Purple Biotech Reaches Recommended Phase 2 Dose for NT219
February 01 2024 - 7:30AM
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 has determined 100mg/kg is the
recommended Phase 2 dose (RP2D) for NT219 in combination with
cetuximab in the treatment of head and neck cancer based on its
Phase 1/2 dose escalation study (NCT04474470). NT219 is a
first-in-class small molecule dual inhibitor of IRS1/2 and STAT3.
The RP2D was determined based on data from the open-label dose
escalation study designed to assess the safety, pharmacokinetics,
pharmacodynamics and efficacy of NT219 in combination with Erbitux®
(cetuximab), in previously treated recurrent and/or metastatic
(R/M) squamous cell carcinoma of the head and neck (SCCHN)
patients. The Company recently reported that NT219, in combination
with cetuximab, demonstrated a dose dependent anti-tumor activity
with confirmed partial responses. No dose-limiting toxicities were
reported. The additional supporting data used for this
determination was pharmacokinetics of NT219 across all dose levels.
Further dose optimization is planned for future studies.
The Phase 1 dose escalation study is being concluded and the
remaining patients' data are expected to be reported during the
first half of 2024. The Company is now advancing its upcoming Phase
2 Proof of Concept study of NT219 for the treatment of R/M
SCCHN.
Detailed clinical results from the dose escalation portion of
the study are intended to be presented at the European Society of
Medical Oncology Targeted Anticancer Therapies (ESMO TAT) Congress
2024 in Paris on February 26, 2024, in an Oral Presentation titled
“Interim results of a Phase 1/2 trial of NT219 in combination with
cetuximab in patients with advanced/metastatic Squamous Cell
Carcinoma of the Head and Neck (SCCHN).”
“This is a major milestone for the development of NT219 for an
indication in need of more effective therapies. As we progress into
a Phase 2 study, our goal is to establish NT219 as standard of care
for squamous cell carcinoma of the head and neck for patients who
have not responded to first line treatments,” stated Gil Efron,
Chief Executive Officer of Purple Biotech. “We look forward to
treating more patients with NT219 in a Phase 2 study.”
About NT219NT219 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
signalling pathways that play a key role in the tumor and its
microenvironment. IRS1/2 acts as scaffolds, organizing signalling
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 FhimaChief Financial
OfficerIR@purple-biotech.com
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