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Themis Bioscience GmbH. (2/25/19). "Press Release: Themis Bioscience Receives FDA Fast Track Designation for Chikungunya Vaccine Candidate". Vienna.

	Region	United States (USA)
	Organisation	Themis Bioscience GmbH
	Group	Merck (US) (MSD) (Group)
	Organisation 2	FDA (US Food and Drug Administration)
	Group	United States (govt)
	Product	MV-CHIK Chikungunya fever vaccine
	Product 2	clinical research
	Person	Tauber, Erich (Themis Bioscience GmbH 201505 CEO)
	Person 2	Schweitzer, Gretchen (Trophic Comunications 201801 before MacDougall European Office)

Themis Bioscience, a biopharmaceutical company focused on immunomodulation therapies for infectious diseases and cancer, announced today that the United States Food and Drug Administration (FDA) has granted fast track designation to the Company’s lead vaccine candidate (MV-CHIK) for the prevention of Chikungunya, a debilitating disease with global outbreak potential. The program is the most advanced Chikungunya vaccine candidate and has already successfully completed Phase 2 clinical development with results recently published in The Lancet. 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, and has already been tested in over 600 study volunteers in the US, EU and Central America.

“Chikungunya has been identified in over 60 countries across Asia, Africa, Europe and the Americas and remains a major public health concern due to the increased outbreak prevalence,” said Erich Tauber, CEO of Themis Bioscience. “The FDA decision to grant fast track designation to MV-CHIK, recognizes the urgency to prevent this disease and will greatly support our pivotal Phase 3 development efforts this year. It will also allow us to work more closely with the FDA and expedite our efforts to provide a vaccine product to the population as soon as possible.”

The fast track process is designed to facilitate the development and expedite the review of investigational drugs to treat severe conditions and fill an unmet medical need.

About Themis

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 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.

Contact

For Themis:
Dr. Erich Tauber, CEO
Phone: +43 1 236 7151
erich.tauber@themisbio.com

Media requests for Themis:
Gretchen Schweitzer or Dr. Stephanie May
Trophic Communications
Phone: +49 89 2388 7730 or +49 171 185 56 82
may@trophic.eu

Record changed: 2023-06-05