We are building a pipeline leveraging GDF-15
for the treatment of oncology and beyond.
Our lead candidate
Our lead candidate Visugromab, formerly known as CTL-002, is a humanized, monoclonal antibody designed to neutralize the tumor-produced Growth Differentiation Factor-15 (GDF-15). GDF-15 secretion by the tumor has been shown to prevent T cell migration into the tumor and suppresses T cell function and the adaptive immune response in the tumor microenvironment. This enables the tumor to evade the immune system and become resistant to standard of care and current immunotherapy approaches such as checkpoint inhibitors. Visugromab counteracts these immuno-suppressive mechanisms by neutralizing GDF-15, enhancing the infiltration of immune cells into the tumor, improving both priming of T cells by dendritic cells and tumor killing by T cells and NK cells.
In the clinic
We are currently investigating visugromab in patients with advanced-stage solid tumors relapsed or refractory to prior anti-PD-1/PD-L1 therapy.
Visugromab has been investigated in a Phase 1 dose escalation trial (GDFATHER-1; GDF-15 Antibody-mediaTed Human Effector cell Relocation; NCT04725474), where 25 subjects received escalating doses of visugromab intravenously (0.3-20 mg/kg) in a 3+3 design with visugromab given as monotherapy and followed by combination with an anti-PD-1 checkpoint inhibitor. In this first-in-human study visugromab in combination with anti-PD-1 demonstrated an impressive efficacy and safety profile.
Currently, visugromab is in phase 2 development in selected solid tumors (GDFATHER-2; NCT04725474). The main endpoints are clinical efficacy as well as safety, pharmacokinetics, and pharmacodynamics.
Additional studies as part of a broader Phase 2 development program are also in preparation.
The GDFATHER-2 trials were initiated in January 2022 and initial readouts are expected within Q1 2023.