–MV-CHIK met the primary endpoint, eliciting a potent immune response as measured by induction of neutralizing antibodies against Chikungunya, in all treatment groups–
–Up to 100% seroconversion rate achieved after two injections–
–Excellent safety and tolerability profile demonstrated–
Vienna, Austria, November 6, 2018 – Themis Bioscience announced today the publication of the Phase 2 results of its lead vaccine candidate (MV-CHIK) in The Lancet. The recently completed Phase 2 clinical trial was designed to assess the safety, tolerability and immunogenicity of MV-CHIK to protect against Chikungunya fever, a mosquito-transmitted disease that has no current treatment or prevention options. The trial, which included 263 healthy participants, was conducted at four study sites in Austria and Germany. The primary endpoint, defined as the presence of neutralizing antibodies against Chikungunya, four weeks after administration of one or two MV-CHIK injections, was met across all treatment groups. The article titled, “Immunogenicity, safety and tolerability of the Measles-vectored Chikungunya vaccine MV-CHIK: A double-blind, randomised, placebo- and Priorix-controlled Phase 2 trial” is available online under the following link:
“These positive results provide an important clinical proof-of-concept for MV-CHIK and position us for the initiation of a Phase 3 trial. They also highlight the capabilities of our measles vector platform to efficiently produce excellent vaccine candidates and bring us one step closer towards providing a vaccine product against Chikungunya, an emerging disease with significant outbreak potential and serious debilitating long-term effects,” commented Dr. Erich Tauber, CEO and founder of Themis. “The recent addition of Chikungunya fever to the Tropical Disease Priority Review Voucher Program of the US Food and Drug Administration is a clear indication that the development of a vaccine is urgently needed and we are highly committed to moving this program forward and seeking approval to commence a pivotal Phase 3 trial in the near term.”
MV-CHIK is the first candidate from Themis’ innovative immunomodulation platform based on the measles vector, one of the safest and most efficacious vaccines available. The double-blinded, randomized, placebo- and active comparator- controlled Phase 2 trial (Clinicaltrial.gov identifier NCT02861586) was designed to evaluate two dose levels by assessing immunogenicity, safety and tolerability of MV-CHIK. The trial also assessed the impact of pre-vaccination against the vector in two groups that received Priorix®, the live attenuated measles, mumps and rubella (MMR) vaccine, prior to MV-CHIK administration.
In the study, MV-CHIK induced neutralizing antibodies against Chikungunya in all treatment groups after two injections, with seroconversion rates ranging from 86.4% to 100.0%, depending on dose and administration schedule. The data also showed that pre-existing antibodies against the measles vaccine virus did not affect immunogenicity against Chikungunya. Adverse events related to the vaccine were highly similar between groups with no serious effects recorded. Overall these results suggest that MV-CHIK is a promising and potentially effective vaccine candidate for the prevention of Chikungunya.
Emil Reisinger from Rostock University Medical Center and a co-principal investigator of the study added, “Chikungunya has been identified in over 60 countries across Asia, Africa, Europe and the Americas. The outbreak prevalence has increased due to higher frequency of travel and the lack of treatment options and thus remains a major public health concern. We are excited about the very promising results we have observed in this study and the potential of MV-CHIK as an effective vaccine candidate against Chikungunya.”
Themis’ lead Chikungunya candidate has already been tested in over 600 study volunteers in the US, EU and Central America and was recently awarded PRIME designation status from the European Medicines Agency.
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, the Company has demonstrated the potential of its versatile platform through the rapid progression into Phase 2 clinical development for a vaccine against Chikungunya, a debilitating disease with global outbreak potential. Funded to date by leading Europe-based VCs, 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.
Dr. Erich Tauber, CEO
Phone: +43 1 236 7151
Media requests for Themis:
Gretchen Schweitzer or Dr. Stephanie May
Phone: +49 89 2388 7730 or +49 171 185 56 82