Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 2517 |
| INN | Vadastuximab talirine |
| Status | Terminated |
| Drug code(s) | SGN-CD33A |
| Brand name | None |
| mAb sequence source | mAb humanized |
| General Molecular Category | ADC |
| Format, general category | Full length Ab conjugate |
| Format details | None |
| Isotype (Fc) | IgG1 |
| Light chain isotype | kappa |
| Linker | Valine-alanine (maleimidocaproyl-Val-Ala; Cleavable linker) |
| Ave. DAR | 2 (Site-specific) |
| Conjugated/fused moiety | DNA binding, Pyrrolobenzodiazepine (PBD) dimer |
| Discovery method/technology | None |
| Target(s) | CD33 |
| Indications of clinical studies | Acute myeloid leukemia, Myelodysplastic Syndrome |
| Primary therapeutic area | Cancer |
| Most advanced stage of development (global) | Terminated at Phase 3 |
| Status | Inactive |
| Start of clinical phase (IND filing or first Phase 1) | July 15, 2013 |
| Start of Phase 2 | |
| Start of Phase 3 | May 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 | Seagen Inc. |
| Licensee/Partner | None |
| Comments about company or candidate | Jun. 19, 2017-- Seattle Genetics, Inc. today announced that it is discontinuing the phase 3 CASCADE clinical trial of vadastuximab talirine (SGN-CD33A) in frontline older acute myeloid leukemia (AML) patients. Seattle Genetics took this action following consultation with the Independent Data Monitoring Committee (IDMC) and after reviewing unblinded data on June 16, 2017. The data indicated a higher rate of deaths, including fatal infections in the vadastuximab talirine-containing arm versus the control arm of the trial. Based on available data, the safety concerns in this trial do not appear related to hepatotoxicity. Seattle Genetics is suspending patient enrollment and treatment in all of its vadastuximab talirine clinical trials including the ongoing phase 1/2 clinical trial in frontline high risk myelodysplastic syndrome (MDS). Seattle Genetics will closely review the data and consult with the U.S. Food and Drug Administration (FDA) to determine future plans for the vadastuximab talirine development program. Press release May 25, 2016: Seattle Genetics Initiates Pivotal Phase 3 Trial of Vadastuximab Talirine (SGN-CD33A) for Patients with Newly Diagnosed Acute Myeloid Leukemia (AML). Phase 1/2 study to be initiated in H1 2016. NCT01902329 Phase 1 study recruiting as of June 2014 |
| Full address of company | Bothell, Washington, United States North America United States of America https://www.seagen.com/ |
NCT02614560 Phase 1/2 study started in Nov 2015. SGN-CD33A consists of a humanized anti-CD33 mAb with 2 engineered cysteine residues through which pyrrolobenzodiazepine (PBD) dimer drug moieties are conjugated via a maleimidocaproyl valine-alanine dipeptide linker. PBD dimers exert their biological activity by covalent binding and interstrand cross-linking of DNA.
| Anticipated events | None |
| Factor(s) contributing to discontinuation | Safety issues |