Kitov Pharma Receives Notice of Intention to Grant Two Patents in China Covering Company’s Lead Oncology Assets, CM24 and NT219
Kitov Pharma (NASDAQ/TASE: KTOV) announced the granting of patents for its lead oncology candidates, CM24 and NT219, in China, complementing existing patents in the U.S. and EU. CM24 is a monoclonal antibody targeting CEACAM1, while NT219 is a small molecule addressing drug resistance in cancers. The company plans to initiate a Phase 1/2 clinical trial for CM24 in combination with nivolumab for non-small cell lung cancer and pancreatic cancer in late 2020. A similar trial for NT219 has already begun. Kitov aims to address the rising cancer rates in China through strategic collaboration and a strong patent portfolio.
- Patent grants for CM24 and NT219 enhance Kitov's intellectual property portfolio in key markets (U.S., EU, China).
- Plans for Phase 1/2 trials with CM24 and NT219 could lead to potential market opportunities if successful.
- There is no guarantee of success in clinical trials, which poses a risk to future product approval.
- Dependence on external factors for regulatory approvals may delay commercialization efforts.
Kitov’s patent coverage for CM24 and NT219 now extends to the U.S., EU, China, and multiple ROW countries
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.
Forward-Looking Statements and Kitov's Safe Harbor Statement
Certain statements in this press release that are forward-looking and not statements of historical fact are forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include, but are not limited to, statements that are not statements of historical fact, and may be identified by words such as “believe”, “expect”, “intend”, “plan”, “may”, “should”, “could”, “might”, “seek”, “target”, “will”, “project”, “forecast”, “continue” or “anticipate” or their negatives or variations of these words or other comparable words or by the fact that these statements do not relate strictly to historical matters. You should not place undue reliance on these forward-looking statements, which are not guarantees of future performance. Forward-looking statements reflect our current views, expectations, beliefs or intentions with respect to future events, and are subject to a number of assumptions, involve known and unknown risks, many of which are beyond our control, as well as uncertainties and other factors that may cause our actual results, performance or achievements to be significantly different from any future results, performance or achievements expressed or implied by the forward-looking statements. Important factors that could cause or contribute to such differences include, among others, risks relating to: the plans, strategies and objectives of management for future operations; product development for NT219 and CM-24; the process by which early stage therapeutic candidates such as NT219 and CM-24 could potentially lead to an approved drug product is long and subject to highly significant risks, particularly with respect to a joint development collaboration; the fact that drug development and commercialization involves a lengthy and expensive process with uncertain outcomes; our ability to successfully develop and commercialize our pharmaceutical products; the expense, length, progress and results of any clinical trials; the lack of sufficient funding to finance the clinical trials; the impact of any changes in regulation and legislation that could affect the pharmaceutical industry; the difficulty in receiving the regulatory approvals necessary in order to commercialize our products; the difficulty of predicting actions of the U.S. Food and Drug Administration or any other applicable regulator of pharmaceutical products; the regulatory environment and changes in the health policies and regimes in the countries in which we operate; the uncertainty surrounding the actual market reception to our pharmaceutical products once cleared for marketing in a particular market; the introduction of competing products; patents attained by competitors; dependence on the effectiveness of our patents and other protections for innovative products; our ability to obtain, maintain and defend issued patents with protective claims; the commencement of any patent interference or infringement action; our ability to prevail, obtain a favorable decision or recover damages in any such action; and the exposure to litigation, including patent litigation, and/or regulatory actions, and other factors that are discussed in our in our Annual Report on Form 20-F for the year ended December 31, 2019 and in our other filings with the SEC, including our cautionary discussion of risks and uncertainties under ‘Risk Factors’ in our Registration Statements and Annual Reports. These are factors that we believe could cause our actual results to differ materially from expected results. Other factors besides those we have listed could also adversely affect us. Any forward-looking statement in this press release speaks only as of the date which it is made. We disclaim any intention or obligation to publicly update or revise any forward-looking statement, or other information contained herein, whether as a result of new information, future events or otherwise, except as required by applicable law. You are advised, however, to consult any additional disclosures we make in our reports to the Securities and Exchange Commission (SEC), which are available on the SEC’s website, http://www.sec.gov.
Company Contact:
Gil Efron
Deputy CEO & Chief Financial Officer
+972-3-933-3121 ext. #105
Investor Relations Contact:
Chuck Padala
+1 646-627-8390
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