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.