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 the completion and data maturity of its
Phase 1 dose escalation study of CM24, a first-in-class
anti-CEACAM1 monoclonal antibody addressing multiple tumor types.
In the dose escalation part of the study, 11
refractory, pancreatic ductal adenocarcinoma (PDAC) patients whose
cancer progressed following two lines of prior therapies were
treated with CM24 at 10, 15 and 20mg/kg once every two weeks (q2w)
and nivolumab at 480mg once every four weeks (q4w).
The investigational immunotherapy combination
was well tolerated across all dose levels with no recorded Drug
Limiting Toxicities (DLTs). Grade 3 adverse events were reported in
6 of the patients and none was considered related to the study
drugs. No Grade 4 or deaths were reported.
Overall Survival (OS) data across all dose
levels from this study with Purple’s chemo free CM24 in combination
with nivolumab, demonstrated comparable OS rate in comparison to
historical data of third line patients treated with chemotherapy,
which demonstrate an OS median rate in a range of 3 to 4
months1.
Among the patients who demonstrated a response
or disease control from the CM24 + nivolumab treatment, one third
line patient has survived for 14.6 months. The patient had
Microsatellite Stable (MSS) and PDL-1 IHC 2+ and 5% staining,
features not expected to respond to immuno-oncology therapy.
Based on the study’s safety, tolerability,
efficacy, pharmacokinetic and pharmacodynamic data, the recommended
Phase 2 dose of CM24 in combination with nivolumab was determined
to be 20mg/kg. We believe that these encouraging and confirmed
final results provide additional support to the rationale for
conducting the already initiated Phase 2 randomized study of CM24
in combination with nivolumab and standard of care chemotherapy vs.
standard of care chemotherapy alone, in the second line PDAC
setting. This randomized Phase 2 study (NCT04731467) is being
conducted as part of Purple Biotech's clinical collaboration with
Bristol Myers Squibb.
“We are highly encouraged by these latest Phase
1 data and plan to provide further details from this study at an
upcoming medical conference,” said Isaac Israel, Purple Biotech’s
Acting Chief Executive Officer. “As we continue the Phase 2,
which is enrolling as planned across multiple sites in the U.S.,
Europe, and Israel, we expect to share initial Phase 2 data by the
end of 2023 and topline results later in 2024.”
1Efficacy of the third-line chemotherapy in
patients with advanced pancreatic cancer.
Bomi Kim, Jinwoo Ahn, Jae Hyup Jung, Kwangrok
Jung, Jong-Chan Lee, Jin-Hyeok Hwang, and Jaihwan Kim, Journal of
Clinical Oncology 2023 41:4_suppl, 711-711
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. In a Phase 1/2 study of NT219, the
Company is currently advancing it in a dose escalation as a
monotherapy treatment of solid tumors, and in a dose escalation in
combination with cetuximab for the treatment of recurrent and
metastatic squamous cell carcinoma of the head and neck (SCCHN) or
colorectal adenocarcinoma (CRC). These studies will be followed by
an expansion phase of NT219 at its recommended Phase 2 level in
combination with cetuximab in patients with recurrent and
metastatic SCCHN. 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.
IM1240 is a preclinical, 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
third arm specifically targets the Tumor Associated Antigen (TAA)
5T4 that is expressed in a variety of solid tumors and is
correlated with advanced disease, increased invasiveness and poor
clinical outcomes. IM1240 has a cleavable capping technology that
confines the compound's therapeutic activity to the local tumor
microenvironment, and thereby potentially increases the anticipated
therapeutic window in patients. 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,
including (without limitation) our belief and expectation relating
to the survival outcome rates for patients treated with CM24 in
combination with nivolumab and our expected timeline to share data
and topline results from the CM24 dose escalation study, 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.
Company Contact: Lior Fhima Chief Financial
Officer IR@purple-biotech.com
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