After offering £1 million last September to help move Themis’ Zika candidate into the clinic, the U.K. government innovation agency, Innovate UK, has injected new funding of £3 million into the biotech's Chikungunya vaccine project.
With an eye on late-stage testing, the Austrian vaccine specialist has also tapped the U.K.’s National Institute for Biological Standards and Control to develop a non-human primate challenge model for analyzing human serum, according to an announcement. After that, as preparation for a large-scale phase 3 study, the team will conduct a small phase 1 trial in the U.K. to validate the vaccine’s correlate of protection and to identify a protective antibody threshold against the Chikungunya virus.
The vaccine is already undergoing three parallel phase 2 trials in central Europe, the U.S. mainland and, most recently and with assistance from the Walter Reed Army Institute of Research, in Puerto Rico, an endemic area. All told, 700 participants will receive the vaccine in those studies.
Themis plans to share first results from the phase 2 program at the upcoming American Society of Tropical Medicine & Hygiene annual meeting in Baltimore, Themis CEO Erich Tauber told FiercePharma on Tuesday. Tauber said his company is discussing the clinical pathway to licensure with the EMA and the FDA. With all of the resources available to Themis right now, phase 3 manufacturing will likely start early next year, the helmsman added.
Themis’ live attenuated vaccine uses a platform developed with measles vaccine as the vector. The company, which licensed the technology from the Pasteur Institute, says the platform allows a rapid upscaling of a cost-effective vaccine production process and has a proven efficacy and safety profile. It is also applied in a Zika vaccine candidate currently in a phase 1 study at the Medical University of Vienna.
Besides Themis, India’s Bharat Biotech, California-based PaxVax, an alliance between Zydus Cadila and Takeda, as well as the U.S. Army are all developing Chikungunya vaccine candidates.