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XENIKOS B.V. Xenikos announces data from phase I/II trial with T-GuardTM for the treatment of steroid-resistant acute GVHD to be presented at ASH Annual Meeting

Directive transparence : information réglementée

02/11/2017 09:00

DGAP-News: Xenikos B.V. / Key word(s): Conference
Xenikos announces data from phase I/II trial with T-GuardTM for the treatment of steroid-resistant acute GVHD to be presented at ASH Annual Meeting

02.11.2017 / 09:00
The issuer is solely responsible for the content of this announcement.


Xenikos announces data from phase I/II trial with T-GuardTM for the treatment of
steroid-resistant acute GVHD to be presented at ASH Annual Meeting


Nijmegen, the Netherlands, November 02, 2017 - 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 detailed data from a European clinical phase I/II trial with T-Guard for the second-line treatment of steroid-resistant acute graft-versus-host disease (GVHD) have been accepted for oral presentation at the 59th Annual Meeting of the American Society of Hematology (ASH) in Atlanta, GA, December 9-12, 2017.

The presentation, titled, "A Phase I/II Study on the Anti-CD3/CD7 Immunotoxin Combination (T-GuardTM) for the Treatment of Steroid-Refractory Acute GVHD," will be given by Walter J. F. M. van der Velden, MD, PhD.
 

Session Name: 722. Clinical Allogeneic Transplantation: Acute and Chronic GVHD,
Immune Reconstitution: Treatment
Presentation Date & Time: Sunday, December 10, 2017, 5:00 PM EST
Room: Georgia World Congress Center, Building B, Level 2, B211-B212
 

T-Guard is a combination of two toxin-loaded anti-T-cell antibodies being developed as a tool to safely and swiftly rebalance the body's immune system in T-cell mediated diseases, such as GVHD. The data being presented at the conference demonstrate strong clinical response rates in combination with a high overall survival rate compared to a case series of historical controls.

"We are excited about the opportunity to present data from this important clinical study providing further evidence for the potential of our lead candidate T-Guardat this highly regarded conference," said Ypke van Oosterhout, PhD, Chief Executive Officer of Xenikos. "We are looking forward to discussing the results with regulatory and medical experts to gain valuable input on the future development of T-Guard, which is important as we prepare to start a pivotal phase III trial shortly, aiming to bring this product to patients as soon as possible."

The abstract can be accessed online at
https://ash.confex.com/ash/2017/webprogram/Paper104267.html.
 

About T-GuardTM
T-Guard is in development for the treatment of acute graft versus host disease (GVHD), a life-threatening immune condition. T-Guard consists of a combination of two toxin-loaded anti-T-cell antibodies and shows promise as a therapeutic tool for safely and swiftly rebalancing the body's immune system in T-cell-mediated diseases. Once injected into the body, T-Guard specifically identifies and eliminates adult T- and NK-cells, with a strong preference for the activated T cells. In preclinical testing, T-Guard was shown to be highly effective in killing these cells through non-inflammatory apoptotic mechanisms (programmed cell death), which are associated with minimal side effects. T-Guard's brief but targeted action is believed to leave patients less vulnerable to opportunistic infections when compared to current best available but not yet registered therapies. T-Guard has been granted Orphan Drug Designation in both the EU and US.

Xenikos recently completed a phase I/II study in 20 patients with severe steroid refractory acute GVHD, who received the one-week treatment course with T-Guard as second line treatment. Based on the results, the Company believes that T-Guard has the potential to offer a curative approach using a single-week treatment for patients with steroid-refractory acute GVHD. Mainly because, unlike other concepts that only improve the symptomatic treatment, T-Guard actively restores the immunological balance, providing a durable remedy for patients with this devastating and potentially lethal disease.

Following the promising outcome of the phase I/II study the Company plans to initiate a pivotal clinical phase III study in 2018. Other areas of future development may include transplant-related rejection, acute solid-organ rejection and several severe autoimmune diseases.


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:

Corporate contact: Media contact:
   
Xenikos B.V. MC Services AG
Ypke van Oosterhout, PhD Dr. Solveigh Mähler
Chief Executive Officer Phone: +49 211 529 252 19
Phone: +31 24 3000100 Email: solveigh.maehler@mc-services.eu
Mobile: +31 6 11017611  
Email: y.vanoosterhout@xenikos.com For US inquiries:
  Laurie Doyle
  Phone: +1 339 832 0752
  Email: laurie.doyle@mc-services.eu


02.11.2017 Dissemination of a Corporate News, transmitted by DGAP - a service of EQS Group AG.
The issuer is solely responsible for the content of this announcement.

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