Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 2456 |
| INN | Gantenerumab |
| Status | Terminated |
| Drug code(s) | RO4909832, RG1450 |
| Brand name | None |
| mAb sequence source | mAb human |
| General Molecular Category | Bispecific |
| Format, general category | Full length Ab |
| Format details | None |
| Isotype (Fc) | IgG1 |
| Light chain isotype | kappa |
| Linker | None |
| Ave. DAR | None |
| Conjugated/fused moiety | None |
| Discovery method/technology | Phage display (HuCAL)-derived |
| Target(s) | Amyloid beta (N-terminal and central portion aggregated and oligomers) |
| Indications of clinical studies | Alzheimer's Disease |
| Primary therapeutic area | Neurological disorders |
| Most advanced stage of development (global) | Terminated at Phase 3 |
| Status | Inactive |
| Start of clinical phase (IND filing or first Phase 1) | January 15, 2006 |
| Start of Phase 2 | |
| Start of Phase 3 | November 15, 2010 |
| 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 | Hoffmann-La Roche |
| Licensee/Partner | MorphoSys |
| Comments about company or candidate | Nov 30 2022: Roche is closing down most clinical trials of its experimental Alzheimer's drug gantenerumab after it failed to slow advance of the mind-robbing disease in a pair of large, late-stage studies. Aug 2022: MorphoSys’ partner Roche expects a pivotal data readout of the GRADUATE 1 and GRADUATE 2 trials with gantenerumab in the second half of 2022. Roche initiated these phase 3 development programs for patients with Alzheimer’s disease in 2018. Oct 2021: gantenerumab, an anti-amyloid beta antibody developed for subcutaneous administration, has been granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration (FDA) for the treatment of people living with Alzheimer’s disease NCT04374253 Phase 3 study recruiting as of Feb 2021. NCT04339413 Phase 3 study in AD not yet recruiting when posted on April 9 2020. NCT03443973 Phase 3 study started in Aug 2018 still recruiting as of Aug 2019. June 12, 2018: MorphoSys AG announced today that the first patient has been enrolled in a new phase 3 trial of gantenerumab in patients with early Alzheimer's disease. Gantenerumab is a monoclonal antibody directed against amyloid-beta generated by MorphoSys using its proprietary HuCAL antibody technology. Roche is fully responsible for the clinical development of gantenerumab. MorphoSys is entitled to receive potential success-based regulatory milestone payments related to gantenerumab and royalties on net sales. NCT02051608 Phase 3 study recruiting as of Sep 2016. In NCT01760005, a Phase 2/3 study sponsored by Washington University School of Medicine, the gantenerumab arm did not meet its primary endpoint in people who have an early-onset, inherited form of Alzheimer’s disease (AD). This form of AD, known as autosomal dominant AD (ADAD), accounts for less than 1% of all cases of the disease. |
| Full address of company | Basel, Switzerland Europe Switzerland https://www.roche.com/about |
Parent molecule of RO7126209, which is composed of a Fab fragment that binds the human transferrin receptor attached to the effector (Fc) domain of gantenerumab. Target is amyloid beta N-terminal and central portion aggregated and oligomers according to https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3832388/
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |