Themis Bioscience announced today the initiation of a Phase 1 clinical trial of a second-generation Zika vaccine. The vaccine candidate is based on Themis’ proprietary measles vector platform, which includes exclusively licensed technology from Institut Pasteur. It was initially developed by Institut Pasteur as part of the ZIKAVAX consortium, coordinated by the European Vaccine Initiative (EVI) and including Themis and the Commissariat à l’énergie atomique et aux énergies alternatives (CEA). The four-year collaborative project covers pre-clinical and clinical development and is funded under the European Union’s Horizon 2020 Research and Innovation Program (H2020 grant agreement No 732432) with an overall budget of €5 million. The Phase 1 program and further development will be run by Themis and this first trial will evaluate the safety and immunogenicity of the candidate in healthy volunteers.
“Zika remains a global health burden with no existing vaccines, a situation exacerbated by the ongoing increase of the geographical areas exposed to the virus,” said Erich Tauber, MD, CEO of Themis Bioscience. “Together with the ZIKAVAX consortium, we have applied the immune modulation potential of our measles vector approach as well as our growing clinical development expertise to provide an urgently needed Zika vaccine. Our long-standing collaborative partnership with the Institut Pasteur has been fundamental in developing this and a number of other innovative vaccine candidates, the first of which has been validated through our Phase 3-ready Chikungunya vaccine.”
Dr Nicola Viebig, Chief Scientific Officer of EVI added: “EVI´s mission to accelerate the development of vaccines for global health crucially depends on bringing together the right partners to leverage synergies. The ZIKAVAX is a good demonstration of these efforts. Based on the in vitro and in vivo data we have gathered within the collaboration, we believe that Themis’ measles vector platform provides a promising approach for developing a safe and efficacious Zika vaccine, which we will further investigate in this clinical study.”
The observer-blinded, randomized trial will investigate the safety and tolerability of the novel Zika vaccine formulation in 48 healthy volunteers. The vaccine will be administered by intra-muscular injection in two different dose levels. Secondary objectives will include optimal dose-finding, immunogenicity and long-term safety evaluation, as well as cell-mediated immunity specific to the Zika antigen.
This is the second Zika program based on Themis’ measles vector platform to enter the clinic. The first Themis-developed Zika program was funded through an InnovateUK grant and clinical evaluation is ongoing. Themis’ lead program is a Phase 3-ready Chikungunya vaccine. The company’s pipeline includes additional earlier-staged vaccines and immuno-oncology development programs. Themis holds an exclusive license from the Institut Pasteur for its measles vector technology.
Zika virus is a mosquito-born infectious disease that causes a mild illness in healthy adults, however, Zika virus infection during pregnancy can cause infants to be born with microcephaly. The first association of Zika infection and microcephaly were reported in 2015 in Brazil. Since that time, outbreaks and evidence of transmission have been documented throughout the world with a total of 86 countries and territories currently reporting evidence of mosquito-transmitted Zika infection.
Themis is developing immunomodulation therapies for infectious diseases and cancer. Through advanced understanding of immune system mechanisms, the Company has built a sophisticated and versatile technology platform for the discovery, development and production of vaccines as well as other immune system activation approaches. Initially focused on preventing infectious diseases, Themis has demonstrated the potential of its versatile platform through the rapid and successful completion of Phase 2 and near-term entry into Phase 3 clinical development for a vaccine against Chikungunya, a debilitating disease with global outbreak potential. Funded to date by leading venture capital firms, Themis has also gained prestigious non-dilutive funding for emerging infectious disease indications. The Company will apply its platform and commercial manufacturing capabilities to diseases with high market potential both alone and for its partners. For more information, visit http://www.themisbio.com.