Inovio Pharmaceuticals (INO): Moving to Phase 3 with First Potential Treatment for HPV Infection of the Cervix

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We've been following a company that has been making demonstrable progress in advancing the science of DNA immunotherapy that activates the body’s immune system to break its tolerance of cancerous cells and protect against diverse, changing strains of infectious diseases. Inovio Pharmaceuticals (NYSE: INO) has developed a platform technology with potentially very broad applicability to target a range of diseases while generating optimal antigen production in the body. Its lead candidate has the potential to be the first available treatment for human papillomavirus (HPV) infection of the cervix and the first non-surgical treatment for pre-cancerous cervical lesions.

Source: Inovio Pharmaceuticals Corporate Presentation, June 2017

Beginning Phase 3 for HPV-caused cervical dysplasia

Last week, Inovio announced that it had initiated a pivotal phase III study to evaluate the safety and efficacy of its lead candidate, VGX-3100, to treat cervical dysplasia caused by HPV. Current surgical methods do not treat the underlying HPV infection and carry increased risk of cervical incompetence and pre-term birth. This study will consist of primary and confirmatory trials conducted in parallel per the FDA’s guidance. The primary endpoint is regression of cervical high-grade squamous intraepithelial lesions (HSIL) and virologic clearance of HPV-16 and/or HPV-18 in the cervix. Each study will enroll 198 patients across over 100 study centers globally. Inovio also recently initiated a phase II study with VGX-3100 for treating patients with vulvar intraepithelial neoplasia (VIN).

Source: Inovio Pharmaceuticals Corporate Presentation, June 2017

Robust Clinical Pipeline

Inovio's platform technology has spawned a deep clinical pipeline, with five studies that have efficacy endpoints. Additionally, the company has partnered and is collaborating with industry leaders including Medimmune, wholly owned by AstraZeneca (NYSE: AZN), Regeneron (Nasdaq: REGN) and Genentech, wholly owned by Roche(Switzerland: ROG; OTCQX: RHHBY). Inovio also has multiple vaccine programs in early clinical stages, including developmental treatments for HIV, Ebola, MERS and Zika.

Source: Inovio Pharmaceuticals Corporate Presentation, June 2017

Experienced Leadership with Merck Roots

CEO Joseph Kim, PhD, co-founded VGX Pharmaceuticals, a synthetic vaccine company, in 2000 to develop intellectual property related to immunotherapeutics licensed from the University of Pennsylvania. He led that company for nine years and combined VGX with Inovio Biomedical in 2009 to form Inovio Pharmaceuticals. Previously, Dr. Kim was a senior vaccine developer at Merck & Co. where he successfully led efforts in manufacturing and process development for several FDA-approved products for hepatitis and developmental vaccines and therapeutics for HIV/AIDS.

The board of directors includes the former president of Merck Vaccines (NYSE: MRK) a former SVP at Merck Vaccines and the EVP of the Vaccine Center. The scientific advisory board includes thought leaders in vaccines, DNA vaccines and electroporation.

The stock trades actively on the NYSE MKT, with average daily volume of 1.5 million shares and a market cap of $580 million. Current revenues ($38 million over the last 12 months) are derived from collaborative R&D arrangements and grants. We'll be keeping close tabs on Inovio Pharmaceuticals, as its broad pipeline should manifest in numerous milestone achievements this year and going forward.

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Symbol Name Price Change % Volume
INO Inovio Pharmaceuticals Inc. 4.84 0.03 0.62 729,493 Trade
AZN Astrazeneca PLC 37.05 0.26 0.71 7,644,145 Trade
MRK Merck & Company Inc. (new) 58.45 -0.12 -0.20 8,928,530 Trade
REGN Regeneron Pharmaceuticals Inc. 294.68 -1.92 -0.65 441,936 Trade
RHHBY Roche Holding Ltd ADR (Sponsored) 28.14 -0.31 -1.07 1,390,381


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