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    DRUG:

    visugromab (CTL-002)

    i
    Other names: CTL-002
    Company:
    CatalYm
    Drug class:
    GDF15 inhibitor
    Related drugs:
    24d
    Decoding GDF15: Impact on prostate cancer metabolism, chemoresistance, and clinical applications. (PubMed, Chin Med J (Engl))
    Clinically, GDF15 has shown potential as a biomarker, offering diagnostic precision and prognostic value, particularly when combined with established markers such as prostate-specific antigen. The review concludes with a discussion on several monoclonal antibodies targeting GDF15 in clinical trials, such as AV-380, NGM120, Visugromab, and AZD8853, highlighting promising strategies for novel therapies and precision medicine.
    Journal
    |
    GDF15 (Growth differentiation factor 15)
    |
    visugromab (CTL-002) • AZD8853 • NGM120
    24d
    Trial Investigating Visugromab and Nivolumab With or Without Docetaxel in 2L Treatment of Participants With Metastatic NSCLC (clinicaltrials.gov)
    P2, N=131, Recruiting, CatalYm GmbH
    New P2 trial
    |
    Opdivo (nivolumab) • docetaxel • visugromab (CTL-002)
    2ms
    GDFATHERHCC01: Visugromab, Nivolumab and a Tyrosine Kinase Inhibitor (TKI) Compared to Double Placebo and a TKI in Unresectable or Metastatic Hepatocellular Carcinoma Post Anti-PD-(L)1 Failure (clinicaltrials.gov)
    P2, N=104, Not yet recruiting, CatalYm GmbH
    New P2 trial
    |
    Opdivo (nivolumab) • visugromab (CTL-002)
    3ms
    GDFATHER-NSCLC-01: Trial Investigating Visugromab in Combination With Immunochemotherapy in 1L Treatment of Participants With Metastatic NSCLC (clinicaltrials.gov)
    P2, N=107, Recruiting, CatalYm GmbH | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Keytruda (pembrolizumab) • carboplatin • pemetrexed • visugromab (CTL-002)
    4ms
    The Multifaceted Role of Growth Differentiation Factor 15 (GDF15): A Narrative Review from Cancer Cachexia to Target Therapy. (PubMed, Biomedicines)
    Targeting the GDF15-GFRAL axis appears therapeutically promising: the monoclonal antibody ponsegromab improved cachexia-related outcomes in the PROACC-1 trial, while visugromab combined with nivolumab enhanced immune response in ICI-refractory tumors. Further investigation is warranted to delineate the role of GDF15 across malignancies, refine patient selection, and evaluate combinatorial approaches with existing treatments.
    Review • Journal • PD(L)-1 Biomarker • IO biomarker
    |
    GDF15 (Growth differentiation factor 15)
    |
    Opdivo (nivolumab) • visugromab (CTL-002) • ponsegromab (PF-06946860)
    4ms
    VINCIT: Visugromab in Cachexia International Trial (clinicaltrials.gov)
    P2/3, N=518, Not yet recruiting, CatalYm GmbH
    New P2/3 trial
    |
    visugromab (CTL-002)
    5ms
    Trial Investigating Visugromab in Combination With Immunochemotherapy in 1L Treatment of Participants With Metastatic NSCLC (clinicaltrials.gov)
    P2, N=107, Not yet recruiting, CatalYm GmbH
    New P2 trial
    |
    Keytruda (pembrolizumab) • carboplatin • pemetrexed • visugromab (CTL-002)
    9ms
    GDFather-NEO: Neoadjuvant Immunotherapy Combined With the Anti-GDF-15 Antibody Visugromab to Treat Muscle Invasive Bladder Cancer (clinicaltrials.gov)
    P2, N=30, Active, not recruiting, CatalYm GmbH | Recruiting --> Active, not recruiting | Trial completion date: Apr 2026 --> Sep 2026 | Trial primary completion date: Apr 2025 --> Aug 2025
    Enrollment closed • Trial completion date • Trial primary completion date
    |
    Opdivo (nivolumab) • visugromab (CTL-002)
    1year
    Neutralizing GDF-15 can overcome anti-PD-1 and anti-PD-L1 resistance in solid tumours. (PubMed, Nature)
    In a first-in-human phase 1-2a study (GDFATHER-1/2a trial, NCT04725474 ), patients with advanced cancers refractory to anti-PD-1 or anti-PD-L1 therapy (termed generally as anti-PD-1/PD-L1 refractoriness) were treated with the neutralizing anti-GDF-15 antibody visugromab (CTL-002) in combination with the anti-PD-1 antibody nivolumab. Increased levels of tumour infiltration, proliferation, interferon-γ-related signalling and granzyme B expression by cytotoxic T cells were observed in response to treatment. Neutralizing GDF-15 holds promise in overcoming resistance to immune checkpoint inhibition in cancer.
    Journal • PD(L)-1 Biomarker • IO biomarker
    |
    IFNG (Interferon, gamma) • GDF15 (Growth differentiation factor 15) • GZMB (Granzyme B)
    |
    Opdivo (nivolumab) • visugromab (CTL-002)
    over1year
    GDFather-NEO: Neoadjuvant Immunotherapy Combined With the Anti-GDF-15 Antibody Visugromab to Treat Muscle Invasive Bladder Cancer (clinicaltrials.gov)
    P2, N=30, Recruiting, CatalYm GmbH | Trial completion date: Aug 2025 --> Apr 2026 | Trial primary completion date: Aug 2024 --> Apr 2025
    Trial completion date • Trial primary completion date • Combination therapy
    |
    Opdivo (nivolumab) • visugromab (CTL-002)
    over1year
    First-in-Human Study of the GDF-15 Neutralizing Antibody Visugromab (CTL-002) in Patients With Advanced Cancer (GDFATHER) (clinicaltrials.gov)
    P1/2, N=274, Active, not recruiting, CatalYm GmbH | Recruiting --> Active, not recruiting
    Enrollment closed • Combination therapy • Checkpoint inhibition • Metastases
    |
    visugromab (CTL-002)