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.
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