Company Expects to Initiate Phase 1/2 Clinical trial, in Collaboration with Bristol Myers Squibb, with CM-24 in Combination with nivolumab (Opdivo®) in Second Half of 2020
TEL AVIV, Israel, May 14, 2020 (GLOBE NEWSWIRE) -- 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.”
About Kitov Pharma
Kitov Pharma (Kitov Pharma Ltd.; NASDAQ/TASE: KTOV) is a clinical-stage company focusing on advancing first-in-class therapies to overcome tumor immune evasion and drug resistance, to create successful long-lasting treatments for people with cancer. Kitov’s oncology pipeline includes NT-219 and CM-24. NT-219 is a small molecule targeting the novel cancer drug resistance pathways IRS1/2 and STAT3. Kitov is currently advancing NT-219 in combination with cetuximab as a third-line or second-line treatment option for the treatment of recurrent and metastatic squamous cell carcinoma of head & neck cancer (SCCHN), as well as a single agent monotherapy treatment in patients with advanced solid tumors in a planned phase 1/2 study. CM-24 is a monoclonal antibody blocking CEACAM1, a novel immune checkpoint that supports tumor immune evasion and survival through multiple pathways. Kitov plans to advance CM-24 as a combination therapy with anti-PD1 checkpoint inhibitors in selected cancer indications in a phase 1 study followed by a phase 2 for the treatment of non-small cell lung cancer NSCLC and pancreatic cancer. Kitov has entered into a clinical collaboration agreement with Bristol Myers Squibb Company (BMY) for the planned Phase 1/2 clinical trials to evaluate the combination of CM-24 with the PD-1 inhibitor nivolumab (Opdivo®). Kitov is also the owner of Consensi™, a fixed-dose combination of celecoxib and amlodipine besylate, for the simultaneous treatment of osteoarthritis pain and hypertension which was approved by the FDA for marketing in the U.S in May 2018 and is expected to be launched in the U.S. during 2020 by its partner Coeptis Pharmaceuticals. Kitov has also partnered to commercialize Consensi in China and South Korea. The company is headquartered in Tel Aviv, Israel. For more information, please visit http://www.kitovpharma.com.