We are building a pipeline leveraging GDF-15
for the treatment of oncology and beyond.
Targeting GDF-15
Visugromab (CTL-002)
Cancer
NSCLC
Bladder cancer
HCC
Other indications
Muscle-invasive
bladder cancer
Visugromab (CTL-002)
Cachexia
Other Programs
CTL-DISC01
Cancer
CTL-DISC02
Autoimmune
Disorders
Visugromab (CTL-002)
Our lead candidate
Visugromab is a monoclonal antibody that neutralizes the tumor-derived Growth Differentiation Factor-15 (GDF-15), a locally acting immunosuppressant fostering immunotherapy resistance. CatalYm has demonstrated that GDF-15 inhibits both the activation and relocation of important players of anti-tumoral immune responses (Nature Communications, 2023; Annals of Oncology, 2023). Neutralizing GDF-15 with visugromab reverses key cancer resistance mechanisms to reinstate an efficient anti-tumor response by reenabling immune cell activation and tumor infiltration. In addition, visugromab also offers the potential to alleviate treatment related side effects of treatment-induced GDF-15 expression, such as nausea, emesis, loss of appetite and exacerbated weight and muscle mass loss (cachexia), thereby increasing the patient’s quality of life and tolerability of cancer therapies.
The antibody has the potential to benefit patients at different stages of their disease and is currently being investigated in ongoing Phase 2 studies in multiple solid tumor indications. Preclinical studies have also shown visugromab’s potential to enhance the efficacy of other immunotherapy approaches including checkpoint inhibitors, chemotherapeutics and T cell engagers.
Visugromab (CTL-002)
In the clinic
Visugromab has completed Phase 1 development and is currently being investigated in a Phase 2 study in selected solid tumors (GDFATHER-2; NCT04725474). The study evaluates visugromab in combination with the anti-PD-1 inhibitor nivolumab in patients with advanced-stage solid tumors relapsed or refractory to prior anti-PD-1/PD-L1 therapy. The main endpoints are clinical efficacy as well as safety, pharmacokinetics, and pharmacodynamics. The study consists of two segments with a total of up to seven cohorts, enrolling up to 164 patients in Simon-2-stage designs to confirm a certain response rate within each tumor type. Additionally, visugromab is being evaluated in combination with neoadjuvant immunotherapy in treatment-naïve patients in first-line muscle invasive bladder cancer (NCT06059547).
To date, visugromab has shown impressive lasting and confirmed responses, as per RECIST criteria, after treatment in combination with the anti-PD-1 inhibitor nivolumab. More than half of all responders experienced a response level and depth that had not been achieved on their prior anti-PD-(L)1 treatment. Anti-tumor responses have been observed in major cancer indications, including non-small cell lung cancer (NSCLC), bladder cancer, and hepatocellular carcinoma (HCC). The combination of visugromab and nivolumab continues to show an overall very good safety and tolerability profile.
Based on the positive results of the GDFather-2 trial, CatalYm is now preparing to launch randomized, controlled studies with visugromab in several major cancer indications in combination with checkpoint inhibitors and standard-of-care in first- and second-line treatment.