Asunercept

EQS-News: Apogenix Enrolls First Patients in Pivotal Phase III Trial for the Treatment of Hospitalized COVID-19 Patients with Asunercept

Retrieved on: 
Sunday, December 18, 2022
European Medicines Agency, Immunotherapy, CD95L, PRIME, Mortality, CD95, SOC, MDS, Safety, Federation, Cancer, Priority, TNF, GITR, Degenerative disease, Doctor of Philosophy, Immunoglobulin G, TRAIL, Lymphocytopenia, III, AbbVie, Immune system, CD40, COVID-19, Disease, FC, HIV disease progression rates, Standard of care, Microdeletion syndrome, Oxygen, Death, WHO, Ventilation, Glioblastoma, Patient, Pharmaceutical industry, Asunercept, EU

The multicenter, double-blind, placebo-controlled trial aims to enroll more than 600 hospitalized patients requiring oxygen in nine different countries.

Key Points: 
  • The multicenter, double-blind, placebo-controlled trial aims to enroll more than 600 hospitalized patients requiring oxygen in nine different countries.
  • Following the successful controlled ASUNCTIS phase II study, the ASUCOV trial aims to confirm the clinical results in a larger study population.
  • The secondary endpoints of the ASUCOV trial assess the reduction of progression to more severe disease, all-cause mortality, and progression to invasive ventilation.
  • We hope to provide an effective treatment option for hospitalized COVID-19 patients because we still see too many deaths worldwide.

EQS-News: Apogenix’ Asunercept Demonstrates Efficacy in Phase II Trial for the Treatment of Hospitalized COVID-19 Patients

Retrieved on: 
Saturday, October 22, 2022
Degenerative disease, European Medicines Agency, Immunoglobulin G, Medical University of Vienna, Disease, TRAIL, SOC, AbbVie, PRIME, Critical Care Medicine (journal), Priority, Medical school, Microdeletion syndrome, MDS, Patient, Data monitoring committee, Acute respiratory distress syndrome, DSMB, Standard of care, Federation, Lymphocytopenia, Mortality, II, Cancer, University, CD95, University of Cologne, WHO, TNF, III, Trial of the century, MD, Doctor of Philosophy, COVID-19, FC, Immunotherapy, Safety, GITR, Lymphatic system, Glioblastoma, Death, Pulmonology, Oxygen, CD40, Pharmaceutical industry, Asunercept, EU

Heidelberg, Germany, October 19, 2022 Apogenix, a biopharmaceutical company developing next generation immunotherapeutics, announced today that asunercept showed statistically significant benefits for hospitalized COVID-19 patients in the ASUNCTIS trial.

Key Points: 
  • Heidelberg, Germany, October 19, 2022 Apogenix, a biopharmaceutical company developing next generation immunotherapeutics, announced today that asunercept showed statistically significant benefits for hospitalized COVID-19 patients in the ASUNCTIS trial.
  • The open-label multi-center phase II trial investigated efficacy and safety of asunercept in 435 patients with moderate to severe COVID-19 disease.
  • COVID-19 patients were randomized equally into four study arms, receiving 25, 100, or 400mg asunercept (once weekly, i.v.)
  • The results show strong trends for clinical efficacy in all treatment groups, indicating a robust activity of asunercept.

DGAP-News: Apogenix Receives EUR 20.7 Million in Public Funding for Pivotal Study and Preparation for Market Production of Asunercept for the Treatment of COVID-19

Retrieved on: 
Thursday, December 9, 2021
FC, GITR, BMG, HERA, Interim, CD40, TRAIL, Population, PEI, Investor, CD95, Immunotherapy, BMBF, AbbVie, Disease, Paul Ehrlich Institute, HVEM, CD27, Oxygen, Death, Acute respiratory distress syndrome, TNF, Patient, Acute myeloid leukemia, Asunercept, Lymphatic system, Cancer, II, Vaccination, COVID-19 vaccine, Government, GMP, Education, Priority, European Medicines Agency, COVID-19, MDS, Degenerative disease, Immunoglobulin G, B-cell lymphoma, PRIME, Glioblastoma, Microdeletion syndrome, III, Lymphocytopenia, National Institute of Pharmaceutical Education and Research, Hajipur, Pharmaceutical industry

In addition, the GMP production process for asunercept will be further developed to market maturity and the required material for the phase III clinical trial will be produced.

Key Points: 
  • In addition, the GMP production process for asunercept will be further developed to market maturity and the required material for the phase III clinical trial will be produced.
  • By directly targeting two critical pathogenic mechanisms, asunercept could represent a unique therapeutic approach for the treatment of COVID-19.
  • Apogenix is a private company developing innovative immunotherapeutics for the treatment of cancer and viral infections, such as COVID-19.
  • Asunercept is exclusively licensed to CANbridge Life Sciences under a development and commercialization license covering China, Macao, Hong Kong, and Taiwan.

Celularity Announces Fast Track Designation by the FDA for its Natural Killer Cell Therapy CYNK-001 in the Treatment of Recurrent Glioblastoma Multiforme

Retrieved on: 
Thursday, March 18, 2021
Health sciences, Health, Clinical research, Pharmaceutical industry, Clinical trial, Design of experiments, Food and Drug Administration, Asunercept

CYNK-001 is currently being investigated in multiple clinical trials, including a Phase 1 clinical trial for GBM.

Key Points: 
  • CYNK-001 is currently being investigated in multiple clinical trials, including a Phase 1 clinical trial for GBM.
  • Fast Track Designation offers early and frequent interaction with the FDA on product development and review process.
  • Treatment of recurrent GBM is challenging due to the lack of standard of care, limited therapeutic options and modest efficacy.
  • Therefore, recurrent GBM is a serious disease and is associated with significant morbidity and a disproportionately high mortality rate.

DGAP-News: Apogenix Advances Clinical Development of CD95L Inhibitor Asunercept in European COVID-19 Phase II Trial

Retrieved on: 
Tuesday, October 13, 2020
Clinical medicine, Medicine, Cancer, Antineoplastic drugs, Cancer immunotherapy, Asunercept, Checkpoint inhibitor, Apogenix, Asunercept

Heidelberg, Germany, October 13, 2020 - Apogenix, a biopharmaceutical company developing next generation immunotherapeutics, announced today that the first patient has been enrolled in the ASUNCTIS trial.

Key Points: 
  • Heidelberg, Germany, October 13, 2020 - Apogenix, a biopharmaceutical company developing next generation immunotherapeutics, announced today that the first patient has been enrolled in the ASUNCTIS trial.
  • The ASUNCTIS trial is a multi-center, randomized, controlled, open-label phase II trial to assess the efficacy and safety of asunercept in patients with severe COVID-19 disease.
  • Checkpoint inhibitor asunercept, the company's lead immunotherapy candidate, is in late-stage clinical development with PRIME (PRIority MEdicines) designation by the European Medicines Agency for the treatment of glioblastoma.
  • Asunercept is exclusively licensed to CANbridge Life Sciences under a development and commercialization license covering China, Macao, Hong Kong, and Taiwan.

Northwest Biotherapeutics Announces Data Lock of Phase III Trial

Retrieved on: 
Monday, October 5, 2020
Health, Medicine, Clinical medicine, Oncology, Brain tumor, Cancer, Glioblastoma, RTT, Clinical trial, Asunercept, Alternating electric field therapy

With the database now locked, the independent service firms managing the Clinical Trial are arranging for the independent statisticians to have access to the unblinded raw data from the Trial.

Key Points: 
  • With the database now locked, the independent service firms managing the Clinical Trial are arranging for the independent statisticians to have access to the unblinded raw data from the Trial.
  • The Company's lead program is a 331-patient Phase III trial of DCVax-L for newly diagnosed Glioblastoma multiforme (GBM).
  • It has completed a 40-patient Phase I trial, and is preparing for Phase II trials.
  • The Company previously conducted a Phase I/II trial with DCVax-L for advanced ovarian cancer together with the University of Pennsylvania.

ERC Announces Interim Results from Phase 2 Trial of Immunotherapy ERC1671 in Recurrent Glioblastoma Patients

Retrieved on: 
Wednesday, August 19, 2020
Biotechnology, Health, Pharmaceutical, Clinical trials, Oncology, Brain tumor, RTT, Health, Clinical medicine, Cancer, Glioblastoma, Bevacizumab, Glioma, GBM, Gliosarcoma, Asunercept, ERC1671, ERC Belgium

The trial, ERC1671/GM CSF/Cyclophosphamide+Bevacizumab vs Placebo, is a double-blind, placebo-controlled study of 84 patients with recurrent GBM.

Key Points: 
  • The trial, ERC1671/GM CSF/Cyclophosphamide+Bevacizumab vs Placebo, is a double-blind, placebo-controlled study of 84 patients with recurrent GBM.
  • Principal investigator of the clinical trial, Daniela Bota, MD, PhD, commented, Prior to this study of ERC1671 immunotherapy for recurrent GBM, it was almost unknown for such patients to experience recovery.
  • ERC1671 is for patients suffering from a grade IV glioma (glioblastoma multiforme and gliosarcoma) when all other traditional treatments have failed.
  • ERCs regimen of therapeutic vaccines has shown early promise in patients suffering from recurrent Glioblastoma multiforme (GBM), the deadliest of brain cancers.

DGAP-News: Apogenix to Start European Clinical Phase II Trial with Asunercept in COVID-19 Patients

Retrieved on: 
Tuesday, July 28, 2020
Clinical medicine, Drugs, Medicine, Asunercept, AbbVie, Protein kinase inhibitors, Lactams, PDGFRA, Devimistat, Apogenix, Asunercept

Heidelberg, Germany, July 28, 2020 - Apogenix, a biopharmaceutical company developing next generation immunotherapeutics, announced today that it has received regulatory approval to start a clinical phase II trial with asunercept in COVID-19 patients in Russia.

Key Points: 
  • Heidelberg, Germany, July 28, 2020 - Apogenix, a biopharmaceutical company developing next generation immunotherapeutics, announced today that it has received regulatory approval to start a clinical phase II trial with asunercept in COVID-19 patients in Russia.
  • The ASUNCTIS trial will be a multi-center, randomized, controlled, open-label trial to assess the efficacy and safety of asunercept in patients with severe COVID-19 disease.
  • "The excellent safety and tolerability of asunercept have already been demonstrated in clinical trials in recurrent glioblastoma and myelodysplastic syndromes.
  • AbbVie is conducting a phase I trial with TRAIL receptor agonist ABBV-621 in patients suffering from solid tumors, non-Hodgkins's lymphoma, or acute myeloid leukemia.

Onconova Therapeutics Submits Application for Rigosertib to Participate in Federally Funded Human Studies in COVID-19 Disease

Retrieved on: 
Monday, July 27, 2020
Life sciences, Biotechnology, Articles, Myelodysplastic syndrome, RTT, Dysplasia, MDS, Biopharmaceutical, Asunercept, Bemcentinib

As an oncology-focused company, Onconova does not currently intend to pursue clinical development in COVID-19 without additional sources of non-dilutive funding.

Key Points: 
  • As an oncology-focused company, Onconova does not currently intend to pursue clinical development in COVID-19 without additional sources of non-dilutive funding.
  • Onconova Therapeutics, Inc. is a Phase 3-stage biopharmaceutical company focused on discovering and developing novel drugs to treat cancer, with an initial focus on myelodysplastic syndromes (MDS).
  • Onconova has a pipeline of proprietary targeted agents designed to work against specific cellular pathways that are important in cancer cells.
  • Advanced clinical trials with the Companys lead compound, rigosertib, are aimed at what the Company believes are unmet medical needs of patients with MDS.