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PTG-007 is an autologous polyclonal regulatory T cell (Treg) therapy developed by PolTREG for the treatment of autoimmune diseases, primarily type 1 diabetes (T1D) and multiple sclerosis (MS). The therapy involves isolating and expanding a patient’s own CD4+CD25+CD127− regulatory T cells, which are then re-infused to restore immune tolerance and suppress autoimmune responses. Clinical studies have shown that PTG-007 can induce long-term clinical remission in early-onset T1D patients, with some remaining insulin-independent for up to 24 months post-treatment and others maintaining remission for up to 12 years. In MS trials, both intravenous and intrathecal administration routes have been explored, with intrathecal delivery showing superior outcomes in reducing relapses and lesion progression. The product is classified as an Advanced Therapy Medicinal Product (ATMP) and represents a novel approach within the field of cellular immunotherapy[1][2][4][5][6][7][9][10].
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