Clinical Study of T-Guard™ in the Treatment of Graft versus Host Disease (GVHD) extends to Germany

Nijmegen, the Netherlands, October 1, 2015 - Xenikos B.V. today announced the extension of its ongoing T-Guard Phase 1/2 study to Germany after approval from the Paul Ehrlich Institute on 31 July, 2015. T-Guard™ is Xenikos’ lead compound that is being developed for treatment of Graft versus Host Disease (GVHD), a frequent and potentially life-threatening complication of bone marrow and blood stem cell transplantation. The Phase 1/2 trial, which began in The Netherlands in March 2014, will be extended to the University Hospital of Muenster, in Germany.

T-Guard is a combination of two toxin-loaded anti-T-cell antibodies that shows promise as a therapeutic tool for safely and swiftly resetting the body’s immune system in T cell mediated diseases. T-Guard is currently being developed for the treatment of therapy resistant acute Graft versus Host Disease (GVHD), a feared and potentially life-threatening complication of hematopoietic stem cell transplantation. There are presently no registered therapies for acute GVHD patients, who have failed standard first-line corticosteroid therapy and the prognosis for these patients is very poor. A Phase 1/2 clinical trial to explore the safety and efficacy of T-Guard was started in March 2014 at the Radboud University Medical Centre in Nijmegen, the Netherlands. Approval from the competent German Authority, the Paul Ehrlich Institute, means that the study can now be extended to Germany, adding the University Hospital Muenster as an additional transplant centre for patients with severe steroid-refractory acute GVHD. The participation of this recognized institute will considerably speed up the inclusion rate. The targeted inclusion of twenty evaluable patients is foreseen around the end of this year.

The University Hospital of Muenster, in Muenster, Germany, is one of the largest hospital-complexes for specialized medical care in northern Germany. Research closely linked to patient-care has contributed largely to the prominent reputation of the University Clinic as a global centre of excellence. The T-Guard study will be managed by a team of dedicated specialists, nurses, and data analysts, led by Professor Matthias Stelljes, Head of the adult Bone Marrow Transplantation Program at the University Hospital and Principal Investigator of the study. Professor Matthias Stelljes is a leading specialist in hematology with a focus on allogeneic stem cell transplantation.

“Global research efforts into GVHD have, until now, been minimally effective, and bearing in mind the currently dismal prognosis for patients with this condition, I have great interest in participating in this study,' said Professor Matthias Stelljes.

The primary endpoint of the Dutch/German study will be the overall response rate at Day 28 (the standard primary endpoint of acute GVHD trials). Secondary endpoints include: six months overall survival and the safety and tolerability of T-Guard. Final trial outcomes are expected during Q1 2016. In the meantime, preparations have been started for an active-controlled follow up study for direct comparison of T-Guard to best Standard of Care which might serve as a pivotal study for obtaining early market access in the form of accelerated approval (US) and conditional marketing authorization (EU).

“With the approval of the Paul Ehrlich Institute and the participation of the Muenster transplant centre we have taken another major step forward in bringing T-Guard to patients to rectify the current lack of registered treatment options for GVHD,” said Ypke van Oosterhout, Chief Executive Officer of Xenikos. “We anticipate that the results will strengthen the evidence of T-Guards’ promise in the treatment of severe acute GVHD.”

Press Release - Extension of T-Guard Phase 1-2 Trial in acute GVHD_FINAL.pdf