Netherlands-based Xenikos B.V. recently announced it will take part in the 2016 BIO International Convention June 6-9 in San Francisco, where it will gather with pharmaceuticals to discuss its new investigational candidate, T-Guard, for acute graft versus host disease (GVHD).
GVHD is a medical complication that sometimes occurs in patients following transplantation of blood stem cells to restore normal blood cell production in patients treated for blood or lymphatic cancers. GVHD is commonly associated with stem cell or bone marrow transplants, but the term also applies to other forms of tissue graft. Immune cells (white blood cells) in the donated tissue (the graft) see the recipient (host) as “foreign,” and the transplanted immune cells attack the host’s body cells.
T-Guard is a medicine under development that combines two toxin-loaded anti-T-cell antibodies that “resets” the body’s immune system. It shows potential in the effective treatment of certain life-threatening immune conditions, such as transplant-related rejection, GVHD, acute solid-organ rejection, and several severe autoimmune diseases.
After injection into the body, T-Guard destroys mature T- and NK cells, with a strong preference for activated T-cells (the troublemakers). T-Guard consists of two anti-T-cell antibodies that act against specific cell membrane antigens, CD3 and CD7. Each antibody in T-Guard is conjugated to an immunotoxin that prevents the cells from making new proteins, thereby inducing programmed cell death (apoptosis).
T-Guard is currently in Phase 1/2 clinical trials in Europe for the second-line treatment of steroid-resistant acute GVHD. Initial clinical data has demonstrated that T-Guard provides a strong clinical response and doubles the overall survival rate at six months compared to controls. A clinical proof-of-concept trial in steroid-resistant acute GVHD also demonstrated the medicine has strong clinical and biological responses and is well tolerated. Xenikos is planning to begin pivotal clinical trials next year.
“We are very excited to discuss our promising product candidate T-Guard for steroid-resistant acute GVHD with industry experts and key opinion leaders in the field of immunotherapy at this important event,” said Xenikox CEO Ypke van Oosterhout in a press release. “We have seen a high level of interest in our company and T-Guard 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.”
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