Entry ID | 1263 |
INN | Sigvotatug vedotin |
Status | Clinical |
Drug code(s) | PF-08046047, SGN-B6A |
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-Citrulline (Cleavable linker) |
Ave. DAR | 4 |
Conjugated/fused moiety | Tubulin inhibitor, Monomethyl auristatin E (MMAE) |
Discovery method/technology | None |
Target(s) | Integrin beta-6 |
Indications of clinical studies | Solid tumors |
Primary therapeutic area | Cancer |
Most advanced stage of development (global) | Phase 3 |
Status | Active |
Start of clinical phase (IND filing or first Phase 1) | May 01, 2020 |
Start of Phase 2 | |
Start of Phase 3 | February 13, 2024 |
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 | Phase 3 in Pfizer pipeline dated Oct 2024. NCT06012435 Phase 3 in non-small cell lung cancer started in Feb 2024. Aug 2023: Planned Initiation of a Phase 3 trial for SGN-B6A for Patients with Metastatic Non-Small Cell Lung Cancer: We plan to initiate a phase 3 trial evaluating SGN-B6A monotherapy compared to standard of care, docetaxel, in patients with previously treated non-small cell lung cancer in the fourth quarter of 2023. NCT04389632 Phase 1 recruiting as of June 10 2022 update. May 1, 2020 earnings call: Turning now to our pipeline. On the horizon with a clinical trial readout is tisotumab vedotin, or TV, which we are developing in collaboration with Genmab. We're conducting a pivotal Phase II single-arm, single agent trial in women with recurrent or metastatic cervical cancer where there is no standard of care and outcomes are poor. We expect to report top line results late this quarter or into the third quarter. Our early stage clinical pipeline is robust. It includes ADCs such as ladiratuzumab vedotin, SGN-CD228 and SGN-B6A, for which an IND had just been submitted. These three ADCs are all targeted to receptors that are widely expressed in solid tumors. |
Full address of company | Bothell, Washington, United States North America United States of America https://www.seagen.com/ |
SGN-B6A is an ADC targeting integrin beta-6 to deliver the clinically validated payload monomethyl auristatin E (MMAE). In preclinical research, this ADC has demonstrated in vivo activity in models spanning a range of antigen expression levels and tumor types.
Anticipated events | None |
Factor(s) contributing to discontinuation | None |