Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 2476 |
| INN | Begelomab |
| Status | Terminated |
| Drug code(s) | SAND-26 |
| Brand name | Begedina |
| mAb sequence source | mAb murine |
| General Molecular Category | Naked monospecific |
| Format, general category | Full length Ab |
| Format details | None |
| Isotype (Fc) | IgG2b |
| Light chain isotype | kappa |
| Linker | None |
| Ave. DAR | None |
| Conjugated/fused moiety | None |
| Discovery method/technology | None |
| Target(s) | CD26 |
| Indications of clinical studies | Graft-versus-host disease |
| Primary therapeutic area | Immune-mediated / inflammatory disorders |
| Most advanced stage of development (global) | Terminated at regulatory review |
| Status | Inactive |
| Start of clinical phase (IND filing or first Phase 1) | July 01, 2008 |
| Start of Phase 2 | January 15, 2011 |
| Start of Phase 3 | February 15, 2016 |
| 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 | Adienne Pharma & Biotech |
| Licensee/Partner | None |
| Comments about company or candidate | Sep 2017 Phase 3 NCT02411084 study terminated for Insufficient rate of accrual. Marketing application submitted in EU in Nov 2015, but withdrawn in July 2016; the company stated that it acknowledges the need to obtain additional data from a confirmatory study. NCT02411084 Phase 3 recruiting patients as of Oct 2016. On 4 July 2016, Adienne S.r.l. S.U. officially notified EMA's Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Begedina, for the treatment of graft-versus-host disease. Need for additional clinical data is cited as the reason for the withdrawal. https://www.ema.europa.eu/en/documents/withdrawal-letter/withdrawal-letter-begedina_en.pdf Listed in co pipeline as of Sept 2012. BEGEDINA® has been approved as Orphan Drug, by EMA in 2010 and by FDA in 2011, for the indication: "Treatment of graft-versus-host disease |
| Full address of company | Via Zurigo 46, CH-6900 Lugano, Switzerland Europe Switzerland https://www.adienne.com/?page_id=1441 |
None
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |