Sustainability at Biocon slide image

Sustainability at Biocon

Biocon Novel Molecules: Pushing scientific boundaries to deliver impactful innovations Disease Area Asset Current Progress Insulin Tregopil- a first- in-class oral, prandial Phase I multiple ascending dose studies in Type 1 DM patients ongoing in Germany; in partnership with US-based Juvenile Diabetes Research Foundation (JDRF), a leading non-profit organization Insulin Diabetes Itolizumab- A novel humanized CD6 antibody • US based partner, Equillium initiated a Pivotal Phase III Study in March 2022 for use in First-Line treatment of Acute Graft- Versus-Host Disease (GVHD) After observing positive trends in the Part A, Equillium expanded Part B portion of its Phase 1b EQUALISE study for Systemic Lupus Erythematosus/Lupus Nephritis indication to clinical centers in India European Commission granted an 'Orphan Medical Product' designation for treatment of GVHD in Jul '21 Inflammation Immuno- oncology BCA101 (formerly FmAb2, a first-in-class EGFR/TGFẞ-trap bifunctional antibody) - part of Bicara Therapeutics**, a US based clinical-stage biotechnology company Repurposed for prevention & treatment of COVID-19 complications in India in 2020; granted 'Restricted Emergency Use' approval in Sep '20 for Cytokine Release Syndrome treatment in 'Moderate to Severe' Acute Respiratory Distress Syndrome Entered a Phase I/II study at leading US and Canadian cancer centers in Jul '20 Under evaluation, both as a single agent & in combination with the checkpoint inhibitor, Pembrolizumab, in patients with advanced EGFR-driven solid tumors, who no longer respond to the standard of care Completed enrollment for dose finding part of Phase I trial & established highest dose with desired level of safety & tolerability, both in monotherapy & in combination with a PD1 inhibitor. Proof of concept is expected in second half of 2022 In Feb '22, initiated dose expansion cohorts in patients with head & neck squamous cell carcinoma (HNSCC), squamous cell carcinoma of the anal canal (SCAC) and cutaneous squamous cell carcinoma (cSCC) Securing additional funding to support clinical development 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. 24
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