CM24 / Merck (MSD), Purple Biotech - LARVOL DELTA

Final analysis of the randomized Phase 2 cohort of CM24 with nivolumab and chemotherapy in pancreatic cancer & potential serum biomarkers (AACR 2025) - P1/2 | "Final data show that adding CM24 and nivolumab to chemotherapy improved all efficacy parameters and had a manageable safety profile. Subgroup analyses demonstrate statistically significant reduction in the risk of OS and PFS, and suggest serum CEACAM1 & NET marker as predictive biomarkers for CM24-based therapy, corresponding with CM24 mechanism of action"

Biomarker • Clinical • P2 data • Oncology • Pancreatic Cancer • Solid Tumor • CEACAM1 • MPO

Purple Biotech Reports Final Data from Phase 2 Study of CM24 in Pancreatic Cancer Patients at AACR 2025 Annual Meeting: Improved Outcomes and Significant Efficacy in Biomarker-Enriched Subgroups (GlobeNewswire) - P1/2 | N=79 | NCT04731467 | "Statistically significant efficacy in biomarker subgroup analyses was observed: 78% reduction in risk of death and 81% reduction in risk of progression or death in defined pretreatment ranges of serum or tumor CEACAM1 subgroup; 61% reduction is risk of death and 72% reduction in risk of progression or death in defined pretreatment ranges of serum CEACAM1 or myeloperoxidase (MPO) subgroup; 90% reduction is risk of death and 81% reduction in risk of progression or death in high tumor CEACAM1 and low PD-L1 combined positive score (CPS) subgroup....The biomarkers identified in the Phase 2 study are planned to be used for patient selection in the next Phase 2b study."

P2 data • Pancreatic Cancer

Purple Biotech Announces Three Posters Accepted for Presentation at the 2025 American Association for Cancer Research Meeting (GlobeNewswire) - "Purple Biotech Ltd...announced upcoming poster presentations including one for CM24 in the treatment of pancreatic cancer, and two for NT219 in the treatment of colorectal and head and neck cancers, at the 2025 American Association for Cancer Research Meeting (2025 AACR), scheduled to take place from April 25th to April 30th in Chicago."

Clinical data • Colorectal Cancer • Pancreatic Cancer • Squamous Cell Carcinoma of Head and Neck

Final analysis of the randomized phase II cohort of CM24 with nivolumab and chemotherapy in pancreatic cancer and potential serum biomarkers (ESMO-TAT 2025) - P1/2 | "Final data show that adding CM24 and nivolumab to chemotherapy improved all efficacy parameters and had a manageable safety profile. Subgroup analyses demonstrate statistically significant reduction in the risk of OS and PFS, and suggest serum CEACAM1 & NET marker as predictive biomarkers for CM24-based therapy, corresponding with CM24 mechanism of action."

Biomarker • Clinical • P2 data • Oncology • Pancreatic Cancer • Solid Tumor • CEACAM1 • MPO

FW-2020-1: A Study of CM24 in Combination with Nivolumab in Adults with Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=79 | Completed | Sponsor: Famewave Ltd. | Active, not recruiting ➔ Completed | Trial completion date: Jan 2025 ➔ Sep 2024

Trial completion • Trial completion date • Colorectal Adenocarcinoma • Colorectal Cancer • Endocrine Cancer • Hepatology • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Pancreatic Adenocarcinoma • Pancreatic Cancer • Solid Tumor • Thyroid Gland Carcinoma • Thyroid Gland Papillary Carcinoma

Purple Biotech Reports Positive Final Results from Randomized Phase 2 Study of CM24 in Second Line Pancreatic Cancer (GlobeNewswire) - P1/2 | N=79 | NCT04731467 | Sponsor: Famewave Ltd. | "Final data demonstrate CM24 in combination with nivolumab and Nal-IRI/5FU/LV chemotherapy clear and consistent improvement across all efficacy endpoints; A biomarker enriched patient population analysis based on pretreatment ranges of serum CEACAM1 demonstrated significant improvement in the treatment arm over the control of 79% reduction in risk of death (HR 0.21, P = 0.04) with median OS improvement of 5.1 months and over 90% reduction in risk of progression or death (HR < 0.1, P = 0.003) with median PFS improvement of 2.9 months and improvement in the treatment arm over the control in ORR of 50% vs. 0%. Phase 2b clinical study is planned in multiple selected indications, potentially targeting patients based on biomarkers."

P2 data • Pancreatic Ductal Adenocarcinoma

Purple Biotech Identifies Potential New Serum Biomarker for its Lead Oncology Therapeutic Candidate CM24: Associated with 79% Reduction in Risk of Death (GlobeNewswire) - P1/2 | N=79 | NCT04731467 | "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 79% reduction in risk of death (HR = 0.21, P = 0.04). The median OS improved from 3.6 months with chemotherapy alone to 8.7 months with the combination....CM24, a CEACAM1 inhibitor, is currently being evaluated in a Phase 2 randomized pancreatic cancer study, with topline results expected in Q4 of 2024."

Biomarker • P2 data • Pancreatic Ductal Adenocarcinoma

Exploratory biomarker evaluation of the randomized Phase 2 cohort of CM24 in combination with nivolumab and chemotherapy in advanced/metastatic pancreatic cancer (AACRPanCa 2024) - P1/2 | "In a Phase 2 study (NCT04731467) 31 patients with advanced/metastatic PDAC progressed after 1st line therapy, were randomized for CM24 (20mg/kg q2wk), nivo (240mg/kg q2wk) and liposomal irinotecan, 5 fluorouracil and leucovorin (Nal-IRI/5FU/LV, q2wk) treatment (experimental arm) vs Nal-IRI/5FU/LV only (control arm). Exploratory biomarker analysis suggests serum MPO as a potential predictive biomarker for CM24-based therapy showing prolonged median OS, PFS and 66% reduction in risk of death vs control in PDAC patients with MPO levels below threshold compared to interim analysis that estimated OS and PFS risk reduction of 26% and 28%, respectively. These findings will be further evaluated in upcoming clinical studies."

Biomarker • Clinical • Combination therapy • Metastases • P2 data • Cardiovascular • Gastrointestinal Cancer • Hematological Disorders • Hepatology • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor • Thrombosis • CEACAM1 • MPO

Purple Biotech Reports Additional Positive Interim Data from its Randomized Phase 2 Study with its Lead Oncology Therapeutic Candidate CM24 (GlobeNewswire) - P1/2 | N=79 | NCT04731467 | Sponsor: Famewave Ltd. | "Improved OS is demonstrated for patients with serum neutrophil extracellular trap (NET) marker myeloperoxidase (MPO) (HR=0.38 and prolongation of 3.3 months in median OS, p value 0.1), similar trend for NET positive tumors....Purple Biotech....today reported new positive biomarker findings for its lead oncology therapeutic candidate CM24. These data were presented yesterday at the American Association for Cancer Research (AACR) Special Conference on Advances in Pancreatic Cancer Research currently ongoing in Boston, in a poster titled, 'Exploratory biomarker evaluation of the randomized Phase 2 cohort of CM24 in combination with nivolumab and chemotherapy in advanced/metastatic pancreatic cancer.''

Biomarker • P2 data • Pancreatic Cancer

Purple Biotech to Present Data for its Lead Oncology Drug CM24 at the AACR Special Conference on Advances in Pancreatic Cancer Research (GlobeNewswire) - "Purple Biotech Ltd...announced it has been selected for a poster presentation at the American Association for Cancer Research (AACR) Special Conference on Advances in Pancreatic Cancer Research which will be held on September 15-18, 2024, in Boston, Massachusetts. Purple Biotech’s poster titled, 'Exploratory biomarker evaluation of the randomized Phase 2 cohort of CM24 in combination with nivolumab and chemotherapy in advanced/metastatic pancreatic cancer' will be presented during a poster session on Tuesday, September 17 from 6:45-9:00 pm ET....Topline data are expected in the fourth quarter of 2024."

P2 data • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Solid Tumor

Purple Biotech Reports Second Quarter 2024 Financial Results and Business Highlights (GlobeNewswire) - "...including more Phase 2 CM24 pancreatic cancer interim data at a medical conference in Sept 2024 and topline results in Q4 2024. Additionally, in the first half of 2025 we expect to have an end of Phase 2 meeting with the U.S. Food and Drug Administration to discuss our plans for pivotal studies with CM24, while we continue to evaluate potential collaborations for our pipeline....Additional interim data expected Q3 2024."

FDA event • P2 data • Pancreatic Adenocarcinoma • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma

Interim results of the randomized phase 2 cohort of study FW-2020-01 assessing the efficacy, safety and pharmacodynamics of CM24 in combination with nivolumab and chemotherapy in advanced/metastatic pancreatic cancer. (ASCO 2024) - P1/2 | "Randomization was either to the experimental groups (EX) receiving CM24 (20mg/kg, q2wk), nivo (240mg/kg, q2wk) with one of the following CH regimens, liposomal irinotecan, 5 fluorouracil and leucovorin (Nal-IRI; q2wk) or gemcitabine/nab-paclitaxel (gem/nab; q1wk x3) or the control groups (C) with one of the CH regimens alone. The interim analysis suggests that the combination of CM24/nivo/Nal-IRI/5FU/LV has a manageable safety profile with a longer PFS supported by higher ORR and DCR. OS Data continues to mature and will be reported once available."

Clinical • Combination therapy • Late-breaking abstract • Metastases • P2 data • PK/PD data • Anemia • Fatigue • Gastrointestinal Cancer • Hematological Disorders • Hepatology • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor • CEACAM1 • CEACAM5

Purple Biotech to Host Virtual KOL Event to Discuss Positive Interim Results from Phase 2 Pancreatic Cancer Study with CM24 on July 11, 2024 (GlobeNewswire) - "Purple Biotech Ltd...announced further details on its virtual key opinion leader (KOL) event on Thursday, July 11, 2024 at 10:30 AM ET. The event will feature Michael Cecchini, MD (Yale School of Medicine) and E. Gabriela Chiorean, MD, FASCO (University of Washington School of Medicine, Fred Hutchinson Cancer Center), who will discuss the positive interim data from the Phase 2 study of CM24, in combination with Bristol Myers Squibb’s immune checkpoint inhibitor nivolumab and standard of care chemotherapy, in second-line metastatic pancreatic ductal adenocarcinoma (PDAC). The event will also focus on data reported at the 2024 ASCO Annual Meeting...Management will discuss Purple Biotech plans for CM24."

P2 data • Gastrointestinal Cancer • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor

Purple Biotech Reports Additional Positive Interim Results from its Randomized Phase 2 Pancreatic Cancer Study with CM24 Regarding a Potential Predictive Biomarker for Overall Survival Benefit (GlobeNewswire) - P1/2 | N=79 | NCT04731467 | Sponsor: Famewave Ltd. | "This interim biomarker analysis comparing the experimental and control arms suggests measured baseline serum MPO as a potential clinical outcome biomarker for CM24-nivolumab therapy. Enhanced MPO levels were measured in >90% of the patients with mean MPO over 6-fold higher than healthy donors. The mean MPO is used as a threshold for evaluating MPO as a potential biomarker. The effect of the CM24-nivolumab therapy in combination with Nal-IRI/5FU/LV is most pronounced among patients with serum MPO levels below the mean MPO and is associated with OS improvement of 3.6 months in median OS of 8.1 months vs. 4.5 months (HR 0.34 (95% CI: 0.099-1.149))....Presentation of the biomarker data is planned at an upcoming medical conference."

Biomarker • P2 data • Gastrointestinal Cancer • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor

Purple Biotech Announces Positive Late-Breaking Interim Randomized Phase 2 Data at ASCO 2024 Demonstrating CM24 Improved Overall Survival and other Efficacy Endpoints in Pancreatic Cancer (GlobeNewswire) - P1/2 | N=79 | NCT04731467 | Sponsor: Famewave Ltd. | "26% reduction in risk of death (HR=0.74) and 28% risk reduction in progression or death (HR=0.72) in previously-treated patients administered with CM24+nivolumab+Nal/IRI/5FU/LV vs. standard-of-care(SoC) based on preliminary interim data; Prolongation of 2.1 months in median overall survival (OS) and 1.9 months in median progression-free survival (PFS) in the CM24+nivolumab+Nal-IRI/5FU/LV regimen vs. standard-of-care; Data supported by higher objective response rate (ORR) (25% vs 7%), disease control rate (DCR) (63% vs 40%), and decrease in CA19-9 level (61% decrease vs. 34% increase)....Topline final data are expected by the end of 2024."

Late-breaking abstract • P2 data • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Solid Tumor

Purple Biotech’s Randomized Phase 2 CM24 Pancreatic Cancer Study Selected as Late-Breaking Abstract Poster Presentation at ASCO 2024 Annual Meeting (GlobeNewswire) - "nterim data suggests reduced risk of progression or death in the CM24/nivolumab plus standard of care Nal-IRI/5FU/LV arm of the study....Purple Biotech...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....'Topline data are expected by the end of this year.'"

Late-breaking abstract • P2 data • Pancreatic Adenocarcinoma • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma

A Study of CM24 in Combination With Nivolumab in Adults With Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=79 | Active, not recruiting | Sponsor: Famewave Ltd. | Trial completion date: Mar 2024 ➔ Jan 2025 | Trial primary completion date: Feb 2024 ➔ Dec 2024

Combination therapy • Metastases • Trial completion date • Trial primary completion date • Colorectal Adenocarcinoma • Colorectal Cancer • Endocrine Cancer • Gastrointestinal Cancer • Hepatology • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Pancreatic Adenocarcinoma • Pancreatic Cancer • Solid Tumor • Thyroid Gland Carcinoma • Thyroid Gland Papillary Carcinoma

Purple Biotech Reports Fourth Quarter and Full-Year 2023 Financial Results (GlobeNewswire) - "CM24 as 2nd Line Treatment for Pancreatic Ductal Adenocarcinoma (PDAC) Data Upcoming...Interim data expected H1 2024 and topline data expected H2 2024; CM24 biomarker data presented at AACR support PDAC indication...The Phase 2 study (NCT04731467) is evaluating CM24 in combination with Bristol Myers Squibb’s nivolumab plus chemotherapy in PDAC patients as a second line treatment as compared to standard of care chemotherapy alone....Research and Development Expenses were $17 million, an increase of $0.7 million, or 4.3%, compared to $16.3 million in 2022. The increase was mainly due to expenses related to the ongoing NT219 and CM24 clinical trials, including chemistry, manufacturing and controls (CMC) expenses."

Commercial • P2 data • Gastrointestinal Cancer • Head and Neck Cancer • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor • Squamous Cell Carcinoma of Head and Neck

A Study of CM24 in Combination With Nivolumab in Adults With Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=79 | Active, not recruiting | Sponsor: Famewave Ltd. | Recruiting ➔ Active, not recruiting

Enrollment closed • Colorectal Adenocarcinoma • Colorectal Cancer • Endocrine Cancer • Gastrointestinal Cancer • Hepatology • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Pancreatic Adenocarcinoma • Pancreatic Cancer • Solid Tumor • Thyroid Gland Carcinoma • Thyroid Gland Papillary Carcinoma

A Study of CM24 in Combination With Nivolumab in Adults With Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=79 | Recruiting | Sponsor: Famewave Ltd.

Combination therapy • Metastases • Trial completion date • Trial primary completion date • Colorectal Adenocarcinoma • Colorectal Cancer • Endocrine Cancer • Gastrointestinal Cancer • Hepatology • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Pancreatic Adenocarcinoma • Pancreatic Cancer • Solid Tumor • Thyroid Gland Carcinoma • Thyroid Gland Papillary Carcinoma

Purple Biotech Completes Patient Enrollment in Phase 2 Pancreatic Cancer Trial (GlobeNewswire) - "Purple Biotech Ltd...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)....The trial was fully enrolled in advance of the anticipated 2024 timeline. An interim analysis of overall survival, the primary endpoint of the study is expected during 1H 2024 and topline analysis is expected in 2H 2024."

Enrollment closed • P2 data • Pancreatic Ductal Adenocarcinoma

Purple Biotech Reports Potential Biomarker Data Support CM24’s Mechanism of Action (GlobeNewswire) - P1/2 | N=79 | NCT04731467 | Sponsor: Famewave Ltd. | "Purple Biotech Ltd...reported new biomarker data for its lead oncology drug, CM24, a first-in-class anti-CEACAM1 monoclonal antibody. Data were presented at the American Association for Cancer Research (AACR) Special Conference: Pancreatic Cancer in Boston in a scientific poster...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. In addition, the poster shows high expression of CEACAM1 on neutrophils and NETs , and enhanced levels of serum NETs in PDAC patients, and demonstrates for the first time that CM24 treatment significantly reduced the level of NET marker in patients’ serum."

Biomarker • P1 data • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor

Purple Biotech to Present New CM24 Pancreatic Cancer Biomarker Data at AACR Special Conference on September 28, 2023 (GlobeNewswire) - "Purple Biotech...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."

Biomarker • P1 data • Pancreatic Cancer

Purple Biotech Reports Positive Results of CM24 Dose Escalation in Advanced Pancreatic Cancer Patients (GlobeNewswire) - P1/2 | N=79 | NCT04731467 | Sponsor: Famewave Ltd. | "Purple Biotech Ltd...announced the completion and data maturity of its Phase 1 dose escalation study of CM24, a first-in-class anti-CEACAM1 monoclonal antibody addressing multiple tumor types....The investigational immunotherapy combination was well tolerated across all dose levels with no recorded Drug Limiting Toxicities (DLTs)....Overall Survival (OS) data across all dose levels from this study with Purple’s chemo free CM24 in combination with nivolumab, demonstrated comparable OS rate in comparison to historical data of third line patients treated with chemotherapy, which demonstrate an OS median rate in a range of 3 to 4 months....'As we continue the Phase 2, which is enrolling as planned across multiple sites in the U.S., Europe, and Israel, we expect to share initial Phase 2 data by the end of 2023 and topline results later in 2024'."

P1 data • P2 data • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor

Purple Biotech Reports Biomarker Data from CM24 Phase 1 Dose Escalation Study (GlobeNewswire) - P1/2 | N=79 | NCT04731467 | Sponsor: Famewave Ltd. | "Purple Biotech Ltd...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 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....Further study results on this topic will be presented at an upcoming medical conference."

Biomarker • P1 data • Colorectal Cancer • Endocrine Cancer • Gastrointestinal Cancer • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor • Thyroid Gland Carcinoma • Thyroid Gland Papillary Carcinoma