Efungumab Terminated Naked monospecific

Antibody Information

Entry ID	2342
INN	Efungumab
Status	Terminated
Drug code(s)	MYC-123
Brand name	Mycograb
mAb sequence source	mAb human
General Molecular Category	Naked monospecific
Format, general category	Fragment
Format details	scFv
Isotype (Fc)	None
Light chain isotype	TBD
Linker	None
Ave. DAR	None
Conjugated/fused moiety	None
Discovery method/technology	None

Therapeutic information

Target(s)	HSP90
Indications of clinical studies	Adjunctive therapy for Cryptococcal Meningitis in patients with AIDS, breast cancer
Primary therapeutic area	Infectious diseases

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 15, 2000
Start of Phase 2	June 15, 2001
Start of Phase 3	December 15, 2002
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	Novartis Pharmaceuticals
Licensee/Partner	None
Comments about company or candidate	Novartis acquired NeuTec US, EU orphan. NeuTec sponsored Phase 1/2 study in breast cancer in 2005. The applicant NeuTec Pharma plc submitted on 11 March 2005 a full application for Marketing Authorisation referring to Art. 8.3 of Directive 2001/83/EC, as amended, to the European Medicines Agency (EMEA) through the centralised procedure for Mycograb, which was designated as an orphan medicinal product EU/3/01/073 on 5 December 2001. CHMP decision was negative in March 2007; quality and safety data were considered unsuitable. An initial safety and tolerance study was performed initially using 0.1 mg/kg and escalating to one and two doses of 1mg/kg/day of Mycograb given i.v. (NTB/Mycograb/001). A pilot (Jun 01 to Nov 02) and confirmatory double-blind placebo-controlled studies of efficacy and safety of 1 mg/kg Mycograb administered iv twice daily over 5 days in the target population (NTB/Mycograb/002; Dec 02 to April 2004)).
Full address of company	Basel, Switzerland Europe Switzerland https://www.novartis.com/contacts

Description/comment

rhMAB-hsp90 is a non-glycosylated 27 kDa peptide, which contains two disulphide bonds. The protein consists of the variable domains of heavy (VH) and light chains (VL) joined via a flexible linker peptide.

Additional information

Anticipated events	None
Factor(s) contributing to discontinuation	None