Xenikos B.V. Secures EUR 5.5 Million in Financing to Support Further Clinical Development of its T-Guard™ Product as an Orphan Drug for Treating Graft-Versus-Host Disease
Published: Jun 19, 2012
Xenikos is developing a combination of two toxin-loaded anti-T-cell antibodies, T-Guard™, as a therapeutic tool for resetting the body’s immune system in T-cell mediated diseases. Once injected in the body, T-Guard™ specifically identifies and eliminates adult T cells, with a strong preference for the activated ones (the ‘trouble makers’). Following a one-week therapy, T- Guard™ is then swiftly washed out of the body, and the T cell compartment will be rapidly restored with newly formed, normal behaving, T cells. T-Guard™ is not only very effective in killing activated T cells, but also acts through mechanisms that are associated with minimal side effects (via apoptosis). Moreover, due to T-Guard’s short half-life and narrow specificity (leaving immune bystander cells unharmed), patients are rendered less vulnerable to opportunistic infections as compared to currently available treatment options.
As a first application, T-Guard™ is being developed for treating steroid-resistant acute Graft- versus-Host Disease (GVHD), a potentially life-threatening complication occurring in about 50% of all patients receiving a donor blood stem cell transplant. T-Guard™ was initially developed at the Radboud University Nijmegen Medical Centre (RUNMC), where it was tested in a clinical pilot-study in critically ill GVHD patients. T-Guard™ demonstrated promising results, showing extensive biological and clinical responses in the absence of any severe acute side effects. Because of this, T-Guard was awarded a European Orphan Product Designation for treating GVHD (EU/3/05/317).
The financing will be used to support the manufacturing of clinical grade product at Sanquin, and the subsequent clinical testing of T-Guard™ in a Dutch multicenter Phase Ib/IIa study in patients with severe acute GVHD not responding on steroid-therapy. The financing will also support the exploratory evaluation of T-Guard™ in xenograft (human-mouse) models of selected autoimmune diseases in which T-cells are involved.
Peter van Mourik will join Xenikos’ Executive Board as co-statutory director. His long-standing experience as former Managing Director of Sanquin Pharmaceutical Services is considered a crucial asset for a successful further development of T-Guard’s manufacturing processes and all quality related issues.
Tytonis BV, The Netherlands, an independent advisory firm for commercial transactions in the life sciences, supported Xenikos and Sanquin during the commercial diligence evaluation. During the early fases, Xenikos was supported by the Technology Transfer Office of RUNMC and Gelderland Knowledge Foundation, which provided business development advice and a pre- seed funding.
Mr. Theo Buunen, Chairman Executive Board of Sanquin said, “Entering into a strategic alliance with Xenikos will provide Sanquin with an opportunity to co-develop a new generation of biopharmaceuticals strengthening Sanquin’s position in the field of clinical immunology.”
Dr. Ypke van Oosterhout, CEO of Xenikos said, “The strong commitment of PPM Oost, and Sanquin’s unique network and know-how in the fields of immunohematology and biopharmaceutical process development, will certainly help us speeding up T-Guard’s route to registration.”
Sanquin Blood Supply Foundation ensures the safe and efficient blood supply in the Netherlands. Sanquin also develops and produces pharmaceutical products, conducts high- quality scientific research relating to blood transfusion medicine and immunology in the broadest sense, and develops and performs a multitude of diagnostic services.
About PPM Oost and IIG
Participatiemaatschappij Oost Nederland NV (PPM Oost) invests public money in promising companies that are contributing to a flourishing economy in the East Netherlands, especially in the food, health and technology sectors. PPM Oost has invested in more than 150 companies. PPM Oost also manages and executes the Provincial Innovation and Investment Fund Gelderland (IIG), a recently established revolving fund that focuses on the strategic areas Food, Health, Energy and Environmental Technology.
About Agentschap NL and the Innovation Credit Scheme
Agentschap NL is an agency of the Dutch Ministry of Economic Affairs, Agriculture and Innovation that promotes sustainable development and innovation with various financial instruments. The Innovation Credit is aimed at supporting high risk, and commercially attractive, technical or clinical development projects.
Dr. Ypke van Oosterhout, CEO
T: +23 24 300 100
Sanquin Blood Supply Foundation
Mr. Robert Heckert
T: +31 20 512 3000
PPM Oost/IIG B.V.
Mr. Pieter Rhemrev
T: +31 26 384 40 44
Agentschap NL, Innovation Credits
Drs. Elisabeth Schless
T: +31 88 602 4631