visugromab (CTL-002) / CatalYm - LARVOL DELTA

Final pathological and radiological outcomes and initial EFS from a blinded, exploratory phase 2 trial of nivolumab ± visugromab in MIBC (GDFather-NEO) (ESMO 2026) - No abstract available

P2 data • Bladder Cancer • Oncology

Phase 2b randomized, blinded, trial to investigate the efficacy and safety of visugromab in combination with nivolumab and lenvatinib in unresectable or metastatic hepatocellular carcinoma after failure of first-line treatment including an anti-PD-(L)1 compound: GDFATHER-HCC-01 (ESMO 2026) - No abstract available

Clinical • Combination therapy • Metastases • P2b data • Hepatocellular Cancer • Oncology • Solid Tumor

Phase 2b randomized, blinded, placebo-controlled trial investigating the efficacy and safety of visugromab plus nivolumab with or without docetaxel in second line metastatic non-squamous NSCLC: GDFATHER-NSCLC-02 (ESMO 2026) - No abstract available

Clinical • Metastases • P2b data • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Neutralizing GDF-15 can overcome anti-PD-1 and anti-PD-L1 resistance in solid tumours. (PubMed, Nature) - P1/2 | "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."

IO biomarker • Journal • Genito-urinary Cancer • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Urothelial Cancer • GDF15 • GZMB • IFNG

A blinded, exploratory phase II trial of nivolumab and the GDF-15 neutralizing antibody visugromab or placebo as neoadjuvant treatment of patients with muscle-invasive bladder cancer (MIBC): Primary results of the GDFather-NEO trial (ESMO 2025) - P2 | "Conclusions In anti-PD(L)-1-naïve MIBC, GDF-15 blockade by visugromab tripled the effect size of nivolumab in neoadjuvant therapy, with excellent tolerability. N/V combination warrants further investigation in larger neoadjuvant trials with a tumor response-guided bladder preservation approach."

Clinical • Late-breaking abstract • P2 data • Bladder Cancer • Genito-urinary Cancer • Oncology • GDF15

Neutralizing GDF-15 in muscle-invasive bladder cancer (MIBC): A neoadjuvant immunotherapy trial of visugromab (CTL-002) in combination with the anti-PD1 antibody nivolumab (NEO-GDFATHER). (ASCO-GU 2023) - "Translational research includes evaluation of immunologic parameters in the tumor, other immune-correlates and molecular profiles, as well as evaluation of treatment-emergent cytokine and chemokine profiles in peripheral blood. * Melero et al., Annals of Oncology (2022) 33 (suppl_7): S331-S355."

Clinical • Combination therapy • IO biomarker • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer • GDF15 • PD-L1

Long-term follow-up GDFATHER-01 trial: GDF-15 neutralization combined with nivolumab can enable deep, long-term remission in heavily pretreated, anti-PD1/-L1 relapsed/refractory non-squamous non-small cell lung cancer (NSCLC), urothelial cancer (UC) and hepatocellular cancer (HCC) (ESMO 2025) - P1/2 | "Conclusions In 77 heavily pre-treated, by strict criteria anti-PD-1/-L1 relapsed/refractory nsq NSCLC, UC and HCC pts, V+N treatment induced very durable and deep long-term response, with 61.5% (8/13) of responders achieving confirmed CR or CMR. GDF-15 neutralization by V may overcome ICI resistance and enable long-term immunologic tumor control in metastatic nsq NSCLC, UC and HCC."

Clinical • Genito-urinary Cancer • Hepatocellular Cancer • Liver Cancer • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Urothelial Cancer • GDF15

Long-term follow-up of a phase 1/2 trial of anti-GDF-15 antibody visugromab plus anti-PD-1 antibody nivolumab in anti-PD-1/-L1 relapsed/refractory solid tumors. (PubMed, J Hematol Oncol) - P1/2 | "In heavily pretreated, advanced/metastatic participants with nsq NSCLC, UC, or HCC who were anti-PD-1/PD-L1-relapsed/refractory, V+N achieved deep and durable objective responses. The observed DoR, depth of response, and CR+CMR rate among responders exceeded those reported for their initial anti-PD-1/PD-L1 therapy. These findings suggest that GDF-15 blockade with visugromab can overcome resistance and enhance the magnitude and durability of anti-PD-1/PD-L1 responses, and warrant further exploration in randomized trials."

First-in-human • Journal • P1/2 data • Hepatocellular Cancer • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Urothelial Cancer • GDF15

Definitive results for NSCLC and Bladder cancer cohorts in the phase 2a trial of visugromab (CTL-002) in advanced/metastatic anti-PD/PD-L1 relapsed/refractory solid tumors (GDFATHER-trial) (ESMO-IO 2023) - P1/2 | "Here we report definitive results for NSCLC and bladder cancer cohorts of the phase 1/2a trial of the GDF-15 neutralizing antibody visugromab (CTL-002) in combination with nivolumab for treatment of patients that were relapsed/refractory to anti-PD1/-PD-L1 therapy and had exhausted standard-of-care. Confirmed partial and complete responses with significant durability up to and beyond 1 year were observed. Biomarker analyses suggest that visugromab can reinvigorate, enhance and deepen response to checkpoint inhibitors mainly in PD-L1+ patients even after documented prior progression on a seamlessly administered checkpoint inhibitor, being relapsed/refractory to it."

IO biomarker • Metastases • P2a data • Bladder Cancer • Genito-urinary Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • GDF15

Initial results from the phase 2A trial of visugromab (CTL-002) + nivolumab in advanced/metastatic anti-PD1/-L1 relapsed/refractory solid tumors (The GDFATHER-TRIAL). (ASCO 2023) - P1/2 | "These initial phase 2a results demonstrate promising clinical activity for the combination of visugromab and nivolumab in heavily pretreated anti-PD1/-PD-L1 refractory/relapsed solid tumor patients across various indications, including induction of confirmed partial and complete responses. Extensive biomarker evaluations are ongoing to further evaluate potential response-predictive markers identified during phase 1 development. Clinical trial information: NCT04725474."

IO biomarker • Metastases • P2a data • Bladder Cancer • Genito-urinary Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Urothelial Cancer • GDF15

GDFather-NEO: Neoadjuvant Immunotherapy Combined With the Anti-GDF-15 Antibody Visugromab to Treat Muscle Invasive Bladder Cancer (clinicaltrials.gov) - P2 | N=31 | Completed | Sponsor: CatalYm GmbH | Active, not recruiting ➔ Completed | Trial completion date: Oct 2026 ➔ Jun 2026

Trial completion • Trial completion date • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor

Phase 2b randomized, blinded, placebo-controlled trial to investigate the efficacy and safety of visugromab added to pembrolizumab, pemetrexed, and carboplatin in first-line metastatic non-squamous NSCLC: GDFATHER-NSCLC-01. (ASCO 2026) - P2 | "Clinical data for the anti–GDF-15 antibody visugromab in combination with nivolumab have been presented, demonstrating reinvigoration with deep and durable responses in relapsed/refractory solid tumors and increased efficacy in an ICI-naïve neoadjuvant setting, strongly supporting further evaluation in ICI-naïve NSCLC...Enrollment status: The SRI has been completed. The randomized part is open to accrual; first patient pending."

Clinical • IO biomarker • Metastases • P2b data • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Solid Tumor • GDF15 • PD-L1

GDFATHER-NSCLC-01: Trial Investigating Visugromab in Combination With Immunochemotherapy in 1L Treatment of Participants With Metastatic NSCLC (clinicaltrials.gov) - P2 | N=107 | Recruiting | Sponsor: CatalYm GmbH

Trial initiation date • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • EGFR • PD-L1

GDFATHERHCC01: Visugromab, Nivolumab and Lenvatinib Compared to Double Placebo and Lenvatinib in Unresectable or Metastatic Hepatocellular Carcinoma Post Anti-PD-(L)1 Failure (clinicaltrials.gov) - P2 | N=104 | Recruiting | Sponsor: CatalYm GmbH

Trial initiation date • Hepatocellular Cancer • Oncology • Solid Tumor

VINCIT: Visugromab in Cachexia International Trial (clinicaltrials.gov) - P2/3 | N=518 | Recruiting | Sponsor: CatalYm GmbH | N=374 ➔ 518

Enrollment change • Trial initiation date • Cachexia • Oncology

VINCIT: Visugromab in Cachexia International Trial (clinicaltrials.gov) - P2/3 | N=374 | Recruiting | Sponsor: CatalYm GmbH | Not yet recruiting ➔ Recruiting

Enrollment open • Cachexia • Oncology

VINCIT: Visugromab in Cachexia International Trial (clinicaltrials.gov) - P2/3 | N=518 | Recruiting | Sponsor: CatalYm GmbH

Trial initiation date • Cachexia • Oncology

FL-501 is a potential best in class GDF-15 inhibitor with extended half-life and potent anti-cachexia activity in preclinical models (AACR 2025) - "In this therapeutic model, mice were treated with cisplatin (5 mg/kg) alone or in combination with either FL-501 or ponsegromab...Further, the targeted inhibition of GDF-15 with FL-501 was able to effectively reverse characteristics of cancer cachexia in multiple pre-clinical models. Taken together, these findings support the continued evaluation of FL501 and its progression into the clinic."

Preclinical • Colorectal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • GDF15

CatalYm Doses First Patient in Phase 2b Trial Evaluating Visugromab in Combination with Chemoimmunotherapy as Second-Line Treatment in Unresectable/Metastatic Hepatocellular Carcinoma (Businesswire) - "The GDFATHER-HCC-01 trial is a global, randomized, blinded Phase 2b study enrolling approximately 104 participants across 40 sites in North America, Europe and Asia-Pacific."

Trial status • Hepatocellular Cancer

VINCIT: Visugromab in Cachexia International Trial (clinicaltrials.gov) - P2/3 | N=518 | Recruiting | Sponsor: CatalYm GmbH

Trial initiation date • Cachexia • Oncology

CTL-002-005: Visugromab, nivolumab and lenvatinib compared to double placebo and lenvatinib in unresectable or metastatic hepatocellular carcinoma post anti-PD-(L)1 failure (clinicaltrialsregister.eu) - P1/2 | N=59 | Not yet recruiting | Sponsor: CatalYm GmbH

New P1/2 trial • Hepatocellular Cancer • Oncology • Solid Tumor

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 | Recruiting | Sponsor: CatalYm GmbH | Not yet recruiting ➔ Recruiting

Enrollment open • Hepatocellular Cancer • Oncology • Solid Tumor

CTL-002-004: A phase 2 placebo-controlled trial to investigate visugromab and nivolumab with or without docetaxel in second-line treatment of participants with metastatic non-squamous non-small cell lung cancer (NSCLC) (clinicaltrialsregister.eu) - P1/2 | N=89 | Recruiting | Sponsor: CatalYm GmbH

Monotherapy • New P1/2 trial • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK

CTL-002-004: A phase 2 placebo-controlled trial to investigate visugromab and nivolumab with or without docetaxel in second-line treatment of participants with metastatic non-squamous non-small cell lung cancer (NSCLC) (clinicaltrialsregister.eu) - P1/2 | N=103 | Recruiting | Sponsor: CatalYm GmbH

Monotherapy • New P1/2 trial • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK

CTL-002-006: Visugromab in Cachexia International Trial (clinicaltrialsregister.eu) - P2/3 | N=354 | Not yet recruiting | Sponsor: CatalYm GmbH

New P2/3 trial • Cachexia • Oncology