Product Description
AGEN2034 is a novel, fully human monoclonal immunoglobulin G4 (IgG4) designed to block PD-1 from interacting with its ligands PD-L1 and PD-L2. (Sourced from: https://agenusbio.com/agen2034-anti-pd-1/)
Mechanisms of Action: PD-1 Inhibitor
Novel Mechanism: No
Modality: Antibody
Route of Administration: Intravenous
FDA Designation: Fast Track - Cervical CancerFast Track - Colorectal Cancer *
Approval Status: Not Approved
Approved Countries: None
Approved Indications: None
Known Adverse Events: None
Company: Agenus
Company Location: LEXINGTON MA 02421
Company CEO: Garo H. Armen
Additional Commercial Interests: None
Clinical Description
Countries in Clinic: Armenia, Australia, Belgium, Brazil, France, Georgia, Italy, Korea, Mexico, Netherlands, Peru, Russia, Spain, Taiwan, Thailand, United Kingdom, United States
Active Clinical Trial Count: 25
Recent & Upcoming Milestones
- Clinical Trial Start Expected - Agenus announced they will initiate a P3 Colorectal Cancer trial in 4Q25 for Balstilimab
- Clinical Outcomes Reported - Agenus presented P1 Oncology Solid Tumor Unspecified results on 2025-10-17 for Balstilimab
- Clinical Outcomes Reported - Agenus presented P1 Colorectal Cancer results on 2025-07-04 for Balstilimab
Highest Development Phases
Phase 3: Adenocarcinoma|Colorectal Cancer|Gastrointestinal Cancer|Oncology Solid Tumor Unspecified
Phase 2: Bladder Cancer|Brain Cancer|Cervical Cancer|Glioblastoma|Gliosarcoma|Head and Neck Cancer|Kidney Cancer|Liver Cancer|Lymphoma|Melanoma|Non-Small-Cell Lung Cancer|Oropharyngeal Cancer|Pancreatic Cancer|Prostate Cancer|Renal Cell Carcinoma|Squamous Cell Carcinoma|Uterine Cancer
Phase 1: Endometrial Cancer|Hemangiosarcoma|Ovarian Cancer
Trial ID |
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|---|
NCT06095674 |
ITHACA | P1 |
Not yet recruiting |
Uterine Cancer|Cervical Cancer |
2026-01-01 |
50% |
2023-10-24 |
Primary Endpoints|Treatments |
NCT06076837 |
The Seven Trial | P1 |
Recruiting |
Pancreatic Cancer|Adenocarcinoma |
2025-06-01 |
12% |
2025-01-14 |
|
NCT03860272 |
C-800-01 | P1 |
Active, not recruiting |
Non-Small-Cell Lung Cancer|Hemangiosarcoma|Prostate Cancer|Liver Cancer|Colorectal Cancer|Endometrial Cancer|Ovarian Cancer |
2025-01-13 |
12% |
2025-02-07 |
|
NCT06322108 |
IMMONC0008 | P2 |
Recruiting |
Non-Small-Cell Lung Cancer |
2030-04-01 |
12% |
2024-05-29 |
Primary Endpoints|Treatments|Trial Status |
NCT05891821 |
IMMONC0001 | P2 |
Recruiting |
Lymphoma |
2029-09-01 |
12% |
2023-09-29 |
|
NCT05363709 |
NCI-2022-03805 | P2 |
Recruiting |
Oropharyngeal Cancer |
2028-02-15 |
12% |
2023-10-27 |
Primary Endpoints|Start Date|Treatments|Trial Status |
NCT06782555 |
EVO-011 | P2 |
Recruiting |
Squamous Cell Carcinoma|Head and Neck Cancer|Prostate Cancer|Pancreatic Cancer |
2027-10-01 |
12% |
2025-01-22 |
Primary Endpoints|Treatments |
NCT05205330 |
CR6086-1-04 | P2 |
Active, not recruiting |
Colorectal Cancer|Gastrointestinal Cancer |
2026-12-01 |
12% |
2025-10-30 |
Primary Endpoints |
NCT06300463 |
NCT06300463 | P2 |
Recruiting |
Colorectal Cancer|Liver Cancer |
2026-09-01 |
12% |
2025-03-21 |
|
NCT05864534 |
NU23C03 | P2 |
Recruiting |
Gliosarcoma|Glioblastoma |
2026-05-01 |
12% |
2025-03-27 |
Primary Endpoints|Treatments |
ACTRN12618000003279 |
ACTRN12618000003279 | P2 |
Recruiting |
Brain Cancer|Prostate Cancer|Cervical Cancer|Bladder Cancer|Kidney Cancer|Melanoma|Non-Small-Cell Lung Cancer|Colorectal Cancer |
2018-12-20 |
|||
2022-502065-23-00 |
C-800-25 | P2 |
Active, not recruiting |
Colorectal Cancer |
2025-12-31 |
2025-05-02 |
Treatments |
|
NCT05928806 |
ARCITECT | P2 |
Recruiting |
Renal Cell Carcinoma |
2025-10-10 |
12% |
2023-09-29 |
|
NCT06279130 |
NEOASIS | P3 |
Recruiting |
Oncology Solid Tumor Unspecified |
2029-01-29 |
14% |
2024-02-27 |
Primary Endpoints|Treatments |
NCT06411691 |
J2456 | P1 |
Recruiting |
Colorectal Cancer|Pancreatic Cancer |
2028-11-01 |
50% |
2025-04-08 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments |
NCT07128355 |
NCT07128355 | P1 |
Not yet recruiting |
Colorectal Cancer|Liver Cancer |
2027-01-01 |
12% |
2025-08-27 |
Primary Endpoints|Treatments |
NCT07152821 |
BATTMAN | P3 |
Not yet recruiting |
Colorectal Cancer |
2028-12-31 |
2025-09-04 |
Primary Endpoints|Treatments |
|
NCT06268015 |
BBOpCo | P2 |
Recruiting |
Colorectal Cancer |
2028-07-01 |
28% |
2024-11-21 |
Primary Endpoints|Start Date|Treatments|Trial Status |
2024-515446-16-00 |
CR6086-1-04 | P2 |
Recruiting |
Colorectal Cancer |
2028-06-30 |
12% |
2025-05-02 |
Treatments |
NCT06843434 |
NCT06843434 | P2 |
Recruiting |
Adenocarcinoma|Colorectal Cancer |
2028-02-20 |
12% |
2025-02-28 |
Primary Endpoints|Treatments |
NCT05608044 |
C-800-25 | P2 |
Active, not recruiting |
Colorectal Cancer |
2027-09-01 |
2% |
2025-05-15 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments |
NCT06589440 |
MSS-CRC | P2 |
Recruiting |
Colorectal Cancer |
2027-09-01 |
12% |
2024-12-28 |
Primary Endpoints|Start Date |
NCT03894215 |
C-750-01/GOG-3028 | P2 |
Active, not recruiting |
Cervical Cancer|Uterine Cancer |
2025-08-01 |
12% |
2025-02-21 |
Primary Completion Date|Primary Endpoints|Treatments |
NCT05638698 |
TESLA | P2 |
Active, not recruiting |
Pancreatic Cancer |
2024-12-01 |
34% |
2025-08-27 |
Primary Endpoints |
NCT06346197 |
CIME | P3 |
Not yet recruiting |
Adenocarcinoma|Gastrointestinal Cancer|Colorectal Cancer |
2028-05-15 |
10% |
2024-04-04 |
Primary Endpoints|Treatments |
Recent News Events
Date |
Type |
Title |
|---|---|---|
|
11/10/2025 |
News Article |
Agenus Reports Q3 2025 Results Showcasing Clinical and Regulatory Advances |
|
11/05/2025 |
News Article |
Agenus to Provide Corporate Update and Third Quarter 2025 Financial Report |
|
10/17/2025 |
News Article |
Agenus Reports 39% of Patients Alive at Two-Years with BOT/BAL Across Multiple Refractory Solid Tumors at ESMO 2025 |
|
10/16/2025 |
News Article |
Agenus to Host October Stakeholder Briefing Showcasing BOT/BAL Global Momentum and Post-ESMO Insights |
|
10/01/2023 |
PubMed |
Neoadjuvant botensilimab plus balstilimab response pattern in locally advanced mismatch repair proficient colorectal cancer. |
|
12/01/2022 |
PubMed |
Beyond Platinum, ICIs in Metastatic Cervical Cancer: A Systematic Review. |
|
07/01/2022 |
PubMed |
Abscobal Effect of Balstilimab and Zalifrelimab Combination as Second-Line Treatment for Advanced Cervical Cancer. |