Modality
Cell Therapy
MOA
USP1i
Target
CGRP
Pathway
Tau
AsthmaThymomaBreast Ca
Development Pipeline
Preclinical
~Nov 2016
→ ~Feb 2018
Phase 1
~May 2018
→ ~Aug 2019
Phase 2
~Nov 2019
→ ~Feb 2021
Phase 3
May 2021
→ Dec 2031
Phase 3Current
NCT06750175
1,283 pts·Breast Ca
2021-05→2031-07·Recruiting
NCT03412060
350 pts·Asthma
2021-12→2027-09·Active
NCT05859495
2,563 pts·Breast Ca
2023-06→2031-12·Recruiting
4,196 total pts2 indications
NDA/BLA
Approved
CompletedCurrentUpcoming
Catalysts (3)
2027-09-181.5y awayPh3 Readout· Asthma
2031-07-105.3y awayPh3 Readout· Breast Ca
2031-12-055.7y awayPh3 Readout· Breast Ca
Trial Timeline
Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2Q3Q42031Q2Q3Q4
P3
Recruit…
P3
Active
P3
Recruit…
Catalysts
Ph3 Readout
2027-09-18 · 1.5y away
Asthma
Ph3 Readout
2031-07-10 · 5.3y away
Breast Ca
Ph3 Readout
2031-12-05 · 5.7y away
Breast Ca
RecruitingActive|StartCompletionToday
Trials (3)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT06750175 | Phase 3 | Breast Ca | Recruiting | 1283 | VA |
| NCT03412060 | Phase 3 | Asthma | Active | 350 | MRD |
| NCT05859495 | Phase 3 | Breast Ca | Recruiting | 2563 | UPCR |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| SNY-2934 | Sanofi | Phase 3 | KRASG12D | |
| TAK-9344 | Takeda | Phase 3 | CGRP | |
| AMG-9052 | Amgen | Phase 2/3 | CDK2 | |
| Datozumab | Regeneron | Phase 1 | B7-H3 | |
| Zenotinib | BioNTech | Phase 1 | CGRP | |
| Capiglumide | BioNTech | Preclinical | CGRP | |
| BII-4342 | Biogen | Phase 2/3 | CGRP | |
| GMA-729 | Genmab | Phase 2 | BCL-2 | |
| LEG-9870 | Legend Biotech | Phase 1 | CGRP | |
| Pexanaritide | Innovent Bio | Preclinical | SGLT2 |