Purple Biotech Identifies Potential New Serum Biomarker for its Lead Oncology Therapeutic Candidate CM24: Associated with 79% Reduction in Risk of Death
Purple Biotech has identified serum CEACAM1 as a potential new blood biomarker for its lead oncology candidate CM24. Pancreatic cancer patients with serum CEACAM1 levels between 6K-15K pg/mL showed significantly improved outcomes when treated with CM24 and nivolumab combined with chemotherapy. The treatment demonstrated a 79% reduction in death risk, improving median overall survival from 3.6 to 8.7 months, and progression-free survival to 4.6 months. CM24, a CEACAM1 inhibitor, is currently in Phase 2 trials with topline results expected in Q4 2024.
Purple Biotech ha identificato il CEACAM1 sierico come un potenziale nuovo biomarker nel sangue per il suo principale candidato oncologico CM24. I pazienti affetti da cancro al pancreas con livelli di CEACAM1 sierico compresi tra 6K-15K pg/mL hanno mostrato risultati significativamente migliorati quando trattati con CM24 e nivolumab in combinazione con la chemioterapia. Il trattamento ha dimostrato una riduzione del 79% del rischio di morte, migliorando la sopravvivenza globale mediana da 3,6 a 8,7 mesi e la sopravvivenza libera da progressione a 4,6 mesi. CM24, un inibitore del CEACAM1, è attualmente in fase 2 di sperimentazione, con risultati preliminari previsti per il quarto trimestre del 2024.
Purple Biotech ha identificado el CEACAM1 en suero como un nuevo biomarcador potencial en sangre para su principal candidato oncológico CM24. Los pacientes con cáncer de páncreas con niveles de CEACAM1 en suero entre 6K-15K pg/mL mostraron resultados significativamente mejorados cuando fueron tratados con CM24 y nivolumab combinado con quimioterapia. El tratamiento demostró una reducción del 79% en el riesgo de muerte, mejorando la supervivencia global media de 3.6 a 8.7 meses, y la supervivencia libre de progresión a 4.6 meses. CM24, un inhibidor de CEACAM1, se encuentra actualmente en ensayos de fase 2, con resultados preliminares esperados para el cuarto trimestre de 2024.
퍼플 바이오텍은 혈중 바이오마커로서 세럼 CEACAM1을 주요 종양학 후보인 CM24의 잠재적 새로운 생체지표로 확인했습니다. 췌장암 환자의 세럼 CEACAM1 수치가 6K-15K pg/mL일 때, CM24와 화학요법과 함께 nivolumab으로 치료받았을 때 유의미하게 개선된 결과를 나타냈습니다. 이 치료는 사망 위험을 79% 감소시켰으며, 전체 생존 기간의 중위치가 3.6개월에서 8.7개월로 향상되었고, 무진행 생존 기간은 4.6개월로 증가했습니다. CEACAM1 억제제인 CM24는 현재 2상 시험 중이며, 주요 결과는 2024년 4분기에 발표될 예정입니다.
Purple Biotech a identifié le CEACAM1 sérique comme un nouveau biomarqueur sanguin potentiel pour son principal candidat en oncologie, le CM24. Les patients atteints de cancer du pancréas avec des niveaux de CEACAM1 sériques compris entre 6K et 15K pg/mL ont montré des résultats significativement améliorés lorsqu'ils ont été traités avec le CM24 et le nivolumab associés à une chimiothérapie. Le traitement a démontré une réduction de 79% du risque de décès, améliorant la survie globale médiane de 3,6 à 8,7 mois, et la survie sans progression à 4,6 mois. Le CM24, un inhibiteur de CEACAM1, est actuellement en phase 2 d'essais, avec des résultats préliminaires attendus au quatrième trimestre 2024.
Purple Biotech hat das Serum CEACAM1 als einen potenziell neuen Blutbiomarker für seinen führenden onkologischen Kandidaten CM24 identifiziert. Pankreaskrebs-Patienten, die Serum-CEACAM1-Werte zwischen 6K-15K pg/mL aufwiesen, zeigten signifikant verbesserte Ergebnisse, als sie mit CM24 und Nivolumab in Kombination mit Chemotherapie behandelt wurden. Die Behandlung zeigte eine 79%ige Reduktion des Sterberisikos, was die mediane Gesamtüberlebenszeit von 3,6 auf 8,7 Monate verbesserte und die progressionsfreie Überlebenszeit auf 4,6 Monate erhöhte. CM24, ein CEACAM1-Inhibitor, befindet sich derzeit in der Phase 2 der klinischen Studien, deren Ergebnisse für das vierte Quartal 2024 erwartet werden.
- 79% reduction in risk of death for patients with specific CEACAM1 levels
- Median overall survival improved from 3.6 to 8.7 months
- Progression-free survival reached 4.6 months (HR < 0.1, P = 0.003)
- Identification of new biomarker for patient selection could improve treatment targeting
- None.
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The identification of serum CEACAM1 as a biomarker for CM24 treatment represents a significant advancement in precision oncology. The data showing a
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Patients with serum CEACAM1 within a defined range prior to treatment demonstrated increased overall survival (OS) and progression free survival (PFS) when treated with CM24
Definition of serum biomarkers for patient selection offers a substantial advantage in developing treatments for cancer
CM24, a CEACAM1 inhibitor, is currently being evaluated in a Phase 2 randomized pancreatic cancer study, with topline results expected in Q4 of 2024
REHOVOT, Israel, Nov. 04, 2024 (GLOBE NEWSWIRE) -- 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 identified serum CEACAM1 as an additional new potential blood biomarker that may help determine which metastatic pancreatic ductal adenocarcinoma (PDAC) patients are most likely to benefit from treatment with CM24. CM24 is a humanized monoclonal antibody that blocks CEACAM1 binding thereby inhibits its activity. CEACAM1 is overexpressed on certain tumor cells, immune cells, and neutrophils extracellular traps (NETs).
PDAC patients who had pretreatment serum CEACAM1 levels between 6K and 15K pg/mL demonstrated the best outcomes following treatment with CM24 and nivolumab in combination with irinotecan/fluoropyrimidine based chemotherapy compared to chemotherapy control, with respect to both progression free survival (PFS) (median = 4.6 months, hazard ratio [HR] < 0.1, P = 0.003) and overall survival (OS) with an
Purple Biotech’s randomized Phase 2 study of CM24 in the second line treatment of PDAC has previously identified multiple potential biomarkers including another serum-based marker, myeloperoxidase (MPO), and tumor markers.
“As we look ahead to topline Phase 2 results before the end of the year and anticipate advancing CM24 into further clinical development, the identification of an additional serum biomarker for patient selection is a critical advantage for our future CM24 study and more importantly, potentially for cancer patients in need of better outcomes, particularly for pancreatic cancer,” said Gil Efron, Purple Biotech CEO.
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/.
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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, performance or achievements. 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.
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