- Study targets patients with advanced disease who have progressed on prior immunotherapy
MUNICH & SAN FRANCISCO--(BUSINESS WIRE)--CatalYm today announced that the first patient has been dosed in the randomized Phase 2b GDFATHER‑NSCLC‑02 (GDF‑15 Antibody‑MediaTed‑Human‑Effector‑T‑Cell Relocation) trial (NCT07246863). The trial evaluates the company’s lead anti-GDF-15 antibody visugromab as a second-line treatment in patients with metastatic non-squamous non-small cell lung cancer (nsq NSCLC) who have progressed following initial systemic treatment including an approved immune checkpoint inhibitor.
The trial will assess multiple treatment strategies combining visugromab with an anti-PD-1 antibody and the chemotherapy docetaxel, including a chemo-free regimen. Standard-of-care chemotherapy alone will serve as the control arm. The trial consists of a safety run-in followed by a randomized phase evaluating visugromab in the different combination regimen settings.
Visugromab is a humanized, monoclonal antibody that targets Growth Differentiation Factor-15 (GDF-15), a tumor-derived cytokine known to drive immune suppression and resistance to anti-PD-(L)1 therapies. In the exploratory Phase 1/2a GDFATHER trial (NCT04725474), visugromab demonstrated encouraging anti-tumor activity when combined with an anti-PD-1 antibody in advanced-stage, anti-PD-(L)1 relapsed/refractory NSCLC patients, demonstrating deep and durable responses, with a median duration of response of 32.2 months and a favorable safety profile. In addition to its ability to restore immune activation, visugromab also showed potential to alleviate cancer cachexia, a severe condition limiting treatment tolerability and responsible for 20-40% of cancer deaths.1
“The decision to evaluate visugromab in second-line nsq NSCLC, in addition to the first-line setting, was driven by the strength of our Phase 1/2a data in heavily pretreated patients, where we observed deep and durable responses well beyond those typically seen with other therapies in this setting,” said Sujata Rao, MD, Chief Medical Officer at CatalYm. “By neutralizing GDF-15, a key driver of immune suppression, visugromab may overcome resistance, restore responsiveness to immunotherapy and extend the benefit of anti-PD-1 agents. Its additional potential to mitigate cancer cachexia and support tolerance to chemotherapies and other anti-cancer regimens offers a distinct advantage in this difficult-to-treat population.”
“We are expanding visugromab’s development into key settings where immune resistance severely limits treatment options,” said Scott Clarke, Chief Executive Officer at CatalYm. “Second-line nsq NSCLC is a particularly challenging indication with limited benefit from current standard-of-care. This trial builds on the compelling rationale for GDF-15 neutralization and is part of our late-stage development program to deliver visugromab’s potential to patients in urgent need of better solutions.”
The randomized, multi-arm Phase 2b GDFATHER-NSCLC-02 trial will enroll approximately 131 patients across multiple sites in the US, EU and Switzerland. Following the safety run-in, patients will be randomized into one of four treatment arms:
- Visugromab + anti-PD-1 inhibitor + chemotherapy
- Visugromab + anti-PD-1 inhibitor (chemo-free)
- Visugromab (at lower dose) + anti-PD-1 inhibitor + chemotherapy
- Chemotherapy alone (control)
The primary endpoint of the study is objective response rate (ORR) defined as the percentage of participants with a best overall response (BOR) of complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Secondary endpoints include duration of response (DOR), progression-free survival (PFS), overall survival (OS), participant weight course over time and safety-related measures.
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 US2. Five-year survival rates in the US for non-squamous NSCLC are low: 12.8% for adenocarcinoma and 5.1% for large-cell carcinoma3. 70-85% of NSCLC patients either exhibit primary resistance to PD-1 blockade or develop acquired resistance to immunotherapy4, 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 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.
About CatalYm
CatalYm is developing visugromab, a first-in-class anti-GDF-15 antibody, in solid tumors and cachexia. In its first-in-human Phase 1/2a study, visugromab demonstrated durable anti-tumor efficacy with long-lasting objective responses in relapsed and refractory metastatic solid tumor patients in combination with anti-PD-1 treatment. In addition, data from the same study demonstrated that visugromab can significantly counteract the effects of cachexia in these patients. This data was published in Nature and presented at the International Conference on Sarcopenia, Cachexia & Wasting Disorders. CatalYm is now advancing visugromab into multiple Phase 2b studies including first-line metastatic non-squamous NSCLC (NCT07098988), second-line metastatic non-squamous NSCLC (NCT07246863) and cachexia (NCT07112196).
Founded in 2016 and based in Munich, Germany and San Francisco, USA, CatalYm is backed by leading international investors including Canaan Partners, Omega Funds, Bioqube Ventures, Forbion, Jeito Capital, Brandon Capital, Gilde Healthcare, Novartis Venture Fund, Vesalius, Bayern Kapital, BioGeneration Ventures, and Coparion.
1 Fearon K. et al. Lancet Oncol. 2011;12(8):489–495.
2 American Cancer Society, Key Statistics for Lung Cancer, 2025: https://www.cancer.org/cancer/types/lung-cancer/about/key-statistics.html, retrieved on Aug. 06, 2025
3 https://seer.cancer.gov/
4 Mariniello A, Borgeaud M, Weiner M, Frisone D, Kim F, Addeo A. Primary and Acquired Resistance to Immunotherapy with Checkpoint Inhibitors in NSCLC: From Bedside to Bench and Back. BioDrugs. 2025 Mar;39(2):215-235. doi: 10.1007/s40259-024-00700-2. Epub 2025 Feb 15. PMID: 39954220; PMCID: PMC11906525.
Contacts
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info@catalym.com
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