"TheraMAB" LLC. launches Phase I clinical trial of "first-in-class" agonistic monoclonal antibody TABO8 in Russia
Moscow, Russia, November, 2011.
"TheraMAB" announced an important step in TAB08 development: the first volunteer was enrolled in the phase I clinical trial, a humanized antibody for the treatment of autoimmune diseases and hemo-oncological disorders. The primary goal of the trial is to study the safety and tolerability of different doses of TAB08 after single intravenous infusion to healthy adult volunteers. It is also planned to evaluate the pharmacokinetics and pharmacodynamics of TAB08 and to characterize biomarkers that are specific for the mechanism of action of the drug.
Novel approach for treatment of autoimmune diseases
TAB08 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 lymphocytes.CD28 receptor is expressed on overwhelming number of human CD4+Т-cells, where it effectively costimulates activation and proliferation of Т-cells. It should be noted that, in contrast to other therapeutic mAbs which are antibodies of "blocking" type,ТАВ08 is a potent cell stimulator.
It increases potential of immune system. The unique characteristic of the product is selective activation ofТ-regulatory cells. The therapeutic activity of TAB08 demonstrated in preclinical animal models resulted in a significant benefit for studied animals with experimented rheumatoid arthritis.
About the trial TABO8
This phase I clinical trial of TAB08/HS/R1 is entitled: "The Open Phase I Trial to Assess the Pharmacokinetics and Tolerability of a Single Dose of TAB08 in Healthy Volunteers". TheraMAB received an official permit from Russian regulatory authorities to conduct Phase I clinical trials No. 385 dated by September 30, 2011.
In order to provide maximum safety of the clinical trial the following steps were done:
I) the dose was calculated in compliance with the requirements of the EMA on calculation of first doses (MABEL concept);
II) an adequate premedication scheme involving corticosteroids, antihistamines and paracetamol is included;
III) escalation of each TAB08 dose will be approved by an independent "Drug Safety Expert Council" after careful analysis of interim safety reports obtained during clinical trials;
IV) individualized approach has been implemented, each volunteer will be prescreened in in-vitro assay “resTore”, specifically designed to address safety parameters of TAB08.
Dmitry Tyrsin, CEO said: "This is a remarkable day for Russian pharmaceutical industry because this is a first ever original monoclonal antibody to be studied in Phase I clinical trial in Russia. I’m proud to be a part of a talented team able to bring an original monoclonal antibody with an innovative mode of action into clinical development in record time. I am confident that this trial will be a first major step on way for changing standards in the treatment of rheumatoid arthritis and other autoimmune disorders."