Tolerx, Inc. was a biopharmaceutical company headquartered in

Cambridge, Massachusetts Cambridge ( ) is a city in Middlesex County, Massachusetts, United States. As part of the Boston metropolitan area, the cities population of the 2020 U.S. census was 118,403, making it the fourth most populous city in the state, behind Boston ...

. The company was focused on discovering and developing new therapies designed to treat patients by reprogramming the immune system, allowing for long-term remission of immune-related diseases after a short course of therapy. Targeted diseases include

type 1 diabetes Type 1 diabetes (T1D), formerly known as juvenile diabetes, is an autoimmune disease that originates when cells that make insulin (beta cells) are destroyed by the immune system. Insulin is a hormone required for the cells to use blood sugar ...

rheumatoid arthritis Rheumatoid arthritis (RA) is a long-term autoimmune disorder that primarily affects joints. It typically results in warm, swollen, and painful joints. Pain and stiffness often worsen following rest. Most commonly, the wrist and hands are invol ...

, Inflammatory bowel disease (IBD),

cancer Cancer is a group of diseases involving abnormal cell growth with the potential to invade or spread to other parts of the body. These contrast with benign tumors, which do not spread. Possible signs and symptoms include a lump, abnormal b ...

, chronic and

viral diseases Viral means "relating to viruses" (small infectious agents). Viral may also refer to: Viral behavior, or virality Memetic behavior likened that of a virus, for example: * Viral marketing, the use of existing social networks to spread a mar ...

. In 2008, Tolerx was named one of Fierce Biotech’s Fierce 15. In October 2011, Tolerx was shut down due to an unsuccessful Phase III trial in patients recently diagnosed with Type 1 diabetes.

Development programs

Tolerx’s lead product candidate,

otelixizumab Otelixizumab, also known as TRX4, is a monoclonal antibody, which is being developed for the treatment of type 1 diabetes and other autoimmune diseases. The antibody is being developed by Tolerx, Inc. in collaboration with GlaxoSmithKline and ...

, also known as TRX4, is a novel

monoclonal antibody A monoclonal antibody (mAb, more rarely called moAb) is an antibody produced from a cell Lineage made by cloning a unique white blood cell. All subsequent antibodies derived this way trace back to a unique parent cell. Monoclonal antibodies ...

being developed for the treatment of autoimmune type 1 diabetes and other autoimmune diseases. The efficacy and safety of otelixizumab in the treatment of type 1 diabetes is currently being studied in a pivotal Phase 3 study called DEFEND (Durable-response therapy Evaluation For Early or New-onset type 1 Diabetes). Tolerx entered into a collaboration with Glaxo SmithKline in October 2007 relating to the development and commercialization of otelixizumab. Otelixizumab has been granted Orphan Drug Status by the

U.S. Food and Drug Administration The United States Food and Drug Administration (FDA or US FDA) is a federal agency of the Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food ...

. Additionally, in collaboration with Genentech, Tolerx is developing a modified version of TRX1, a humanized monoclonal antibody that binds to the CD4 receptor found on both T effector and T regulatory cells. The safety and activity of TRX1 was evaluated by Tolerx in a single-dose, placebo-controlled, double-blind Phase 1 clinical trial. The data from the Phase 1 clinical trial showed TRX1 was well tolerated, did not deplete T cells, and had no observed first-dose side effect. The modified version of TRX1, designated MTRX1011A, is being developed for the treatment of autoimmune diseases, which may include rheumatoid arthritis, cutaneous

lupus erythematosus Lupus erythematosus is a collection of autoimmune diseases in which the human immune system becomes hyperactive and attacks healthy tissues. Symptoms of these diseases can affect many different body systems, including joints, skin, kidneys, blo ...

(CLE), multiple sclerosis (MS), and systemic lupus erythematosus (SLE). The Tolerx pipeline also includes two pre-clinical candidates: TRX518, an antibody directed to

GITR Tumor necrosis factor receptor superfamily member 18 (TNFRSF18), also known as glucocorticoid-induced TNFR-related protein (GITR) or CD357. GITR is encoded and tnfrsf18 gene at chromosome 4 in mice. GITR is type I transmembrane protein and is descr ...

(glucocorticoid-induced tumor necrosis factor receptor), a surface receptor molecule that has been shown to be involved in inhibiting the suppressive activity of T regulatory cells and extending the survival of T effector cells, and TRX385, a monoclonal antibody that recognizes ILT3, an inhibitory receptor expressed by dendritic cells and

monocyte Monocytes are a type of leukocyte or white blood cell. They are the largest type of leukocyte in blood and can differentiate into macrophages and conventional dendritic cells. As a part of the vertebrate innate immune system monocytes also ...

s. These pre-clinical candidates may be developed for the treatment of cancer and viral diseases.

Leadership

Herman Waldmann, PhD, FRCPath, MRCP, FRS, FMedSci, Co-Founder, Chairman, Scientific Advisory Board, Professor of Pathology, Head of the Sir William Dunn School of Pathology and Clinical Director of the Therapeutic Antibody Centre (TAC), University of Oxford “A pioneer in the field of monoclonal antibody production” Douglas J. Ringler, VMD,OneMedPlace Profile
/ref> Co-Founder, President & CEO Louis Vaickus, MD Chief Medical Officer Thomas A. Shea, MBABusiness Week Personal Profile
/ref> Chief Financial Officer

References

{{reflist, 2 Biotechnology companies of the United States Defunct companies based in Massachusetts Companies based in Cambridge, Massachusetts Pharmaceutical companies established in 2000 Pharmaceutical companies disestablished in 2011 Privately held companies based in Massachusetts