This phase Ib trial is the first to emerge from . Half the patients also received the PD-1 inhibitor nivolumab. Varadhachary G, et al. APX005M is currently in Phase 2 clinical development for the treatment of cancers such as pancreatic cancer, esophageal and gastroesophageal junction cancers, melanoma, non-small cell lung cancer, rectal cancer and sarcoma in various combinations with immunotherapy, chemotherapy, radiation therapy or a cancer vaccine. APX005M is currently in Phase 2 clinical development for the treatment of cancers such as pancreatic cancer, esophageal and gastroesophageal junction cancers, melanoma, non-small cell lung cancer, rectal cancer and sarcoma in various combinations with immunotherapy, chemotherapy, radiation therapy or a cancer vaccine. This study is being done to test the safety and effectiveness of combining domvanalimab (AB154), zimberelimab (AB122), and APX005M with pancreatic cancer that has spread to other parts of body. Pancreatic adenocarcinoma is one of the most lethal cancers worldwide with 5-year survival rates of less than 10%, 1 and is predicted to become the second leading cause of cancer-related mortality in the USA by 2030. APX005M and gemcitabine plus nab-paclitaxel, with or without nivolumab, is tolerable in metastatic pancreatic adenocarcinoma and shows clinical activity. CD40 agonist antibodies induce tumor regression in mouse models of pancreatic cancer as a single-agent . Adenocarcinoma of the Pancreas. APX005M is currently in Phase 2 clinical development for the treatment of cancers such as pancreatic cancer, melanoma, esophageal and gastroesophageal junction cancers, non-small cell lung cancer, renal cell carcinoma, sarcomas, and pediatric brain cancer in various combinations with immunotherapy, a cancer vaccine, chemotherapy or radiation . The Cancer Research Institute and Parker Institute for Cancer Immunotherapy Announce First Patients Treated in Pancreatic Cancer Clinical Trial Combining Immunotherapy and Chemotherapy. Show that a custom peptide-based vaccine in combination with imiquiomod, pembrolizumab, and/or sotigalimab (APX005M) is safe. On October 15, the U.S. FDA granted orphan drug designation for APX005M—a CD40 immunomodulator—for the treatment of pancreatic cancer as well as esophageal and gastroesophageal junction cancer. . APX005M is currently in Phase 2 clinical development for the treatment of cancers such as melanoma, non-small cell lung cancer, pancreatic cancer, esophageal and gastroesophageal junction cancers and renal cell carcinoma and pediatric brain cancer in various combinations with immunotherapy, a cancer vaccine, chemotherapy or radiation therapy. APX005M and the Company's . . Please note that this information is not intended to be a . APX005M is a highly potent inducer of innate and adaptive immune effector responses and represents a promising CD40 agonist antibody for induction of an effective anti-tumor immune response with a favorable safety profile. . APX005M is intended to stimulate the body's own immune system so that the immune cells can more effectively invade and destroy the tumor, adding to the benefits of the chemotherapy and radiation therapy. Download Citation | On Jan 1, 2021, Michele Reni published APX005M, a CD40 monoclonal antibody, for patients with pancreatic adenocarcinoma | Find, read and cite all the research you need on . The study evaluated 30 previously untreated patients with metastatic ductal pancreatic adenocarcinoma. Funding A multilevel treatment for pancreatic cancer has been associated with tumor shrinkage, according to a phase Ib study presented at the American Association for Cancer Research's annual meeting. If confirmed in later phase trials, this treatment regimen could replace chemotherapy-only standard of care in this population. Pancreatic cancer remains one of the deadliest malignancies, recording 432242 new deaths in 2018, with 458918 new pancreatic cancer cases reported globally [ 1 ]. The drug combinations are APX005M (from Apexigen) plus nivolumab (brand name Opdivo, from Bristol-Myers Squibb) plus gemcitabine and nab-paclitaxel, . 7,11,34,35 Palliative care plays a critical role in the management of . Combining an agonistic CD40 monoclonal antibody with chemotherapy induces T-cell-dependent tumour regression in mice and improves survival. the poster titled, "gemcitabine and nab-paclitaxel ± nivolumab ± cd40 agonistic monoclonal antibody sotigalimab (apx005m) in participants with untreated metastatic pancreatic adenocarcinoma: phase. Pancreatic Cancer is an online community for sharing information about innovative, science-based treatments for pancreatic cancer. Here we analyzed gene expression data from The Cancer Genome Atlas in melanoma, renal cell carcinoma, and pancreatic adenocarcinoma and . A new combination of immunotherapy and chemotherapy for pancreatic cancer caused tumours to shrink in the majority of evaluable patients - 20 out of 24 as of an interim analysis of the phase 1b trial data. Median follow up is 32.2 weeks. The FOLFIRINOX regimen remains the treatment of choice for patients with pancreatic cancer even as clinical trials exploring potential therapies, including CD40 and CPI-613, offer the possibility of new options for a notoriously difficult-to-treat disease, Davendra P.S. The drug combinations are APX005M+Nivolumab+Gemcitabine+nab-Paclitaxel, or APX005M+Gemcitabine+nab-Paclitaxel. (cohorts A and B and C and D) SECONDARY OBJECTIVES: . APX005M, a CD40 monoclonal antibody, for patients with pancreatic adenocarcinoma Despite progress, chemotherapy yields disappointing results in metastatic pancreatic ductal adenocarcinoma and median overall survival is less than 12 months. The main purposes of this study are to learn how effective the study drug combinations are in treating patients with metastatic pancreatic adenocarcinoma. Another cohort will receive all four drugs. APX005M is currently in Phase 2 clinical development for the treatment of cancers such as pancreatic cancer, melanoma, esophageal and gastroesophageal junction cancers, non-small cell lung cancer, renal cell carcinoma, sarcomas, and pediatric brain cancer in various combinations with immunotherapy, a cancer vaccine, chemotherapy or radiation . The findings are so promising that human clinical trials are . APX005M is currently in Phase 2 clinical development for the treatment of cancers such as pancreatic cancer, esophageal and gastroesophageal junction cancers, melanoma, non-small cell lung cancer, rectal cancer and sarcoma in various combinations with immunotherapy, chemotherapy, radiation therapy or a cancer vaccine. ATLANTA - A new combination of immunotherapy and chemotherapy for pancreatic cancer caused tumors to shrink in the majority of evaluable patients - 20 out of 24 as of an interim analysis of the phase 1b trial data. Each patient will receive gemcitabine and nab-paclitaxel, two chemotherapy drugs that are standard of care. APX005M is a highly potent inducer of innate and adaptive immune effector responses and represents a promising CD40 agonist antibody for induction of an effective anti-tumor immune response with a favorable safety profile. Around 62,210 new cases of pancreatic cancer (PDAC accounts for >90% of pancreatic cancers) were estimated in the United States in 2022, accounting for 49,830 deaths in the same year [ 1 ]. Sohal, MD, MPH, told an audience at the 2019 Gastrointestinal Oncology Conference. as well as an experimental antibody targeting CD40 called APX005M. Those will be tested in combinations with Apexigen's APX005M, a novel monoclonal antibody that targets CD40, and Bristol-Myers Squibb's anti-PD-1 checkpoint inhibitor nivolumab. In this open-label, single-centre (Erasmus Univsersity Medical Center, Rotterdam, Netherlands), single-arm, phase I dose finding study, adult patients with metastatic pancreatic cancer with progressive disease after FOLFIRINOX chemotherapy will receive monocyte-derived DCs loaded with an allogeneic tumour lysate in conjunction with a CD40 agonistic antibody. Pancreatic Cancer Clinical Trials. Study Design Go to Resource links provided by the National Library of Medicine SAN CARLOS, Calif., April 1, 2019 /PRNewswire/ -- Apexigen, Inc., a clinical-stage biopharmaceutical company, today presented new clinical data on. Analyses were performed on dose-limiting toxicity (DLT)-evaluable subjects, defined as receiving 1 dose of APX005M and ≥ 2 doses of gem/NP during Cycle 1 and remaining on study through Cycle 2 Day 1. Squamous Cell Carcinoma of Pancreas. "Agonistic CD40 is a reasonable partner for combination treatment." Methods and analysis. The drug combinations are APX005M+Nivolumab+Gemcitabine+nab-Paclitaxel, or APX005M+Gemcitabine+nab-Paclitaxel. activation in cancer patients 19 Summary of APX005M Profile Fab Fc High affinity binding to CD40L binding . apx005m is currently in phase 2 clinical development for the treatment of cancers such as pancreatic cancer, melanoma, esophageal and gastroesophageal junction cancers, non-small cell lung cancer,. Pancreatic ductal adenocarcinoma (PDAC) is the most common malignancy of the pancreas and is associated with abysmal prognosis. "CD40 activation is a promising pathway to pursue clinically, especially for patients with pancreatic and other cancers that are immune to checkpoint therapy," said Katelyn T. Byrne, PhD, Perelman School of Medicine Abramson Cancer Center, University of Pennsylvania. The drug combinations are APX005M+Nivolumab+Gemcitabine+nab-Paclitaxel, or APX005M+Gemcitabine+nab-Paclitaxel. Demonstrate that developing a custom vaccine for metastatic pancreatic ductal adenocarcinoma (PDA) and colorectal cancer (CRC) patients is feasible. CD40 is expressed on a variety of antigen-presenting cells. View duration . To combat the nation's third deadliest cancer, the . Numerous vaccine strategies for cancer therapy are . patients with previously untreated metastatic pancreatic cancer were treated with standard chemotherapy consisting of gemzar (gemcitabine) and abraxane (nab-paclitaxel) plus apx005m an experimental precision cancer medicine that targets the cd40 to enhance the immune system and half the patients also received the "checkpoint inhibitor" opdivo … Selicrelumab (RO7009789) and sotigalimab (APX005M) monoclonal antibodies are currently under clinical trials in the treatment of different solid tumors (e.g., pancreatic cancer, melanoma, sarcomas . Pancreatic cancer is characterized by a high symptom burden at the time of diagnosis with a short survival expectancy. Supplementary Information The online version contains supplementary material available at 10.1007/s00262-020-02814-2. The latest clinical trials on Pancreatic Cancer. The poster titled, "Gemcitabine and nab-Paclitaxel ± Nivolumab ± CD40 Agonistic Monoclonal Antibody Sotigalimab (APX005M) in Participants with Untreated Metastatic Pancreatic Adenocarcinoma: Phase 2 Final Results", will be presented by Mark O'Hara, M.D., an assistant professor of Medicine, in the division of Hematology-Oncology in the . "APX005M: agonistic monoclonal antibody binds to CD40 on a variety of immune cell types. . Apply to this Phase 1 & 2 clinical trial treating Pancreatic Neoplasms, Squamous Cell Carcinoma of Pancreas, Carcinoma, Adenosquamous, Adenosquamous Carcinoma of the Pancreas, Carcinoma, Adenocarcinomas of the Pancreas, Adenocarcinoma, Carcinoma, Squamous Cell, Malignant Neoplasm of Pancreas. 1 These orphan drug designations are important regulatory milestones for Apexigen in its . Standard chemotherapy remains inadequate in metastatic pancreatic adenocarcinoma. The poster titled, "Gemcitabine and nab-Paclitaxel ± Nivolumab ± CD40 Agonistic Monoclonal Antibody Sotigalimab (APX005M) in Participants with Untreated Metastatic Pancreatic Adenocarcinoma: Phase 2 Final Results", will be presented by Mark O'Hara, M.D., an assistant professor of Medicine, in the division of Hematology-Oncology in the . Herein, we report results from the follow-on, randomized (rand) ph2 trial evaluating gem/NP ± nivo ± APX005M. APX005M is a monoclonal antibody targeting CD40, a co-stimulatory receptor, and is being evaluated in multiple clinical trials in different types of solid tumours. Immunotherapy triggers the body's immune system to fight cancer cells. CD40 agonist antibodies induce tumor regression in mouse models of pancreatic cancer as a single-agent [5] and when combined with ICI [11, 12]. The designation applies to use of the agent for. Results from a phase Ib trial of patients with newly diagnosed metastatic pancreatic cancer, treated with chemotherapy and APX005M—with or without nivolumab—are promising . A novel combination of immunotherapy and chemotherapy shows promise as a first-line option in patients with metastatic pancreatic cancer, according to interim results from a Cancer Research Institute-funded clinical trial that are being revealed today at the 2019 Annual Meeting of the American Association for Cancer Research (AACR19) in Atlanta.. which manufactures APX005M, and Bristol-Myers Squibb . Metastatic Pancreatic Adenocarcinoma Nivolumab APX005M previously untreated metastatic pancreatic adenocarcinoma Gemcitabine nab-Paclitaxel . March 31, 2019. Track the progress of clinical trials, drug applications, pubmed articles, and patent filings. The objective response rates for the two most common standard-of-care regimens—gemcitabine plus nab-paclitaxel and FOLFIRINOX (fluorouracil, leucovorin, irinotecan . apx005m is currently in phase 2 clinical development for the treatment of cancers such as pancreatic cancer, melanoma, esophageal and gastroesophageal junction cancers, non-small cell lung cancer,. We hypothesized that a bimodal treatment approach consisting of dendritic cell (DC) vaccination to prime tumor-specific T cells, and a strategy to reprogram the desmoplastic tumor microenvironment (TME) would be needed to break tolerance to these pancreatic . ATLANTA — The combination of the experimental CD40 antibody APX005M with nivolumab and standard chemotherapy demonstrated a manageable safety profile and promising antitumor activity among . APX005M is currently in Phase 2 clinical development for the treatment of cancers such as pancreatic cancer, melanoma, esophageal and gastroesophageal junction cancers, non-small cell lung cancer, renal cell carcinoma, sarcomas, and pediatric brain cancer in various combinations with immunotherapy, a cancer vaccine, chemotherapy or radiation . FULL STORY. Methods: Pts with untreated mPDAC were rand to 1 of 3 open-label arms: gem/NP . Safety and Efficacy of APX005M With Gemcitabine and Nab-Paclitaxel With or Without Nivolumab in Patients With Previously Untreated Metastatic Pancreatic Adenocarcinoma. This is the same immunomodulator used in the CRI Clinical Accelerator's PRINCE trial , which is exploring new treatments for metastatic pancreatic . (cohorts A and B) II. apx005m is currently in phase 2 clinical development for the treatment of cancers such as pancreatic cancer, melanoma, esophageal and gastroesophageal junction cancers, non-small cell lung cancer, renal cell carcinoma, sarcomas, and pediatric brain cancer in various combinations with immunotherapy, a cancer vaccine, chemotherapy or radiation … Adenocarcinoma is the most common type of exocrine (non-endocrine) pancreatic cancer, accounting for over 90 percent of pancreatic cancer diagnoses. Patients initially diagnosed with locally advanced pancreatic cancer who have undergone chemotherapy then resection and were with no evidence of disease are eligible if metastatic relapse of disease has . Collaboration with Bristol-Myers Squibb, Apexigen will test CD40 antibody APX005M, nivolumab and chemotherapy SAN FRANCISCO - Sept. 20, 2017 - The Parker Institute for Cancer Immunotherapy and the Cancer Research Institute today announced the first patients have begun treatment in a new pancreatic cancer multi-center clinical trial. A new combination of immunotherapy and chemotherapy for pancreatic cancer caused tumors to shrink in the majority of evaluable patients—20 out of 24 as of an interim analysis of the phase 1b . Patients initially diagnosed with locally advanced pancreatic cancer who have undergone chemotherapy then resection and were with no evidence of disease are eligible if metastatic relapse of disease has occurred and if the last . Approximately 60 430 new diagnoses of pancreatic cancer are anticipated in the US in 2021. The Global Pancreatic Cancer Diagnostic Market will register a CAGR of 8.8% by 2027. . . Principal Investigator: Robert H. Vonderheide, MD, DPhil, University of PennsylvaniaThe main purposes of this study are to learn how effective the study drug combinations are in treating patients with metastatic pancreatic adenocarcinoma. Category:Adult Status:Active Displaying all 22 Trial. Apexigen has presented positive Phase Ib clinical trial data of its lead immuno-oncology (I-O) therapeutic, APX005M, in patients with metastatic pancreatic cancer. Compare against other conditions. The early findings provide hope that this strategy involving a CD40 antibody, a checkpoint . In this study, we aimed to evaluate the safety of combining APX005M (sotigalimab) with gemcitabine plus nab-paclitaxel, with and without nivolumab, in patients with . Pancreatic cancer is a highly fatal disease with a 5-year . FGK45, 1C10, 3/23 as Surrogates for APX005M . APX005M is currently in Phase 2 clinical development for the treatment of cancers such as pancreatic cancer, melanoma, esophageal and gastroesophageal junction cancers, non-small cell lung cancer, renal cell carcinoma, sarcomas, and pediatric brain cancer in various combinations with immunotherapy, a cancer vaccine, chemotherapy or radiation . A new combination of immunotherapy and chemotherapy for pancreatic cancer caused tumors to shrink in the majority of evaluable patients -- 20 out of 24 as of an interim analysis of the . In addition to the standard drugs typically prescribed for pancreatic cancer, patients were given a third drug, an "experimental antibody" called APX005M. Pancreatic Cancer Diagnostic Market Size, Status, Growing Demand and Regional Analysis 2027 | IDA . . Apexigen has presented positive Phase Ib clinical trial data of its lead immuno-oncology (I-O) therapeutic, APX005M, in patients with metastatic pancreatic cancer. 4019 Background: Results from a ph1b trial evaluating gem/NP with CD40 agonistic monoclonal antibody APX005M ± nivo demonstrated promising clinical activity in pts with untreated mPDAC (O'Hara 2021). Pancreatic Ductal Adenocarcinoma Model . APX005M is currently in Phase 2 clinical development for the treatment of cancers such as pancreatic cancer, esophageal and gastroesophageal junction cancers, melanoma, non-small cell lung cancer,. Stimulation of CD40 results in inflammation by upregulation of other costimulatory molecules, increased antigen presentation, maturation (licensing) of dendritic cells, and activation of CD8+ T cells. CD40 agonistic monoclonal antibody APX005M (sotigalimab) and chemotherapy, with or without nivolumab, for the treatment of metastatic pancreatic adenocarcinoma: an open . A new study in mice by researchers at Fred Hutchinson Cancer Research Center has found that a specialized type of immunotherapy — even when used without chemotherapy or radiation — can boost survival from pancreatic cancer, a nearly almost-lethal disease, by more than 75 percent. Pancreatic Cancer. And half of the patients in the trial . APX005M is currently in Phase 2 clinical development for the treatment of cancers such as pancreatic cancer, melanoma, esophageal and gastroesophageal junction cancers, non-small cell lung cancer, renal cell carcinoma, sarcomas, and pediatric brain cancer in various combinations with immunotherapy, a cancer vaccine, chemotherapy or radiation . Mark H. O'Hara, MD. ATLANTA — The combination of the experimental CD40 antibody APX005M with nivolumab and standard chemotherapy demonstrated a manageable safety profile and promising antitumor activity among . Get access to cutting edge treatment via DOMVANALIMAB, ZIMBERELIMAB, APX005M, FOLFIRI. This research study involves immunotherapy. Introduction. An Orphan Drug Designation had been granted by the FDA to the CD40 antagonistic monoclonal antibody, APX005M for the treatment esophageal and gastroesophageal junction cancer (GEJ), as well as for the treatment of patients with pancreatic cancer, announced the developer Apexigen, in a press release. APX005M 0.3 mg/kg was selected as the dose for a randomized Phase II study in which the primary endpoint is 1-year overall survival. 1854 Cancer Immunology, Immunotherapy (2021) 70:1853-1865 1 3 single-agent activity when administered either systemi-cally or locally [ 10]. The FDA granted orphan drug designation to APX005M for the treatment of three gastrointestinal cancer types, according to the agent's manufacturer. AB122, and APX005M in Patients With Metastatic Pancreatic Cancer. APX005M is currently in Phase 2 clinical development for the treatment of cancers such as pancreatic cancer, melanoma, esophageal and gastroesophageal junction cancers, non-small cell lung cancer, renal cell carcinoma, sarcomas, and pediatric brain cancer in various combinations with immunotherapy, a cancer vaccine, chemotherapy or radiation . A new combination of immunotherapy and chemotherapy for pancreatic cancer caused tumors to shrink in the majority of evaluable patients. Combining immunotherapy with chemotherapy shrank tumors in 20 out of 24 patients with advanced pancreatic cancer, according to early phase 1b data being unveile (APX005M) for the Treatment of Soft Tissue Sarcoma In October 2020, Apexigen Inc. obtained the US Food and Drug Administration (FDA) grant of orphan drug . Background Pancreatic ductal adenocarcinoma (PDAC) is notoriously resistant to treatment including checkpoint-blockade immunotherapy. Results: N=30 pts dosed; 24 DLT-evaluable (6 per cohort). Mark H. O'Hara, MD, assistant professor of medicine, Hospital of the University of Pennsylvania, discusses the rationale for evaluating APX005M in combination with chemotherapy and nivolumab . This triggers the cellular proliferation and activation of antigen-presenting cells (APCs), and activates B-cells, and effector and memory T-cells. . As of . Based on preclinical studies in KPC mice, this trial was designed so each patient received gemcitabine and nab-paclitaxel weekly (days 1, 8, and 15 of each cycle per . 1 The incidence is rising at a rate of 0.5 % to 1.0% . CD40 agonistic monoclonal antibody APX005M (sotigalimab) and chemotherapy, with or without nivolumab, for the treatment of metastatic pancreatic adenocarcinoma: an open-label, multicentre, phase 1b study Parker Institute for Cancer Immunotherapy, Cancer Research Institute, and Bristol Myers Squibb. APX005M is a monoclonal antibody targeting CD40, a co-stimulatory receptor, and is being evaluated in multiple clinical trials in different types of solid tumours. Apexigen Announces Presentation of Phase 2 Clinical Data on CD40 Antibody, Sotigalimab (APX005M), in Combination Therapy for Metastatic Pancreatic Cancer at the ASCO 2021 Annual Meeting with an emphasis on new immuno-oncology agents that could harness the patient's immune system to combat and eradicate cancer. APX005M is evaluated in several trials, one of them in combination with chemotherapy in pancreatic .

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