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DRUG:

NC525

i
Other names: NC525, LAIR-1 mAb
Associations
Trials
Company:
NextCure
Drug class:
LAIR1 antagonist
Associations
Trials
13d
A Safety, Tolerability and Efficacy Study of NC525 in Subjects with Advanced Myeloid Neoplasms (clinicaltrials.gov)
P1, N=63, Active, not recruiting, NextCure, Inc. | Recruiting --> Active, not recruiting
Enrollment closed
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NC525
1year
LAIR-1 agonism as a therapy for acute myeloid leukemia. (PubMed, J Clin Invest)
We showed that LAIR-1 agonism drives a unique apoptotic signaling program in leukemic cells that was enhanced in the presence of collagen. NC525 also significantly improved the activity of azacitidine and venetoclax to establish LAIR-1 targeting as a therapeutic strategy for AML that may synergize with standard-of-care therapies.
Journal
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LAIR1 (Leukocyte Associated Immunoglobulin Like Receptor 1)
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Venclexta (venetoclax) • azacitidine • NC525
2years
A Phase 1, Open-Label, Safety, Tolerability, and Efficacy Study of NC525 in Subjects with Advanced Myeloid Neoplasms (ASH 2022)
Safety and tolerability will be further assessed through the expansion of a few dose levels to determine an optimal recommended Phase 2 Dose (RP2D) and administration schedule of NC525, based on the PK/PD profiles. Taken together, preclinical data suggest that targeting LAIR-1 in AML and other myeloid malignancies may be an effective therapy for these diseases with the advantage of specifically eradicating leukemic stem cells and sparing normal HSCs.
Clinical • P1 data • IO biomarker
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BCL2 (B-cell CLL/lymphoma 2) • CD34 (CD34 molecule) • LAIR1 (Leukocyte Associated Immunoglobulin Like Receptor 1)
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LAIR1 expression
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NC525
3years
A Novel Lair-1 Antibody Selectively Targets Acute Myeloid Leukemia (AML) Stem Cells (ASH 2021)
Extensive research has led to recent approval of novel therapies such as mylotarg, venetoclax, glasdegib and CC486, and small molecule inhibitors against actionable mutations such as ivosidenib (IDH1), enasidenib (IDH2), gliteritinib and midostaurin (FLT3) in AML...Taken together, our studies suggest that the LAIR-1 mAb we generated is a novel AML immunomedicine that preferentially eradicates AML LSCs and blasts while preserving healthy HSCs through disruption of AML survival signals and clearance of AML through ADCP and ADCC. Additional studies are currently evaluating if this novel LAIR-1 mAb has other mechanisms of action that contribute to overall in vivo activity, including reduction of AML niche implantation, regulation of bone marrow homing and regulation of anti-tumor immunity.
IO biomarker
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FLT3 (Fms-related tyrosine kinase 3) • KIT (KIT proto-oncogene, receptor tyrosine kinase) • IDH1 (Isocitrate dehydrogenase (NADP(+)) 1) • IDH2 (Isocitrate Dehydrogenase (NADP(+)) 2) • CD19 (CD19 Molecule) • CD22 (CD22 Molecule) • CD33 (CD33 Molecule) • CD34 (CD34 molecule) • THY1 (Thy-1 membrane glycoprotein) • LAIR1 (Leukocyte Associated Immunoglobulin Like Receptor 1)
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LAIR1 expression
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Venclexta (venetoclax) • Rydapt (midostaurin) • Tibsovo (ivosidenib) • Mylotarg (gemtuzumab ozogamicin) • Idhifa (enasidenib) • Onureg (azacitidine oral) • Daurismo (glasdegib) • NC525