Clivatuzumab tetraxetan Terminated Radioimmunotherapy, RIC

Antibody Information

Entry ID	2164
INN	Clivatuzumab tetraxetan
Status	Terminated
Drug code(s)	IMMU-107, PAM4-DOTA
Brand name	PAM4-Cide
mAb sequence source	mAb humanized
General Molecular Category	Radioimmunotherapy, RIC
Format, general category	Full length Ab conjugate
Format details	None
Isotype (Fc)	IgG1
Light chain isotype	kappa
Linker	None
Ave. DAR	None
Conjugated/fused moiety	Y-90
Discovery method/technology	None

Therapeutic information

Target(s)	MUC5AC
Indications of clinical studies	Pancreatic Cancer
Primary therapeutic area	Cancer

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 Phase 3
Status	Inactive
Start of clinical phase (IND filing or first Phase 1)	November 15, 2003
Start of Phase 2	January 15, 2008
Start of Phase 3	January 15, 2014
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	Gilead Sciences Inc
Licensee/Partner	None
Comments about company or candidate	Oct 2020: Gilead Sciences acquired biotech company Immunomedics in a $21 billion deal March 2016: as a result of an interim futility analysis by the Data and Safety Monitoring Board, IMMU has discontinued the ph 3 PANCRIT-1 trial testing clivatuzumab in metastatic pancreatic cancer. The DSMB conducted an interim analysis on overall survival, which showed that the treatment arm did not demonstrate a sufficient improvement in OS vs. placebo. Fast track, orphan designations in US; Immunomedics seeks to out-license
Full address of company	333 Lakeside Drive Foster City, CA 94404 North America United States of America https://www.gilead.com/our-company/us-locations

Description/comment

Described in https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4015478/

Additional information

Anticipated events	None
Factor(s) contributing to discontinuation	Lack of efficacy