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TheraMAB Resurrects Novel Regulatory T-Cell Activator Drug (TAB08) That Once Had Disastrous Clinical Results, But May Be Effective and Safe at Much Lower Doses

TheraMAB, a small German-Russian biotech firm presented new data on its drug theralizumab (TAB08) in Nature Biotechnology’s December 2014 special issue on Biopharma Dealmakers. The link to this open-access article is provided at the end of this story. According to the article, TheraMAB is progressing in the clinical development of this novel regulatory T-cell activator for use in rheumatoid arthritis and other autoimmune diseases based on encouraging interimresults of its continuing phase 1b clinical trial. The mechanism of action and good preclinical data suggest that TAB08 may also be effective for treating autoimmune diseases such as systemic lupus erythematosus (SLE) and psoriasis. Following the company’s presentation of data at the Bio 2014 conference in June 2014, TheraMAB CEO Dr. Dimitry Tyrsin was encouraged to publish the company’s interesting data on this drug in Nature Biotechnology. In this Nature Biotechnology article, TheraMAB overviews the history of the drug molecule, and reviews the novel methods used to further characterize mechanism of action of TAB08 in preclinical models. Special attention is brought to recent clinical data in healthy volunteers and patients with rheumatoid arthritis. It has been demonstrated that theralizumab (TAB08) can be administered safely to healthy volunteers and rheumatoid arthritis patients, and preliminary phase 1b findings show promising clinical effect data. “The presentation of our phase 1a/b results at recent meetings has drawn significant interest from both scientists and clinicians,” said Dr. Tyrsin. “The results obtained are very encouraging. TAB08 has the potential to meet the substantial medical need of patients suffering from rheumatoid arthritis and other autoimmune diseases.

“Now we are glad that interest in our project resulted in publication of our article in the very prestigious journal Nature Biotechnology. And it will help us complete the next stages of clinical development of our first-in-class humanized monoclonal antibody of the IgG4 subclass,” Dr. Tyrsin added.

The medicinal product which is being developed by the company TheraMAB LLC represents the “first-in-class”, humanized monoclonal antibody (mAb) of the IgG4 class, for which the mode of action is based on binding to the co-stimulating receptor CD28, specific for human Т-lymphocytes.

The CD28 receptor is expressed on the majority of human CD4+ Т-cells, where it effectively co-stimulates activation and proliferation of Т-cells. The uniqueness of mode of action of ТАВ08s compared to that of other monoclonal antibodies lies in the ability of the antibody to affect key aspects of pathogenesis via normalization of the functional balance of various immune cells.

As opposed to TAB08, the majority of other antibodies (versus TNFa, IL-1, IL-6, etc.) address only the consequences of autoimmune diseases by neutralizing secreted pro-inflammatory factors produced.

In a March 24, 2015 exclusive article in Reuters, writer Ben Hirschler commented on TAB08 from TheraMAB, noting that “an experimental drug that caused appalling side effects in a clinical trial nine years ago is back in tests for rheumatoid arthritis and is showing promise when given at a fraction of the original dose.” Additional details of the Reuters story can be found at the link below.

The image shows a regulatory T-cell.

[TheraMAB press release] [Nature Biotechnology article] [Reuters article]