Gancotamab Terminated Immunoconjugate, Unconventional ADC, Immunoliposome

Antibody Information

Entry ID	2319
INN	Gancotamab
Status	Terminated
Drug code(s)	MM-302
Brand name	None
mAb sequence source	mAb human
General Molecular Category	Immunoconjugate, Unconventional ADC, Immunoliposome
Format, general category	Fragment conjugate
Format details	scFv-liposome
Isotype (Fc)	None
Light chain isotype	TBD
Linker	PEG-DSPE (polyethylene glycol-distearoylphosphatidylethanolamine)
Ave. DAR	None
Conjugated/fused moiety	Topoisomerase II inhibitor, Doxorubicin liposome
Discovery method/technology	Phage display-derived

Therapeutic information

Target(s)	HER2
Indications of clinical studies	Breast 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 2/3
Status	Inactive
Start of clinical phase (IND filing or first Phase 1)	March 15, 2011
Start of Phase 2
Start of Phase 3	July 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	Merrimack Pharmaceuticals
Licensee/Partner	None
Comments about company or candidate	Not listed in Merrimack pipeline as of July 2017. Dec 21, 2016: Following a recent independent Data and Safety Monitoring Board (DSMB) recommendation and subsequent futility analysis, it has decided to stop the Phase 2 HERMIONE study of MM-302 (HER2 antibody-targeted liposomal doxorubicin) in HER2-positive metastatic breast cancer patients who had previously been treated with trastuzumab (Herceptin®), pertuzumab (Perjeta®) and ado-trastuzumab emtansine. NCT02213744 Phase 2/3 study started in July 2014; terminated in Jan 2017 for not showing benefit over control per DMC and confirmed via futility analysis. The Phase 2 trial was designed with input from the U.S. Food and Drug Administration (FDA) to support a potential accelerated approval application.
Full address of company	One Broadway, 14th floor, Cambridge, MA 02142 North America United States of America https://www.merrimack.com/contact/

Description/comment

scFv-targeted liposome containing doxorubicin
https://doi.org/10.1186/s12885-016-2385-z

Additional information

Anticipated events	None
Factor(s) contributing to discontinuation	None