Biocon arm gets DCGI nod to initiate clinical study for Itolizumab

Bengaluru: Biocon Biologics Ltd., a subsidiary of Biocon Ltd., has recently announced that U.S.-based Equillium Inc., Biocon's partner, has expanded its EQUALISE study in Systemic Lupus Erythematosus (SLE) and Lupus Nephritis for Itolizumab (ALZUMAb-L*) to clinical centers in India.

EQUALISE is a Phase 1b openlabel, proof-of-concept clinical study currently studying Lupus Nephritis patients in the Part B portion of the clinical trial. Equillium has initiated this study across several tertiary hospitals specialised to deal with Lupus Nephritis patients in India after obtaining approval from the Drugs Controller General of India (DCGI).

Systemic Lupus Erythematosus, or Lupus, is an autoimmune chronic inflammatory disease. The prevalence of SLE in the U.S. has been reported to be between 20 to 150 cases per 100,000. In India, the reported prevalence of SLE is 3.2 per 100,000.

Dr. Sandeep Athalye, Chief Medical Officer, Biocon Biologics, said: "We are happy to announce the commencement of our partner Equillium's Phase 1b clinical study in India to evaluate the safety and early efficacy of Biocon Biologics' novel antibody, Itolizumab, in treating Lupus Nephritis. In India, approximately 45,000 patients are diagnosed with Systemic Lupus Erythematosus (SLE), of which over 20,000 patients have kidney involvement (nephritis), many of which do not respond to standard available therapy with steroids and immunosuppressive drugs.

 "We believe that ALZUMAb-L (Itolizumab) can address this unmet need for Lupus with better remission rates, more durable responses, and a better safety profile. Our partner Equillium has observed positive trends in the Part A portion of the Phase 1b study in SLE patients and hence is expanding the Part B portion of the study in Lupus Nephritis patients in the U.S. and India."

"Even with recent U.S. FDA approvals, treatments for patients with lupus nephritis have significant side effect profiles and do not result in complete responses for most patients, which are critical for long-term kidney survival," said Dolca Thomas, M.D., 2 Equillium's Executive Vice President of Research & Development and Chief Medical Officer. "We're very excited to see our study expand to India in hopes of filling a significant unmet medical need for lupus nephritis patients."

Itolizumab is a clinical-stage, first-in-class anti-CD6 monoclonal antibody that selectively targets the CD6-ALCAM pathway. This pathway plays a central role in modulating the activity and trafficking of T cells that drive several immunoinflammatory diseases. This unique molecule holds the potential for multiple highvalue indications.

Biocon out-licensed Itolizumab to U.S.-based biotechnology company Equillium in 2017 for them to develop this molecule for the treatment of severe autoimmune and inflammatory disorders. Equillium is currently developing Itolizumab for multiple indications, including acute graft-versus-host-disease (aGVHD), Lupus and Lupus Nephritis and uncontrolled Asthma. Equillium had in March this year unveiled favorable topline data from the Type A group of the EQUALISE study in patients with SLE.

In this study, Itolizumab, was safe and well tolerated. In addition, Itolizumab demonstrated a dose-dependent reduction of cell surface CD6 expression on effector T cells, a leading indicator of drug activity, consistent with its mechanism of action. The initial data from the EQUALISE study demonstrated a favorable safety and tolerability profile for subcutaneous delivery of Itolizumab in SLE patients. The EQUALISE study is evaluating the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD), and clinical activity of Itolizumab in patients with SLE and Lupus Nephritis.

The trial design and initiation has been a joint effort with the Lupus community including working closely with leading global clinical and scientific experts in the Lupus field, the Lupus Research Alliance, and patients living with Lupus and/or Lupus Nephritis. Importantly, the study is also evaluating urinary biomarkers including soluble ALCAM and CD6, which may help address the heterogeneity of the disease and tackle a key issue that has been a challenging aspect of developing drugs in this field.

ALZUMAb-L is Biocon Biologics' brand of Itolizumab, developed by Biocon and commercialized in India since 2013 as a novel anti-CD6 antibody for chronic plaque psoriasis. It has also received restricted emergency use authorization from the DCGI for the treatment of moderate to severe acute respiratory distress syndrome (ARDS) in COVID-19 patients and since then has saved thousands of lives.

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