ExpreS2ion Biotech announces clinical trial update for the

PamVac (Placental Malaria Vaccine) phase I study

ExpreS2ion Biotech announces the second successful evaluation of safety by the
independent safety monitoring board for the phase Ia clinical trial of the
placental malaria vaccine candidate, PAMVAC. Due to the trial’s staggered
approach, the second evaluation allows initiation of the phase Ib clinical trial
to be conducted in Benin, Africa. The clinical trial is funded by the EU under
the FP7 program and coordinated by associate professor Morten A Nielsen at
University of Copenhagen in collaboration with University of Tübingen,
Université d'Abomey-Calavi, European Vaccine Initiative, Institut de Recherche
pour le Développement, and ExpreS2ion Biotech.
Placental malaria

Women, who have acquired immunity against malaria during childhood, nevertheless
become susceptible to malaria again during their first pregnancies. Parasites
accumulate in the placenta, where a combination of altered blood flow and
expression of chondroitin sulphate A (CSA) provides a new niche for parasites to
sequester. Malaria in pregnant women thus constitutes a major health problem in
areas south of the Sahara, manifesting as severe disease, anemia in the mother,
impaired fetal development, low birth weight or spontaneous abortion. Placental
malaria has been estimated by the WHO to be responsible for 20,000 maternal and
200,000 infant deaths annually. Fortunately, women acquire immunity against
placental malaria, and in malaria endemic areas the average birth weight is
significantly higher among second- and third- compared to first-born babies.
This relatively fast development of protection has raised the hope that a
vaccine for placental malaria can be developed.

Worldwide collaborations on the vaccine

In 2003 Professor Ali Salanti and others at University of Copenhagen discovered
the antigen VAR2CSA, which enable parasite accumulation in the placenta. Since
then collaborations with many groups around the world, especially Professor
Philippe Deloron at Institut de Recherche pour le Développement, France, has
enabled the preclinical development of the vaccine. The European Vaccine
Initiative has been instrumental in the mobilization of funds and in the
clinical development of the vaccine, where its fast-track strategy is
implemented allowing a more efficient development of the vaccine candidate. The
phase Ia clinical trial is led by Professor Benjamin Mordmüller (University of
Tübingen) and the phase Ib trial is led by Dr. Saadou Issifou (Institut de
Recherche Clinique du Bénin). Preparations for a Phase II clinical trial are led
by Professor Achille Massougbodji (Université d'Abomey-Calavi), Dr Jean-Philippe
Chippaux (Institut de Recherche pour le Developement) and Dr Adrian JF Luty
(Institut de Recherche pour le Développement).

ExpreS2ion Biotech contributed to the collaboration through supply of protein
antigen variants for selection of the best candidate, as well as developing the
production cell line and manufacturing process. Copenhagen University obtained a
license to the ExpreS2 system for the production of the PAMVAC vaccine antigen.

The clinical trial

To induce high concentrations of specific IgGs, subjects will receive escalating
doses of PAMVAC vaccine antigen adjuvanted with Alhydrogel, GLA-emulsion or GLA
-liposome. Three injections with the same dosage and adjuvant will be done, each
28 days apart (Day 0, 28 and 56). Dosage escalation will be staggered to ensure
safety during the trial. Control subjects will receive physiological saline
instead of the vaccine. The clinical trial is a phase I, staggered, two-center,
dose-escalation trial. The trial will be conducted in two stages. The first in
Germany (first in man and dose escalation) and the second in a malaria-endemic
area in the target group (randomized, controlled, dose-finding). First in man
administration and dose escalation from 20 to 50 μg per injection of PAMVAC
adjuvanted with Alhydrogel, GLA-emulsion or GLA-liposome will be done in
healthy, malaria-naïve adults in Germany (phase 1a). Subsequently, PAMVAC will
be administered to healthy, lifelong malaria exposed nulligravid women in Benin
at doses of 50 and 100 μg, adjuvanted with Alhydrogel and GLA-emulsion (phase
Ib). In Benin, one group will receive a placebo control (physiological saline).
Allocation to placebo, PAMVAC+Alhydrogel or PAMVAC+GLA-emulsion, will be
randomized. Each dose-escalation is conditional on a positive safety assessment
by an independent safety monitoring board (ISMB) and sponsor approval. One
individual of each PAMVAC-adjuvant combination will serve as sentinel. The
sentinel will be injected one day before the rest of the group. There will be a
minimum of four weeks stagger between the first immunizations in phase Ia and
phase Ib.

Grant Funding: The PAMCPH project supporting the cGMP manufacture of the vaccine
was funded by the German Federal Ministry of Education and Research (BMBF)
through Kreditanstalt für Wiederaufbau (KfW) and European Vaccine Initiative,
the PlacMalVac (University of Copenhagen, Denmark) project supporting the cGMP
manufacture, clinical trial and preparation for phase II was funded by the
European Union Seventh Framework Programme, FP7-HEALTH-2012-INNOVATION under
grant agreement n° 304815
(http://ec.europa.eu/research/fp7/index_en.cfm?pg=health), the preclinical
development of the vaccine was supported by Danish Advanced Technology
Foundation under grant number 005-2011-1 (http://innovationsfonden.dk/en).

CEO Steen Klysner comments

“This is a very exciting project and we now look forward to the outcome of the
trial. I also note that this further validates the regulatory acceptance of the
ExpreS2 platform under GMP for clinical use"
For further information about ExpreS2ion, please contact:

Steen Klysner, CEO
Telephone: +45 2062 9908
E-mail: 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 12.00 CET, July the 28th 2016.
About ExpreS2ion

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