Inovio Stock Up as Second Zika Virus Vaccine Study Begins

Inovio Pharmaceuticals, Inc. INO announced that it has initiated the second study on its preventive Zika vaccine, GLS-5700, in Puerto Rico. The company’s shares gained 4.6% on the news.

The placebo-controlled, double-blind study is being conducted in 160 healthy adult volunteers (80 patients will receive vaccine, while the other 80 will receive placebo) to evaluate the safety, tolerability and immunogenicity of GLS-5700 when administered with Inovio’s proprietary intradermal DNA vaccine delivery device. The company will also evaluate the differences in Zika infection rates in participants given either placebo or vaccine as part of an exploratory endpoint.

Positive results from the study will allow Inovio to meet regulators in 2017 to determine the path forward for the Zika vaccine. This June, Inovio initiated the first study (phase I) on GLS-5700 in the U.S. and Canada. The study has been fully enrolled and patients have been dosed and Inovio anticipates results by the year end.

We note that Inovio is co-developing the Zika vaccine with South Korean DNA vaccine developer, GeneOne Life Science, Inc., and academic collaborators from the U.S. and Canada. These academic collaborators have also been working with Inovio to advance its Ebola and MERS vaccines through clinical development.

Zika Outbreak: Public Health Emergency in Puerto Rico

The commencement of the second study by Inovio followed the U.S. Department of Health and Human Services declaration of the outbreak of Zika virus in Puerto Rico as a public health emergency in early August. The Center for Disease Control and Prevention believes that Zika virus will infect more than 25% of the Puerto Rican population by the year end.

The widespread Zika outbreak in Puerto Rico has created an immediate and exclusive opportunity for Inovio to explore the early signals of its vaccine efficacy. It is aimed to help contain the outbreak, which has now expanded into the continental U.S.

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About the Zika Virus

Per Inovio’s press release, this mosquito-borne virus has spread rapidly through the South Pacific and into South America, Central America and the Caribbean over the past 10 years. As of Aug 2016, 66 countries and territories have reported evidence of mosquito-borne transmission of the Zika virus since 2015, compared to the World Health Organization’s (WHO) first Zika situation report of 33 countries in Feb 2016. The outbreak of Zika virus was declared a public health emergency of international concern by the WHO in February.

Although Zika virus is generally associated with common symptoms like fever, rash, joint pain and conjunctivitis, it may also lead to a severe birth defect, called microcephaly (underdeveloped brains), in infants if their mothers are infected during pregnancy. Zika virus is also associated with Guillain-Barré syndrome, which causes muscle weakness of the limbs and in severe cases, may cause almost total paralysis including the inability to breathe.

With no approved vaccine or treatment for this contagious virus yet, companies including Intrexon Corporation XON are looking to develop Zika virus vaccines. However, only Inovio and a U.S. government research center have started clinical studies so far.

Inovio is a Zacks Rank #3 (Hold) stock. A couple of better-ranked stocks in the health care sector are ANI Pharmaceuticals, Inc. ANIP and Geron Corporation GERN, both sporting a Zacks Rank #1 (Strong Buy).

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