India Approves Novel Biologic To Treat Hospitalized COVID-19 Patients
An India based biopharmaceutical company presented key insights into the results of the pivotal study that demonstrated its novel biologic, Itolizumab, significantly reduced mortality in moderate to severe ARDS (acute respiratory distress syndrome) patients hospitalized with COVID-19.
This study’s results led the Drug Controller General of India (DCGI) to approve Biocon Ltd.’s novel biologic therapy for restricted emergency use in India, as of July 13, 2020.
Upon COVID-19 viral invasion, the antigen-presenting cells (APCs) in the airways/lungs, such as dendritic cells and macrophages, initiate the innate and adaptive T cell responses.
This is done through an interaction between CD6 (a surface glycoprotein on the T-cells) and ALCAM (activated leukocyte cell adhesion molecule) which modulates T-cell activation.
Biocon initially received approval for Itolizumab in the treatment of chronic plaque psoriasis in India in 2013, demonstrating the product was safe and well-tolerated.
In May 2017, Itolizumab was out-licensed for the USA and Canada markets to U.S.-based biotechnology company Equillium. During FY20, the scope of the licensing agreement with Equillium for Itolizumab was expanded to include the countries of Australia and New Zealand.
Equillium is moving quickly to initiate a global study of Itolizumab that would support the approval of the therapeutic in the USA and elsewhere, so that the therapy may become available in the shortest time possible to the greatest number of patients worldwide.
Equillium is currently studying Itolizumab under open U.S. INDs for the treatment of acute graft-versus-host disease (aGVHD) and lupus nephritis.
Itolizumab is a ‘first-in-class,’ humanized IgG1 monoclonal antibody (mAb) that selectively targets CD6 cells.
This anti-CD6 mAb inhibits the activity and trafficking of Teff cells by selectively targeting the CD6/ALCAM pathways.
CD6 is a pan T-cell marker involved in co-stimulation, adhesion, and maturation of T-cells.
Itolizumab, by binding to CD6, downregulates T-cell activation, causes a reduction in synthesis of pro-inflammatory cytokines, and possibly plays an important role by reducing T-cell infiltration at sites of inflammation.
Itolizumab holds broad potential as a ‘pipeline in a product’ with multiple high-value indications applicable with three clinical studies underway across the globe in acute graft-versus-host disease, severe asthma, and lupus nephritis.
Itolizumab is produced at a commercial scale at Biocon’s cGMP bio-manufacturing facility that is regulated by the U.S. Food & Drug Administration.
Biocon Limited, publicly listed in 2004, is an innovation-led global biopharmaceutical company committed to enhancing affordable access to complex therapies for chronic conditions like diabetes, cancer, and autoimmune.
It also has a pipeline of promising novel assets in immunotherapy under development.
CoronavriusToday publishes COVID-19 treatment development news.