Purple Biotech Granted New U.S. Patent for NT219 in Combination with EGFR Antibody Therapy, Enhancing Global IP Protection in Major Markets

Rhea-AI Summary

Purple Biotech (NASDAQ/TASE: PPBT) has received a new U.S. patent for NT219 in combination with EGFR antibody therapy for cancer treatment. The patent covers NT219's use with cetuximab (Erbitux) and other EGFR antibodies like panitumumab and necitumumab in treating EGFR therapy-resistant tumors.

NT219, a first-in-class small molecule drug targeting cancer resistance mechanisms, has advanced to Phase 2 clinical trials for second-line patients with recurrent and/or metastatic head and neck cancer. The study will evaluate the drug's effectiveness when combined with standard therapies including cetuximab and pembrolizumab.

The head and neck cancer treatment market is projected to reach $5 billion by 2030. This patent complements Purple Biotech's existing IP portfolio, which includes protection in major markets like Europe, China, and Japan.

Positive

• Secured new U.S. patent strengthening IP protection in major markets
• NT219 advancing to Phase 2 clinical trials
• Targeting $5 billion head and neck cancer market by 2030
• Expanded patent coverage across US, Europe, China, and Japan

Negative

• None.

Insights

Biotechnology Patent Expert

Purple Biotech's new U.S. patent significantly strengthens their intellectual property position for NT219, creating multiple layers of protection for this novel cancer therapy. This patent specifically covers NT219 in combination with EGFR antibodies like cetuximab (Erbitux) for treating resistant cancers - completing a comprehensive IP strategy that now spans all major markets including the U.S., Europe, China, and Japan.

The timing is particularly strategic as NT219 advances into Phase 2 clinical trials in recurrent/metastatic head and neck cancer. This patent complements Purple's existing IP covering NT219 combinations with small molecule EGFR inhibitors, creating a robust protective barrier around various therapeutic applications.

Strong patent protection is important in oncology drug development, as it secures market exclusivity and enhances partnership potential. The specific focus on resistance mechanisms addresses a critical unmet need, as many patients develop resistance to first-line EGFR therapies. By targeting both IRS1/2 degradation and blocking IGF1R/IRS1 and STAT3 pathways, NT219 takes a novel mechanistic approach that differentiates it from existing treatments.

This patent expansion positions Purple Biotech more competitively within the $5 billion head and neck cancer market projected for 2030, providing essential commercial protection should NT219 demonstrate clinical efficacy in ongoing trials.

Oncology Research Analyst

The advancement of NT219 into Phase 2 trials alongside this expanded patent protection represents meaningful clinical progress for Purple Biotech's lead asset. The focus on drug resistance is particularly significant in head and neck cancer, where resistance to EGFR therapies like cetuximab remains a major clinical challenge limiting treatment efficacy.

NT219's dual-targeting mechanism - degrading IRS1/2 while blocking IGF1R/IRS1 and STAT3 survival pathways - addresses fundamental resistance mechanisms that often enable cancer cells to evade treatment. The Phase 2 study design evaluating NT219 in combination with both cetuximab and pembrolizumab is strategically sound, targeting second-line patients with recurrent/metastatic disease where options remain

The head and neck cancer landscape has seen relatively few therapeutic innovations compared to other oncology areas, creating opportunity for novel approaches. Current standard treatments offer modest benefits with considerable toxicity, making resistance-addressing combinations potentially valuable. The market projection of $5 billion by 2030 reflects growing recognition of this unmet need.

From a development perspective, having secured comprehensive patent protection before Phase 2 data readouts enhances Purple Biotech's negotiating position for potential partnerships while providing clear commercialization pathways if clinical outcomes prove positive. This methodical approach to both clinical development and IP strategy demonstrates sound pipeline management for a clinical-stage biotech company.

i

The recent patent granted to Purple Biotech for NT219 in combination with EGFR antibody therapy represents a significant strengthening of their intellectual property position. This patent specifically protects NT219 when used with cetuximab (Erbitux) and other EGFR antibodies in treating patients who have developed resistance to EGFR therapies - a common clinical challenge in oncology. The timing is particularly strategic as NT219 is currently entering Phase 2 clinical trials for head and neck cancer in combination with standard treatments including cetuximab and pembrolizumab. By securing comprehensive geographic protection across major markets (US, Europe, China, Japan), Purple Biotech has established a robust foundation for potential commercialization. NT219's unique mechanism of action - targeting IRS1/2 degradation while blocking IGF1R/IRS1 and STAT3 pathways - provides a novel approach to addressing treatment resistance in cancer. This fits within the growing head and neck cancer treatment market, projected to reach $5 billion by 2030. While clinical efficacy remains to be proven in the ongoing Phase 2 study, this patent complements Purple Biotech's existing IP covering NT219 with small molecule EGFR inhibitors, creating multiple layers of protection that enhance the asset's value and future commercial prospects. For investors, this development reduces intellectual property risk and strengthens Purple Biotech's competitive positioning in oncology drug development.

c

Initial assessment identifies key strengths: 1) Patent completes global IP protection in major markets; 2) Timing aligns with Phase 2 study initiation; 3) Addresses resistance mechanism - critical unmet need; 4) Targets sizable market opportunity. First reflection: Need to clarify clinical significance - patent alone doesn't guarantee efficacy, but protects commercial opportunity if successful. Need deeper examination of resistance mechanisms and why NT219's approach matters clinically. Competition analysis missing - how crowded is the head/neck cancer pipeline? Second reflection: Should temper optimism slightly - Phase 2 is still relatively early stage with significant clinical risk remaining. Patent value ultimately depends on clinical success. Importance of dual-targeting mechanism needs more emphasis - this is the scientific differentiation. Market size mention needs context - what share could NT219 realistically capture? Third reflection: Balanced view achieved but must avoid over-extrapolating from patent news alone. Clinical data remains the ultimate value driver. Rating maintained at positive (1) as enhanced IP protection in conjunction with Phase 2 advancement represents material value enhancement despite remaining clinical risk.

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 therapy.

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 pathways.

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 by 2030.

“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 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:
IR@purple-biotech.com

FAQ

What is the significance of Purple Biotech's (PPBT) new U.S. patent for NT219?

The patent protects NT219's combination with EGFR antibodies for treating cancer patients resistant to EGFR therapies, strengthening Purple Biotech's intellectual property position in major markets.

What phase of clinical trials is PPBT's NT219 drug currently in for head and neck cancer?

NT219 has advanced to Phase 2 clinical trials for second-line patients with recurrent and/or metastatic head and neck cancer.

How large is the market potential for PPBT's head and neck cancer treatment?

The head and neck cancer treatment market is forecast to reach $5 billion by 2030.

Which standard cancer therapies will NT219 be combined with in PPBT's Phase 2 study?

NT219 will be evaluated in combination with cetuximab and pembrolizumab, which are standard-of-care head and neck cancer therapies.