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

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-Guard(TM) 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