Balstilimab

Phase 3Monoclonal antibody

Balstilimab is a monoclonal antibody that works as a Programmed Cell Death Protein 1 Antagonist.[2] It is being investigated across 21 indications, with its most advanced program in Phase 3.[1]

Balstilimab is one of 483 small molecule programs targeting Oropharynx Cancer. It is currently in Phase 3.

Indications

Total Trials

Active Trials

482

Competitors

Pipeline

Status by Indication[3][1]

Indication

Oropharynx CancerActive, not recruiting

Colon AdenocarcinomaRecruiting

LymphomaActive, not recruiting

Gastric AdenocarcinomaActive, not recruiting

Adenoid Cystic CarcinomaActive, not recruiting

Colorectal NeoplasmActive, not recruiting

Rectal AdenocarcinomaActive, not recruiting

Ewing SarcomaNot yet recruiting

Metastatic Colorectal CancerActive, not recruiting

Colorectal AdenocarcinomaActive, not recruiting

Oropharynx CancerPhase 2

Active, not recruiting

Colon AdenocarcinomaPhase 2

Recruiting

LymphomaPhase 2

Active, not recruiting

Gastric AdenocarcinomaPhase 3

Active, not recruiting

Adenoid Cystic CarcinomaPhase 1

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

Showing 10 of 21 indications

Competition

Competitive Landscape

1774 competitors in Lymphoma

#DrugCompanyPhaseTrials

Balstilimab

AAgenus Inc.

Phase 3

1 2

Blenoxane

SSequus Pharmaceuticals

Preclinical

25 3

Oncaspar

SServier

Preclinical

15 4

Tafasitamab

Incyte

Preclinical

7 5

Kenalog

BBausch Health Americas, Inc.

Preclinical

1 6

PEG-Intron

Merck & Co.

Preclinical

1 7

Systemic Therapy

Bristol-Myers Squibb

Preclinical

1 8

Solu-Medrol

MMassachusetts Eye and Ear Infirmary

Preclinical

—9

Rhg-CSF

CCSPC Baike (Shandong) Biopharmaceutical Co., Ltd.

Preclinical

3 10

CAR-T

HHebei Senlang Biotechnology Inc., Ltd.

Preclinical

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 2Recruiting

Colon Adenocarcinoma

NCT07595874

Q3 2027

Phase 2Recruiting

Gastroesophageal Junction Cancer

NCT06251973

Phase 1Not yet recruiting

Colorectal Cancer

NCT07128355

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

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

Show 7 more trials

Botensilimab and Balstilimab Optimization in Colorectal Cancer

Active, not recruiting·—·Phase 2·NCT06268015·16 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, and SBRT in Colorectal Cancer

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

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

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

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

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

Pancreatic Cancer3 trials

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

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

Tg01 Vaccine / Qs-21 Stimulon™ With Or Without Balstilimab As Maintenance Therapy Following Adjuvant Chemotherapy In Patients With Resected Pancreatic Cancer

Active, not recruiting·UUniversity of Kansas Medical Center·Phase 2·NCT05638698·24 enrolled

Comparing Neoadjuvant/Adjuvant GVAX vs a mKRASvax Given With Anti-PD-1 and Anti-CD137 for Surgically Resectable Pancreatic Cancer

Recruiting·SSidney Kimmel Comprehensive Cancer Center at Johns Hopkins·Phase 1/2·NCT06782932·38 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

Melanoma2 trials

A Study of ONCOS-102 in Combination With Other Novel Immune-therapies in Advanced Treatment-resistant Melanoma Patients

Withdrawn·TTargovax Oy·Phase 2·NCT05561491

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

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

18 more indications

Cervical Cancer2 trials

A Phase II Study of Balstilimab Independently or in Combination With Zalifrelimab in Advanced Cervical Cancer

Withdrawn·AAgenus Inc.·Phase 2·NCT05033132

Balstilimab Versus Investigator Choice Chemotherapy in Patients With Recurrent Cervical Cancer (BRAVA)

Withdrawn·AAgenus Inc.·Phase 3·NCT04943627

Glioblastoma1 trial

Phase 2a Immune Modulation With Ultrasound for Newly Diagnosed Glioblastoma

Recruiting·NNorthwestern University·Phase 2·NCT05864534·25 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

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

Lymphoma1 trial

Assessment of the Safety and Efficacy of Balstilimab for the Treatment of Relapsed/Refractory Lymphomas (IMMONC0001)

Recruiting·IImmune Oncology Research Institute·Phase 2·NCT05891821·20 enrolled

Adenoid Cystic Carcinoma1 trial

Study of OBT076 Associated or Not in Patients With Recurrent or Metastatic Adenoid Cystic Carcinoma of the Head and Neck

Terminated·GGroupe Oncologie Radiotherapie Tete et Cou·Phase 1·NCT05930951·19 enrolled

Treatment1 trial

Expanded Access for Cancer Treatment With Balstilimab (AGEN2034) and Zalifrelimab (AGEN1884)

Available·AAgenus Inc.··NCT05572970

Oropharyngeal Cancer1 trial

BALSTILIMAB on Viral Clearance in HPV+ Oropharyngeal Cancer Patients

Recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT05363709·20 enrolled

ALS1 trial

A Study of Evofosfamide in Combination with Zalifrelimab and Balstilimab

Recruiting·IImmunoGenesis·Phase 1/2·NCT06782555·71 enrolled

Newly Diagnosed1 trial

rHSC-DIPGVax Plus Checkpoint Blockade for the Treatment of Newly Diagnosed DIPG and DMG

Recruiting·—·Phase 1·NCT04943848·36 enrolled

Soft Tissue Sarcoma1 trial

Doxorubicin Plus Dual Checkpoint Blockade for Soft Tissue Sarcomas

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

Advanced Cancer1 trial

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

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

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

Details

Drug Info

Quick Facts

Mechanism of Action: Programmed Cell Death Protein 1 Antagonist[2]
Modality: Monoclonal antibody[2]
Highest Phase: Phase 3[1]
Company: AAgenus Inc.

Balstilimab

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q3 2026

Q1 2027

Q2 2027

Q3 2027

Trials by Indication[1]

Colorectal Cancer10 trials

Pancreatic Cancer3 trials

Metastatic Colorectal Cancer3 trials

Melanoma2 trials

Rectal Adenocarcinoma2 trials

Cervical Cancer2 trials

Glioblastoma1 trial

Gastroesophageal Junction Cancer1 trial

Neoadjuvant1 trial

Renal Cell Cancer1 trial

Advanced Solid Tumors1 trial

Lymphoma1 trial

Adenoid Cystic Carcinoma1 trial

Treatment1 trial

Oropharyngeal Cancer1 trial

ALS1 trial

Newly Diagnosed1 trial

Soft Tissue Sarcoma1 trial

Advanced Cancer1 trial

Ewing sarcoma1 trial

Colon Adenocarcinoma1 trial

Gastric Cancer1 trial

Pancreatic Cancer Metastatic1 trial

References

Drug Info

Quick Facts

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