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.
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