Kitov Pharma Ltd. (NASDAQ/TASE: KTOV), an innovative pharmaceutical
company developing first-in-class combination oncology therapies,
today announces a key milestone in the acquisition of FameWave
Ltd., following signature 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, a monoclonal antibody targeting the novel immune checkpoint
carcinoembryonic antigen-related cell adhesion molecule 1 (CEACAM1)
with nivolumab (Opdivo®), a PD-1 inhibitor, in patients with
non-small cell lung cancer (NSCLC).
“We look forward to completing the acquisition
of FameWave and advancing CM-24 studies in the clinic,” said Isaac
Israel, chief executive officer of Kitov. “Our goal is to assess
the innovative combination of CM-24 with Opdivo® In NSCLC patients.
Since we believe CM-24 has great potential as a novel checkpoint
inhibitor to be used in combination therapies to provide new
options to address the significant unmet medical need in
hard-to-treat cancers.”
Preclinical studies have shown a strong
synergetic anti-cancer effect using CM-24 in combination with a
PD-1 antibody. Based on Kitov’s review of the initial Phase I dose
ranging study of CM24 as a single agent, performed by Merck Sharpe
& Dohme, Kitov plans to explore higher doses in order to reach
receptor saturation,.
Kitov isacquiring FameWave, pending completion
of certain additional closing conditions, including approval by the
shareholders of Kitov of the acquisition.
Conference Call and Webcast Information:
The Company will host a conference call Monday,
April 15, 2019, at 8:30 a.m. EDT to discuss the
FameWave acquisition deal and new asset CM-24.
The conference call will be broadcast live and will be available
for replay for 30 days on the Company's website. Please
access the webcast and conference line dial-in at least 15 minutes
ahead of the conference call to register. Conference ID: 13689863;
U.S dial in: 877-705-6003; Israel dial in: 1 809 406
247; International dial in: 201-493-6725.
Webcast: http://public.viavid.com/index.php?id=134109
About CEACAM1 and CM-24
CM-24 is a humanized monoclonal antibody
directed against carcinoembryonic antigen-related cell adhesion
molecule 1 (CEACAM1), an immune checkpoint protein belonging to the
Human CEA (Carcino-Embryonic Antigen) protein family. Evidence has
shown that CEACAM1 is expressed on tumor lymphocytes and is
up-regulated in several cancer types. Preclinical studies have
shown evidence that CM-24 enhances the cytotoxic activity of
tumor-infiltrating lymphocytes (TILs) against various
CEACAM1-positive tumor cell lines. CM-24 is being developed for
multiple oncological indications according to the expression
pattern of its target protein.
As part of the recently announced agreement for
the acquisition of FameWave by Kitov, cCAM BioTherapeutics Ltd., a
wholly owned subsidiary of Merck Sharp and Dohme Corp., known as
“MSD” in Israel, has returned the rights to CM-24 to former
cCAM shareholders and founders of FameWave, following an initial
Phase 1 dose ranging study of CM-24 as single agent.
About Kitov Pharma
Kitov Pharma (Kitov Pharma Ltd.; NASDAQ/TASE:
KTOV) is an innovative pharmaceutical drug development company.
Leveraging deep regulatory and clinical trial expertise, Kitov's
veteran team of healthcare and business professionals maintains a
proven track record in streamlined end-to-end drug development and
approval. Kitov's combination drug, Consensi™, treating
osteoarthritis pain and hypertension simultaneously, was approved
by the FDA for marketing in the U.S and is partnered in the U.S,
China and South Korea. In addition, Kitov’s NT219, is a novel
patented small molecule designed to overcome cancer drug resistance
that is currently in pre-clinical development. By lowering
development risk and cost through fast-track regulatory approval of
novel late-stage therapeutics, Kitov plans to deliver rapid ROI and
long-term potential to investors, while making a meaningful impact
on people's lives. For more information on Kitov, the content of
which is not part of this press release, please
visit http://www.kitovpharma.com.
Forward-Looking Statements and Kitov's
Safe Harbor Statement
Certain statements in this press release are
forward-looking statements within the meaning of the safe harbor
provisions of the Private Securities Litigation Reform Act of 1995
and other applicable securities laws. Forward-looking statements
can be identified by the use of forward-looking 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. Examples
of forward-looking statements include, among others, statements we
make regarding: (i) the therapeutic and commercial potential of
CM-24; (ii) research and development plans related to the CM-24
therapies; (iii) the potential of CM-24 for the treatment of
against various CEACAM1-positive tumor cell lines; (iv) the
potential for the collaboration between Kitov (FameWave) and
Bristol Myers Squibb; and (v) the closing of the transactions
between the shareholders of FameWave and Kitov, which is subject to
closing conditions, including approval of the transactions by Kitov
shareholders. 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, including conditions related to Kitov shareholder
approvals; the plans, strategies and objectives of management for
future operations; product development for 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; the
uncertainty surrounding an investigation by the Israel Securities
Authority into our historical public disclosures and the potential
impact of such investigation on the trading of our securities or on
our clinical, commercial and other business relationships, or on
receiving the regulatory approvals necessary in order to
commercialize our products, 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
For further information, contact: Gil Efron Deputy
CEO & Chief Financial Officer +972-3-933-3121 ext.
#105
IR@kitovpharma.com
Media Inquiries:Darren Opland,
Ph.D.darren@lifescipublicrelations.com+1 646 627 8387
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