Acasunlimab Clinical Bispecific

Antibody Information

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

Therapeutic information

Target(s)	PD-L1, 4-1BB
Indications of clinical studies	Non-Small Cell Lung Cancer, Solid tumors
Primary therapeutic area	Cancer

Development stage information

Phase lengths*

*The graph represents early-stage clinical development phase lengths. For molecules approved or under evaluation for marketing authorization in the US is provided a complete overview of all clinical development phase lengths. Phase lengths are calculated from the start of the first in human (FIH) study (Start of clinical phase). “Start of Phase 2” bar represents Phase 1 length (Start of clinical phase to start of Phase 2); “Start of Phase 3” bar represents Phase 1+2 length (Start of clinical phase to start of Phase 3); “Date BLA/NDA submitted” bar represents Phase 1+2+3 length (Start of clinical phase to Date BLA/NDA submitted); and “Date of first US approval” bar represents Phase 1 to first US approval length (Start of clinical phase to Date of first US approval).

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 information

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/

Description/comment

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.

Additional information

Anticipated events	None
Factor(s) contributing to discontinuation	None