GLS-5700 SynCon® immunotherapy targeting Zika virus


Phase I

  • Zika preventive                      

Milestone

Initiated phase I trial 2Q 2016

Description
Inovio is developing GLS-5700, a DNA immunotherapy designed to provide broad protective antibody and therapeutic T cell responses against multiple strains of Zika virus.

Development Status
Inovio's Zika vaccine advanced into a phase I clinical trial in healthy volunteers in the second quarter of 2016. Inovio and GeneOne Life Science Inc. are co-developing GLS-5700 with academic collaborators from the US and Canada with whom they have previously collaborated to advance Inovio's Ebola and MERS vaccines into clinical development.

Disease State
Zika virus is a flavivirus, a family of viruses including yellow fever, dengue, and West Nile virus, which are introduced to people through mosquito bites. The Aedes mosquitoes species that spreads Zika virus is found throughout the world. As of July 2016, 65 countries and territories reported continuing mosquito-borne transmission of the Zika virus, compared to 33 countries stated by WHO in their first Zika situation report in February 2016. Zika can also be sexually transmitted.

No vaccine or therapy currently exists for the prevention or treatment of infection with the Zika virus.



Clinical Trials

Clinical Trials

GLS-5700 SynCon® Zika immunotherapy

GLS-5700 is a synthetic DNA plasmid vaccine against the Zika virus. ZIKA-001 is the first in man clinical trial of this vaccine which encodes for the pre-membrane, membrane and envelope regions of Zika virus.

The phase I, open-label, dose-ranging study of 40 healthy adult volunteers is evaluating the safety, tolerability and immunogenicity of GLS-5700 administered with the CELLECTRA®-3P device, Inovio’s proprietary intradermal DNA delivery device. In preclinical testing, this synthetic vaccine induced robust antibody and T cell responses - the immune responses necessary to fight viral infections - in small and large animal models.

Study Data

Study Data

GLS-5700 SynCon® Zika immunotherapy

Inovio’s synthetically generated DNA vaccine constructs target multiple Zika virus antigens using its SynCon vaccine technology. In a pre-clinical study, these SynCon constructs were administered using Inovio's CELLECTRA® electroporation delivery technology. Two doses of the Zika DNA vaccine delivered either intramuscularly or intradermally resulted in seroconversion, or the development of detectable specific antibodies in the blood, in all vaccinated non-human primates and mice. Researchers also observed that vaccination generated robust and broad T cell responses as analyzed by the standardized T cell ELISPOT assay. These findings are vital given the potential importance of neutralizing antibodies in preventing infection and the role T cells play in clearing infection by killing cells that harbor the virus.

More Information

More Information

Zika

The most common symptoms of Zika virus are fever, rash, joint pain, and conjunctivitis. Zika has been linked to a severe birth defect called microcephaly which arises from infection during pregnancy. Microcephaly is marked by an abnormally small head and incomplete brain development. Zika 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 breath. Recent reports suggest Zika may also be linked to other neurological abnormalities.