Botensilimab

Phase 3Monoclonal antibody

AAgenus Inc.

Botensilimab is one of 395 biologic programs targeting Colon Adenocarcinoma. It is currently in Phase 3.

Indications

Total Trials

Active Trials

394

Competitors

Pipeline

Status by Indication[3][1]

Indication

Colon AdenocarcinomaRecruiting

Gastric AdenocarcinomaActive, not recruiting

Colorectal NeoplasmActive, not recruiting

Rectal AdenocarcinomaActive, not recruiting

Ewing SarcomaNot yet recruiting

Metastatic Colorectal CancerActive, not recruiting

Colorectal AdenocarcinomaActive, not recruiting

Non-Small Cell Lung CancerActive, not recruiting

Colorectal CancerActive, not recruiting

MelanomaActive, not recruiting

Colon AdenocarcinomaPhase 2

Recruiting

Gastric AdenocarcinomaPhase 3

Active, not recruiting

Colorectal NeoplasmPhase 2

Active, not recruiting

Rectal AdenocarcinomaPhase 2

Active, not recruiting

Ewing SarcomaPhase 1

Not yet recruiting

Metastatic Colorectal CancerPhase 2

Active, not recruiting

Colorectal AdenocarcinomaPhase 3

Active, not recruiting

Non-Small Cell Lung CancerPhase 2

Active, not recruiting

Colorectal CancerPhase 3

Active, not recruiting

MelanomaPhase 2

Active, not recruiting

Showing 10 of 17 indications

Competition

Competitive Landscape

1639 competitors in Non-Small Cell Lung Cancer

#DrugCompanyPhaseTrials

Botensilimab

AAgenus Inc.

Phase 3

32 2

Lenvima

Eisai

Preclinical

6 3

Imjudo

AstraZeneca

Preclinical

5 4

Vizimpro

Pfizer

Preclinical

4 5

Ofev

Boehringer Ingelheim

Preclinical

7 6

Remeron

OOrganon and Co

Preclinical

1 7

Tyrosine Kinase Inhibitor

Pfizer

Preclinical

2 8

Aqupla

Jiangsu Simcere Pharmaceutical Co., Ltd.

Preclinical

—9

Vibramycin

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Treatment

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q3 2026

Phase 2Recruiting

Glioblastoma

NCT05864534

Phase 1/2Active, not recruiting

Metastatic Colorectal Cancer

NCT05672316

Q1 2027

Phase 2Recruiting

Colorectal Cancer

NCT06300463

Q2 2027

Phase 2Active, not recruiting

Advanced Pancreatic Ductal Adenocarcinoma

NCT05632328

Phase 2Recruiting

Colon Adenocarcinoma

NCT07595874

Q3 2027

Phase 2Recruiting

Gastroesophageal Junction Cancer

NCT06251973

Clinical

Trials by Indication[1]

Colorectal Cancer10 trials

Botensilimab, Balstilimab and Regorafenib or Botensilimab and Balstilimab for the Treatment of Advanced or Metastatic Microsatellite Stable Colorectal Cancer

Withdrawn·—·Phase 2·NCT06575725

A Study of Botensilimab and Balstilimab for the Treatment of Colorectal Cancer

Active, not recruiting·AAgenus Inc.·Phase 2·NCT05608044·234 enrolled

Botensilimab, Balstilimab, and SBRT in Colorectal Cancer

Not yet recruiting·MMassachusetts General Hospital·Phase 1·NCT07128355·15 enrolled

Show 7 more trials

KRAS-Targeted Vaccine Combined With Balstilimab and Botensilimab for Patients With Stage IV MMR-p Colorectal Cancer and Pancreatic Ductal Cancer

Recruiting·SSidney Kimmel Comprehensive Cancer Center at Johns Hopkins·Phase 1·NCT06411691·54 enrolled

Combination Immunotherapy in Colorectal Cancer

Suspended·WWeill Medical College of Cornell University·Phase 2·NCT05571293·36 enrolled

A Study of Botensilimab and Balstilimab for Colorectal Cancer With ctDNA+ After Surgery and Chemotherapy

Recruiting·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT07227636·284 enrolled

Botensilimab and Balstilimab Optimization in Colorectal Cancer

Active, not recruiting·—·Phase 2·NCT06268015·16 enrolled

Pre-operative Targeted Treatments in Molecularly Selected Resectable Colorectal Cancer (UNICORN)

Recruiting·GGruppo Oncologico del Nord-Ovest·Phase 2·NCT05845450·197 enrolled

Platform Study of Immunotherapy Combinations in Colorectal Cancer Liver Metastases

Recruiting·WWeill Medical College of Cornell University·Phase 2·NCT06300463·24 enrolled

Botensilimab + Balstilimab vs Best Supportive Care as Therapy in Chemo-refractory, Unresectable, Colorectal Adenocarcinoma: The BATTMAN Trial

Recruiting·CCanadian Cancer Trials Group·Phase 3·NCT07152821·834 enrolled

Metastatic Colorectal Cancer3 trials

Botensilimab Plus Balstilimab and Fasting Mimicking Diet Plus Vitamin C for Patients With KRAS-Mutant Metastatic Colorectal Cancer

Recruiting·UUniversity of Southern California·Phase 1·NCT06336902·15 enrolled

Botensilimab, Balstilimab and Regorafenib for the Treatment of Patients With Microsatellite Stable Metastatic Colorectal Cancer Who Have Progressed on Prior Chemotherapy

Active, not recruiting·—·Phase 1/2·NCT05672316·28 enrolled

FOLFOX and Bevacizumab in Combination With Botensilimab and Balstilimab (3B-FOLFOX) for the Treatment of Microsatellite Stable (MSS) Metastatic Colorectal Cancer

Active, not recruiting·—·Phase 1/2·NCT05627635·20 enrolled

Rectal Adenocarcinoma2 trials

A Study of Botensilimab and Balstilimab for Rectal Adenocarcinoma

Recruiting·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT06843434·40 enrolled

Phase II Clinical Trial of FOLFOX, Botensilimab, Plus Balstilimab in Patients With Localized Rectal Cancer

Recruiting·CCity of Hope Medical Center·Phase 2·NCT06780787·26 enrolled

Pancreatic Cancer2 trials

The Miami "EMPIRE" Trial - Eradication of Metastatic Pancreatic Cancer With Immuno-Radiation

Recruiting·BBenjamin Spieler·Phase 2·NCT06843551·20 enrolled

A Study of Botensilimab in Participants With Metastatic Pancreatic Cancer

Active, not recruiting·AAgenus Inc.·Phase 2·NCT05630183·81 enrolled

Advanced Cancer2 trials

Fc-Engineered Anti-CTLA-4 Monoclonal Antibody in Advanced Cancer

Active, not recruiting·AAgenus Inc.·Phase 1·NCT03860272·499 enrolled

Anti-CD137 and Anti-CTLA-4 Monoclonal Antibody in Patients With Advanced Cancer

Completed·AAgenus Inc.·Phase 1·NCT04121676·91 enrolled

13 more indications

Neoadjuvant1 trial

Pan-tumor Neoadjuvant Basket Study of Immune Check-point Inhibition and Novel Immuno-oncology Combinations

Recruiting·TThe Netherlands Cancer Institute·Phase 2/3·NCT06279130·133 enrolled

Renal Cell Cancer1 trial

Advanced Renal Cell Cancer Combination ImmunoThErapy Clinical Trial

Suspended·MMichael B. Atkins, MD·Phase 2·NCT05928806·120 enrolled

Advanced Solid Tumors1 trial

Study of AGEN1571 in Participants With Advanced Solid Tumors

Completed·AAgenus Inc.·Phase 1·NCT05377528·22 enrolled

Gastroesophageal Junction Cancer1 trial

A Study of agenT-797 in Combination With Botensilimab, Balstilimab, Ramucirumab, and Paclitaxel for People With Esophageal, Gastric, or Gastro-esophageal Junction Cancer

Recruiting·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT06251973·37 enrolled

ALS1 trial

Expanded Access Program (EAP) Designed to Provide Access to Botensilimab and Balstilimab Before Regulatory Approval

Available·AAgenus Inc.··NCT06751524

Soft Tissue Sarcoma1 trial

Doxorubicin Plus Dual Checkpoint Blockade for Soft Tissue Sarcomas

Recruiting·UUniversity of Colorado, Denver·Phase 2·NCT04028063·65 enrolled

Glioblastoma1 trial

Phase 2a Immune Modulation With Ultrasound for Newly Diagnosed Glioblastoma

Recruiting·NNorthwestern University·Phase 2·NCT05864534·25 enrolled

Melanoma1 trial

A Study of Botensilimab (AGEN1181) for the Treatment of Advanced Melanoma

Active, not recruiting·AAgenus Inc.·Phase 2·NCT05529316·150 enrolled

Ewing sarcoma1 trial

Precision Analysis of Fusion Genes in Ewing Sarcoma (ES) and Desmoplastic Small Round Cell Tumor (DSRCT), Then EWSR1 (Ewing Sarcoma Gene Breakpoint Region 1 Gene) Immunotherapy Without or With Anti-CTLA-4 (Botensilimab) and Anti-PD1 (Balstilimab)

Not yet recruiting·RRabi Hanna·Phase 1·NCT07695311·24 enrolled

Advanced Pancreatic Ductal Adenocarcinoma1 trial

A Phase 2 Study of AGEN1423, an Anti-CD73-TGFβ-Trap Bifunctional Antibody, in Combination With Botensilimab, With or Without Chemotherapy in Subjects With Advanced Pancreatic Cancer.

Active, not recruiting·BBruno Bockorny·Phase 2·NCT05632328·24 enrolled

Colon Adenocarcinoma1 trial

A Phase II Novel Exploratory Study to Test Neoadjuvant Immunotherapy Combinations in Patients With Resectable Colon Cancer (NEST3)

Recruiting·CCity of Hope Medical Center·Phase 2·NCT07595874·100 enrolled

Gastric Cancer1 trial

A Multicenter, Randomised, Comparative, Open-label Phase III Aiming to Compare the Survival of Patients With Locally Advanced or Metastatic MSI/dMMR Esogastric Adenocarcinomas Treated by a Combination of Immune Checkpoint Inhibitors (Botensilimab + Balstilimab) Versus the Standard of Care (FOLFOX/XELOX + Nivolumab)

Recruiting·CCentre Leon Berard·Phase 3·NCT06346197·132 enrolled

Pancreatic Cancer Metastatic1 trial

An Open-label, Phase I Trial With Expansion Cohort of Nab-Paclitaxel + Gemcitabine + Cisplatin + Botensilimab (AGEN1811) + Balsilimab (AGEN2034) + Chloroquine + Celecoxib in Patients With Previously Untreated Metastatic Pancreatic Cancer

Terminated·HHonorHealth Research Institute·Phase 1·NCT06076837·6 enrolled

Sources

References

[1]
ClinicalTrials.gov — 32 trial records for Botensilimab. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Botensilimab compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Botensilimab. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Agenus Inc. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Monoclonal antibody[2]
Highest Phase: Phase 3[1]
Company: AAgenus Inc.

Botensilimab

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q3 2026

Q1 2027

Q2 2027

Q3 2027

Trials by Indication[1]

Colorectal Cancer10 trials

Metastatic Colorectal Cancer3 trials

Rectal Adenocarcinoma2 trials

Pancreatic Cancer2 trials

Advanced Cancer2 trials

Neoadjuvant1 trial

Renal Cell Cancer1 trial

Advanced Solid Tumors1 trial

Gastroesophageal Junction Cancer1 trial

ALS1 trial

Soft Tissue Sarcoma1 trial

Glioblastoma1 trial

Melanoma1 trial

Ewing sarcoma1 trial

Advanced Pancreatic Ductal Adenocarcinoma1 trial

Colon Adenocarcinoma1 trial

Gastric Cancer1 trial

Pancreatic Cancer Metastatic1 trial

References

Drug Info

Quick Facts

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