Purple Biotech Presents Data of its Phase 1 Head & Neck Cancer of NT219 in combination with Cetuximab at ESMO TAT Congress 2024
February 27 2024 - 7:00AM
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 clinical results from its Phase 1/2
dose escalation study of NT219 in combination with cetuximab in the
treatment of patients with recurrent/metastatic head and neck
cancer (R/M SCCHN).
The data were presented at the European Society of Medical
Oncology Targeted Anticancer Therapies (ESMO TAT) Congress 2024 in
Paris on Monday, February 26, 2024 by Dr. Ari Rosenberg,
Assistant Professor of Medicine at the University of Chicago,
clinical investigator in the study, and member of Purple Biotech’s
Head & Neck Cancer Scientific Advisory Board, 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)”.
The Phase 1/2 dose escalation study (NCT04474470) evaluated
NT219 as a monotherapy in various indications and in combination
with cetuximab in the treatment of R/M SCCHN and colorectal
cancer.
As of cut-off date of January 25, 2024:
- Seventeen patients with R/M SCCHN were enrolled in the
combination arm of NT219 + cetuximab. The median number of prior
lines of therapy was 2 and 94% of the patients received prior
immunotherapy.
- Safety profile was well tolerated and manageable including at
100 mg/kg. Most frequent treatment emergent adverse events (AEs)
were infusion related reactions and nausea, and no
treatment-related Grade 4/5 AEs were observed.
- Pharmacokinetic analysis demonstrated dose dependent increase
in NT219 plasma concentrations.
- Fifteen patients were evaluable for efficacy, 7 of whom were at
the relevant highest dose levels of 50 and 100 mg/kg in which
anti-tumor activity was observed. Out of these 7 patients, 2 had
confirmed partial responses and 3 stable diseases (all patients
with partial response and stable disease have HPV negative
disease), representing a 29% ORR and 71% DCR. Median follow-up
across all dose levels is 9.4 months (95% CI: 3.4-10.0, 8 out
of 15 patients remaining in follow up).
The Company recently reported NT219’s recommended Phase 2 dose
of 100 mg/kg.
“We were encouraged to see anti-tumor activity in HPV negative
patients,” said Dr. Michael Schickler, Purple Biotech’s Head of
Clinical and Regulatory Affairs. “There is an unmet medical need
for patients in second- and third-line R/M SCCHN, most of them
having HPV negative disease, with relatively short survival of less
than nine months. NT219 should continue to be tested to establish
better treatment options for this patient population.”
“These positive data support our path forward for NT219 as we
plan to initiate a Phase 2 study in combination with cetuximab in
head and neck cancer in the first half of 2024,” stated Gil Efron,
Chief Executive Officer of Purple Biotech. “We thank the study
participants, their families, and clinical researchers for
participating in this important study.”
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 1 dose escalation study is being
concluded and a phase 2 study of NT219 at its
recommended Phase 2 dose 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 tribody
platform with its lead tribody 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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