Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
DMR-001 · 1 trial · 1 indication
Incidence and severity of AEs and SAEs, including DLTs and AEs resulting in dose modification (interruption, reduction, or discontinuation)
| Arm | Type | Description |
|---|---|---|
| Part 1: DMR-001 monotherapy dose escalation phase. | EXPERIMENTAL | DMR-001 will be administered starting once every 4 weeks as a subcutaneous injection at the protocol defined starting dose and dosing schedule to identify the maximum tolerated dose and/or recommended dose(s) for expansion. |
| Part 2: DMR-001 monotherapy dose expansion phase. | EXPERIMENTAL | DMR-001 will be administered starting once every 4 weeks as a subcutaneous injection at the determined recommended dose(s) for expansion based on Part 1. |
| Part 3: DMR-001 and ruxolitinib combination dose escalation followed by dose expansion. | EXPERIMENTAL | DMR-001 will be administered starting once every 4 weeks as a subcutaneous injection at the determined dose and regimen, but in combination with an oral tablet of ruxolitinib, a standard of care drug approved therapy for the treatment of MF. |
| Name | Type | Description |
|---|---|---|
| DMR-001 | DRUG | DMR-001 will be administered at protocol defined dose at a frequency of every 4 weeks. |
| Ruxolitinib | DRUG | Ruxolitinib will be administered according to Prescribing Information/SmPC. |
Inclusion Criteria: * Signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and the protocol. * Diagnosis/confirmation of ET or MF as defined in the protocol. * Documented CALR exon-9 mutation. * Willingness to undergo bone marrow biopsy and asp...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Bristol-Myers Squibb Company | BMY | 5 | PHASE3 | Luspatercept, Fedratinib, BMS-986158 |
| AbbVie, Inc. | ABBV | 4 | PHASE3 | Navitoclax, ABBV-744, IMGN632 |
| Novartis AG Sponsored ADR | NVS | 3 | PHASE3 | Pelabresib, Ruxolitinib |
| Karyopharm Therapeutics, Inc. | KPTI | 4 | PHASE3 | Selinexor |
| Geron Corporation | GERN | 2 | PHASE3 | Imetelstat |
| Merck & Co., Inc. | MRK | 1 | PHASE3 | Bomedemstat |
| Incyte Corporation | INCY | 8 | PHASE2 | Ruxolitinib, INCB160058, INCB057643, INCA033989, INCA036978 |
| GSK plc Sponsored ADR | GSK | 2 | PHASE2 | Momelotinib |
| Takeda Pharmaceutical Co. Ltd. Sponsored ADR | TAK | 1 | PHASE2 | Elritercept |
| Eli Lilly and Company | LLY | 1 | PHASE1 | LY3410738 |
| Disc Medicine, Inc. | IRON | 1 | PHASE1 | DISC-0974 |
| Damora Therapeutics, Inc. | DMRA | 1 | PHASE2 | GB2064 |
| Prelude Therapeutics, Inc. | PRLD | 1 | PHASE1 | PRT12396 |