San Carlos, CA, and New Haven, CT - June 14, 2018 - Apexigen, Inc., and Yale Cancer Center today announced a clinical trial collaboration to evaluate Apexigen's APX005M in combination with cabiralizumab and Opdivo in patients with advanced solid tumors. Secondary objectives include an evaluation of the pharmacokinetic, immune pharmacodynamic and antitumor effects of APX005M. This is a brief summary of a clinical trial, a type of therapeutic research study. APX005M is a humanized IgG1 mAb that binds to CD40. Preclinical data strongly suggest that combination of a CD40 agonistic antibody with an immune checkpoint inhibitor, such as an anti-PD-1, anti-PD-L1 and/or anti-CTLA4 antibody, will result in synergistic anti-tumor efficacy. Herein, we report results from the follow-on, randomized (rand) ph2 trial evaluating gem/NP nivo APX005M. 2022-04-22. APX005M-001 is an open-label study and comprises a dose-escalation portion of approximately 8 dose level cohorts, plus an expansion cohort. The drug combinations are APX005M+Nivolumab+Gemcitabine+nab-Paclitaxel, or APX005M+Gemcitabine+nab-Paclitaxel. Of the 5 subjects with metastatic melanoma, 1 had a confirmed partial response (PR), 2 had prolonged stable disease (SD) (>8 months), and 2 had progressive disease (PD) as the best . The aim of the study is to evaluate the efficacy of APX005M administered at 2 different schedules to adult subjects with unresectable or metastatic melanoma. . For more information on these trials, call AskMDAnderson toll-free at 1-877-632-6789. . . Recruitment is ongoing, with a target enrollment of approximately 32 subjects across 3 centers in the United States. APX005M is a humanized monoclonal antibody designed to stimulate the anti-tumor immune response. SAN CARLOS, Calif., April 1, 2019 /PRNewswire/ -- Apexigen, Inc., a clinical-stage biopharmaceutical company, today presented new clinical data on. Primary Objective To assess the safety and tolerability of APX005M in combination with nivolumab and ipilimumab The hypotheses in this study is, that the CD-40 agonist APX005M with or without radiotherapy, and in combination with platinum-doublet chemotherapy, will provide the necessary immune activation and serve as a basis for increased clinical effect of the combination. Let's stay in touch! . This phase I trial studies the side effects and best dose of APX005M in treating younger patients with primary malignant central nervous system tumor that is growing, spreading, or getting worse (progressive), or newly diagnosed diffuse intrinsic pontine glioma. 1University of Tennessee Health Science Center, Memphis, TN, USA, Memphis, TN . Secondary objectives include an evaluation of the pharmacokinetic, immune pharmacodynamic and antitumor effects of APX005M. In the Phase 1b portion of this clinical trial, APX005M was well tolerated and no dose-limiting toxicities (DLTs) were observed. Clinical trial in progress: A phase 1b trial of talimogene laherparepvec (T-VEC) in combination with dabrafenib and trametinib in advanced melanoma with an activating BRAF mutation. Of the 5 subjects with metastatic melanoma, 1 had a confirmed partial response (PR), 2 had prolonged stable disease (SD) (>8 months), and 2 had progressive disease (PD) as the best . Clinical trials include only patients who choose, or whose parents permit them to take part in the research study. Kenneth Byrd1, Nibedita Chakraborty2, Mehmet Kocak1, Alisa Harber2, Ari Vanderwalde2. The RP2D for APX005M is 0.3 mg/kg. The goal of Part 1 of this clinical research study is to find the highest tolerable dose of APX005M that can be given with pembrolizumab that can be given to patients with metastatic melanoma. APX005M can mediate a direct cytotoxic effect on CD40+ tumor cells. APX005M is a humanized IgG1 antibody generated by Apexigen using its APXiMAB technology consisting of a rabbit hybridoma platform and mutational lineage-guided (MLG) humanization method [ 30 - 32 ]. NCT03123783. Drugs used in chemotherapy, such as doxorubicin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from . APX005M targets CD40, a co-stimulatory receptor that is essential for activating both innate and adaptive immune systems. To determine the maximum tolerated dose and/or the recommended phase II dose of APX005M. "We are excited to dose the first patient in this clinical trial to evaluate the potential of a new treatment approach, combining our CD40 agonist APX005M with Opdivo, a PD-1 immune checkpoint inhibitor," said Xiaodong Yang, M.D., Ph.D., President and CEO of Apexigen. Indications. A phase III clinical trial enrolling 436 patients affected by unresectable injectable melanoma randomized to receive intralesional T-VEC . Contacts: Emerging Medicine 855-216-0098 PennCancerTrials@emergingmed.com Publications: Rahib L, Smith BD, Aizenberg R, Rosenzweig AB, Fleshman JM, Matrisian LM. 8 in progress, 3 open to eligible people . APX005M and gemcitabine plus nab-paclitaxel, with or without nivolumab, is tolerable in metastatic pancreatic adenocarcinoma and shows clinical activity. This phase 1 clinical trial is to study APX005M in children with central nervous system tumors. NCT02482168. To evaluate the safety of CD40 agonistic monoclonal antibody APX005M (APX005M) administered intravenously every 3 weeks to children with central nervous system tumors. Eligible subjects with non-small cell lung cancer or metastatic melanoma will receive intravenous APX005M in combination with nivolumab until disease progression, unacceptable toxicity or death, whichever . Apexigen, Inc. Carcinoma, Non-Small-Cell Lung Carcinoma, Transitional Cell Head and Neck Neoplasms Melanoma Microsatellite Instability Neoplasms. The goal of Part 2 of this study is to learn if the combination can help to control . Ipilimumab is a humanized IgG1 monoclonal antibody directed against CTLA-4. Preclinical data suggest that chemotherapy with agonistic CD40 antibodies can be combined with anti-PD-1 to trigger effective T cell immunity. Recently, for newly diagnosed metastatic pancreatic cancer patients, a result of a phase Ib trial of APX005M and chemotherapy with or without nivolumab reported an ORR of 58% . Conclusions: APX005M + nivo demonstrated a good safety profile and promising antitumor activity in M subjects with PD while receiving anti-PD-1 therapy and potential activity in NSCLC. Phase I Study of APX005M in Pediatric CNS Tumors. SAN CARLOS, CA, August 5, 2021 - Apexigen, Inc., a clinical-stage biopharmaceutical company focused on discovering and developing a new generation of antibody therapeutics for oncology, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to sotigalimab (APX005M) for the treatment of soft tissue . About this Clinical Trial. Monoclonal Antibody APX005M in Pediatric Subjects with Recurrent/Refractory Brain Tumors and Newly Diagnosed Brain Stem Glioma . 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 Multiple clinical trials are being conducted with APX005M alone and in combination with other therapies across several tumor types [28, 29]. We are conducting a multi-center, open label Phase Ib/II clinical trial to evaluate the combination of APX005M with nivo in subjects with M or NSCLC. Additional information on clinical trials for APX005M can be found at www.clinicaltrials.gov. Additional information on clinical trials for APX005M can be found at www.clinicaltrials.gov. This research study involves immunotherapy. APX005M can trigger activation of B cells, monocytes, and dendritic cells and . Background: Checkpoint inhibitors such as anti-PD-1 are ineffective as single agents for patients (pts) with PDAC. Eligible subjects with solid tumors will receive intravenous APX005M every 3 week, every 2 week or every 1 week until disease progression, unacceptable toxicity or death, whichever occurs first. Binding of APX005M to CD40 on antigen presenting cells (i.e., dendritic cells, monocytes and B-cells) is believed to initiate a . Full Title Phase I Study to Evaluate the Safety and Tolerability of the CD40 Agonistic Monoclonal Antibody APX005M in Pediatric Subjects with Recurrent/Refractory Brain Tumors and Newly Diagnosed Brain Stem Glioma (CIRB) Purpose The purpose of this study is to find the highest dose of the investigational immunotherapy drug APX005M that can be given safely in children with brain tumors that . Chemotherapy drugs, such as fluorouracil, leucovorin calcium, and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them . Sponsor. Of the 5 subjects with metastatic melanoma, 1 had a confirmed partial response (PR), 2 had prolonged stable disease (SD) (>8 months), and 2 had progressive disease (PD) as the best . Eli Lilly and Company Phase 1. II. Clinical Trials marked as "Trial now transitioned" were transitioned to the Clinical Trial Regulation 536/2014 and can be further followed in the Clinical Trial Information System Examples: Cancer AND drug name. About Sotigalimab (APX005M) Sotigalimab is a novel, humanized monoclonal antibody that stimulates the anti-tumor immune response. Deciding to Take Part in a Trial. The RP2D for APX005M is 0.3 mg/kg. Indications. Study Design Go to Resource links provided by the National Library of Medicine Description This pilot phase II trial studies the side effects of CD40 agonistic monoclonal antibody APX005M (APX005M), chemotherapy, and radiation therapy, and to see how well they work when given before surgery in treating patients with esophageal cancer or gastroesophageal cancer that can be removed by surgery. In a recently completed clinical trial, APX005M demonstrated robust immune activation and an excellent safety profile. This is a multicenter phase I trial of APX005M in patients with recurrent or refractory primary malignant central nervous system tumor, or newly diagnosed diffuse intrinsic pontine glioma.APX005M is a humanized IgG1 mAb that binds to CD40.APX005M binds to both human and cynomolgus monkey CD40 with high affinity, triggering activation of B cells, monocytes, and dendritic cells and stimulating . A point mutation was introduced in the Fc-domain at position 267 from serine to aspartic acid (S267E mutation). APX005M is a humanized IgG1 agonistic monoclonal antibody that binds CD40. In the Phase 1b portion of this clinical trial, APX005M was well tolerated and no dose-limiting toxicities (DLTs) were observed. Federal Government Programs. About Sotigalimab (APX005M) . To determine the pharmacokinetics of APX005M. III. . "We think this clinical trial offers great hope based on what we have observed in prior studies," said the study's lead investigator, Robert Vonderheide, M.D., DPhil, director of the Abramson Cancer Center of the University of Pennsylvania. Scientific Review. Additional information on clinical trials for APX005M can be found at www.clinicaltrials.gov. The purpose of this clinical trial is to evaluate the safety of doxorubicin, olaratumab and APX005M when used together, and to see if this study treatment is effective for patients with Dedifferentiated liposarcoma, Leiomyosarcoma, and Undifferentiated pleomorphic sarcoma Are you Eligible? 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 . APX005M is evaluated in several trials, one of them in combination with chemotherapy in pancreatic cancer, with encouraging early results (NCT03214250 ) Location . APX005M and the Company's additional preclinical programs were discovered using APXiMABTM . Patient Safety. A randomized phase II . Phase I Study of APX005M in Pediatric CNS Tumors Last Updated: 2022-06-21 Originally Posted: 2017-12-15. The names of the study drugs involved in this study are: - Domvanalimab (also known as . Immunotherapy with APX005M, may induce changes in the body's immune system, and may interfere with the ability of tumor cells to grow and spread. You are being asked to take part in this study because you have metastatic (cancer that has spread) melanoma. Detailed Description: This is a multicenter phase I trial of APX005M in patients with recurrent or refractory primary malignant central nervous system tumor, or newly diagnosed diffuse intrinsic pontine glioma. Evaluar la seguridad de APX005M en sujetos con melanoma no resecable o metastsico, no tratados . National Institutes of Health Clinical Center (CC) . SAN CARLOS, Calif., March 21, 2017 /PRNewswire/ -- Apexigen, Inc., a clinical-stage biopharmaceutical company focusing on discovering and developing antibody-based therapeutics for the treatment of cancer with an emphasis on new Immuno-Oncology (I-O) agents, today announced the initiation of patient enrollment in a Phase 1/2 clinical trial at The University of Texas MD Anderson Cancer Center. APX005M is a type of immunotherapy called a monoclonal antibody which may help treat cancer by strengthening the immune system. In an interim analysis of an ongoing Phase 1b clinical trial, 20 of 24 evaluable patients with metastatic pancreatic cancer demonstrated tumor shrinkage following treatment with APX005M in . Apexigen has presented positive Phase Ib clinical trial data of its lead immuno-oncology (I-O) therapeutic, APX005M, in patients with metastatic pancreatic cancer. 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. All Female Male . The trial is a Phase 1, open-label dose-escalation study of APX005M in adults with solid tumors that is intended to establish the maximum tolerated dose, the pharmacokinetic profile and the . Informed Consent. 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. (n = 12), non-small cell lung cancer (n = 1) and renal cell carcinoma (n = 13), evaluated the safety of the CD40 agonist APX005M (sotigalimab) and CSF1R inhibitor (cabiralizumab) . Open-label, Multicenter, Phase 1b/2 Clinical Study to Evaluate the Safety and Efficacy of CD40 Agonistic Monoclonal Antibody (APX005M) Administered Together With Gemcitabine and Nab-Paclitaxel With or Without PD-1 Blocking Antibody (Nivolumab) in Patients With Previously Untreated Metastatic Pancreatic Adenocarcinoma Subjects who have not received prior immunotherapy will be alternately assigned to 1 of 2 cohorts (2 different APX005M administration schedules) as long as both are open. Apexigen is a clinical-stage biopharmaceutical company discovering and developing a new generation of antibody therapeutics for oncology, with an emphasis on new immuno-oncology agents that could harness the patient's immune system to . This Phase 1/2 clinical trial plans to enroll patients with metastatic melanoma and will evaluate the safety, tolerability and preliminary efficacy of APX005M, administered locally into the tumor . Clinical Study Identifier: s20-01940 Country. 05/01/2015. Clinical Trial. We conducted a multi-center, open label clinical trial to evaluate the combination of APX005M with nivo and standard . Insurance Coverage and Clinical Trials. 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. Abstract. Questions to Ask about Treatment Clinical Trials. The RP2D for APX005M is 0.3 mg/kg. Clinical trial information: NCT02482168. Clinical trial information: NCT02482168. How to Work With Your Health Insurance Plan. Immunotherapy triggers the body's immune system to fight cancer cells. The goal of Part 2 of this study is to learn if the combination . About Apexigen. About Apexigen. The study drug APX005M is investigational, which means that it has not been approved by the U.S Food and Drug Administration (FDA), the health authority that gives approval for new medicines to be prescribed in the United States, but the FDA has given its permission to test this agent in the current trial. Apexigen is a clinical-stage biopharmaceutical company discovering and developing a new generation of antibody therapeutics for oncology, with an emphasis on new immuno-oncology agents that could harness the patient's immune system to . Official Title. APX005M and gemcitabine plus nab-paclitaxel, with or without nivolumab, is tolerable in metastatic pancreatic adenocarcinoma and shows clinical activity. SECONDARY OBJECTIVE: I. 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). ClinicalTrials.gov Identifier: NCT03214250, UPCC 11217 . [email protected] 28 Argonaut, Suite 150 Aliso Viejo, CA 92656 Phone: (+1) 949-248-RARE (7273) The RP2D for APX005M is 0.3 mg/kg. The RP2D for APX005M is 0.3 mg/kg. This study is a Phase 1-2 open-label dose escalation study of the immuno-activating monoclonal antibody APX005M administered in combination with nivolumab to adult subjects with non-small cell lung cancer or metastatic melanoma. IgG1 Fc domain engineering was employed for APX005M based on the finding in a murine model that the potency of a CD40 agonist can be enhanced by increased binding affinity to FcRIIB ( 52, 53 ). Apexigen is a clinical-stage biopharmaceutical company focused on discovering and developing a new generation of antibody therapeutics for oncology, with an emphasis on new immuno-oncology agents that may harness the patient's immune . Children's Assent. This phase I trial studies the side effects and best dose of APX005M in treating younger patients with primary malignant central nervous system tumor that is growing, spreading, or getting worse (progressive), or newly diagnosed diffuse intrinsic pontine glioma. NCT03123783. The goal of Part 1 of this clinical research study is to find the highest tolerable dose of APX005M that can be given with pembrolizumab that can be given to patients with metastatic melanoma. Showing trials for . Sotigalimab targets CD40, a co-stimulatory receptor that is. This trial (PRINCE, PICI0002) is registered with ClinicalTrials.gov, NCT03214250and is ongoing. In an interim analysis of an ongoing Phase 1b clinical trial, 20 of 24 evaluable patients with metastatic pancreatic cancer demonstrated tumor shrinkage following treatment with APX005M in . If confirmed in later phase trials, this treatment regimen could replace chemotherapy-only standard of care in this population. Safety and Efficacy of APX005M With Gemcitabine and Nab-Paclitaxel With or Without Nivolumab in Patients With Previously Untreated Metastatic Pancreatic Adenocarcinoma. If confirmed in later phase trials, this treatment regimen could replace chemotherapy-only standard of care in this population. I. One study (clinical trial identifier: NCT03389802) has investigated the potential to overcome resistance to PD-1/PD-L1 blockade immunotherapy by the combination of APX005M with cabiralizumab, an anti-CSF1R antagonist, with and without nivolumab in several solid tumours .