Full Press Release Details
Purple Biotech Granted New
U.S. Patent for NT219 in Combination with EGFR Antibody Therapy, Enhancing Global IP Protection in Major Markets
NT219 in combination with
EGFR antibody cetuximab (Erbitux) is currently entering a Phase 2 study for head and neck cancer
REHOVOT, Israel, March
05, 2025 (GLOBE NEWSWIRE) -- Purple Biotech Ltd. ("Purple Biotech" or "the Company") (NASDAQ/TASE: PPBT),
a clinical-stage company developing first-in-class therapies that seek to overcome tumor immune evasion and drug resistance,
announced today that the U.S. Patent and Trademark Office has issued a patent for NT219 used in combination with epidermal growth
factor receptor (EGFR) antibodies for treating cancer patients who have acquired resistance to EGFR therapies. The patent, titled
"Combinations of IRS/STAT3 dual modulators and anti-cancer agents for treating cancer" addresses NT219 in combination
with cetuximab (Erbitux) as well as other EGFR antibodies such as panitumumab (Vectibix) and necitumumab (Portrazza) in treating
tumors resistant to EGFR therapy and in preventing or delaying cancer tumor recurrence following cessation of treatment with an EGFR
Purple Biotech's NT219 is a first-in-class
small molecule drug designed to target key cancer resistance mechanisms by degrading IRS1/2 and blocking IGF1R/IRS1 and STAT3 survival
NT219 recently advanced into a Phase 2 study in
second-line patients with recurrent and/or metastatic head and neck cancer to evaluate the drug in combination with standard-of-care head
and neck cancer therapies, including cetuximab and pembrolizumab. The head and neck cancer treatment market is forecast to reach $5 billion
"This latest U.S. patent completes geographic
patent protection of NT219 used in combination with cetuximab in major markets such as the United States, Europe, China and Japan,"
stated Gil Efron, Purple Biotech CEO. "We believe this additional patent strongly positions us for the potential future commercialization
of our novel NT219 therapy."
Purple Biotech's growing intellectual property
portfolio for NT219 in combination with anti-cancer standard-of-care therapies includes a previously issued U.S. patent that covers the
pharmaceutical combinations of NT219 with small molecule EGFR inhibitors. This patent has also been granted or allowed in major markets.
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 CAPTN-3. CM24 is a humanized monoclonal antibody that blocks CEACAM1, which supports tumor immune evasion and
survival through multiple pathways. CEACAM1 on tumor cells, immune cells and neutrophil extracellular traps is a novel target for the
treatment of multiple cancer indications. As proof of concept of these novel pathways, the Company completed a Phase 2 study for the treatment
of pancreatic ductal adenocarcinoma (PDAC) with CM24 as a combination therapy with the anti-PD-1 checkpoint inhibitor nivolumab and chemotherapy,
demonstrating clear and consistent improvement across all efficacy endpoints and the identification of two potential serum biomarkers.
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 squamous cell carcinoma of the head and neck (R/M SCCHN). The Company is advancing NT219 into
a Phase 2 study in collaboration with the University of Colorado, to treat R/M SCCHN patients in combination with cetuximab or pembrolizumab.
The Company is advancing CAPTN-3, a preclinical platform of conditionally activated tri-specific antibodies, which engage 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, thereby potentially increasing 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 the 5T4 antigen, which is expressed in a variety of solid tumors and is associated 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
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.