Biocon Corporate Presentation slide image

Biocon Corporate Presentation

Novel Molecules: Pushing scientific boundaries to deliver impactful innovations Biocon Disease Area ៨ Diabetes Inflammation Immuno-oncology Asset Insulin Tregopil- a first-in-class oral, prandial Insulin Itolizumab- A novel humanized CD6 antibody BCA101- (formerly FmAb2, a first-in-class EGFR/ TGFB-trap bifunctional antibody).This asset is part of Bicara Therapeutics, a clinical-stage biotechnology company based in US* Current Progress • Phase I multiple ascending dose studies in Type 1 DM patients making progress in Germany. This trial is in partnership with the US-based Juvenile Diabetes Research Foundation (JDRF), a leading non-profit organization. . Phase 1 component of this trial expected to be completed in FY22 US, Canada, Australia and New Zealand rights out-licensed to the US-based Equillium Inc. Currently, Equillium is conducting clinical trials on the use of Itolizumab in the treatment of acute graft-versus-host disease (aGVHD), uncontrolled asthma and lupus nephritis. ⚫ The European Commission granted an 'Orphan Medical Product' designation to Itolizumab in the treatment of Graft versus Host disease in July 2021 ⚫ In 2020, Itolizumab was repurposed for the prevention and treatment of COVID-19 complications and we were granted Restricted Emergency Use approval in September 2020 for the treatment of Cytokine Release Syndrome (CRS) in moderate to Severe Acute Respiratory Distress Syndrome (ARDS) patients in India. Phase 4 studies are making good progress. • Entered a Phase 1/2 study at leading US and Canadian cancer centers in July 2020. Under evaluation, both as a single agent and in combination with the checkpoint inhibitor Pembrolizumab, in patients with advanced EGFR-driven solid tumors, who no longer respond to the standard of care. Bicara anticipates transitioning to dose expansion studies in the second half of 2021. *In Q4FY21, Biocon ceded control over the Board of Directors and Operations of Bicara Therapeutics Inc. to enable it to operate independently under a US based leadership team and raise funds to advance its development programs. As a result of this change, Bicara was classified as an Associate from a Subsidiary under IND-AS. 14
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