Modality
Gene Therapy
MOA
BCL-2i
Target
AHR
Pathway
PD-1/PD-L1
Melanoma
Development Pipeline
Preclinical
~Sep 2015
→ ~Dec 2016
Phase 1
~Mar 2017
→ ~Jun 2018
Phase 2
~Sep 2018
→ ~Dec 2019
Phase 3
Mar 2020
→ Aug 2028
Phase 3Current
NCT05963893
940 pts·Melanoma
2025-03→2028-08·Completed
NCT05373035
1,181 pts·Melanoma
2020-03→2027-09·Completed
2,121 total pts1 indication
NDA/BLA
Approved
CompletedCurrentUpcoming
Catalysts (2)
2027-09-121.5y awayPh3 Readout· Melanoma
2028-08-012.3y awayPh3 Readout· Melanoma
Trial Timeline
2020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q4
P3
Complet…
P3
Complet…
Catalysts
Ph3 Readout
2027-09-12 · 1.5y away
Melanoma
Ph3 Readout
2028-08-01 · 2.3y away
Melanoma
Completed|StartCompletionToday
Trials (2)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT05963893 | Phase 3 | Melanoma | Completed | 940 | CR |
| NCT05373035 | Phase 3 | Melanoma | Completed | 1181 | EDSS |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| PFE-5501 | Pfizer | Phase 1 | BTK | |
| PFE-2901 | Pfizer | Phase 2 | AHR | |
| RHH-3592 | Roche | Phase 1/2 | GIP-R | |
| Geliderotide | Novartis | NDA/BLA | IL-17A | |
| AZN-1715 | AstraZeneca | Phase 3 | AHR | |
| Tezecilimab | Takeda | NDA/BLA | Tau | |
| BAY-6520 | Bayer | Phase 2 | AHR | |
| Rimaosocimab | Amgen | Preclinical | FXIa | |
| Capifutibatinib | Incyte | Phase 3 | PCSK9 | |
| NBI-408 | Neurocrine | Phase 2/3 | KRASG12D |