Xenikos B.V.
Xenikos to participate in BIO-Europe(R) 2016 – 22nd Annual International Partnering Conference

Xenikos to participate in BIO-Europe^(R) 2016 – 22^nd Annual International Partnering Conference

Company to discuss its proprietary immunotherapy T-Guard(TM) with potential pharmaceutical partners

Final results of Phase 1/2 trial with T-Guard(TM) against acute graft-versus-host disease expected in first half of 2017

Nijmegen, the Netherlands, October 25, 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-Europe 2016 – 22^nd Annual International Partnering Conference being held November 7-9, 2016 in Cologne, Germany. At the conference, Xenikos will meet with pharmaceutical companies to discuss its product candidate, T-Guard(TM), which is in Phase 1/2 testing for the treatment of steroid-resistant acute graft versus host disease (GVHD). T-Guard(TM) consists of a combination of two toxin-loaded anti-T-cell antibodies and has shown promise as a therapeutic tool for safely and swiftly resetting the body’s immune system in T-cell-mediated diseases.

Ypke van Oosterhout, Chief Executive Officer of Xenikos, said: “We look forward to discussing our promising product candidate T-Guard(TM) with potential partners at this important event. We believe this to be the ideal time for partnering discussions given the last patient in an ongoing Phase I/II trial has just been treated with our product and final results are expected as early as the first half of 2017. We have seen a high level of interest in our Company and T-Guard(TM) by a number of pharmaceutical companies already and look forward to evaluating further development opportunities, as we strongly believe that this innovative approach can help restore patients’ health and save lives.”

Companies interested in meeting with Xenikos at BIO-Europe are asked to request a meeting through the event’s partneringONE(R) online system or to contact Ypke van Oosterhout at y.vanoosterhout@xenikos.com. In addition, the Company will also be available to the media for interviews and background discussions.
 

About BIO-Europe(R)
BIO-Europe is the preeminent partnering conference for the life sciences, bringing together international decision makers from the biotechnology, pharmaceutical and financial sectors, offering networking opportunities, workshop and panel participation, a high profile exhibition, and private, prescheduled one-on-one meetings. The BIO-Europe 2016 partnering event is expected to draw over 3,500 industry attendees for three days of high level networking, representing upwards of 1,900 companies from over 50 countries.
 

About T-Guard(TM)
T-Guard(TM) is currently in development by Xenikos 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 apoptotic (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 indicated a substantial improvement over published institutional historical survival rates, 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 US. The Company plans to initiate a pivotal clinical study in the second half of 2017.
 

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.

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