological revolutions. Apple sold a mere 1 billion iPhones in 10 years but a new breakthrough is expected to generate more than 27 billion devices in just 3 years, creating a $1.7 trillion market.
Zacks has just released a Special Report that spotlights this fast-emerging phenomenon and 6 tickers for taking advantage of it. If you don't buy now, you may kick yourself in 2020. Click here for the 6 trades >>