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First-in-man Zika vaccine trials get green light

pharmafile | June 21, 2016 | News story | Manufacturing and Production, Research and Development trials, zika vaccine 

Inovio Pharmaceuticals (NASDAQ: INO) and GeneOne Life Science (KSE: 011000) have announced that approval has been granted for the commencement of the first Phase I human trial for their Zika virus vaccine, GLS-5700.

In preclinical testing, GLS-5700 managed to induce robust antibody and T cell responses in small and large animal models, demonstrating the its potential to prevent infection from the harmful pathogen in humans.

Zika was first identified in Uganda, but has spread rapidly over the past two years. To date it has reached the South Pacific, South America, Central America and the Caribbean. Studies have revealed that the potentially fatal virus also causes microcephaly and other birth defects.

The Phase I trial will test the safety, tolerability and immunogenicity of GLS-5700 in 40 healthy subjects. The vaccine will be delivered via Inovio’s proprietary DNA delivery device.

Inovio CEO, Dr J. Joseph Kim, says: “We are proud to have attained the approval to initiate the first Zika vaccine study in human volunteers. As of May 2016, 58 countries and territories reported continuing mosquito-borne transmission of the Zika virus; the incidences of viral infection and medical conditions caused by the virus are expanding, not contracting. We plan to dose our first subjects in the next weeks and expect to report Phase I interim results later this year.”

Inovia and GeneOne are developing this vaccine with academic collaborators from the US and Canada.

Inovio’s stock has risen 7% at the time of writing.

Sean Murray

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