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Lung cancer is a disease in which abnormal cells multiply uncontrollably in the lungs, damaging their function. Often, these abnormal cells also spread to other organs, where they can settle and form secondary tumors (metastases). Lung cancer is one of the most common cancer types and remains the leading cause of cancer-related mortality globally.

Within the group of all lung cancer types, NSCLC is the most common form and accounts for approximately 87% of the 210,000 annual lung cancer diagnoses in the US. It is commonly categorized into different subtypes based on the specific kind of cells in which the cancer begins and how the cells appear under the microscope. The broader categories often referred to are squamous (thin, flat cells) versus non-squamous NSCLC.

Despite significant progress in the field, five-year survival rates in the US for non-squamous NSCLC are still low: 12.8% for adenocarcinoma and 5.1% for large-cell carcinoma. An estimated 70-85% of NSCLC patients either exhibit primary resistance to standard immunotherapy with a PD-1 inhibitor or develop acquired resistance to immunotherapy, emphasizing the need for innovative approaches to overcome this challenge.

CatalYm is currently evaluating visugromab in two early-line treatment settings in patients with non-squamous NSCLC, that harbor no targetable gene mutations such as mutations in EGFR, NTRK, ALK or others:

The two trials build on promising efficacy and safety data from CatalYm’s GDFATHER Phase 1/2a trial (NCT04725474) in patients with advanced solid tumors, who progressed on/relapsed after at least one prior anti-PD-(L)1 treatment. In this setting, treatment with visugromab in combination with nivolumab demonstrated deep and durable anti-tumor responses in the non-squamous NSCLC cohort.

Hepatocellular carcinoma (HCC) develops from hepatocytes, the main type of liver cells responsible for processing nutrients, removing toxins and supporting digestion. HCC is the most common primary liver cancer and the third leading cause of cancer-related death worldwide.

The five-year survival rate for HCC is only 18%, second lowest among common cancers. While checkpoint inhibitors, mainly PD-(L)1 inhibitors, have become a first-line standard of care, most patients with advanced-stage HCC experience disease progression or relapse, with only 15-20% achieving durable benefit. Treatment options in the second-line setting remain limited, underscoring the urgent need for more effective and well-tolerated therapies.

CatalYm is currently evaluating visugromab as a second-line treatment in patients with advanced HCC:

The trial builds on promising efficacy and safety data from CatalYm’s GDFATHER Phase 1/2a trial (NCT04725474) in patients with advanced solid tumors, who progressed on/relapsed after at least one prior anti-PD-(L)1 treatment. In this setting, treatment with visugromab in combination with nivolumab demonstrated deep and durable anti-tumor responses in the HCC cohort.

Bladder cancer is the ninth most commonly diagnosed cancer type worldwide, with both incidence and mortality rates increasing. Urothelial carcinoma (UC) accounts for about 90% of bladder cancers and arises from the urothelial lining of the bladder.

For treatment purposes, UC is often grouped by whether the tumor has invaded surrounding muscle tissue. Muscle-invasive bladder cancer (MIBC), which has grown into the muscle layer of the bladder wall and possibly deeper, is more likely to spread and tends to be harder to treat, reflected in a poor five-year survival rate of around 50%.

As many patients are diagnosed at an older age and/or with existing comorbidities, a significant number of patients are not eligible for aggressive standard-of-care neoadjuvant chemotherapy. Some may also decline radical cystectomy, surgical removal of the entire urinary bladder, surrounding lymph nodes and nearby organs like the prostate or ovaries, after neoadjuvant therapy.

Prior combinations of chemotherapy and anti-PD-(L)1 therapy have shown limited or non-additive clinical benefit in pathological response, highlighting the need for more efficient regimens with manageable tolerability.

CatalYm is currently evaluating visugromab as a neoadjuvant treatment in patients with MIBC:

Proof-of-concept data from the trial demonstrated substantially increased anti-tumor activity for the visugromab-nivolumab combination arm, resulting in a higher proportion of patients who were eligible for bladder-sparing tumor resection via re-TURBT. These results were presented at the ESMO Congress 2025.

The GDFATHER-NEO trial builds on promising efficacy and safety data from CatalYm’s GDFATHER Phase 1/2a trial (NCT04725474) in patients with advanced solid tumors, who progressed on/relapsed after at least one prior anti-PD-(L)1 treatment. In this setting, treatment with visugromab in combination with nivolumab demonstrated deep and durable anti-tumor responses in the UC cohort.

Cancer cachexia is a complex and debilitating syndrome that affects up to 70% of patients with advanced cancer and is responsible for 20-40% of cancer-related deaths.

The condition is closely linked to elevated GDF-15 levels, which can 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 reversed with nutritional support alone, as it is driven by a combination of tumor-derived factors, including systemic inflammation and metabolic dysregulation.

Cachexia can significantly diminish 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. Despite the high unmet medical need, there are currently no approved pharmacological treatments available, leaving cachexia as one of the most under-addressed complications in oncology.

CatalYm is currently evaluating visugromab as a novel treatment in patients with cancer cachexia:

The VINCIT trial builds on promising data from CatalYm’s GDFATHER Phase 1/2a trial (NCT04725474) in patients with advanced solid tumors, who progressed on/relapsed after at least one prior anti-PD-(L)1 treatment. In this setting, patients with confirmed cachexia showed meaningful weight gain in the visugromab treatment arm.