Our lead candidate
Our lead candidate, CTL-002 is a humanized, monoclonal antibody designed to neutralize tumor-derived GDF-15. Our preclinical in vitro and in vivo models demonstrated potent neutralization of GDF-15 by CTL-002 in the tumor microenvironment enabling T cell infiltration into tumor tissue and fostering anti-tumor responses. CTL-002 is currently being investigated in a Phase 1/2a study in patients with advanced-stage anti-PD1/-PD-L1 refractory solid tumors, as a monotherapy and in combination with anti-PD1 treatment and potentially other immunotherapies.
In the clinic
We are currently investigating CTL-002 in a two-part, first-in-human, open-label Phase 1/2a clinical trial in patients with advanced-stage solid tumors who relapsed post or were refractory to a prior anti-PD-1/PD-L1 therapy and have no other approved standard treatments available. The GDFATHER (GDF-15 Antibody-mediaTed Effector cell Relocation) trial will evaluate CTL-002 as monotherapy alone and in combination with an anti-PD-1 antibody.
In part A (phase 1), the dose escalation part of the trial, up to 24 subjects will receive 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.
In part B (phase 2a), the expansion part of the trial, up to 5 cohorts with up to 25 subjects per cohort with defined tumor indications that are GDF-15 dependent, will be treated to evaluate safety and preliminary efficacy of CTL-002 monotherapy as well as in combination with anti-PD1 and to further consolidate the selected phase 2 dose.
The main endpoints of the study are the safety of CTL-002 as a monotherapy and CTL-002 in combination with an anti-PD-1 antibody, pharmacokinetics, pharmacodynamics as well as preliminary clinical efficacy. The study was initiated in December 2020 with the first data readout from the dose escalation phase expected at the end of 2021.