Modality
mAb
MOA
Anti-Aβ
Target
SHP2
Pathway
Sphingolipid
GBM
Development Pipeline
Preclinical
~Feb 2016
→ ~May 2017
Phase 1
~Aug 2017
→ ~Nov 2018
Phase 2
~Feb 2019
→ ~May 2020
Phase 3
Aug 2020
→ Nov 2030
Phase 3Current
NCT08902240
2,187 pts·GBM
2020-08→2027-06·Active
NCT04286616
2,137 pts·GBM
2023-11→2030-11·Not yet recruiting
4,324 total pts1 indication
NDA/BLA
Approved
CompletedCurrentUpcoming
Catalysts (2)
2027-06-031.2y awayPh3 Readout· GBM
2030-11-034.6y awayPh3 Readout· GBM
Trial Timeline
Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2Q3Q4
P3
Active
P3
Not yet…
Catalysts
Ph3 Readout
2027-06-03 · 1.2y away
GBM
Ph3 Readout
2030-11-03 · 4.6y away
GBM
ActiveNot yet recruiting|StartCompletionToday
Trials (2)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT08902240 | Phase 3 | GBM | Active | 2187 | PFS |
| NCT04286616 | Phase 3 | GBM | Not yet recr... | 2137 | SRI-4 |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| LLY-8369 | Eli Lilly | Approved | Menin | |
| NVS-5126 | Novartis | Phase 3 | SHP2 | |
| MRK-1380 | Merck & Co | Preclinical | SHP2 | |
| ABB-8696 | AbbVie | Phase 3 | BCMA | |
| ABB-1817 | AbbVie | Phase 3 | SHP2 | |
| AZN-8281 | AstraZeneca | Phase 1 | SHP2 | |
| AZN-8478 | AstraZeneca | NDA/BLA | SHP2 | |
| BAY-6035 | Bayer | Phase 1 | C5 | |
| MRN-7409 | Moderna | NDA/BLA | SHP2 | |
| Zenotinib | BioNTech | Phase 1 | CGRP |