Themis’ live attenuated recombinant Zika vaccine enters human testing

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Vienna-based Themis has moved its live attenuated recombinant Zika vaccine into clinical studies.

Themis is the most recent group to usher a Zika vaccine to the clinic with its live attenuated recombinant candidate, following other efforts by Inovio, the NIH, and a partnership between the Walter Reed Army Institute of Research and Sanofi.

The Austrian biotech created its shot with the measles virus vaccine vector platform it licensed from Institut Pasteur last summer. With the technology, selected antigens of Zika can be inserted, and when delivered, could trigger an immune response against the virus.

RELATED: Themis Biosciences nabs Institut Pasteur license for Zika vax; clinical trials planned

Erich Tauber, CEO and founder of Themis, said in a statement that the technology has a strong safety profile and could “induce a faster and more complete activation of the immune system leading to durable immunity.” The company previously used the platform in the development of a Chikungunya vaccine currently in phase 2; as soon as that project showed promise, they started applying it to development of a Zika candidate.

The phase 1 trial, to be conducted at the Department of Clinical Pharmacology and the Institute of Specific Prophylaxis and Tropical Medicine at the Medical University of Vienna, will enroll up to 48 healthy volunteers and will test three different regimens against placebo to determine the best dose, along with the typical target of immunogenicity, safety and tolerability.

The Vienna-based vaccine company closed its second round of financing worth €10 million (about $10.6 million) last November, and combined that with £1 million ($1.25 million) from the U.K. government to help move the Zika vaccine into clinical trials.

RELATED: Themis closes €10M Series B to support Chikungunya, Zika prospects

Before the clinical testing, Themis had already tested several Zika vaccine candidates in animal models, initiated a toxicity study and established GMP manufacturing, the company said in the release. 

Inovio’s first-in-human Zika vaccine has returned positive top-line data from an ongoing phase 1 trial. The NIH has also pushed its DNA vaccine into phase 2 while the phase 1 is ongoing. Sanofi is working with Brazil’s Fiocruz and Walter Reed on a candidate in clinical testing, with the NIH's National Institute of Allergy and Infectious Diseases currently helping the collaboration in several phase 1 trials.