Full Press Release Details
Biotech Fortifies NT219 Patent Protection
patent granted in China for pharmaceutical composition of NT219 expands IP protection
REHOVOT, Israel, Nov. 02, 2023 (GLOBE NEWSWIRE) -- 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 that the China National Intellectual Property Administration ("CNIPA") has granted
a new patent for maintaining a pharmaceutical composition of NT219 in its active form.
new patent protects the method which prevents the conversion of NT219 from its active form to a less active form and supports maintenance
of the active form during manufacturing, storage and handling until administered to the patient.
new patent granted in China (# CN 115466205 B) expands Purple Biotech's patent protection for NT219 in China. The drug was previously
issued patent in China that relates to the combinations of NT219 with various anti-cancer agents.
is being developed for the treatment of head and neck cancer, a large market opportunity in China. Recent data demonstrate NT219's
activity in the treatment of recurrent and metastatic squamous cell carcinoma of the head and neck (SCCHN) in a Phase 1 dose escalation
study in combination with cetuximab. Patients continue to be treated with higher dose for optimization prior to entering a Phase 2 study.
patent protection for NT219's composition is strategic for Purple Biotech and we believe that the grant of this new patent marks
another step forward in our global intellectual property strategy. China is a large and important market opportunity for us, and strengthening
our patent coverage improves our competitive positioning in this territory," stated Purple Biotech CEO, Gil Efron.
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/.
Statements and Safe Harbor Statement
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.
Chief Financial Officer