ExpreS2ion announces the initiation of a Phase I/IIa clinical trial for a new blood-stage malaria vaccine

Horsholm, Denmark, October 18, 2016 – Today, ExpreS2ion Biotech Holding AB
(“ExpreS2ion”) announces that its collaboration partner, the Jenner Institute of
the University of Oxford, initiates a Phase I/IIa clinical trial to assess the
safety, immunogenicity, and efficacy of the blood-stage Plasmodium falciparum
malaria antigen RH5.1, which is produced in ExpreS2ion’s proprietary platform,
ExpreS2.
The Vaccine

RH5.1 is a novel, recombinant malaria antigen developed at the Jenner Institute.
It is based on recombinant RH5.1 protein produced in the ExpreS2 platform using
Drosophila Schneider 2 cells. RH5.1 is a part of a larger protein complex
expressed by the malaria parasite during infection, helping it to invade red
blood cells and causing the disease.  The RH5.1 vaccine is intended to block red
blood cell invasion and thus the progression of the disease.

The study

The present study is funded by Leidos Inc as part of the company’s prime
contract (http://investors.leidos.com/phoenix.zhtml?c=193857&p=irol
-newsArticle&ID=2057336) with the United States Agency for International
Development (USAID) for the creation and testing of malaria vaccines.  The
clinical trial will include 36-48 healthy UK volunteers. The initial purpose is
to assess the safety of the vaccine and the extent of the immune response, as
well as to identify the optimal dosing regimen of the vaccine. A following step
of the trial will test how effective the vaccine is at preventing malaria by
comparing individuals from this study given the best dose of the vaccine will be
compared to subjects who have not received the vaccine, when challenged with
malaria parasites. The first part of the study will run for at least one year.

Background

Malaria is a major global problem, with 3.2 billion people living at risk of
malaria infection. In 2015, malaria was thought to have caused 438,000 deaths,
most of which (70%) occurred in children under five years old. Currently, there
is no generally approved vaccine available for malaria, which means that there
is a great need for a safe, effective malaria vaccine.

The Jenner Institute and the University of Oxford

The Jenner Institute is a research partnership between the University of Oxford
and the Pirbright Institute focused on the development of vaccines against major
global diseases. The University of Oxford’s Medical Sciences Division is one of
the largest biomedical research centres in Europe. The University is rated as
the best in the world and it has one of the largest clinical trial portfolios in
the UK and great expertise in taking discoveries from the laboratory into the
clinic.

CEO Steen Klysner comments

“It is a pleasure to announce the initiation of the blood stage malaria clinical
trial by such a highly esteemed collaboration partner, and we are proud that the
ExpreS2 platform has become an enabling technology for this exciting project.”

Certified Advisor

Sedermera Fondkommission is appointed as Certified Adviser for ExpreS2ion.
For further information, please contact:

ExpreS2ion Biotechnologies, Steen Klysner, CEO
Telephone: +45 2062 9908
E-mail: sk@expres2ionbio.com (sk@expres2ionbio.com)

This press release contains information that ExpreS2ion is obligated to make
public pursuant to the EU Market Abuse Regulation. The information was submitted
for publication through the agency of the contact person set out above at 10.00
CET, October 18, 2016.
About ExpreS2ion

ExpreS2ion Biotechnologies ApS, is a fully owned Danish subsidiary of ExpreS2ion
Biotech Holding AB with company register number 559033-3729. The subsidiary has
developed a unique platform technology, ExpreS2, enabling cost effective
development and robust production of complex proteins for new vaccines and
diagnostics for e.g. Malaria and Zika. Since founded in 2010, the company has
used its patented ExpreS2 platform to produce more than 200 proteins in
collaborations with research institutions and biopharmaceutical companies, with
a superior efficiency and success rate.