Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 24 |
| INN | Dinutuximab |
| Status | Approved |
| Drug code(s) | APN311, ch14.18 |
| Brand name | Qarziba, Unituxin |
| mAb sequence source | mAb chimeric |
| General Molecular Category | Naked monospecific |
| 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 | None |
| Target(s) | GD2 |
| Indications of clinical studies | Neuroblastoma |
| Primary therapeutic area | Cancer |
| Most advanced stage of development (global) | Approved EU, US, Japan, Australia |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | December 01, 1991 |
| Start of Phase 2 | |
| Start of Phase 3 | |
| Date BLA/NDA submitted to FDA | April 11, 2014 |
| Year of first approval (global) | 2015 |
| Date of first US approval | March 10, 2015 |
| INN, US product name | Dinutuximab |
| US or EU approved indications | Neuroblastoma (first-line therapy for pediatric patients with high-risk neuroblastoma) |
| Company | Apeiron |
| Licensee/Partner | Paladin Labs, United Therapeutics |
| Comments about company or candidate | Approved in US 3/10/2015; approved in EU Aug 2015 but withdrawn in March 2017 On May 5, 2017, EUSA Pharma (Netherlands) BV was granted approval for dinutuximab beta (Qarziba) in the EU. On March 20, 2017, marketing authorization of Unituxin for the treatment of high-risk neuroblastoma in patients aged 12 months to 17 years, who have previously received induction chemotherapy and achieved at least a partial response, followed by myeloablative therapy and autologous stem cell transplantation (ASCT) was withdrawn from the European Community Register at the request of United Therapeutics. 2015 United Therapeutics awarded rare pediatric disease designation priority review voucher for Unituxin (dinutuximab) to treat high-risk neuroblastoma. Sold to AbbVie for $350 million. Unused. BLA filed in April 2014, decision expected in April 2015. Substantial non-commercial involvement (e.g., Phase 3 studies by NCI); Aperion has license agreements with Medison and Gen Ilac. The two deals grant Medison and Gen Ilac exclusive rights to market and sell APN311 in Israel and Turkey, respectively. |
| Full address of company | Campus-Vienna-Biocenter 5, 1030 Vienna, Austria Europe Austria https://www.apeiron-biologics.com/about-us/#:~:text=APEIRON%20was%20founded%20in%202003,initially%20focusing%20on%20discovery%20projects. |
None
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |