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REHOVOT, Israel, Feb. 01, 2024 (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 it has determined 100mg/kg is the recommended Phase 2 dose (RP2D) for NT219 in combination with cetuximab in the treatment of head and neck cancer based on its Phase 1/2 dose escalation study (NCT04474470). NT219 is a first-in-class small molecule dual inhibitor of IRS1/2 and STAT3. The RP2D was determined based on data from the open-label dose escalation study designed to assess the safety, pharmacokinetics, pharmacodynamics and efficacy of NT219 in combination with Erbitux® (cetuximab), in previously treated recurrent and/or metastatic (R/M) squamous cell carcinoma of the head and neck (SCCHN) patients. The Company recently reported that NT219, in combination with cetuximab, demonstrated a dose dependent anti-tumor activity with confirmed partial responses. No dose-limiting toxicities were reported. The additional supporting data used for this determination was pharmacokinetics of NT219 across all dose levels. Further dose optimization is planned for future studies. The Phase 1 dose escalation study is being concluded and the remaining patients' data are expected to be reported during the first half of 2024. The Company is now advancing its upcoming Phase 2 Proof of Concept study of NT219 for the treatment of R/M SCCHN. Detailed clinical results from the dose escalation portion of the study are intended to be presented at the European Society of Medical Oncology Targeted Anticancer Therapies (ESMO TAT) Congress 2024 in Paris on February 26, 2024, in an Oral Presentation titled “Interim results of a Phase 1/2 trial of NT219 in combination with cetuximab in patients with advanced/metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN).” “This is a major milestone for the development of NT219 for an indication in need of more effective therapies. As we progress into a Phase 2 study, our goal is to establish NT219 as standard of care for squamous cell carcinoma of the head and neck for patients who have not responded to first line treatments,” stated Gil Efron, Chief Executive Officer of Purple Biotech. “We look forward to treating more patients with NT219 in a Phase 2 study.” About NT219 NT219 is a first-in-class, small molecule that promotes Insulin Receptor Substrates 1/2 (IRS) degradation and inhibits Signal Transducer and Activator of Transcription 3 (STAT3) phosphorylation, two major complementary signalling pathways that play a key role in the tumor and its microenvironment. IRS1/2 acts as scaffolds, organizing signalling complexes that mediate mitogenic, metastatic, angiogenic, and anti-apoptotic signals from IGF1R and other oncogenes, consisting of an important driver in multiple cancers and is highly involved in triggering drug resistance. STAT3 is a transcription factor that is broadly hyperactivated in many cancers, promoting proliferation, survival, angiogenesis, metastasis, and tumor immune evasion. Feedback activation of STAT3 plays a prominent role in mediating drug resistance to various anti-cancer therapies. As an inhibitor of both IRS1/2 and STAT3, NT219 has the potential to prevent the development of resistance to multiple approved therapies. 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. A phase 2 study of NT219 at its recommended Phase 2 level in combination with cetuximab in patients with recurrent and/or metastatic SCCHN is planned. 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. The Company is advancing a preclinical platform of 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 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 . 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, 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, . CONTACTS: Company Contact: Lior Fhima Chief Financial Officer IR@purple-biotech.com

Data to be presented at World Conference on Lung Cancer ANN ARBOR, Mich., Sept. 7, 2023 /PRNewswire/ -- Strata Oncology, Inc. ("Strata"), a next-generation precision oncology company enabling smarter and earlier cancer treatment, today announced new data showing its proprietary biomarker algorithm, Immunotherapy Response Score (IRS), supports informed clinical decisions for first-line treatment of patients with non-small cell lung cancer (NSCLC) beyond the standard of care biomarker PD-L1 immunohistochemistry (IHC). Strata Oncology announces data supporting utility of IRS score to guide first-line treatment decisions in NSCLC. The data from Kaiser Permanente Northern California — the first of its kind for first-line treatment of patients with NSCLC — will be presented at the 2023 World Conference on Lung Cancer in Singapore on Sunday, September 10, 2023 in the Pathology and Biomarkers – Biomarkers for Immuno-Oncology poster session from 5:30 PM to 7:30 PM SGT. A pre-specified blinded analysis of more than 200 NSCLC patients initially treated with pembrolizumab either alone or in combination with chemotherapy, showed that IRS was significantly associated with time-to-next-treatment (TTNT) independent of therapy type and PD-L1 IHC by tumor proportion score (TPS). Subgroup analysis demonstrated that among patients with PD-L1 High (TPS>=50%), IRS High patients had significantly longer single-agent pembrolizumab TTNT than IRS Low patients, illustrating the opportunity to fill a clear unmet need. "In NSCLC with PD-L1 TPS>=50%, guidelines recommend either pembrolizumab alone or in combination with chemotherapy. IRS can potentially guide treatment selection in this important and frequent clinical scenario," said Kat Kwiatkowski, Ph.D., Strata Oncology SVP, Clinical Development. "Given the significant difference between IRS groups, IRS High status would favor treatment with pembrolizumab alone, whereas IRS Low status would favor combination therapy." IRS has been validated as a pan-solid tumor predictive biomarker for anti-PD-1/PD-L1 checkpoint inhibitor monotherapy benefit in multiple studies, most recently in a publication in Cancer Research Communications, where the clinical utility of IRS beyond standard biomarkers used to guide anti-PD-1/PD-L1 therapy, including tumor mutation burden (TMB), microsatellite instability (MSI) and PD-L1 IHC was shown. This study also demonstrated the clinical utility of IRS as a useful tool to help guide the choice between chemotherapy alone, anti-PD-1/PD-L1 monotherapy, or anti-PD-1/PD-L1 in combination with chemotherapy, across five tumor types where this is a critical treatment decision. "Our Immunotherapy Response Score meets a significant unmet medical need for an integrative diagnostic test that can predict benefit across tumor types, and in this case, specifically help clinicians make informed decisions for first-line treatment of patients with NSCLC," said Scott Tomlins, M.D., Ph.D., Strata Oncology co-founder and Chief Medical Officer. "This new data marks significant progress in the effort to provide clinicians with the ability to make accurate and precise treatment recommendations that patients with NSCLC require." Immunotherapy Response Score is available clinically as part of the Strata SelectTM test, which is covered for Medicare beneficiaries with advanced solid tumors seeking additional treatment. Learn more at About Strata Oncology Strata Oncology, Inc. is a precision oncology company dedicated to delivering the best possible treatment for each patient with cancer. The company combines molecular profiling, real-world data, and a large-scale clinical trial platform to identify and deliver optimal treatments for patients with cancer. For more information visit strataoncology.com. Media Inquiries Rachel Ford Hutman rachel@fordhutmanmedia.com 301.801.5540

Immunotherapy Response Score predicts rwPFS and OS across tumor types Presents opportunity to expand immunotherapy benefit to more patients and optimize use ANN ARBOR, Mich., Feb. 7, 2023 /PRNewswire/ -- Strata Oncology, Inc., a next-generation precision oncology company enabling smarter and earlier cancer treatment, today announced the publication of a new peer-reviewed study validating the clinical utility of the company's proprietary pan-solid tumor predictive biomarker for anti-PD-1/PD-L1 checkpoint inhibitor monotherapy benefit, Immunotherapy Response Score (IRS). The study was published by Communications Medicine, a Nature publication. Strata Oncology developed IRS using treatment data and comprehensive, clinically validated genomic and transcriptomic profiling of tumor tissue from the Strata Trial®, an ongoing observational clinical trial evaluating the impact of molecular profiling for patients with advanced solid tumors. The biomarker algorithm, which was validated in an independent cohort of trial patients, captures the biology of the tumor and its microenvironment by combining tumor mutation burden (TMB) with quantitative expression of PD-L1, PD-1, ADAM12 and TOP2A. "Our Immunotherapy Response Score meets a significant unmet medical need for an integrative diagnostic test that better predicts likelihood of benefit from anti-PD-1/PD-L1 checkpoint inhibitor monotherapy, across solid tumor types," said Scott Tomlins, M.D., Ph.D., Strata Oncology co-founder and Chief Medical Officer. "Current pan-tumor biomarkers for these treatments identify only a fraction of responsive patients, meaning far too many people who could benefit from these therapies are not being identified." Tomlins continued: "Additionally, immunotherapy is now often combined with chemotherapy. Our exploratory data in non-small cell lung cancer indicate that IRS may be a useful tool to help determine which patients can achieve similar benefit without the toxic effects of chemotherapy." Key findings from the study include: IRS predicted real-world progression-free survival and overall survival in anti-PD-1/PD-L1 monotherapy treated patients across tumor types IRS-high status predicted similar duration of benefit as tumor mutational burden (TMB)-high status across tumor types, but identified twice as many patients who may benefit from checkpoint inhibitor treatment as TMB In non-small cell lung cancer (NSCLC) patients who were IRS-high, there was no significant benefit of combination therapy (pembrolizumab + chemotherapy) compared to monotherapy (pembrolizumab) "Immunotherapy has transformed cancer care and now with IRS we have the ability to predict benefit across tumor types," said Dan Rhodes, Ph.D., Strata Oncology co-founder and Chief Executive Officer. "We are excited to put this novel biomarker into the hands of physicians to help them ensure every patient gets their best possible therapy." About Strata Oncology Strata Oncology, Inc. is a precision oncology company dedicated to delivering the best possible treatment for each patient with cancer. The company combines molecular profiling, real-world data, and a large-scale clinical trial platform to identify and deliver optimal treatments for patients with cancer. For more information visit strataoncology.com. Media Inquiries: Rachel Ford Hutman [email protected] +1 (301) 801 5540 SOURCE Strata Oncology, Inc.