DGAP-News: Xenikos B.V. to introduce immunotherapy T-Guard(TM) to potential pharmaceutical partners at BIO International Convention 2016

DGAP-News: Xenikos B.V. / Key word(s): Conference/Miscellaneous
Xenikos B.V. to introduce immunotherapy T-Guard(TM) to potential
pharmaceutical partners at BIO International Convention 2016

24.05.2016 / 14:00
The issuer is solely responsible for the content of this announcement.

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Xenikos B.V. to introduce immunotherapy T-Guard(TM) to potential
pharmaceutical partners at BIO International Convention 2016

Nijmegen, the Netherlands, May 24, 2016 - Xenikos B.V., focused on the
development of innovative immunotherapies for the treatment of patients
suffering from serious immune diseases or rejection after transplantation,
announced today that it will participate in the upcoming BIO International
Convention (BIO), being held June 6-9, 2016 at the Moscone Center in San
Francisco, CA, USA. At this conference, Xenikos will meet with
pharmaceutical companies to discuss its product candidate, T-Guard(TM), for
its lead indication acute graft versus host disease (GVHD).

T-Guard(TM) is a combination of two toxin-loaded anti-T-cell antibodies
being developed as a tool to safely and swiftly reset the body's immune
system in T-cell mediated diseases, such as GVHD. T-Guard(TM) is currently
in clinical phase 1/2 testing in Europe for the second-line treatment of
steroid- resistant acute GVHD. Preliminary results from this study showed
strong clinical responses and a doubling of the 6-months overall survival
rate compared to a case series of historical controls. A clinical
proof-of-concept study in this indication also showed that T-Guard(TM)
appeared to be well tolerated with strong biological and clinical responses
observed. Based on these promising results, the Company plans to initiate
pivotal clinical studies mid 2017.

Ypke van Oosterhout, Chief Executive Officer of Xenikos, said: "We are very
excited to discuss our promising product candidate T-Guard(TM) for steroid-
resistant acute GVHD with industry experts and key opinion leaders in the
field of immunotherapy at this important event. We have seen a high level
of interest in our Company and T-Guard(TM) by a number of pharmaceutical
companies and look forward to evaluating further development opportunities,
as we strongly believe that this innovative approach can help restore
patients' health and save lives."

Xenikos also said today that it has engaged U.S.-based strategic advisory
firm Destum Partners, Inc. to support the Company with its partnering
activities.

Companies interested in meeting with Xenikos at BIO are asked to request a
meeting through the BIO partnering online system or to contact Ypke van
Oosterhout at y.vanoosterhout@xenikos.com.


About T-Guard(TM)
T-Guard(TM) is currently under development by Xenikos B.V. for the
treatment of certain life-threatening immune conditions, such as
transplant-related rejection, graft versus host disease (GVHD), acute
solid-organ rejection and several severe autoimmune diseases. T-Guard(TM)
consists of a combination of two toxin-loaded anti-T-cell antibodies and
shows promise as a therapeutic tool for safely and swiftly resetting the
body's immune system in T-cell-mediated diseases. Once injected into the
body, T-Guard(TM) specifically identifies and eliminates adult T cells,
with a strong preference for the activated ones. The particular combination
of immunotoxins used to construct T-Guard(TM) was designed to provide a
unique blend of synergistic efficacy, narrow specificity and multiple,
gentle mechanisms of action. In preclinical testing, T-Guard(TM) was shown
to be highly effective in killing activated T cells and to act through
apoptosis (programmed cell death) mechanisms, which are associated with
minimal side effects. T-Guard's targeted action is believed to leave
patients less vulnerable to opportunistic infections when compared to
historical controls of institutional standard of care. In a clinical proof-
of-concept study, T-Guard(TM) appeared to be well tolerated with strong
biological and clinical responses observed. T-Guard(TM) is currently in
clinical phase 1/2 testing in Europe for the second-line treatment of
steroid-resistant acute GVHD. The primary endpoint of the study is response
rate at 28 days. Other endpoints include overall survival at 180 days;
safety and tolerability are also being evaluated. Preliminary results from
this study showed strong clinical responses and a doubling of the 6-months
overall survival rate compared to historical controls with a well-
manageable side effect profile without severe infusion reactions. T-
Guard(TM) has been granted Orphan Drug Designation in both the EU and U.S.

About Graft versus Host Disease (GVHD)
Transplantation of allogeneic (donor-derived) blood stem cells is a widely
accepted medical procedure to restore normal blood cell production
(hematopoiesis) in patients treated for blood- or lymphatic cancers, or
otherwise suffering from defective blood formation or immunity. Today,
approximately 30,000 patients worldwide receive allogeneic stem cell
transplants every year. Approximately 50% of all blood stem cell transplant
patients develop acute GVHD, a complication where donor-derived T cells
(immune cells) attack the normal tissues of the patient. Half of these
patients do not respond adequately to standard first-line therapy and have
a poor long-term prognosis with severe morbidity and high mortality rates.
This number is expected to grow substantially as the number of patients
receiving high-risk transplants from unrelated donors is expected to double
in the next five years. As of today, there is no approved second-line
treatment available.

About Xenikos B.V.
Xenikos B.V. is developing new, innovative immunotherapies to help restore
patients' health and save lives. It is developing new therapies based on
the action of conjugated antibodies that enables patients suffering from
serious immune diseases or rejection after transplantation to reset their
immune systems quickly and efficiently. Its lead product candidate T-
GuardTM is currently being developed for the second-line treatment of
steroid-resistant acute GVHD. Further information is available at
www.xenikos.com.

For further information, please contact:

Xenikos B.V.

Ypke van Oosterhout
Chief Executive Officer
Telephone: +31 24 3000100
Mobile: +31 6 11017611
Email: y.vanoosterhout@xenikos.com

Additional contact information

MC Services AG
Dr. Solveigh Mähler
Telephone: +49 211 529 252 19
E-mail: solveigh.maehler@mc-services.eu

In the U.S.:
Laurie Doyle
Telephone: +1 339 832 0752
E-mail: laurie.doyle@mc-services.eu


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