Database for
Therapeutic Antibodies
Therapeutic Antibodies
| 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 |
| 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 |
| 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 | 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 |
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)
| Anticipated events | None |
| Factor(s) contributing to discontinuation | Lack of efficacy |