Newton, Massachusetts, June 7, 2022, Abcuro, Inc., a clinical-stage biotechnology company developing therapies for the treatment of autoimmune diseases and cancer through precise modulation of cytotoxic T and NK cells, today announced the presentation of additional clinical results from its ongoing Phase 1 clinical trial of its lead product candidate ABC008 in patients with inclusion body myositis (IBM) at the 4th Global Conference on Myositis (GCOM) 2022 being held in Prague, Czech Republic on June 6-9, 2022. The additional data finds that ABC008 demonstrates proof-of-mechanism for depleting highly cytotoxic T cells, which attack and destroy muscle tissue in IBM.
This analysis included 11 patients treated in the open-label clinical trial across three dose cohorts as of the data cut-off date of May 26, 2022. The trial is intended to characterize the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of single, subcutaneous injections of ABC008.
Across the three dose levels of 0.1 mg/kg (n=3), 0.5 mg/kg (n=3) and 2.0 mg/kg (n=5 (ongoing)), the analysis observed potent, durable and dose-dependent depletion of CD8+KLRG1+ T cells, which represent the most highly cytotoxic T cells. At the two highest dose levels to date, near complete (>95%) depletion of target cells was observed at 28 days post injection. As expected from scientific literature, given the expression profile of ABC008’s target KLRG1, the immuno-protective cell populations of regulatory T cells and central memory T cells were not significantly affected by ABC008 administration. As of the data cut-off date, ABC008 exhibited a favorable safety profile without drug-related severe or serious adverse events, lymphopenia or neutropenia. The results being presented at GCOM 2022 and the associated poster can be found here . Additional details about the trial are available on ClinicalTrials.gov (NCT04659031).
“We are very excited about the compelling proof-of-mechanism observed with ABC008 to date in this first-in-human study in IBM patients,” said Steven Greenberg, M.D. founder and Senior Scientific Advisor of Abcuro. “These data represent promise in ABC008’s ability to potently deplete highly cytotoxic T cells selectively without affecting important protective T cells populations, differentiating ABC008 from previous broad T cell depleters and an important step forward for finding a potential treatment for IBM.”
“We are encouraged by the safety, PK and PD results in this Phase 1 clinical trial. Based on the data from this study we intend to advance ABC008 into further clinical studies in IBM and additional indications, such as T cell large granular lymphocytic leukemia (T-LGLL),” said John Edwards, Executive Chair of Abcuro.
ABC008 is a first-in-class anti-KLRG1 antibody capable of selectively depleting highly cytotoxic T cells, while sparing regulatory and central memory T cells. ABC008 has been designed to treat diseases mediated by highly cytotoxic T cells, including the autoimmune muscle disease inclusion body myositis (IBM), T cell large granular lymphocytic leukemia (T-LGLL), and other mature T cell malignancies. The US Food and Drug Administration (FDA) has granted Orphan Drug Designation to ABC008 for the treatment of IBM.
About Inclusion Body Myositis (IMB)
IBM is an autoimmune disease in which highly cytotoxic T cells chronically attack muscle tissue leading to progressive weakness and limb muscle atrophy. Patients progressively lose muscle function, including loss of grip and dexterity and loss of mobility. There are currently no available disease-modifying treatment options for IBM. Based on published epidemiology literature, about 50,000 patients suffer from IBM across the US and Europe.
Abcuro is a clinical stage biotechnology company developing first-in-class immunotherapies for the treatment of autoimmune diseases and cancer through precise modulation of highly cytotoxic T and NK cells. The company’s lead program is ABC008, which is currently in clinical trials for inclusion body myositis (IBM). ABC008 is also advancing into a clinical trial for T cell large granular lymphocytic leukemia (T-LGLL). The company is also developing ABC015 to selectively activate highly cytotoxic T and NK cells for treating cancer. For more information, visit us on LinkedIn and at abcuro.com.