Xaluritamig Clinical Bispecific

Antibody Information

Entry ID	287
INN	Xaluritamig
Status	Clinical
Drug code(s)	AMG 509
Brand name	None
mAb sequence source	mAb humanized
General Molecular Category	Bispecific
Format, general category	Fragment-Fc
Format details	Fab-h-CH2-CH3 x Fab-scFv-h-CH2-CH3, 2 + 1 XmAb
Isotype (Fc)	TBD
Light chain isotype	TBD
Linker	None
Ave. DAR	None
Conjugated/fused moiety	None
Discovery method/technology	Xmab

Therapeutic information

Target(s)	STEAP1, CD3
Indications of clinical studies	Prostate cancer
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)	December 15, 2019
Start of Phase 2
Start of Phase 3	December 15, 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	Amgen
Licensee/Partner	Xencor, BeiGene
Comments about company or candidate	NCT06691984 Phase 3 in prostate cancer started in Dec 2024. NCT06555796 Phase 1 due to start in Sep 2024. NCT04221542 Phase 1 in Subjects With Metastatic Castration-Resistant Prostate Cancer. Xmab. 60th ASH meeting presentation (http://investors.amgen.com/phoenix.zhtml?c=61656&p=irol-presentations) US Orphan drug for Treatment of Ewing Sarcoma, granted July 7, 2020.
Full address of company	Thousand Oaks, California, United States North America United States of America https://www.amgen.com/

Description/comment

Xmab 2+1 technology. Fc engineered with various mutations including but not limited to S267K (reduced effector function), N293G (no glycosylation), R302C, V302C (additional disulfide bridges).
Xencor: Amgen applied our bispecific Fc technology to create, AMG 509, a STEAP1 x CD3 2+1 bispecific antibody, which Amgen is developing for patients with prostate cancer and Ewing sarcoma. Preclinical data were presented at the American Association for Cancer Research (AACR) Virtual Annual Meeting I in April 2020.

Additional information

Anticipated events	None
Factor(s) contributing to discontinuation	None