Sabatolimab Terminated Naked monospecific

Antibody Information

Entry ID	2257
INN	Sabatolimab
Status	Terminated
Drug code(s)	MBG453
Brand name	None
mAb sequence source	mAb humanized
General Molecular Category	Naked monospecific
Format, general category	Full length Ab
Format details	None
Isotype (Fc)	IgG4
Light chain isotype	kappa
Linker	None
Ave. DAR	None
Conjugated/fused moiety	None
Discovery method/technology	None

Therapeutic information

Target(s)	TIM3
Indications of clinical studies	Acute myeloid leukemia, Myelodysplastic syndrome, Advanced malignancies, acute myeloid leukemia or high risk myelodysplastic syndrome (single Phase 1 study)
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)	Terminated at Phase 3
Status	Inactive
Start of clinical phase (IND filing or first Phase 1)	November 23, 2015
Start of Phase 2	May 13, 2019
Start of Phase 3	June 08, 2020
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	Novartis Pharmaceuticals
Licensee/Partner	None
Comments about company or candidate	Q4 2023 and year end results: Ph3 STIMULUS MDS2 did not meet (sabatolimab) primary endpoint; Program discontinued to prioritize other key programs in portfolio Dec 2022: Q4 2022 update lists asset as possible 2024 reg. filing pending Phase 3 in MDS. Aug 2021: The European Commission (EC) has granted orphan drug designation for Novartis’ drug, sabatolimab (MBG453), to treat myelodysplastic syndromes NCT04266301 Phase 3 study of Efficacy and Safety of MBG453 in Combination With Azacitidine in Subjects With Intermediate, High or Very High Risk Myelodysplastic Syndrome (MDS) as Per IPSS-R, or Chronic Myelomonocytic Leukemia-2 (CMML-2) (STIMULUS-MDS2) started in June 2020. The pivotal MDS program is expected to lead to MBG453's first regulatory submission. FDA Fast Track in MDS NCT04623216 Phase 1/2 in AML NCT04150029 Phase 2 in AML not yet recruiting as of Nov 5, 2019. NCT04097821 Phase 1/2 study in Myelofibrosis not yet recruiting as of Sep 20, 2019. Pivotal NCT03946670 Phase 2 study in MDS started in May 2019. NCT03940352 and NCT03961971 (in glioblastoma) Phase 1 studies not yet recruiting as of May 23 2019. Listed as ready to enter clinic as of Oct 21 2015 press release, and in Phase 1 as of Jan 11 2016 press release. NCT02608268 and NCT02608268 studies recruiting as of Aug 2018.
Full address of company	Basel, Switzerland Europe Switzerland https://www.novartis.com/contacts

Description/comment

Immune checkpoint target. Hinge stabalized (S228P).Target is T-cell immunoglobulin and mucin-domain domain-containing molecule-3 (TIM-3). http://cancerres.aacrjournals.org/content/79/13_Supplement/CT183, Characterization data published in Aug 2022 (Immunotherapy Advances, ltac019, https://doi.org/10.1093/immadv/ltac019)

Additional information

Anticipated events	None
Factor(s) contributing to discontinuation	Lack of efficacy