Abcuro, Inc., a clinical-stage biotechnology company, is taking a major step forward in the fight against autoimmune diseases and cancer with the initiation of a registrational Phase 2/3 study of ABC008 in inclusion body myositis (IBM).
ABC008 is a revolutionary anti-KLRG1 antibody, designed to precisely modulate cytotoxic T and NK cells and selectively depleting highly cytotoxic T cells while preserving regulatory and central memory T cells. This groundbreaking approach offers hope to millions of patients suffering from these debilitating conditions.
IBM is an autoimmune disorder that can cause devastating muscle loss, leading to the loss of grip, dexterity, and mobility. The disease is characterized by the presence of highly differentiated and destructive KLRG1+ cytotoxic T cells that attack muscle tissue. Unfortunately, there are no effective treatment options available, making IBM a particularly challenging condition to manage.
Abcuro is proud to announce the commencement of its Phase 2/3 clinical trial for the treatment of Inclusion Body Myositis (IBM). Jeffrey Wilkins, M.D., Chief Medical Officer of Abcuro, emphasized the importance of this trial and its potential to offer a breakthrough solution for IBM patients.
ABC008 has been designed to selectively deplete highly cytotoxic T cells that attack and destroy muscle tissue, while leaving protective T cell populations unaffected. This approach stands in contrast to the limited use of broad T cell depleters, which can cause adverse effects due to their wide-ranging immune-cell depletion.
In the Phase 1 trial of a groundbreaking new treatment, we observed potent, durable, and dose-dependent depletion of CD8+KLRG1+ T cells, the most highly cytotoxic T cells, with near complete (97%) depletion at 28 days post injection. We are now looking ahead to our Phase 2/3 trial, which will enroll more than 200 patients across 30 global sites and is sure to be a major step forward in our fight against this devastating illness.
The lack of available treatments for Inclusion Body Myositis (IBM) can cause severe disability, but Abcuro is aiming to change this with their new Phase 2/3 trial of ABC008. If successful, this first-in-class therapeutic could provide much-needed treatment for IBM patients and bring hope for a better quality of life.
As co-founder and Chief Scientific Advisor, Steven A. Greenberg, M.D., has expressed, “We look forward to advancing ABC008 in this Phase 2/3 trial and providing a potential first-in-class therapeutic for patients in need of treatment.”
ABC008 is a revolutionary new anti-KLRG1 antibody that selectively targets and depletes highly cytotoxic T cells while leaving regulatory and central memory T cells alone. This groundbreaking discovery has opened the door to potentially treating diseases caused by these cytotoxic T cells, such as inclusion body myositis (IBM), T cell large granular lymphocytic leukemia (T-LGLL), and mature T cell malignancies. The US Food and Drug Administration (FDA) has even granted Orphan Drug Designation to ABC008 for the treatment of IBM, making it the first of its kind.
Abcuro is pioneering a novel approach to healing autoimmune diseases and cancer – precise modulation of highly cytotoxic T and NK cells. Our lead program, ABC008, is a first-of-its-kind immunotherapy that is currently being tested in clinical trials for inclusion body myositis (IBM) and T cell large granular lymphocytic leukemia. By tapping into the power of the body’s own immune system, Abcuro is on the path to unlocking revolutionary treatments for some of the toughest diseases.