On September 30, 2025 CatalYm reported that the first patient has been dosed in the randomized Phase 2b GDFATHER-NSCLC-01 trial (NCT07098988) (Press release, Catalym, SEP 30, 2025, View Source [SID1234656364]). The trial investigates the efficacy and safety of the company’s anti-GDF-15 antibody visugromab, in combination with standard-of-care chemoimmunotherapy, compared to placebo plus chemoimmunotherapy, as a first-line treatment for patients with newly diagnosed metastatic non-squamous non-small cell lung cancer (NSQ mNSCLC).

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Visugromab is a humanized, monoclonal antibody designed to neutralize Growth Differentiation Factor-15 (GDF-15), a tumor-derived cytokine that plays a central role in immune suppression and anti-PD-(L)-1 resistance. CatalYm demonstrated visugromab’s therapeutic potential in the exploratory Phase 1/2a GDFATHER trial (NCT04725474), where the combination of visugromab and an anti-PD-1 inhibitor led to deep and durable responses across multiple solid tumor types while maintaining a favorable safety profile. Visugromab also showed potential to mitigate cancer cachexia, enhancing patients’ quality of life and treatment tolerability, which could extend therapy duration. Results from an additional blinded, exploratory phase 2 trial of nivolumab and visugromab or placebo as neoadjuvant treatment in patients with muscle-invasive bladder cancer will be announced at ESMO (Free ESMO Whitepaper) 2025.

"Our clinical trials have clearly shown visugromab’s impact for solid tumor patients in multiple settings," said Scott Clarke, Chief Executive Officer at CatalYm. "Given the strong anti-tumor effect with long durability, we believe that visugromab is uniquely positioned to demonstrate compelling efficacy as part of a first-line treatment regimen. We will explore the full potential of GDF-15 neutralization through our targeted Phase 2b development program across different tumor types, treatment settings and associated conditions like cancer cachexia."

The randomized, blinded, placebo-controlled Phase 2b GDFATHER-NSCLC-01 (GDF-15 Antibody-mediaTed Human Effector Cell Relocation) trial will enroll approximately 107 patients across multiple sites in the US, EU and Switzerland. The trial consists of an initial non-randomized safety run-in, followed by a randomized part. The primary endpoint of the trial is objective response rate (ORR). Key secondary endpoints include duration of response (DOR), complete and partial response rates (CR and PR), progression-free survival (PFS), overall survival (OS), body weight trends as well as safety and tolerability parameters.

"Joining CatalYm at this pivotal stage, I am encouraged by the clear scientific rationale supporting visugromab’s mechanism of action. GDF-15 plays a critical role in shielding tumors from immune attack, limiting the effectiveness of current immunotherapies. This mechanism is particularly relevant in first-line metastatic NCSLC, where many patients fail to respond or relapse early on immunotherapy. This trial marks an important step in evaluating visugromab’s potential to overcome this resistance and improve outcomes in a setting with limited options," said Sujata Rao, MD, Chief Medical Officer at CatalYm.

About NSCLC

Lung cancers remain the leading cause of cancer-related mortality globally and non-small cell lung cancers (NSCLCs) account for approximately 87% of the 210,000 annual lung cancer diagnoses in the US1. Five-year survival rates in the US for non-squamous NSCLC are low: 12.8% for adenocarcinoma and 5.1% for large-cell carcinoma2. 70-85% of NSCLC patients either exhibit primary resistance to PD-1 blockade or develop acquired resistance to immunotherapy3, emphasizing the need for innovative approaches to overcome immunotherapy resistance.

About Visugromab

Visugromab is a 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.