Full Press Release Details
Pharma Expands Planned NT-219 Clinical Program for Difficult to Treat Cancers
to Evaluate NT-219 as Monotherapy Treatment of Advanced Solid Tumors, as well as in Combination with cetuximab for Treatment of
Recurrent or Metastatic Solid Tumors and Head and Neck Cancer
Details of Planned Phase 1/2 Trial and Preclinical Data Demonstrating Anti-tumor Activity of NT-219 in Poster at 2020 Multidisciplinary
Head and Neck Cancers Symposium
Feb. 24, 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 it will expand the planned
Phase 1/2 clinical trial of NT-219 with cetuximab trial in patients with recurrent or metastatic head and neck cancer, to also
include evaluation of NT-219 as monotherapy treatment in patients with advanced solid tumors. Kitov expects to initiate this
study in the second quarter of 2020, pending clearance of its Investigational New Drug application by the U.S. Food and Drug Administration.
NT-219 is a small molecule dual inhibitor of IRS1/2 and STAT3, pathways associated with treatment resistance.
the planned Phase 1/2 trial will be presented in a poster at the 2020 Multidisciplinary Head and Neck Cancers Symposium, which
is being held in Scottsdale, Arizona, from February 27-29, 2020. The presentation will include details of the Phase 1/2 study,
as well as new preclinical data demonstrating the anti-tumor activity of NT-219 as both a monotherapy and in combination with cetuximab,
an epithelial growth factor receptor (EGFR) blocking monoclonal antibody.
decision to expand our planned clinical study to evaluate NT-219 as monotherapy is based on the significant compelling preclinical
evidence generated in various studies with NT-219, including the data we will be presenting this week," said Isaac Israel,
chief executive officer of Kitov. "The promising preclinical data demonstrate the anti-cancer potential of NT-219,
both as a monotherapy and in combination with cetuximab, anti-PD1 inhibitors and other agents. We expect that the establishment
of standalone safety data and potential efficacy will provide a solid foundation for further evaluation of NT-219 in a number of
different clinical settings. We look forward to advancing NT-219 into the clinic in the second quarter of this year."
study will be an open-label, dose escalation and subsequent expansion phase study. The study will have a dose escalation
component of NT-219 as a single agent; a dose escalation phase of NT-219 in combination with cetuximab; and an expansion phase
of NT-219 at its recommended Phase 2 level in combination with a standard dose of cetuximab. Advanced solid tumors, as well as
recurrent or metastatic squamous cell carcinoma of the head and neck, will be evaluated. Other possible expansion cohorts
will be determined based on the Phase 1 dose escalation and further preclinical data.
The primary objectives
of the study will be to assess plasma pharmacokinetics, safety, tolerability and maximum tolerated dose of NT219 as a single agent,
and in combination with cetuximab. The secondary objectives will be to assess pharmacokinetics and efficacy of different
dose levels of NT219, alone and in combination with cetuximab.
Presentation details are as follows:
Phase 1/2, Open-Label, Dose Escalation Followed by Single-Arm Expansion to Assess the Safety and Efficacy of NT219 in Combination
with Cetuximab in Patients with Recurrent/Metastatic (R/M) Head and Neck Squamous Cell Carcinoma (HNSCC)
Date: February 27-29, 2020
Presentation number: 312
Location: Exhibit Hall
The poster will also be available
for download from February 27, 2020 at: http://kitovpharma.investorroom.com/index.php?s=151
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. CM-24 is 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). Kitov has entered into a clinical collaboration agreement with
Bristol Myers Squibb (NYSE: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.
Forward-Looking Statements and Kitov's
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in this press release that are forward-looking and not statements of historical fact are forward-looking statements within the
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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: different results from the expected benefits, synergies and costs of the acquisition of FameWave
by Kitov; management plans relating to the transaction; 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 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, 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
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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
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