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 CTL-002 in the large group of patients with advanced-stage solid tumors who are approved for anti-PD1/-L1 treatment but who did relapsed post or were refractory to this anti-PD-1/PD-L1 therapy. Another group we investigate in de-novo fashion are tumors that far were not treated with anti-PD1/-L1 therapy as it was not shown to be effective in these indications.
Initially, CTL-002 was investigated in a dose escalation trial (GDFATHER-1; GDF-15 Antibody-mediaTed Human Effector cell Relocation; NCT04725474), where 25 subjects received escalating doses of CTL-002 intravenously (0.3-20 mg/kg) in a “monotherapy-followed-by-combination”-design with CTL-002 given as monotherapy and followed by combination with an anti-PD-1 checkpoint inhibitor. Observed safety and tolerability was excellent and promising PK/PD information and several responses in previously fully anti-PD1/-L1 patients was observed.
Currently, CTL-002 is in phase 2 development, where in six cohorts in the GDFATHER-2 (NCT04725474) trial series main tumor types of interest are evaluated with CTL-002 treatment in combination with an anti-PD-1 antibody. The main endpoints of the cohorts are are clinical efficacy as well as safety, pharmacokinetics, and pharmacodynamics.
Further phase 2 trials are in preparation.
The GDFATHER-2 trials were initiated in January 2022 and initial readouts are expected within 2H/2022.