Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 1 |
| INN | Racotumomab |
| Status | Approved |
| Drug code(s) | 1 E10 |
| Brand name | Vaxira® |
| mAb sequence source | mAb murine |
| General Molecular Category | Vaccine, Anti-idiotype antibody |
| 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 | Mouse origin (BALB/C mouse derived) |
| Target(s) | NeuGcGM3 idiotype |
| Indications of clinical studies | Neuroblastoma; Ewing's Sarcoma; Wilm's Tumor; Retinoblastoma; Glioma, Non-small Cell Lung Cancer |
| Primary therapeutic area | Cancer |
| Most advanced stage of development (global) | Approved Argentina, Cuba |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | January 15, 2000 |
| Start of Phase 2 | |
| Start of Phase 3 | September 15, 2010 |
| Date BLA/NDA submitted to FDA | |
| Year of first approval (global) | 2013 |
| Date of first US approval | |
| INN, US product name | Racotumomab |
| US or EU approved indications | None |
| Company | Center of Molecular Immunology |
| Licensee/Partner | Recombio, Laboratorio Elea SACIFyA |
| Comments about company or candidate | Vaxira® is marketed in Argentina and Cuba for the treatment of recurrent or advanced NSCLC, or NSCLC independent of the disease stage when no other standard therapy can be administered for lung cancer. NCT02998983 Phase 2 study in neuroblastoma recruiting as of July 2018. Status of Phase 3 NCT01460472 study unknown as of July 2018; primary completion date was Sep 2016. |
| Full address of company | 15 Street and 216 Street, Siboney, Playa, La Habana, Cuba. A.P 16040, La Habana 11600, Cuba North America Republic of Cuba https://www.cim.cu/SobreNosotros/QuienesSomos |
The anti-GM3 antibody racotumomab (1E10) uses a vaccine mechanism of action. It is an anti-idiotypic monoclonal antibody that induces an immune response against glycolylated gangliosides (NeuGcGM3) present in the tumor cells. Originally developed in Cuba at the Center of Molecular Immunology, Vaxira® is marketed in Argentina and Cuba for the treatment of recurrent or advanced NSCLC, or NSCLC independent of the disease stage when no other standard therapy can be administered for lung cancer.
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |