apx005m pancreatic cancer

Sohal, MD, MPH, told an audience at the 2019 Gastrointestinal Oncology Conference. CD40 agonist antibodies induce tumor regression in mouse models of pancreatic cancer as a single-agent [5] and when combined with ICI [11, 12]. 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 . Funding 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. Here we analyzed gene expression data from The Cancer Genome Atlas in melanoma, renal cell carcinoma, and pancreatic adenocarcinoma and . APX005M is evaluated in several trials, one of them in combination with chemotherapy in pancreatic . CD40 is expressed on a variety of antigen-presenting cells. Methods and analysis. The designation applies to use of the agent for. 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,. 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. 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 . Compare against other conditions. View duration . 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 . 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 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. 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 . . 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 This research study involves immunotherapy. Pancreatic Cancer is an online community for sharing information about innovative, science-based treatments for pancreatic cancer. 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. On October 15, the U.S. FDA granted orphan drug designation for APX005Ma CD40 immunomodulatorfor the treatment of pancreatic cancer as well as esophageal and gastroesophageal junction cancer. Adenocarcinoma of the Pancreas. 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 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. Another cohort will receive all four drugs. 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. CD40 agonistic monoclonal antibody APX005M (sotigalimab) and chemotherapy, with or without nivolumab, for the treatment of metastatic pancreatic adenocarcinoma: an open . 1854 Cancer Immunology, Immunotherapy (2021) 70:1853-1865 1 3 single-agent activity when administered either systemi-cally or locally [ 10]. The Cancer Research Institute and Parker Institute for Cancer Immunotherapy Announce First Patients Treated in Pancreatic Cancer Clinical Trial Combining Immunotherapy and Chemotherapy. 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, 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. Metastatic Pancreatic Adenocarcinoma Nivolumab APX005M previously untreated metastatic pancreatic adenocarcinoma Gemcitabine nab-Paclitaxel . FULL STORY. Track the progress of clinical trials, drug applications, pubmed articles, and patent filings. 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 . Category:Adult Status:Active Displaying all 22 Trial. If confirmed in later phase trials, this treatment regimen could replace chemotherapy-only standard of care in this population. Supplementary Information The online version contains supplementary material available at 10.1007/s00262-020-02814-2. 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 . (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 . Results: N=30 pts dosed; 24 DLT-evaluable (6 per cohort). The drug combinations are APX005M+Nivolumab+Gemcitabine+nab-Paclitaxel, or APX005M+Gemcitabine+nab-Paclitaxel. 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. 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 . 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. 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.. 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 . activation in cancer patients 19 Summary of APX005M Profile Fab Fc High affinity binding to CD40L binding . 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. 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. 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 . Get access to cutting edge treatment via DOMVANALIMAB, ZIMBERELIMAB, APX005M, FOLFIRI. (cohorts A and B and C and D) SECONDARY OBJECTIVES: Pancreatic Cancer Clinical Trials. 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 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. . . This is the same immunomodulator used in the CRI Clinical Accelerator's PRINCE trial , which is exploring new treatments for metastatic pancreatic . Median follow up is 32.2 weeks. And half of the patients in the trial . 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 ]. The FDA granted orphan drug designation to APX005M for the treatment of three gastrointestinal cancer types, according to the agent's manufacturer. 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. Each patient will receive gemcitabine and nab-paclitaxel, two chemotherapy drugs that are standard of care. 1 The incidence is rising at a rate of 0.5 % to 1.0% . 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 . . 7,11,34,35 Palliative care plays a critical role in the management of . 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. 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. which manufactures APX005M, and Bristol-Myers Squibb . FGK45, 1C10, 3/23 as Surrogates for APX005M . "Agonistic CD40 is a reasonable partner for combination treatment." Demonstrate that developing a custom vaccine for metastatic pancreatic ductal adenocarcinoma (PDA) and colorectal cancer (CRC) patients is feasible. 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. To combat the nation's third deadliest cancer, the . the poster titled, "gemcitabine and nab-paclitaxel nivolumab cd40 agonistic monoclonal antibody sotigalimab (apx005m) in participants with untreated metastatic pancreatic adenocarcinoma: phase. Pancreatic ductal adenocarcinoma (PDAC) is the most common malignancy of the pancreas and is associated with abysmal prognosis. Numerous vaccine strategies for cancer therapy are . The findings are so promising that human clinical trials are . March 31, 2019. The drug combinations are APX005M+Nivolumab+Gemcitabine+nab-Paclitaxel, or APX005M+Gemcitabine+nab-Paclitaxel. 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. . As of . 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 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,. The drug combinations are APX005M (from Apexigen) plus nivolumab (brand name Opdivo, from Bristol-Myers Squibb) plus gemcitabine and nab-paclitaxel, . Pancreatic Ductal Adenocarcinoma Model . Pancreatic cancer is a highly fatal disease with a 5-year . The main purposes of this study are to learn how effective the study drug combinations are in treating patients with metastatic pancreatic adenocarcinoma. Introduction. 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. Apexigen has presented positive Phase Ib clinical trial data of its lead immuno-oncology (I-O) therapeutic, APX005M, in patients with metastatic pancreatic cancer. Please note that this information is not intended to be a . 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.