Sabatolimab

Summary

Sabatolimab (CHEMBL4594575) is a phase-3 clinical-stage antibody (ATC L01FX19) targeting HAVCR2; indicated across 7 conditions including myelodysplastic syndrome and neoplasm.

At a glance

• Status: Max clinical phase 3 (not approved)
• Modality: Antibody
• ATC class: L01FX19
• Targets: 1 (HAVCR2)
• Indications: 7 conditions
• Clinical trials: 17

Identifiers

Drug identity and classification

Field	Value
ChEMBL ID	CHEMBL4594575
Name	Sabatolimab
Type	Antibody
Max phase	3
ATC	L01FX19

Also known as: Mbg 453, MBG-453, Mbg453, MBG453, NVP-MBG453, Sabatolimab, SABATOLIMAB

Targets

Targets

Primary targets (GtoPdb curated mechanism): the Cancer dependency column is the DepMap CRISPR fitness signal (% of screened cell lines dependent on the target).

Gene	Target	Action	pAffinity	Cancer dependency	UniProt
HAVCR2	TIM3 (CD366)	Binding	9.78	0.1%	Q8TDQ0

Bioactivity

No ChEMBL bioactivity rows at pChembl ≥ 5 (expected for biologics / antibodies).

Target pathways

Aggregated over 1 target gene(s): HAVCR2.

Top Reactome pathways

1 total, by targets touching each:

Pathway	Targets	Genes
Interleukin-2 family signaling	1	HAVCR2

Dominant GO biological processes

GO term	Targets
adaptive immune response	1
macrophage activation involved in immune response	1
natural killer cell tolerance induction	1
regulation of tolerance induction dependent upon immune response	1
negative regulation of T-helper 1 type immune response	1
negative regulation of natural killer cell mediated cytotoxicity directed against tumor cell target	1
regulation of transcription by RNA polymerase II	1
inflammatory response	1
negative regulation of gene expression	1
negative regulation of myeloid dendritic cell activation	1
obsolete negative regulation of NF-kappaB transcription factor activity	1
negative regulation of interferon-alpha production	1
negative regulation of type II interferon production	1
negative regulation of interleukin-2 production	1
negative regulation of interleukin-3 production	1

Indications & clinical

Indications

7 indications (0 at ChEMBL trial phase 4). Phase below is the highest clinical-trial phase recorded for this drug against each disease — not the molecule’s overall approval status (that is in the Summary).

Indication	Trial phase	MONDO	EFO
myelodysplastic syndrome	3	MONDO:0018881	EFO:0000198
neoplasm	3	MONDO:0005070	EFO:0000616
acute myeloid leukemia	2	MONDO:0018874	EFO:0000222
glioblastoma	1	MONDO:0018177	EFO:0000519
primary myelofibrosis	1	MONDO:0009692	MONDO:0044903
autoimmune disease	1	MONDO:0007179	EFO:0005809

1 further indication record had no mapped disease name (EFO/MeSH-only) or were duplicates, and are omitted.

Clinical trials

Total trials: 17.

Phase distribution

Phase	Trials
PHASE2	6
PHASE1/PHASE2	5
PHASE1	5
PHASE3	1

Top trials by phase / activity

NCT	Phase	Status	Title
NCT04266301	PHASE3	TERMINATED	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)
NCT05201066	PHASE2	ACTIVE_NOT_RECRUITING	Roll-over Study for Patients Who Have Completed a Prior Novartis-sponsored Sabatolimab (MBG453) Study and Are Judged by the Investigator to Benefit From Continued Treatment With Sabatolimab.
NCT06664879	PHASE1/PHASE2	ACTIVE_NOT_RECRUITING	ALLG AMLM26 INTERCEPT (Investigating Novel Therapy to Target Early Relapse and Clonal Evolution as Pre-emptive Therapy in AML): A Multi-arm, Precision-based, Recursive, Platform Trial
NCT02608268	PHASE1/PHASE2	TERMINATED	Phase I-Ib/II Study of MBG453 as Single Agent and in Combination With PDR001 in Patients With Advanced Malignancies
NCT03946670	PHASE2	TERMINATED	A Study of MBG453 in Combination With Hypomethylating Agents in Subjects With IPSS-R Intermediate, High or Very High Risk Myelodysplastic Syndrome (MDS).
NCT04097821	PHASE1/PHASE2	TERMINATED	Platform Study of Novel Ruxolitinib Combinations in Myelofibrosis Patients
NCT04150029	PHASE2	TERMINATED	A Study of MBG453 in Combination With Azacitidine and Venetoclax in AML Patients Unfit for Chemotherapy
NCT04623216	PHASE1/PHASE2	TERMINATED	Sabatolimab as a Treatment for Patients With Acute Myeloid Leukemia and Presence of Measurable Residual Disease After Allogeneic Stem Cell Transplantation.
NCT04812548	PHASE2	TERMINATED	A Study of Sabatolimab in Combination With Azacitidine and Venetoclax in High or Very High Risk MDS Participants
NCT04823624	PHASE2	TERMINATED	MBG453 in Lower Risk MDS
NCT04878432	PHASE2	TERMINATED	STIMULUS MDS-US : Sabatolimab Added to HMA in Higher Risk MDS
NCT05367401	PHASE1/PHASE2	WITHDRAWN	A Study of Sabatolimab and Magrolimab-based Treatment in AML or Higher Risk MDS Participants
NCT03961971	PHASE1	ACTIVE_NOT_RECRUITING	Trial of Anti-Tim-3 in Combination With Anti-PD-1 and SRS in Recurrent GBM
NCT03066648	PHASE1	COMPLETED	Study of PDR001 and/or MBG453 in Combination With Decitabine in Patients With AML or High Risk MDS
NCT03940352	PHASE1	TERMINATED	HDM201 in Combination With MBG453 or Venetoclax in Patients With Acute Myeloid Leukemia (AML) or High-risk Myelodysplastic Syndrome (MDS)
NCT04283526	PHASE1	WITHDRAWN	Study of Select Combinations in Adults With Myelofibrosis
NCT04810611	PHASE1	TERMINATED	Phase Ib Study of Select Drug Combinations in Patients With Lower Risk MDS

Clinical evidence (CIViC)

No CIViC predictive evidence (expected for non-precision-medicine drugs).

Pharmacology

Pharmacogenomics

No PharmGKB pharmacogenomic data curated for this drug.

Related molecules

Related molecules

No competitor molecules sharing a primary target (ChEMBL phase ≥2 or PubChem drug-class).