Agenus Inc. AGEN
Agenus Inc. (Nasdaq: AGEN) is an oncology drug developer. Its lead program, botensilimab (BOT) + balstilimab (BAL), is in Phase 3 for neoadjuvant high-risk Stage II and Stage III MSS colon cancer. Its next catalyst on record is ROBBIN (BOT/BAL neoadjuvant MSS colon cancer): First patient dosed (Q1 2027).
Upcoming catalysts
No catalyst is dated to the next 30 days or to an FDA action date.
Next further out: ROBBIN (BOT/BAL neoadjuvant MSS colon cancer) — First patient dosed (Q1 2027). 4 catalysts on record beyond the next 30 days; subscribers see each with its filing sentence.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| STIMULON QS-21 adjuvant | vaccine adjuvant | biologic-other | Approved |
| botensilimab (BOT) + balstilimab (BAL) | neoadjuvant high-risk Stage II and Stage III MSS colon cancer (ROBBIN) | antibody | Phase 3 |
| botensilimab (BOT) + balstilimab (BAL) | refractory MSS metastatic colorectal cancer | antibody | Phase 2 |
| botensilimab (BOT) + balstilimab (BAL) | checkpoint-refractory melanoma | antibody | Phase 2 |
| botensilimab (BOT) + balstilimab (BAL) | hepatocellular carcinoma following prior immunotherapy | antibody | Phase 2 |
| botensilimab (BOT) + balstilimab (BAL) | platinum-resistant or platinum-refractory ovarian cancer | antibody | Phase 1 |
| botensilimab (BOT) + balstilimab (BAL) | advanced soft-tissue sarcomas | antibody | Phase 1 |
| botensilimab (BOT) + balstilimab (BAL) | non-small cell lung cancer | antibody | Phase 1 |
| botensilimab (BOT) + balstilimab (BAL) | pancreatic cancer | antibody | Phase 1 |
| botensilimab (BOT) + balstilimab (BAL) | triple-negative breast cancer | antibody | Phase 1 |
| Other antibody programs | various (CD137, CD73/TGF-beta, ILT2, LAG-3, TIM-3, TIGIT) | antibody | Pre-clinical |
Recent results and decisions
- Nov 5, 2026approval Armenia's Ministry of Health granted marketing authorizations for Botvymo (botensilimab) and Evamplix (balstilimab), the first marketing authorizations for either medicine anywhere in the world.
These are the first marketing authorizations for either medicine anywhere in the world.
Filing - Jul 13, 2026positive Neoadjuvant BOT+BAL in NEST and UNICORN Phase 2 studies: pathologic response ~60-70%, major pathologic response ~35-40%, pCR ~30%; all treated patients disease free at 9-18 months follow-up.
BOT+BAL has produced deep, durable responses, including pathologic response (PR) in approximately 60-70% of patients, major pathologic response (MPR) in approximately 35-40% of patients and pathologic complete response (pCR) in approximately 30% of patients.
Filing - Mar 16, 2026started BATTMAN Phase 3 registrational trial of BOT+BAL in refractory MSS metastatic colorectal cancer is underway (approx. 830 patients planned).
BATTMAN Phase 3 registrational trial underway: First global next-generation CTLA-4/PD-1 combination registrational trial in refractory MSS mCRC
Filing
For subscribers
- Cash runway against each catalyst, with the company's own runway statement
- Track record: every Phase 3 readout, FDA decision and guidance slip since 2014
- Expected move for each dated catalyst, from comparable past events
- Phase 2 evidence behind each Phase 3 readout
- Companies on the same target or class
- Full catalyst list with filing sentences, deals, registered trials, Excel export
Other phase 3 oncology companies
- Astrazeneca PLC AZN
- Gilead Sciences, Inc. GILD
- Moderna, Inc. MRNA
- Revolution Medicines, Inc. RVMD
- Genmab A/S GMAB
- BioNTech SE BNTX
- Guardant Health, Inc. GH
- Exelixis, Inc. EXEL
The free Monday brief
Last week's readouts and FDA decisions and the dated catalysts in the week ahead, each with its filing sentence.