Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 649 |
| INN | Acasunlimab |
| Status | Clinical |
| Drug code(s) | GEN1046, DuoBody-PD-L1x4, BNT311 |
| Brand name | None |
| mAb sequence source | mAb humanized |
| General Molecular Category | Bispecific |
| Format, general category | Full length Ab |
| Format details | Duobody |
| Isotype (Fc) | IgG1 |
| Light chain isotype | kappa/lambda |
| Linker | None |
| Ave. DAR | None |
| Conjugated/fused moiety | None |
| Discovery method/technology | Transgenic rat (OmniRat), DuoBody platform |
| Target(s) | PD-L1, 4-1BB |
| Indications of clinical studies | Non-Small Cell Lung Cancer, 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 14, 2019 |
| Start of Phase 2 | October 27, 2022 |
| Start of Phase 3 | October 01, 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 | Genmab |
| Licensee/Partner | None |
| Comments about company or candidate | NCT06635824 Phase 3 in PD-L1-positive Metastatic NSCLC started in Oct 2024. August 5, 2024 – Genmab A/S announced that it will assume sole responsibility for the continued development and potential commercialization of acasunlimab. BioNTech SE (BioNTech) has opted not to participate in the further development of the acasunlimab program under the parties’ existing collaboration agreement. Genmab plans to initiate the Phase 3 study in the second half of this year. While the emerging clinical profile of acasunlimab is encouraging, BioNTech informed the company that it has taken this decision for reasons relating to its portfolio strategy. https://ir.genmab.com/news-releases/news-release-details/genmab-takes-full-control-acasunlimab-development-program NCT05117242 Phase 2 in NSCLC start in Oct 2021 recruiting as of last update in Mar 2023. NCT04937153 Phase 1 in solid tumors started in June 2021. NCT03917381 Phase 1/2 study in solid tumors started in May 2019. DuoBody-PD-L1x4-1BB is the first product candidate from the companies’ worldwide 50% cost-sharing 50% profit-sharing collaboration to enter the clinic. The objective of the collaboration, signed in 2015 and expanded in 2016 to include additional targets and technologies, is to develop and commercialize multiple novel bispecific antibodies with superior in vivo efficacy that specifically activate the immune system against cancer cells. |
| Full address of company | Copenhagen, Denmark Europe Denmark https://www.genmab.com/ |
Immune checkpoint targets. DuoBody-PD-L1x4-1BB (GEN1046) is a first-in-class bispecific antibody for conditional engagement of T-cell co-stimulatory receptor 4-1BB in concert with PD-L1 checkpoint blockade. DuoBody-PD-L1x4-1BB is an Fc-silenced IgG1 bispecific antibody that was obtained by controlled Fab-arm exchange of human(ized) PD-L1 and 4-1BB monoclonal antibodies.
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |