TEL AVIV, Israel, Sept. 04, 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 receipt of notification from the Chinese Patent Office to grant two separate patents for Kitov’s lead oncology product candidates for advanced cancer patients, CM24, a monoclonal antibody targeting CEACAM1, a novel immune checkpoint that supports tumor immune evasion and survival through multiple pathways, and NT219, a dual inhibitor, novel small molecule targeting IRS1/2 and STAT3, important oncogenic drivers and major drug resistance pathways in many hard-to-treat cancers.
The CM24 patent application, titled “Humanized antibodies against CEACAM1,” covers the humanized antibodies capable of specific binding to human CEACAM1 molecules, pharmaceutical compositions and methods of their use in treating and diagnosing cancer and other conditions. This is the foundational patent within the current CM24 patent portfolio, and was previously granted in the U.S., EU and multiple rest of world countries.
The NT219 patent application, titled “Combinations of IRS/STAT3 Dual Modulators and Anti-Cancer Agents for Treating Cancer,” covers the various combinations of NT219 with multiple EGFR inhibitors, including cetuximab, which was selected to be combined with NT219 for the treatment of recurrent or metastatic squamous cell carcinoma of head and neck cancer (SCCHN) as part of Kitov’s planned Phase 1/2 study.
“In recent years, China has experienced a rapid increase in the incidences of and deaths from cancer, thus escalating the need for safe and effective oncology drugs in the country,” said Isaac Israel, Kitov’s Chief Executive Officer. “As such, China represents a key target market for Kitov and an opportunity for potential collaboration partners. We believe that our growing intellectual property portfolio in China is critical in supporting our goal of establishing a potential market for CM24 and NT219, if approved, in this large territory.”
Kitov is currently advancing preparations to initiate a Phase 1/2 clinical trial of CM24 in combination with nivolumab (Opdivo®) in patients with non-small cell lung cancer, and in combination with nivolumab in addition to nab-paclitaxel (ABRAXANE®) in patients with pancreatic cancer. The trial will be conducted under a clinical collaboration agreement with Bristol-Myers Squibb Company, and is expected to begin in the second half of 2020.
A Phase 1/2 trial evaluating NT219 as monotherapy treatment of advanced solid tumors, as well as in combination with cetuximab for the treatment of recurrent and/or metastatic SCCHN or colorectal adenocarcinoma was recently initiated. Preliminary data from part one of the study, which will encompass a dose escalation evaluation of NT219 monotherapy administered weekly in patients with refractory advanced solid tumors, is expected in the second half of 2021.
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 as a monotherapy treatment of advanced solid tumors and in combination with cetuximab for the treatment of recurrent or metastatic squamous cell carcinoma of head and neck cancer (SCCHN) in a recently initiated 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 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 that was approved by the FDA for marketing in the U.S. Consensi™ is being sold in the U.S. by Burke Therapeutics, the marketing partner of Kitov’s U.S. distributor, 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.