CM24

Purple Biotech's Randomized Phase 2 CM24 Pancreatic Cancer Study Selected as Late-Breaking Abstract Poster Presentation at ASCO 2024 Annual Meeting

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목요일, 4월 25, 2024

REHOVOT, Israel, April 25, 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 that interim results from its randomized, controlled, open label, multicenter Phase 2 study of CM24, a first in class immune checkpoint inhibitor, for the treatment of pancreatic ductal adenocarcinoma (PDAC), have been selected as late-breaking abstract poster presentation at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting which will take place on May 31 – June 4, 2024 in Chicago, Illinois.

Key Points: 
  • The primary endpoint of the study is overall survival (OS), with progression free survival (PFS) and objective response rate (ORR) as secondary endpoints.
  • The study was designed as Bayesian to evaluate the potential benefit of the experimental arm vs SoC and is not powered for hypothesis testing.
  • Approximately 60 patients have been enrolled in the randomized study in 18 centers in the U.S., Spain and Israel.
  • “We are honored to be selected by the ASCO committee with our late breaking abstract poster presentation and are looking forward to presenting our interim results from our randomized Phase 2 CM24 study at the ASCO 2024 annual meeting.” stated Gil Efron, Chief Executive Officer of Purple Biotech.

Purple Biotech Reports Fourth Quarter and Full-Year 2023 Financial Results

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화요일, 3월 5, 2024

REHOVOT, Israel, March 05, 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 financial results for the fourth quarter and full year ended December 31, 2023.

Key Points: 
  • REHOVOT, Israel, March 05, 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 financial results for the fourth quarter and full year ended December 31, 2023.
  • At the American Association for Cancer Research (AACR) Special Conference on pancreatic cancer, Purple Biotech presented new potential PDAC biomarker data for CM24.
  • In February 2023, Purple Biotech acquired a platform of conditionally activated T cell and NK cell engagers that selectively activate immune response within the tumor microenvironment.
  • As of December 31, 2023, Purple Biotech had cash and cash equivalents and short-term deposits of $15.3 million, compared to $31.7 million on December 31, 2022.

Purple Biotech Completes Patient Enrollment in Phase 2 Pancreatic Cancer Trial

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목요일, 12월 14, 2023

REHOVOT, Israel, Dec. 14, 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 it has completed patient enrollment in a Phase 2 study of CM24, a multi-functional immune checkpoint inhibitor, for the treatment of pancreatic ductal adenocarcinoma (PDAC).

Key Points: 
  • “Having completed patient enrollment, we now look forward to reporting overall survival results in 2024.
  • Survival rates in pancreatic cancer are unfortunately very low and with CM24’s novel CEACAM1 target, we believe we may have a positive impact on extending survival,” stated Purple Biotech CEO, Gil Efron.
  • An estimated 60,000 people are diagnosed with pancreatic cancer in the U.S. alone with a 5-year survival rate of only 12%.
  • In patients treated with chemotherapy as a 2nd line treatment, the 5-year survival drops to 3%.

Purple Biotech Reports Third Quarter 2023 Financial Results

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화요일, 11월 21, 2023

REHOVOT, Israel, Nov. 21, 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 financial results for the third quarter and nine months ended September 30, 2023.

Key Points: 
  • REHOVOT, Israel, Nov. 21, 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 financial results for the third quarter and nine months ended September 30, 2023.
  • Recently reported biomarker data demonstrates CM24’s mechanism of action for this important indication in dire need of a more effective drug that prolongs survival,” stated Purple Biotech CEO, Gil Efron.
  • The increase was mainly due to clinical trials expenses in our CM24 study offset by lower CMC costs in 2023.
  • A reconciliation of certain IFRS to non-IFRS financial measures has been provided in the tables included in this press release.

Purple Biotech Reports Potential Biomarker Data Support CM24’s Mechanism of Action

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금요일, 10월 6, 2023

The poster shows that higher pre-treatment levels of tumor infiltrating lymphocytes that express CEACAM1may associated with longer survival in patients treated with CM24 and nivolumab.

Key Points: 
  • The poster shows that higher pre-treatment levels of tumor infiltrating lymphocytes that express CEACAM1may associated with longer survival in patients treated with CM24 and nivolumab.
  • “These encouraging data, demonstrating increased survival of PDAC patients whose biopsies show higher CEACAM1-positive lymphocytes, are consistent with the CM24 Mechanism of Action (MoA) in suppressing the immune evasion and suggest CEACAM1 expressing lymphocytes as a potential biomarker for CM24 therapy” said Purple Biotech VP R&D, Dr. Hadas Reuveni.
  • “NETs and CEACAM1 will continue to be monitored and investigated in our ongoing randomized Phase 2 study of CM24 in pancreatic cancer patients,” stated Purple Biotech CEO, Gil Efron.
  • “We look forward to reporting data from this study in the near term.”

Purple Biotech to Present New CM24 Pancreatic Cancer Biomarker Data at AACR Special Conference on September 28, 2023

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목요일, 9월 21, 2023

REHOVOT, Israel, Sept. 21, 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 it will present a poster titled: “Phase 1 Study of CM24 in Combination with Nivolumab in Patients with Advanced Pancreatic Cancer – Survival, Potential Biomarker and Effect on Neutrophil Extracellular Traps (NETs)” at the American Association for Cancer Research ( AACR ) Special Conference: Pancreatic Cancer, on September 28, 2023 at 4:40 pm ET in Boston.

Key Points: 
  • REHOVOT, Israel, Sept. 21, 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 it will present a poster titled: “Phase 1 Study of CM24 in Combination with Nivolumab in Patients with Advanced Pancreatic Cancer – Survival, Potential Biomarker and Effect on Neutrophil Extracellular Traps (NETs)” at the American Association for Cancer Research ( AACR ) Special Conference: Pancreatic Cancer, on September 28, 2023 at 4:40 pm ET in Boston.
  • New biomarker data presented at the AACR conference will be shared via a press release by Purple Biotech subsequent to the poster presentation.

Purple Biotech Reports Second Quarter 2023 Financial Results

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화요일, 8월 22, 2023

REHOVOT, Israel, Aug. 22, 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 financial results for the second quarter and six months ended June 30, 2023.

Key Points: 
  • REHOVOT, Israel, Aug. 22, 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 financial results for the second quarter and six months ended June 30, 2023.
  • Our financial results in the first half of 2023 represent our clinical trials’ progress with recruitment at a pace faster than expected in our CM24 study.
  • As we reprioritize our objectives from time to time, we have extended our cash runway into the first half of 2025,” stated Purple Biotech CEO, Gil Efron.
  • As of June 30, 2023, Purple Biotech had cash and cash equivalents and short-term deposits of $18.0 million.

Purple Biotech Reports Positive Results of CM24 Dose Escalation in Advanced Pancreatic Cancer Patients

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화요일, 7월 11, 2023

The investigational immunotherapy combination was well tolerated across all dose levels with no recorded Drug Limiting Toxicities (DLTs).

Key Points: 
  • The investigational immunotherapy combination was well tolerated across all dose levels with no recorded Drug Limiting Toxicities (DLTs).
  • Grade 3 adverse events were reported in 6 of the patients and none was considered related to the study drugs.
  • Among the patients who demonstrated a response or disease control from the CM24 + nivolumab treatment, one third line patient has survived for 14.6 months.
  • This randomized Phase 2 study ( NCT04731467 ) is being conducted as part of Purple Biotech's clinical collaboration with Bristol Myers Squibb.

Purple Biotech Reports First Quarter 2023 Financial Results and Provides Business Update

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화요일, 5월 16, 2023

REHOVOT, Israel, May 16, 2023 (GLOBE NEWSWIRE) -- Purple Biotech Ltd. (“Purple Biotech” or “the Company”) (NASDAQ/TASE: PPBT), a clinical-stage company developing first-in-class, effective and durable therapies that harness the power of the tumor microenvironment to overcome tumor immune evasion and drug resistance, today announced financial results for the three months ended March 31, 2023.

Key Points: 
  • The acquisition provides Purple Biotech with a technology platform for tri-specific antibody compounds and offers the potential to further expand to additional targets.
  • On March 16, 2023, Purple Biotech shared new results from exploratory analyses from a Phase 1 dose escalation study that assessed the safety and tolerability of CM24 plus nivolumab ( NCT04731467 ).
  • On April 19, 2023, Purple Biotech announced research findings at the American Association for Cancer Research (AACR) Annual Meeting 2023 in Orlando.
  • Purple Biotech announced on April 25, 2023, the inauguration of its Scientific Advisory Board (SAB).

Purple Biotech Reports Biomarker Data from CM24 Phase 1 Dose Escalation Study

Retrieved on: 
목요일, 3월 16, 2023

REHOVOT, Israel, March 16, 2023 (GLOBE NEWSWIRE) -- Purple Biotech Ltd. ("Purple Biotech", or the "Company") (NASDAQ/TASE: PPBT), a clinical-stage company developing first-in-class, effective and durable therapies that harness the power of the tumor microenvironment (TME) to overcome tumor immune evasion and drug resistance, today provided new results from exploratory analyses conducted as part of a Phase 1 dose escalation study that assessed the safety and tolerability of CM24 plus nivolumab (NCT04731467). The study enrolled 14 patients with advanced cancers including 11 patients with pancreatic adenocarcinoma (PDAC), two patients with colorectal adenocarcinoma (CRC) and one patient with papillary thyroid cancer. The analyses conducted in eight evaluable PDAC patients demonstrate clinically meaningful and durable reductions in serum myeloperoxidase, a biomarker for NETs, following treatment with CM24 plus nivolumab, immediately and 15 days after the first administration. In addition, analyses of tumor samples derived from the evaluable PDAC patients suggest that patient survival may be positively associated with higher levels of CEACAM1+ tumor-infiltrating lymphocytes in the TME. These results, along with additional data from this clinical study, are part of the Company’s effort aimed at identifying and evaluating the potential utility of a biomarker to optimize patient selection and treatment. Further study results on this topic will be presented at an upcoming medical conference.

Key Points: 
  • These results, along with additional data from this clinical study, are part of the Company’s effort aimed at identifying and evaluating the potential utility of a biomarker to optimize patient selection and treatment.
  • The Company is evaluating CM24 in patients with metastatic pancreatic cancer (PDAC) in combination with the PD-1 inhibitor nivolumab and chemotherapy in a randomized Phase 2 study.
  • The primary endpoint of this Phase 2 study is to evaluate preliminary efficacy through overall survival in second-line PDAC.
  • “We look forward to further data that may establish these findings in our ongoing randomized Phase 2 clinical study evaluating CM24 in combination with nivolumab and chemotherapy for treatment of PDAC."