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2016-11-21

Idogen: Idogen signs agreement with global contract research partner

Idogen AB ("Idogen") today announces that the company has signed an
agreement with Advinus Therapeutics, a leading global contract
research organization, for synthesis of zebularine for future
pre-clinical and clinical trials. Zebularine is a key component in
Idogen's tolerogenic vaccine. The agreement means that zebularine
will be synthesized according to current regulations for GMP ("Good
Manufacturing Practice"). This represents an important step taken by
Idogen towards a product for clinical trials.

Idogen is starting cooperation to synthesis the company's drug
candidate zebularine in accordance with current regulations for
pharmaceuticals (GMP), with a leading global contract researcher.
Zebularine in GMP-quality is required for preclinical safety studies
of the company's tolerogenic dendritic cells and for the upcoming
clinical trial, which the company estimates to commence during 2018.
Idogen has performed an on-site quality audit at Advinus and ensured
that the necessary regulatory requirements are fulfilled.

"The successful proof-of-concept-study in human cells, together with
the recent timely financing event, we are now taking another step
toward being able to produce our tolerogenic vaccine. Having the
agreement ready for GMP synthesis of zebularine means that we are
adhering to the communicated schedule for the development toward
clinical trials and treatment of patients with severe hemophilia A
and antibodies to factor VIII.", CEO Lars Hedbys comments.

Advinus Therapeutics

Advinus is a Contract Research Organization (CRO) with a wide range of
services, in the areas of preclinical toxicology testing, chemical
process development, analytical R&D, drug metabolism and
pharmacokinetics for pharmaceutical and biotechnology industries. The
company has over 24 years of experience of studies performed in
accordance with global regulations for pharmaceutical development.
For additional information about Advinus Therapeutics, see
www.advinus.com.

For additional information about Idogen, please contact:

Lars Hedbys, CEO

Tel: +46 (0)46-275 63 30

E-mail: lars.hedbys@idogen.com

This is an English version of an original Swedish press release
communicated by Idogen AB. In case of interpretation issues or
possible differences between the different versions, the Swedish
version shall apply. This constitutes information that Idogen AB is
required to publish under the EU's Market Abuse Regulation. The
information was submitted for publication through the above contact
person on the 21st of November 2016.

Idogen develops tolerogenic vaccines which re-program the immune
system. The term "tolerogenic" refers to that the immune system will
tolerate the selected molecule after treatment. It represents a new
treatment method for autoimmune diseases, organ rejection after
transplantation and patients without treatment after developing
antibodies against standard treatment. The first indication for the
therapy will be patients with the bleeding disorder hemophilia A who
have developed an immunological reaction against their necessary
factor VIII replacement.

The treatment method comprises cells from the patient's blood being
reprogrammed to dendritic cells with the capacity to specifically
counteract the adverse immune reaction. The company's technology
platform has the potential to develop long-acting treatment of
anti-drug antibodies as well as autoimmune diseases that currently
cannot be cured. In addition, Idogen has the potential to change the
transplantation market by reducing the need for immunosuppressive
therapy after transplantation. Idogen was founded in 2008 based on a
fundamental immunological discovery at Lund University. For more
information, visit www.idogen.com

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http://news.cision.com/idogen/r/idogen-signs-agreement-with-global-contr...
http://mb.cision.com/Main/12368/2127140/592900.pdf

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