Begelomab Terminated Naked monospecific

Antibody Information

Entry ID	2476
INN	Begelomab
Status	Terminated
Drug code(s)	SAND-26
Brand name	Begedina
mAb sequence source	mAb murine
General Molecular Category	Naked monospecific
Format, general category	Full length Ab
Format details	None
Isotype (Fc)	IgG2b
Light chain isotype	kappa
Linker	None
Ave. DAR	None
Conjugated/fused moiety	None
Discovery method/technology	None

Therapeutic information

Target(s)	CD26
Indications of clinical studies	Graft-versus-host disease
Primary therapeutic area	Immune-mediated / inflammatory disorders

Development stage information

Phase lengths*

*The graph represents early-stage clinical development phase lengths. For molecules approved or under evaluation for marketing authorization in the US is provided a complete overview of all clinical development phase lengths. Phase lengths are calculated from the start of the first in human (FIH) study (Start of clinical phase). “Start of Phase 2” bar represents Phase 1 length (Start of clinical phase to start of Phase 2); “Start of Phase 3” bar represents Phase 1+2 length (Start of clinical phase to start of Phase 3); “Date BLA/NDA submitted” bar represents Phase 1+2+3 length (Start of clinical phase to Date BLA/NDA submitted); and “Date of first US approval” bar represents Phase 1 to first US approval length (Start of clinical phase to Date of first US approval).

Most advanced stage of development (global)	Terminated at regulatory review
Status	Inactive
Start of clinical phase (IND filing or first Phase 1)	July 01, 2008
Start of Phase 2	January 15, 2011
Start of Phase 3	February 15, 2016
Date BLA/NDA submitted to FDA
Year of first approval (global)	None
Date of first US approval
INN, US product name	None
US or EU approved indications	None

Company information

Company	Adienne Pharma & Biotech
Licensee/Partner	None
Comments about company or candidate	Sep 2017 Phase 3 NCT02411084 study terminated for Insufficient rate of accrual. Marketing application submitted in EU in Nov 2015, but withdrawn in July 2016; the company stated that it acknowledges the need to obtain additional data from a confirmatory study. NCT02411084 Phase 3 recruiting patients as of Oct 2016. On 4 July 2016, Adienne S.r.l. S.U. officially notified EMA's Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Begedina, for the treatment of graft-versus-host disease. Need for additional clinical data is cited as the reason for the withdrawal. https://www.ema.europa.eu/en/documents/withdrawal-letter/withdrawal-letter-begedina_en.pdf Listed in co pipeline as of Sept 2012. BEGEDINA® has been approved as Orphan Drug, by EMA in 2010 and by FDA in 2011, for the indication: "Treatment of graft-versus-host disease
Full address of company	Via Zurigo 46, CH-6900 Lugano, Switzerland Europe Switzerland https://www.adienne.com/?page_id=1441

Description/comment

None

Additional information

Anticipated events	None
Factor(s) contributing to discontinuation	None