Building on our deep scientific insights in the pathobiology of GDF-15, we are advancing our neutralizing antibody, visugromab, across multiple solid tumor indications with high medical need. Our goal is to simultaneously address two key hurdles in oncology: therapy resistance and cancer-associated cachexia, a severe wasting condition. Supported by encouraging clinical proof-of-concept data, we are currently evaluating visugromab in earlier treatment settings to unlock its full potential to improve treatment outcomes and enhance patients’ quality of life.
The Phase 2b GDFATHER-NSCLC-01 trial (NCT07098988) evaluates the efficacy and safety of visugromab in combination with standard-of-care chemoimmunotherapy (pembrolizumab, pemetrexed and carboplatin) compared to chemoimmunotherapy alone as a 1L treatment for patients with newly diagnosed metastatic non-squamous non-small cell lung cancer (nsq mNSCLC).
The Phase 2b GDFATHER NSCLC 02 trial (NCT07246863) evaluates the efficacy and safety of visugromab in combination with nivolumab with or without docetaxel versus docetaxel alone as a 2L treatment in patients with metastatic non-squamous non-small cell lung cancer (nsq mNSCLC) who have progressed following initial systemic treatment including an approved immune checkpoint inhibitor.
The Phase 2b GDFATHER-HCC-01 trial (NCT07219459) is evaluating the efficacy and safety of visugromab in combination with chemoimmunotherapy (nivolumab and lenvatinib) compared to lenvatinib alone as a 2L treatment for patients with unresectable or metastatic hepatocellular carcinoma (HCC), who have progressed following 1L treatment with an anti-PD-(L)1-based therapy.
The Phase 2/3 VINCIT trial (NCT07112196) is evaluating visugromab versus placebo in patients with cachexia associated with a range of advanced cancers, including non-small cell lung cancer (NSCLC), colorectal cancer (CRC), and other solid tumors.
The Phase 2 GDFATHER-NEO trial (NCT06059547) is evaluating the efficacy and safety of neoadjuvant visugromab in combination with nivolumab compared to nivolumab alone in cisplatin-ineligible/refusing patients with newly diagnosed muscle-invasive bladder cancer (MIBC) set to undergo radical cystectomy or re-transurethral resection of the bladder tumor.
Proof-of-concept data from the trial, which demonstrated substantially increased anti-tumor activity for the visugromab-nivolumab combination, were presented at the ESMO Congress 2025.
The first-in-human Phase 1/2a GDFATHER trial (NCT04725474) is evaluating the efficacy and safety of visugromab in combination with nivolumab in patients with advanced solid tumors, who progressed on/relapsed after at least one prior anti-PD-(L)1 treatment.
Proof-of-concept data from this trial, which demonstrated deep and durable responses in NSCLC, HCC and UC cohorts, were published in Nature in 2024, followed by a long-term data update presented at the ESMO Congress 2025. The data provided the basis for CatalYm’s ongoing earlier-line trials with visugromab in 1L and 2L NSCLC and 2L HCC.
About
Visugromab
Visugromab is a first-in-class monoclonal antibody that neutralizes Growth Differentiation Factor-15 (GDF-15), a locally acting immunosuppressant produced by tumors which fosters immunotherapy resistance and drives cachexia in people with cancer. Neutralizing GDF-15 with visugromab reverses key cancer resistance mechanisms to reinstate an efficient anti-tumor response by re-enabling immune cell activation, proliferation and induction of interferon-γ. In addition, visugromab also mitigates cancer cachexia, a severe condition affecting a significant number of advanced cancer patients by inhibiting the activation of the GFRAL pathway in the brainstem, a key driver of weight loss and appetite suppression in cancer patients.
Click here to read more about the science behind visugromab.
For a deep-dive into our clinical and preclinical data around visugromab and GDF-15, browse our scientific publications.