Full Press Release Details
Pharma Presents Newly Released Data for NT-219 in Reversing Pancreatic Cancer Drug Resistance
AVIV, Israel, Sept. 09, 2019 (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, presented newly released proof-of-concept
data showing evidence of NT-219 mechanism of action in reversing cancer drug resistance in PDX models. The data
was presented in a poster at the American Association for Cancer Research's (AACR) Pancreatic Cancer: Advances in Science and
Clinical Care conference in Boston on September 8, 2019.
is a first-in-class small molecule bi-specific inhibitor of two key cancer resistance pathways STAT3 and IRS1/2. As previously
disclosed, the preclinical study initially evaluated the efficacy of NT-219 in combination with the approved chemotherapy agent
gemcitabine on four PDX models of mutated KRAS pancreatic cancer. Data demonstrated reversal of gemcitabine-resistant tumors in
all PDX models following treatment with NT-219 and gemcitabine. One of these models demonstrated complete response in about half
of the animal group upon addition of NT-219 to gemcitabine. The study was then extended to define an optimal dose regimen and
future clinical protocol.
released data from the NT-219 poster showed:
and IRS play an important role in KRAS-induced pancreatic tumorigenesis and drug resistance. Demonstrating efficacy of NT-219
in pancreatic cancer models is in line with previous results in other cancer types. We believe that targeting IRS and STAT3 may
be a tumor-agnostic solution to combat resistance to multiple oncology drugs," said Hadas Reuveni, PhD, VP Research and Development
of Kitov. "NT-219 is a first-in-class small molecule which suppresses both targets using a unique mechanism of action, and
is crucial for overcoming cancer drug resistance."
are encouraged by the results of the study which demonstrate the potential of NT-219 to reverse resistance to oncology therapies
in a wide range of PDX models. We plan to clinically explore its efficacy in multiple hard-to-treat oncology indications including
squamous cell carcinoma of the head and neck in a planned clinical study to be launched soon. We are also exploring its potential
in pancreatic cancer," said Isaac Israel, CEO of Kitov. "Resistance to chemotherapy and targeted therapies is a major
problem facing oncology patients. Kitov is now strategically focused on developing first-in-class oncology therapies, including
such which are targeted to overcome drug resistance and tumor immune evasion, and to ultimately provide patients long-lasting
treatment alternatives."
plans to submit an Investigational New Drug Application (IND) to the U.S Food and Drug Authority (FDA) for a clinical study on
NT-219 in combination with cetuximab in patients with recurrent or metastatic squamous cell carcinoma of the head and neck before
the end of 2019, and to initiate the trial immediately following FDA's clearance.
poster is available on the "Investor Relations" section on the Kitov website: http://kitovpharma.investorroom.com/index.php?s=151
Pharma (Kitov Pharma Ltd.; NASDAQ/TASE: KTOV) is a clinical-stage company 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, 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). Kitov is also under
contract to acquire 100% of FameWave Ltd. which owns CM-24, a monoclonal antibody blocking CEACAM1, a novel immune checkpoint
that supports tumor immune evasion and survival through multiple pathways. Kitov will advance CM-24 as a combination therapy
with anti-PD1 checkpoint inhibitors for the treatment of non-small cell lung cancer (NSCLC). Following the receipt of the
approval of Kitov's shareholders for the acquisition of FameWave, and the finalization of a clinical collaboration
agreement between FameWave and Bristol Myers Squibb (NYSE:BMY) for their planned Phase 1/2 clinical trials to evaluate the
combination of CM-24 with the PD-1 inhibitor nivolumab (Opdivo ), the acquisition is expected to close during the third
quarter of 2019, subject to fulfillment of certain additional closing conditions. Consensi, a fixed-dose combination of
celecoxib and amlodipine besylate, for the simultaneous treatment of osteoarthritis pain and hypertension was approved by the
FDA for marketing in the U.S in May 2018 and is expected to be launched in the U.S. at the end of 2019 by its partner Coeptis
Pharmaceuticals. Kitov has also partnered to commercialize Consensi in China and South Korea.
company is headquartered in Tel Aviv, Israel. For more information, please visit http://www.kitovpharma.com.
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 manner in which the parties to
the transaction for the acquisition of FameWave by Kitov plan to effect the transaction; the expected benefits, synergies and
costs of the transaction; management plans relating to the transaction; the expected timing of the completion of the transaction;
the parties' ability to complete the transaction considering the various closing conditions; the plans, strategies and objectives
of management for future operations; product development for NT219 and CM-24; the potential future financial impact of the transaction;
and any assumptions underlying any of the foregoing; the process by which early stage products such as CM-24 could potentially
lead to an approved 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, 2018 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 SEC, which are available on the SEC's website, http://www.sec.gov
Deputy CEO & Chief Financial Officer
+972-3-933-3121 ext. #105
Darren Opland, Ph.D.