CEPI Awards up to US$21 Million to Themis Bioscience for Phase 3 Chikungunya Vaccine Development

Funding will support this registration study and rapid global
availability of the vaccine against Chikungunya

VIENNA & OSLO, Norway–(BUSINESS WIRE)–Themis
Bioscience and the Coalition for Epidemic Preparedness
Innovations (CEPI) announced a second partnering agreement under which
CEPI, with support from the European Union’s (EU’s) Horizon 2020
programme, will provide up to US$21 million of non-dilutive capital* for
Themis’ Phase 3-ready Chikungunya vaccine (MV-CHIK). The funding will
underwrite a collaborative effort to accelerate regulatory approval of
Themis’ Chikungunya vaccine and ensure that at-risk populations have
access to the vaccine. The agreement will provide a significant portion
of the capital required for Themis’ Phase 3 clinical trial. Clinical
trial applications will be submitted to regulatory authorities in the
second half of 2019, with the trial initiation expected shortly
thereafter. The pivotal multi-center Phase 3 trial will be launched in
Europe, US and the Americas and will also test a single-shot regimen.

The investment is part of CEPI’s third call for proposals, launched
earlier this year with support from the EU’s Horizon 2020 research and
innovation programme under grant agreement No. 857934. This call, which
is focused on the development of human vaccines against Chikungunya and
Rift Valley Fever viruses, is the first to be launched under the CEPI–EU
Framework Partnership Agreement to develop vaccines against emerging
infectious diseases.¹ CEPI’s collaboration with Themis is
also the first major agreement it has signed under its Chikungunya
vaccine development program.

The World Health Organization (WHO) has highlighted Chikungunya as a
major public health risk.² The disease was first identified
in Tanzania in 1952, with sporadic outbreaks of the disease reported
subsequently across Africa and Asia.^3,4 In 2004 the disease
began to spread quickly, causing large-scale outbreaks around the world.
Since the re-emergence of the virus, the total number of cases has been
estimated at over 3.4 million in 43 countries.⁵ Chikungunya
is spread by the bites of infected female Aedes mosquitoes and
causes fever, severe joint pain, muscle pain, headache, nausea, fatigue
and rash. Joint pain is often debilitating and can persist for weeks to
years.⁶

Climate change could further amplify the threat posed by Chikungunya. As
the climate warms, more areas across the world will become habitable for
the mosquito vectors that transmit the virus, thereby increasing the
size of the human population at risk of infection. In 2007, for example,
an outbreak of Chikungunya virus infections was declared for the first
time in Europe, with more than 200 human cases reported in Italy.⁷

Dr Richard Hatchett CEO of CEPI said:

“Our partnership with Themis represents an important step forward in the
world’s efforts to address Chikungunya. Through our partnership we look
to accelerate the development of this vaccine candidate and to ensure
that the people most affected by this virus can also benefit from this
product.”

Dr. Erich Tauber, CEO and founder of Themis said:

“We are honored to expand our partnership with CEPI and are grateful for
the positive collaboration to date as well as this funding, which will
help us start the Phase 3 trial of our vaccine, which will also test a
single-shot regimen, as well as further accelerate our rapid path toward
regulatory approval. Over the last year we have significantly solidified
our front-runner position in Chikungunya with the superior data from our
international Phase 2 study as well as positive interactions and
continued support from both the EMA and FDA.”

“The agreement with CEPI will further enable us to provide a vaccine in
case of an outbreak and keeps us within the timeline we had proposed in
delivering a vaccine for Chikungunya. This non-dilutive funding will
also extend our current resources for our earlier-stage vaccine and
oncology programs.”

Themis’ vaccine against Chikungunya virus has already received the
United States Food and Drug Administration (FDA) fast track designation
and the PRIority MEdicines (PRIME) designation by the European Medicines
Agency (EMA). Additionally, compelling positive results from the
completed Phase 2 trial to assess the safety, tolerability and
immunogenicity of the product, MV-CHIK, were published in the
peer-reviewed journal, The
Lancet.

Themis has established a versatile technology platform for the
discovery, development and production of vaccines as well as
immunomodulating therapies for cancer. The company’s first partnership
with CEPI, announced in March 2018, provided up to US$37 million in
funding to support vaccine development and manufacturing for Lassa fever
and MERS. It was the first partnering agreement that CEPI signed since
it was established in 2017 as a coalition to finance and coordinate the
development of new vaccines to prevent and contain infectious disease
epidemics. This followed shortly after the Global Health Investment Fund
(GHIF), a social impact investment fund, committed to lead the company’s
Series C financing round joining existing investors aws Gründerfonds,
Omnes Capital, Ventech and Wellington Partners.

About CEPI

CEPI is an innovative partnership between public, private,
philanthropic, and civil organisations launched in Davos in 2017 to
develop vaccines to stop future epidemics. CEPI has received multi-year
funding from Norway, Germany, Japan, Canada, Australia, and the Bill &
Melinda Gates Foundation, and Wellcome. CEPI has also received
single-year investments from the Government of Belgium and the United
Kingdom. The European Union provides financial support for relevant
projects through their Horizon 2020 programme as well as through the
European and Developing Countries Clinical Trials Partnership. CEPI has
reached over US$ 750 million of its $1 billion funding target. Since its
launch in January 2017, CEPI has announced three calls for proposals.
The first call was for candidate vaccines against Lassa virus, Middle
East Respiratory Syndrome coronavirus (MERS-CoV), and Nipah virus. The
second call was for the development of platforms that can be used for
rapid vaccine development against unknown pathogens. The third call is
for candidate vaccines against Chikungunya and Rift Valley fever
viruses. To date, CEPI has committed to investing over $370 million in
13 vaccine candidates (five against Lassa virus, four against MERS-CoV,
three against Nipah virus, one against Chikungunya) and three vaccine
platforms to develop vaccines against Disease X.

Learn more at CEPI.net. Follow us at @CEPIvaccines.

About Themis Bioscience

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 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.

¹ https://cepi.net/news_cepi/cepi-launches-call-for-proposals-to-develop-vaccines-against-rift-valley-fever-and-chikungunya-viruses/
²
https://www.who.int/blueprint/priority-diseases/en/
³
https://www.who.int/news-room/fact-sheets/detail/chikungunya
⁴
https://academic.oup.com/jid/article/214/suppl_5/S441/2632641
⁵
https://cmr.asm.org/content/31/1/e00104-16
⁶
https://jvi.asm.org/content/jvi/88/20/11644.full.pdf
⁷
https://ecdc.europa.eu/en/chikungunya/threats-and-outbreaks/chikungunya-fever-eueea
*Non-dilutive
capital: financing that does not require the sale of a company’s
shares, and hence does not cause dilution of the existing shareholders

Contacts

CEPI
Rachel Grant, Director of Communications and Advocacy:
+44(0)7891249190
[email protected]

Mario
Christodoulou, Communications and Advocacy Manager
+44(0)7979300222
[email protected]

Themis
Dr.
Stephanie May, Trophic Communications:
+49 171 185 56 82
[email protected]

Gretchen
Schweitzer, Trophic Communications:
+49 89 2388 7730
[email protected]