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ApoFasL
The lead product for the ProtEx technology is ApoFasL, an immunotherapy treatment that improves current organ and tissue transplant therapies by regulating the immune system of the recipient. ApoFasL is applied to the organ/tissue/cell to be transplanted and protects it from being attacked when transplanted into the recipient. An added benefit of ApoFasL is that it reduces the need for powerful immunosuppressive drugs with highly toxic effects that are required after transplantation.
As with ApoVax104, ApoFasL consists of a SA chimeric protein fused to the extracellular domain of an immunoregulatory protein, here Fas ligand (FasL). The SA domain again allows the formation of tetramers leading to an active form of FasL. In addition, the SA domain is used to attach the chimeric protein to the surface of a biotinylated cell membrane.
Pre-clinical proof-of-principle has been obtained using several different animal models for different transplant settings including heart, pancreatic islet, and blood stem cell transplantation. Of particular interest to ApoImmune is the use of the technology to induce transplant tolerance in Type 1 Diabetes. ApoImmune researchers are working to develop a novel insulin-replacement therapy using ApoFasL that will allow successful pancreatic islet transplantation without using immunosuppressive drugs, thus eliminating side effects that accompany their long-term use. Induction of tolerance without the chronic use of immunosuppressive drugs will be an important therapeutic advancement required for the efficient treatment of Type 1 Diabetes in the clinic.
The first clinical application for ApoFasL will be as an insulin replacement therapy for the treatment of Type I Diabetes using ApoFasL-treated pancreatic islets. After completion of a non-human primate study, ApoImmune expects to begin a Phase I clinical trial.
ApoImmune has licensed a component of its technology from a major pharmaceutical company which management believes provides the Company freedom to practice its ApoFasL technology.
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