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DRUG:

ISB 1342

i
Other names: ISB 1342, GBR 1342
Company:
Glenmark
Drug class:
CD3 agonist, CD38 inhibitor
Related drugs:
5ms
Study of ISB 1342, a CD38/CD3 Bispecific Antibody, in Subjects With Previously Treated Multiple Myeloma (clinicaltrials.gov)
P1, N=81, Completed, Ichnos Sciences SA | Recruiting --> Completed | N=245 --> 81 | Trial completion date: May 2024 --> Dec 2023
Trial completion • Enrollment change • Trial completion date
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ISB 1342
1year
Dose Escalation of ISB 1342, a Novel CD38xCD3 Bispecific Antibody, in Patients with Relapsed / Refractory Multiple Myeloma (RRMM) (ASH 2023)
This mechanism of action is different from existing monospecific CD38 targeting therapies and was designed to overcome resistance to daratumumab in MM. Treatment with ISB 1342 was well tolerated at higher dose levels evaluated. Observed CRS events were moderate. No increased risk of infection has been observed .
Clinical • IO biomarker
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CD8 (cluster of differentiation 8) • IFNG (Interferon, gamma) • IL6 (Interleukin 6) • TNFA (Tumor Necrosis Factor-Alpha) • CD4 (CD4 Molecule) • CD69 (CD69 Molecule) • IL2 (Interleukin 2) • IL10 (Interleukin 10)
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Darzalex (daratumumab) • ISB 1342
over1year
Pre-clinical characterization of ISB 1342, a CD38xCD3 T-cell engager for relapsed/refractory multiple myeloma. (PubMed, Blood)
Although treatment of multiple myeloma (MM) with daratumumab significantly extends the patient's lifespan, resistance to therapy is inevitable. These data suggest that ISB 1342 may be an option in patients with r/rMM refractory to prior anti-CD38 bivalent monoclonal antibody therapies. It is currently developed in a phase 1 clinical study.
Preclinical • Journal
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Darzalex (daratumumab) • ISB 1342
2years
Initial Results of Dose Escalation of ISB 1342, a Novel CD3xCD38 Bispecific Antibody, in Patients with Relapsed / Refractory Multiple Myeloma (RRMM) (ASH 2022)
This mechanism of action is differentiated from existing monospecific CD38 targeting therapies and was designed to overcome resistance to daratumumab in MM. Treatment with ISB 1342 was well tolerated at the dose levels evaluated. The observed CRS events were moderate. Dose escalation continues with additional dose cohorts accruing.
Clinical • IO biomarker
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IFNG (Interferon, gamma) • IL6 (Interleukin 6) • TNFA (Tumor Necrosis Factor-Alpha) • IL2 (Interleukin 2) • IL10 (Interleukin 10)
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CD38 expression
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Darzalex (daratumumab) • ISB 1342
over3years
[VIRTUAL] ISB 1342: A FIRST-IN-CLASS CD38 T CELL ENGAGER FOR THE TREATMENT OF RELAPSED REFRACTORY MULTIPLE MYELOMA (EHA 2021)
The release of the Granzyme A and B, TNF-alpha and CXCL-10 in the tumor micro-environment one week post-treatment was strongly and significantly increased by ISB 1342 but not by daratumumab and ISB 1342_13DU; this represents a correlate of anti-tumor immunity associated with ISB 1342 efficacy in vivo. Conclusion Hence the higher potency of ISB 1342 relative to daratumumab supports the ongoing clinical development in multiple myeloma patients.
IO biomarker
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TNFA (Tumor Necrosis Factor-Alpha) • CXCL10 (Chemokine (C-X-C motif) ligand 10) • GZMA (Granzyme A)
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CD38 expression • CD38 positive
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Darzalex (daratumumab) • ISB 1342