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    DRUG:

    balstilimab (AGEN2034)

    i
    Other names: AGEN2034, RebmAb-700, AGEN 2034, AGEN-2034, RebmAb700, RebmAb 700
    Company:
    Agenus, Betta Pharma, Zydus Lifesciences
    Drug class:
    PD1 inhibitor
    Related drugs:
    3d
    Transcriptomic profiling identifies immunotherapy-responsive phenotypes in microsatellite-stable metastatic colorectal cancer. (PubMed, Oncogene)
    We present a comprehensive transcriptomics analysis of metastatic and primary tumor biopsies from MSS mCRC patients treated with botensilimab (BOT; Fc-enhanced anti-CTLA-4) ± balstilimab (BAL; anti-PD-1). This study identified distinct tumor microenvironment states that align along an immunophenotype axis marked by CD74, interferon-γ, and APOBEC3 expression identified previously for primary CRC. Our findings provide novel insights into molecular correlates of immunotherapy response in MSS mCRC, potentially informing future therapeutic strategies to expand ICI efficacy to historically unresponsive tumors.
    Journal • PD(L)-1 Biomarker • IO biomarker
    |
    CD74 (CD74 Molecule) • IFNG (Interferon, gamma)
    |
    balstilimab (AGEN2034) • botensilimab (AGEN1181)
    10d
    Assessment of the Safety and Efficacy of Balstilimab in Combination With Botensilimab for the Treatment of Non-Small Cell Lung Cancer (IMMONC0008) (clinicaltrials.gov)
    P2, N=45, Active, not recruiting, Immune Oncology Research Institute | Recruiting --> Active, not recruiting
    Enrollment closed • IO biomarker
    |
    EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • ALK (Anaplastic lymphoma kinase)
    |
    EGFR mutation • ALK rearrangement
    |
    balstilimab (AGEN2034) • botensilimab (AGEN1181)
    27d
    NEST-1: Combination Immunotherapy in Colorectal Cancer (clinicaltrials.gov)
    P2, N=26, Active, not recruiting, Weill Medical College of Cornell University | Suspended --> Active, not recruiting
    Enrollment closed
    |
    MSI-H/dMMR
    |
    balstilimab (AGEN2034) • botensilimab (AGEN1181)
    1m
    Neoadjuvant Botensilimab and Balstilimab for the Treatment of Advanced Resectable Colorectal Cancer (clinicaltrials.gov)
    P2, N=100, Not yet recruiting, City of Hope Medical Center
    New P2 trial
    |
    balstilimab (AGEN2034) • botensilimab (AGEN1181)
    1m
    A Phase 1b Study of Botensilimab and Balstilimab in Treatment-Refractory Hepatocellular Carcinoma. (PubMed, Liver Cancer)
    An expanded cohort of 19 patients with HCC who progressed on or after prior immunotherapy (primarily atezolizumab/bevacizumab) are included in this analysis. The BOT+BAL combination demonstrated durable responses and manageable safety in treatment-refractory patients with HCC previously treated with immunotherapy, supporting further investigation in randomized studies. Despite the small sample size and high percentage of patients with albumin-bilirubin grade 2 liver disease, these results provide early evidence of antitumor activity in a difficult-to-treat disease setting.
    Clinical • P1 data • Journal
    |
    CTLA4 (Cytotoxic T-Lymphocyte Associated Protein 4)
    |
    Avastin (bevacizumab) • Tecentriq (atezolizumab) • balstilimab (AGEN2034) • botensilimab (AGEN1181)
    1m
    A Study of agenT-797 in Combination With Botensilimab, Balstilimab, Ramucirumab, and Paclitaxel for People With Esophageal, Gastric, or Gastro-esophageal Junction Cancer (clinicaltrials.gov)
    P2, N=20, Active, not recruiting, Memorial Sloan Kettering Cancer Center | Recruiting --> Active, not recruiting | N=37 --> 20
    Enrollment closed • Enrollment change
    |
    paclitaxel • Cyramza (ramucirumab) • balstilimab (AGEN2034) • botensilimab (AGEN1181) • AgenT-797
    1m
    Botensilimab, Balstilimab, and SBRT in Colorectal Cancer (clinicaltrials.gov)
    P1, N=15, Recruiting, Massachusetts General Hospital | Not yet recruiting --> Recruiting
    Enrollment open • MSI-H • pMMR
    |
    balstilimab (AGEN2034) • botensilimab (AGEN1181)
    1m
    Phase 2a Immune Modulation With Ultrasound for Newly Diagnosed Glioblastoma (clinicaltrials.gov)
    P2, N=25, Recruiting, Northwestern University | Trial completion date: Aug 2026 --> Aug 2031 | Trial primary completion date: May 2026 --> Jul 2031
    Trial completion date • Trial primary completion date
    |
    balstilimab (AGEN2034) • botensilimab (AGEN1181)
    1m
    NCI-2022-03805: BALSTILIMAB on Viral Clearance in HPV+ Oropharyngeal Cancer Patients (clinicaltrials.gov)
    P2, N=0, Withdrawn, M.D. Anderson Cancer Center | N=20 --> 0 | Trial completion date: Feb 2028 --> May 2026 | Active, not recruiting --> Withdrawn | Trial primary completion date: Feb 2028 --> May 2026
    Enrollment change • Trial completion date • Trial withdrawal • Trial primary completion date
    |
    balstilimab (AGEN2034)
    1m
    NUMANTIA-2: A Clinical Study Evaluating a New Treatment Strategy for Patients With Advanced Pancreatic Cancer Who Have Not Received Prior Treatment for Advanced Disease. (clinicaltrials.gov)
    P2, N=40, Not yet recruiting, Nelum Corp
    New P2 trial
    |
    gemcitabine • albumin-bound paclitaxel • balstilimab (AGEN2034) • botensilimab (AGEN1181) • NLM-001
    2ms
    Testing the Combination of Anti-Cancer Drugs, Botensilimab (AGEN1181) and Balstilimab (AGEN2034), After Standard Treatment for Colorectal Cancer, Combat Trial (clinicaltrials.gov)
    P2, N=20, Not yet recruiting, National Cancer Institute (NCI)
    New P2 trial
    |
    Signatera™
    |
    balstilimab (AGEN2034) • botensilimab (AGEN1181)
    2ms
    Doxorubicin Plus Dual Checkpoint Blockade for Soft Tissue Sarcomas (clinicaltrials.gov)
    P2, N=65, Active, not recruiting, University of Colorado, Denver | Recruiting --> Active, not recruiting
    Enrollment closed • Checkpoint inhibition
    |
    pegylated liposomal doxorubicin • balstilimab (AGEN2034) • botensilimab (AGEN1181) • zalifrelimab (UGN-301)