Database for
Therapeutic Antibodies
Therapeutic Antibodies
| 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 |
| Target(s) | HSP90 |
| Indications of clinical studies | Adjunctive therapy for Cryptococcal Meningitis in patients with AIDS, breast cancer |
| Primary therapeutic area | Infectious diseases |
| 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 | 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 |
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.
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |