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Clinical Trials

Date: 2016-06-11

Type of information: Presentation of results at a congress

phase: preclinical

Announcement: presentation of results at the American Diabetes Association's 76th Scientific Sessions

Company: Fate Therapeutics (USA - CA)

Product: ToleraCyte™ (programmed CD34+ immuno-regulatory cell product)

Action mechanism:

cell therapy/cell immunotherapy. ToleraCyte is a programmed CD34+ cell immunotherapy that is undergoing preclinical investigation for the treatment of autoimmune and inflammatory disorders. The immuno-regulatory cell therapy is comprised of CD34+ cells that have been programmed ex vivo with a proprietary combination of pharmacologic modulators. ToleraCyte is designed to optimize the capacity of CD34+ cells to effectively traffic to sites of inflammation and express potent T-cell regulatory factors, including PD?L1 and IDO1.

Disease:

Therapeutic area: Autoimmune diseases

Country:

Trial details:

Latest news:

* On June 11, 2016, Fate Therapeutics announced that it will present preclinical data for ToleraCyte™, its programmed CD34+ immuno-regulatory cell product candidate for autoimmune diseases, at the American Diabetes Association's 76th Scientific Sessions being held June 10-14 in New Orleans, Louisiana. Scientists from Fate Therapeutics and Boston Children's Hospital demonstrated that a single administration of programmed cells results in durable correction of type 1 diabetes in a well-established non-obese diabetic (NOD) mouse model. In addition, the group showed that a single administration of programmed cells significantly delays the onset of type 1 diabetes in NOD mice. Fate Therapeutics is advancing ToleraCyte through late-stage preclinical development under a collaboration with Boston Children's Hospital led by Paolo Fiorina, M.D., Ph.D., Assistant Professor of Pediatrics at Boston Children's Hospital and Harvard Medical School.
The scientific team at Fate Therapeutics and Boston Children's Hospital explored the disease-modifying potential of ToleraCyte in humanized and mouse models of type 1 diabetes. In in vivo studies using hyperglycemic NOD mice designed to mimic new-onset type 1 diabetes, a one-time administration of programmed cells resulted in the durable correction of disease, as compared to vehicle-treated cells. Additionally, in pre-hyperglycemic NOD mice, a one-time administration of programmed cells demonstrated a statistically-significant delay in the onset of disease, where the median time to onset was not reached by Day 140 as compared to untreated mice (median time to onset = Day 115; p=0.0004). Finally, in a humanized model of type 1 diabetes, programmed CD34+ cells showed enhanced trafficking to the pancreas and regulation of T-cell activation. Together, these preclinical results support the premise that ToleraCyte may serve as a disease-modifying immunotherapy for patients with type 1 diabetes.

Is general: Yes