Kitov Pharma Presents Newly Released Data for NT-219 in Reversing Pancreatic Cancer Drug Resistance
September 09 2019 - 8:30AM
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.
NT-219 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.
Newly released data from the NT-219 poster showed:
- The combination of NT-219 with the targeted therapies
trametinib (MEK inhibitor) or folfirinox (chemotherapy) reversed
tumor resistance to the treatments.
- Administering NT-219 prior to chemotherapy suppressed
activation of two key cancer survival pathways, STAT3 and
IRS. The sequence of administering the therapies had a
remarkable impact on the efficacy of NT-219 in reversing
resistance.
- Gene expression analysis of the tumors in a PDX model of
KRAS mutated pancreatic cancer revealed an average 80% reduction in
IRS1 levels compared to the control group following a single
treatment with NT-219 and gemcitabine combined therapy. Similar
reductions were observed in the expression of STAT3-regulated genes
and the proliferation marker Ki67, confirming NT-219 mechanism of
action.
- A dose-dependent therapeutic effect of NT-219 was demonstrated
on tumor-growth and correlated with NT-219 levels in plasma.
“STAT3 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."
“We 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.”
Kitov 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.
The poster is available on the “Investor
Relations” section on the Kitov
website: http://kitovpharma.investorroom.com/index.php?s=151
About Kitov PharmaKitov 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.The company is headquartered in Tel Aviv,
Israel. For more information, please visit
http://www.kitovpharma.com.
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and are subject to a number of assumptions, involve known and
unknown risks, many of which are beyond our control, as well as
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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
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Investor Contact: Gil Efron Deputy CEO & Chief Financial
Officer IR@kitovpharma.com+972-3-933-3121 ext.
#105
Media Contact:Darren Opland,
Ph.D.darren@lifescipublicrelations.com+1 646 627 8387
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