TheraMAB LLC. announces initiation of Phase II clinical trial of mAb TABO8 for the treatment of Rheumatoid Arthritis
Moscow, Russia, January 2014
"TheraMAB" LLC. announces the beginning of multicenter Phase Ib/IIa clinical trial of multiple TAB08 i.v. administration. This is “first-in-class” anti-CD28 humanized mAb of IgG4 type for the treatment of patients with autoimmune diseases. The study is being conducted in patients with active RA. Treatment of the first patient was started at the end of December 2013.
The main objective of the first stage of the study is to assess safety, pharmacokinetics, pharmacodynamics and clinical effects pattern with multiple i.v. administrations of different TAB08 doses in combination with methotrexate (MTX). Second stage of the study will evaluate safety and clinical efficiency of several TAB08 doses and regiments. More than 120 patients with active Rheumatoid Arthritis (RA) are planned to enroll for this clinical trial. Clinical trial TAB08_RA01 was approved by the Ministry of Health of the Russian Federation in October, 2013. Information about the study is available at: www.clinicaltrials.gov.
"TheraMAB" CEO, Dr. Dmitry Tyrsin, commented: “Excellent safety profile of mAb TAB08 demonstrated during CT Phase I on healthy volunteers clearly shows that combination of serious scientific analysis, novel thoroughly designed preclinical program and careful stepwise clinical strategy of the evaluation of safety parameters, makes the development of potential risky biological drugs predictable and secure process. After failure of clinical trial in London 2006 we brought back the potential blockbuster, mAb TAB08 into CT Phase II and reaffirmed Paracelsus paradigm that "The dose makes the poison". Dr. Tyrsin emphasized that first promising data on surrogate markers prove the correctness of our initial scientific hypothesis of TAB08 mechanism of action and indicate high potential efficacy of our antibody”.
"Bioprocess Capital Partners" CEO, Vladimir Tezov, MD, MBA commented: “TheraMAB" project was the first investment of the Fund in the biotechnology sector. Taking into account complicated story of the project, one of the key development stages was Phase I clinical trials in Russia aimed to confirm safety of the drug. Successful results of Phase I clinical trials have removed one of the most serious risks of the project, strengthened the company's reputation and positioned "TheraMAB" as a serious player in the global market of biotechnology developments. Current success of the project was made possible due to contribution of the team formed by the leading scientists and clinicians of Russia and Europe and experienced managers working for the project and the Management Company. Successful completion of the project will provide serious progress in solving the problem of import substitution in the field of autoimmune diseases and cancer, not by generics, but original drug, potentially surpassing the best world analogues and able to become the "gold standard" of treatment in the world".
The medicinal product which is being developed by the company “TheraMAB” LLC represents the “first-in-class”, humanized mAb of IgG4 class, which mode of action is based on binding to costimulating receptor CD28, specific for human Т-lymphocytes. CD28 receptor is expressed on majority of human CD4+ Т-cells, where it effectively costimulates activation and proliferation of Т-cells. The uniqueness of mode of action of ТАВ08s compared to other mAbs lies in the ability of the antibody to affect key aspects of pathogenesis via normalization of functional balance of various immune cell. Opposite to TAB08, majority of other antibodies (TNFa, IL-1, IL-6, etc.) address only the consequences of autoimmune diseases by neutralizing secreted pro-inflammatory factors produced.