Drugs / ISB 2001
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1 | NCT05862012 | Nov 2023 → Jul 2027 expected | refractory plasma cell neoplasm | Ichnos Sciences SA | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 10
| Date | Issuer | Release |
|---|---|---|
| 2025-06-02 | Ichnos Sciences SA | Results Full Dose-Escalation Data Show Continued High Response Rates and Favorable Safety Profile of ISB 2001, a First-in-Class BCMA × CD38 × CD3 Trispecific Antibody, for the Treatment of Relapsed/Refractory Multiple Myeloma iginnovate.com ↗
TRIgnite-1 study shows an overall response rate (ORR) of 74% across nine dose levels, in heavily pretreated patients with a median of six prior lines of therapy |
| 2025-05-05 | Ichnos Sciences SA | Regulatory Ichnos Glenmark Innovation (IGI) Receives U.S. FDA Fast Track Designation for ISB 2001 for Relapsed/Refractory Multiple Myeloma iginnovate.com ↗
IGI, a global, fully integrated clinical-stage biotechnology company focused on developing multispecifics TM in oncology, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for ISB 2001. |
| 2024-12-10 | Glenmark Pharmaceuticals Ltd. India | Results Ichnos Glenmark Innovation (IGI) Presents First Clinical Data from Phase 1 Study of Trispecific TREAT™ Antibody, ISB 2001 in relapsed/refractory Multiple Myeloma (r/rMM) at ASH Annual Meeting glenmarkpharma.com ↗
ISB 2001 demonstrated an ORR of 83% in heavily pretreated paƟents treated at acƟve doses (0.05 mg/kg and higher). |
| 2024-12-09 | Ichnos Sciences SA | Results Ichnos Glenmark Innovation (IGI) Presents First Clinical Data from Phase 1 Study of Trispecific TREAT™ Antibody, ISB 2001, Showing High Overall Response Rate (ORR) with Durable Responses and Favorable Safety Profile in Patients with Heavily Pretreated Multiple Myeloma iginnovate.com ↗
ISB 2001 demonstrated an ORR of 83% in heavily pretreated patients treated at active doses (0.05 mg/kg and higher). |
| 2024-11-05 | Ichnos Sciences SA | Results Ichnos Glenmark Innovation (IGI) Announces First Presentation of Data from Phase 1 Study of the Trispecific ISB 2001 in Relapsed/Refractory Multiple Myeloma (r/rMM) at Upcoming ASH Annual Meeting iginnovate.com ↗
ISB 2001 demonstrated a favorable safety and tolerability profile, and an overall response rate (ORR) of 75% in r/r MM |
| 2024-11-05 | Glenmark Pharmaceuticals Ltd. India | Results Ichnos Glenmark Innovation (IGI) Announces First Presentation of Data from Phase 1 Study of the Trispecific ISB 2001 in Relapsed/Refractory Multiple Myeloma (r/rMM) at Upcoming ASH Annual Meeting glenmarkpharma.com ↗
An overall response rate (ORR) of 75% (9/12) in efficacy-evaluable patients, including one (1) MRD negative stringent complete response (sCR) |
| 2024-04-30 | Ichnos Sciences SA | Results Corporate Presentation April 2024 iginnovate.com ↗
ISB 2001 Exhibits Desirable PK and shows 100% Complete Responses In Vivo in a BCMAlow CD38low MM Model |
| 2024-04-07 | Ichnos Sciences SA | Results IGI presents preclinical data for ISB 2001 at AACR 2024 iginnovate.com ↗
ISB 2001 exhibited superior cytotoxicity over teclistamab in bone marrow aspirates from patients with either newly diagnosed or relapsed/refractory (r/r) MM (as well as smoldering MM and Plasma Cell Leukemia patients). |
| 2023-03-20 | Ichnos Sciences SA | Regulatory Ichnos Sciences Receives Orphan Drug Designation for First-In-Class Bispecific (CD38 x CD47) Antibody Innate Cell Modulator, ISB 1442 iginnovate.com ↗
Ichnos Sciences Inc., a global clinical-stage biotechnology company developing innovative multispecific immune cell engager antibodies in oncology, today announced it has been granted orphan drug designation (ODD) by the U.S. Food and Drug Administration (FDA) for its first-in-class T-cell engaging trispecific antibody, ISB 2001, for the treatment of multiple myeloma. |
| 2022-12-12 | Ichnos Sciences SA | Results Ichnos Sciences Presents Data Supporting Three Oncology Assets at ASH 2022 Annual Meeting iginnovate.com ↗ |
All press releases naming this drug 14 releases
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | ISB 2001 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05862012 ↗ |
| Target | CD38 | “ISB 2001 is a CD3+ T cell engager (TCE) co-targeting BCMA and CD38 designed to improve cytotoxicity against multiple myeloma.” PMID 39261676 ↗ Sep 2024 |