Info

Androclus is developing epitope-specific immunotherapy as a breakthrough technology for the treatment of autoimmune diseases. The proprietary technology platform is based on identification of compounds with specific immunomodulatory activity. In contrast to prior attempts at antigen-specific immunotherapy, Androclus' technology targets a mechanism that modulates inflammation, rather than a trigger of autoimmunity. Such mechanism is modulated by regulatory T cells and involves heat shock proteins. Androclus' drug candidates are short synthetic hsp-derived peptides that, when administered via a mucosal route, selectively down-regulate autoimmune inflammation by inducing an immune deviation of T cell function from inflammatory to regulatory. The peptides are first designed in silico for optimal HLA binding and are further selected for each therapeutic indication, based on ex vivo screening of patients with the disease and in vivo animal models. The approach is common for multiple T cell-mediated inflammatory conditions such as RA, MS and IBD. In contrast to currently available therapies for autoimmune diseases that are not antigen-specific and often broadly immunosuppressive, Androclus therapeutic peptides are designed to selectively target autoimmune inflammation, thus preserving the ability of patient's immune system to respond to infection and cancer and resulting in a favorable safety profile. That is important for long-term therapy of chronic autoimmune diseases and is especially attractive given growing concerns about drug safety and recent prominent drug withdrawals. Androclus' technology is particularly innovative because unlike previous attempts at antigen-specific immunotherapy, Androclus' approach does not target hypothetical and elusive triggers of autoimmunity, but rather targets a trigger-independent pathogenic mechanism shared among various autoimmune diseases. Administration is oral, providing an additional advantage over marketed biologics. The technology platform has demonstrated consistent results in RA (human clinical data and adjuvant arthritis model), MS (EAE model) and IBD (SCID-transfer colitis model): Ability to control the disease, as measured by clinical scores of patients (RA) and by disease scores in animal models (MS, IBD). Down-regulation of proinflammatory cytokines such as TNF-alpha and up-regulation of antiinflammatory cytokines such as IL-10. Confirmation of mechanism of action, as evidenced by markers of regulatory T cell activation such as TGF-beta and FoxP3.Androclus' technology platform has been validated by Phase II results of AT-001 in RA, by consistent results in proof-of-concept animal models of RA, MS and IBD, and by publications in leading journals including Nature Medicine, PNAS and Lancet. An IP portfolio comprising over 70 pending or granted patent applications protects the composition of matter and use of Androclus' drug candidates.