Purple Biotech to Present Data for its Lead Oncology Drug CM24 at the AACR Special Conference on Advances in Pancreatic Cancer Research
September 10 2024 - 6:00AM
Purple Biotech Ltd. ("Purple Biotech" or "the Company")
(NASDAQ/TASE: PPBT), a clinical-stage company developing
first-in-class therapies that overcome tumor immune evasion and
drug resistance, today announced it has been selected for a poster
presentation at the American Association for Cancer Research®
(AACR) Special Conference on Advances in Pancreatic Cancer Research
which will be held on September 15-18, 2024, in Boston,
Massachusetts.
Purple Biotech’s poster titled, “Exploratory
biomarker evaluation of the randomized Phase 2 cohort of CM24 in
combination with nivolumab and chemotherapy in advanced/metastatic
pancreatic cancer” will be presented during a poster session on
Tuesday, September 17 from 6:45-9:00 pm ET.
The Company’s Phase 2 study is evaluating CM24 in
combination with Bristol Myers Squibb's PD-1 inhibitor nivolumab
plus standard of care (SoC) chemotherapy in second line pancreatic
ductal adenocarcinoma (PDAC) patients compared to SoC chemotherapy
alone. Sixty-three patients have been enrolled in the randomized
study across 18 centers in the U.S., Spain, and Israel.
Interim data from the Phase 2 study presented in
June at the 2024 American Society of Clinical Oncology (ASCO)
Annual Meeting demonstrated improvement in overall survival (OS),
progression free survival (PFS), objective response rate (ORR) and
all other efficacy endpoints in the CM24+nivolumab+Nal-IRI/5FU/LV
experimental arm as compared with the SoC control arm. Topline data
are expected in the fourth quarter of 2024.
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 CM24, NT219 and IM1240. CM24
is a humanized monoclonal antibody that blocks CEACAM1, that
supports tumor immune evasion and survival through multiple
pathways. CEACAM1 on tumor cells, immune cells and neutrophils
extracellular traps is a novel target for the treatment of multiple
cancer indications. As a proof of concept of these novel 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. NT219 is a dual inhibitor, novel small molecule
that simultaneously targets IRS1/2 and STAT3. A Phase 1 dose
escalation study was concluded as a monotherapy and in combination
with cetuximab in which NT219 demonstrated anti-tumor activity in
combination with cetuximab in second line patients with recurrent
and/or metastatic SCCHN (R/N SCCHN). The Company is advancing
CAPTN-3, a preclinical platform of conditionally-activated
tri-specific antibody that engages both T cells and NK cells to
induce 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, 2023 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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