Kitov Pharma Ltd. (“Kitov”) (NASDAQ/TASE: KTOV), a clinical-stage company advancing first-in-class therapies to overcome tumor immune evasion and drug resistance, today announced that the positive results of a previously reported Phase 1 trial of CM-24, a monoclonal antibody targeting CEACAM1, a novel immune checkpoint that supports tumor immune evasion and survival through multiple pathways, in patients with advanced cancer will be presented in a poster presentation at the American Society of Clinical Oncology (ASCO) 2020 Virtual Scientific Program.
The presentation, titled, “Abstract 3094: A phase 1, open-label, multicenter, single-dose escalation and multi-dose study of a monoclonal antibody targeting CEACAM1 in subjects with selected advanced or recurrent malignancies,” includes the positive results of a Phase 1 study consisting of a monotherapy dose escalating IV administration of CM-24, administered every two weeks, in 27 patients with advanced malignancies. CM-24 was found to be safe and well-tolerated in all patients, with no discontinuations of study drug or dose limiting toxicities (up to 10mg/kg). In the efficacy evaluable patients (n=24), subjects were highly refractory to therapy, having received between two and seven prior therapies (median of 4). Eight patients (33%) achieved stable disease, with most patients responding at the higher dose levels of 3mg/kg and 10mg/kg. Pharmacokinetic analysis revealed non-linearity, and modeling suggested a dose of 20mg/kg administered every two weeks as the recommended next Phase 2 evaluation.
“These Phase 1 results are encouraging and indicate that CM-24 at higher doses warrants further evaluation in a larger clinical study, and we are proud to be able to present them as a poster at ASCO 2020” said Isaac Israel, Chief Executive Officer of Kitov. “Importantly, PK modelling suggests that higher doses of CM-24 of up to 20mg/kg administered every two weeks would be required for target saturation. We look forward to the anticipated initiation of our planned Phase 1/2 clinical trial to evaluate the combination of CM-24 with the PD-1 inhibitor, nivolumab (Opdivo®), which will be conducted in collaboration with Bristol Myers Squibb, in the second half of this year.”
|Title:||Abstract 3094: A phase 1, open-label, multicenter, single-dose escalation and multi-dose study of a monoclonal antibody targeting CEACAM1 in subjects with selected advanced or recurrent malignancies|
|Date:||May 29, 2020|
|Time:||8:00 a.m. ET|
|Location:||ASCO Meeting Library|