CatalYm Highlights Visugromab’s Potential to Treat Cachexia in Cancer Patients at International SCWD Conference

• Preclinical and clinical data demonstrate that neutralizing GDF-15 with visugromab effectively alleviates cancer-induced cachexia, characterized by severe weight and muscle mass loss
• Patients with elevated GDF-15 serum levels experienced significant weight gain during visugromab treatment, addressing one of the most debilitating symptoms of advanced cancer
• Findings further validate GDF-15 as critical therapeutic target with potential dual benefits in oncology: overcoming immune resistance and mitigating cachexia

MUNICH--(BUSINESS WIRE)--CatalYm today announced new findings from its ongoing Phase 1/2a study as well as preclinical research, highlighting the therapeutic potential of its lead drug candidate, visugromab, to mitigate cancer cachexia by neutralizing the Growth Differentiation Factor 15 (GDF-15). Cachexia, a condition affecting a significant number of advanced cancer patients, leads to severe weight loss, muscle wasting, and reduced quality of life, often limiting the ability to tolerate cancer therapies. The data were presented at the 17^th International Conference on Sarcopenia, Cachexia & Wasting Disorders (SCWD).

Preclinical and clinical data from the CatalYm’s ongoing GDFATHER Phase 1/2a study (GDF-15 Antibody-mediaTed Human Effector T Cell Relocation Phase 1/2a Trial; NCT04725474) demonstrate that visugromab, a humanized monoclonal antibody targeting GDF-15, can significantly counteract the effects of cachexia. By neutralizing GDF-15, visugromab inhibits the activation of the GFRAL pathway in the brainstem, a key driver of weight loss and appetite suppression in cancer patients. Beyond its immuno-oncology benefits in overcoming resistance to checkpoint inhibitors, visugromab shows potential to improve the overall treatment experience and quality of life for cancer patients.

“Cachexia is one of the most challenging complications in advanced cancer with GDF-15 being one of its most important drivers,” commented Christine Schuberth-Wagner, Chief Scientific Officer at CatalYm. “Elevated GDF-15 levels promoting cachexia development can result from GDF-15-producing tumors or standard of care treatments like chemotherapy. In addition to blocking GDF-15 mediated immunosuppression within tumor, our latest data demonstrate visugromab’s strong potential to counteract cachexia development.”

“Cachexia is significantly affecting patients’ quality of life and ability to undergo intensive anticancer treatment regimen,” added Eugen Leo MD PhD MBA, Chief Medical Officer at CatalYm. “Our latest clinical data show that GDF-15 neutralization with visugromab not only enhances immune response but also alleviates the symptoms of cachexia, offering a dual benefit for patients, which we aim to further investigate in our broad Phase 2 clinical development program.”

Key findings include:

• Clinical impact: A distinct subgroup of patients in the GDFATHER Phase 1/2a trial that entered the trial with manifest cachexia and elevated GDF-15 levels experienced meaningful weight gain during combination treatment of visugromab and nivolumab.
• Preclinical evidence: In xenograft mouse models with GDF-15 overexpression, visugromab effectively inhibited the GFRAL/Erk1/2 pathway, reversing weight loss and restoring normal food intake.
• Dual benefit in cancer care: The findings reinforce visugromab’s potential to address both immune suppression and cachexia, establishing it as a promising therapeutic option to improve patient outcomes and quality of life.

About Cancer cachexia and GDF-15

Cancer cachexia is a complex and debilitating syndrome that affects up to 80% of patients with advanced cancer. The condition is closely linked to elevated GDF-15 levels, which drive severe and progressive weight loss, muscle wasting, reduced appetite, and metabolic disturbances through activation of the GFRAL receptor in the brainstem. Unlike starvation, cachexia cannot be fully reversed with nutritional support alone, as it is driven by a combination of systemic inflammation, tumor-derived factors, and metabolic dysregulation. This condition significantly diminishes the quality of life for cancer patients and severely impacts their ability to tolerate and respond to treatment, often leading to poorer outcomes and increased mortality.

About Visugromab (CTL-002)

Visugromab is a monoclonal antibody that neutralizes the tumor-derived Growth Differentiation Factor-15 (GDF-15), a locally acting immunosuppressant fostering immunotherapy resistance. 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 Interferon-γ signature induction. Visugromab has demonstrated a good safety profile and potent and durable anti-tumor efficacy in combination with anti-PD-1 treatment in advanced cancer patients The antibody will now be investigated in Phase 2b studies in multiple solid tumor indications.

About CatalYm

CatalYm has identified GDF-15 as a key cancer therapy resistance mechanism and is developing it as safe and efficacious immune therapy for solid tumors. GDF-15 is an immunosuppressant that is hijacked by cancer cells to evade immune system attack. Visugromab, CatalYm’s lead antibody, has 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. CatalYm is now advancing to Phase 2b studies to confirm visugromab as a new class of cancer immunotherapy in a broad range of anti-cancer regimens.