Purple Biotech Ltd.("Purple Biotech" or "the Company")
(NASDAQ/TASE: PPBT), a clinical-stage company developing
first-in-class therapies that harness the power of the tumor
microenvironment to overcome tumor immune evasion and drug
resistance, today announced it convened a Scientific Advisory Board
(SAB) focusing the discussions on NT219’s indication in
recurrent/metastatic squamous cell carcinoma of the head and neck
(R/M SCCHN).
“This scientific advisory board of head and neck cancer key
opinion leaders, who are oncologists, researchers, and
investigators, provided us their insights on the therapeutic
landscape of R/M SCCHN treatment and invaluable guidance on
clinical studies for NT219 in combination with cetuximab as a
second/third line treatment and potentially in combination with a
PD1 inhibitor as a first line treatment,” stated Purple Biotech
CEO, Gil Efron. “Their recognition of the critical unmet need in
recurrent and metastatic head and neck cancer provides further
support and momentum to our development program. Now that we have
determined the recommended Phase 2 dose, we are prepared to move to
our next phase of development. We look forward to the head and neck
cancer SAB’s continued guidance and support.”
Head & Neck Cancer SAB Members Include:
Douglas Adkins, MD – Dr. Adkins is a Professor
of Medicine and Director, Head and Neck and Thyroid Medical
Oncology, at the Siteman Cancer Center, Washington University
School of Medicine. He is a nationally recognized expert in head
and neck cancer known for his commitment to advancing patient care
through clinical research. With approximately 350 publications to
his name, Dr. Adkins serves on committees including the National
Cancer Institute: Head and Neck Steering Committee and Focus Group
Member, Metastatic and Recurrent Head and Neck Cancer Task Force
from 2015 to 2021.
Ezra Cohen, MD – Dr. Cohen is a Chief Medical
Officer of oncology of Tempus AI. He was most recently the Chief of
the Division of the Hematology-Oncology and Associate Director of
Translational Science at Moores Cancer Center in San Diego,
California, and Lead Principal Investigator of Purple Biotech’s
Phase 1 /2 dose escalation study of NT219 in the treatment of R/M
SCCHN. Dr. Cohen is a medical oncologist and an internationally
recognized cancer researcher. He cares for patients with all types
of head and neck cancers, including esophageal, thyroid and
salivary gland cancers. As a physician-scientist, Dr. Cohen also
leads a laboratory that studies novel cancer treatments, including
immunotherapy, and has made major contributions in understanding
how targeted cancer therapies work. A frequent speaker at national
and international meetings, he has authored more than 170
peer-reviewed papers and has been the principal investigator of
multiple clinical trials of new drugs for head and neck cancer and
other solid tumors in all phases of development.
Antonio Jimeno, MD, PhD – Dr. Jimeno is a
Professor at the University of Colorado School of Medicine, the
Director of the Head and Neck Cancer (HNC) Program and the
Communicating PI of the Colorado HNC SPORE. Clinically, he has an
active portfolio of trials investigating relevant targets to
modulate immunity and the microenvironment in HNC. Preclinically,
his focus is studying how HNC regulates key immune ligands
deploying humanized models of HNC to investigate susceptibility to
immune modulation and immune evasion mechanisms. Overall, his work
furthers understanding of cancer and microenvironment interactions
and the development of increasingly powerful and complex
models.
Lisa Licitra Francesca Linda, MD – Professor
Licitra is a Scientific Director of CNAO, the Hadrontherapy
facility in Pavia, Italy. Prof. Licitra served as Associate
Professor, Department of Oncology and Hemato-Oncology and Chief of
Head and Neck Cancer Medical Oncology Department at Fondazione
IRCCS Istituto Nazionale dei Tumori, Milano, Italy. She is
Co-founder and member of the European Head and Neck Cancer Society.
Prof. Licitra has authored nearly 400 papers in peer-reviewed
journals, written 20 book chapters, and approximately 150
scientific articles.
Ari Rosenberg, MD - Dr. Rosenberg is Assistant
Professor of Medicine at the University of Chicago and an
oncologist who specializes in using basic, translational, and
clinical research to improve the lives of his patients. As a
clinical investigator, Dr. Rosenberg develops and conducts clinical
trials that incorporate novel tissue and blood-based biomarkers,
and he has a particular focus on novel therapies and
immunotherapeutic strategies, as well as developing multimodality
treatment paradigms to reduce treatment-related toxicity.
About NT219
NT219 is a first-in-class, small molecule that
promotes Insulin Receptor Substrates 1/2 (IRS) degradation and
inhibits Signal Transducer and Activator of Transcription 3 (STAT3)
phosphorylation, two major complementary signaling pathways that
play a key role in the tumor and its microenvironment. IRS1/2 acts
as scaffolds, organizing signaling complexes that mediate
mitogenic, metastatic, angiogenic, and anti-apoptotic signals from
IGF1R and other oncogenes, consisting of an important driver in
multiple cancers and is highly involved in triggering drug
resistance. STAT3 is a transcription factor that is broadly
hyperactivated in many cancers, promoting proliferation, survival,
angiogenesis, metastasis, and tumor immune evasion. Feedback
activation of STAT3 plays a prominent role in mediating drug
resistance to various anti-cancer therapies. As an inhibitor of
both IRS1/2 and STAT3, NT219 has the potential to prevent the
development of resistance to multiple approved therapies.
About Purple Biotech
Purple Biotech Ltd. (NASDAQ/TASE: PPBT) is a
clinical-stage company developing first-in-class therapies that
seek to overcome tumor immune evasion and drug resistance. The
Company's oncology pipeline includes NT219, CM24 and IM1240. NT219
is a dual inhibitor, novel small molecule that simultaneously
targets IRS1/2 and STAT3. A phase 2 study of NT219 at its
recommended Phase 2 level in combination with cetuximab in patients
with recurrent and/or metastatic SCCHN is planned. CM24 is a
humanized monoclonal antibody that blocks CEACAM1, an immune
checkpoint protein that supports tumor immune evasion and survival
through multiple pathways. The Company is advancing CM24 as a
combination therapy with anti-PD-1 checkpoint inhibitors in a Phase
2 study for the treatment of pancreatic ductal adenocarcinoma
(PDAC). The Company has entered into a clinical collaboration
agreement with Bristol Myers Squibb for the Phase 2 clinical trials
to evaluate the combination of CM24 with the PD-1 inhibitor
nivolumab in addition to chemotherapy. The Company is advancing a
preclinical platform of conditionally-activated tri-specific
antibody that engages both T cells and NK cells to mount a strong,
localized immune response within the tumor microenvironment. The
cleavable capping technology confines the compound's therapeutic
activity to the local tumor microenvironment, and thereby
potentially increases the anticipated therapeutic window in
patients. The third arm specifically targets the Tumor Associated
Antigen (TAA). The technology presents a novel mechanism of
action by unleashing both Innate and adaptive immune systems to
mount an optimal anti-tumoral immune response. IM1240 is the first
tri-specific antibody in development that targets 5T4 expressed in
a variety of solid tumors and is correlated with advanced disease,
increased invasiveness and poor clinical outcomes. The Company's
corporate headquarters are located in Rehovot, Israel. For more
information, please visit https://purple-biotech.com/.
Forward-Looking Statements and 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, CM24 and IM1240;
the process by which such early stage therapeutic candidates 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 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 obtained by
competitors; dependence on the effectiveness of our patents and
other protections for innovative products; our ability to obtain,
maintain and defend issued patents; the commencement of any patent
interference or infringement action against our patents, and 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 Annual Report on Form 20-F for the year
ended December 31, 2022 and in our other filings with the U.S.
Securities and Exchange Commission ("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, https://www.sec.gov.
CONTACTS:
Company Contact: Lior Fhima Chief Financial
Officer IR@purple-biotech.com
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