Apogenix Advances Clinical Development of CD95L Inhibitor Asunercept in European COVID-19 Phase II Trial
HEIDELBERG, GERMANY / ACCESSWIRE / 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 study is a multicenter, randomized, controlled, open-label phase II study to evaluate the efficacy and safety of asunercept in patients with severe COVID-19 disease. In four treatment arms, three different doses of Asunercept plus standard of care compared to standard of care alone are evaluated in a total of 400 patients. Apogenix has now received regulatory approval for the ASUNCTIS study in both Spain and Russia and will enroll patients in several study centers in Madrid and Saint Petersburg, among others.
"The increasing number of COVID-19 infections in Europe underscores the urgent need for safe and effective treatment options," said Dr. Thomas Hoeger, Chief Executive Officer of Apogenix. "We are very confident that our lead immunotherapy candidate, Asunercept, will prove effective in patients with severe COVID-19 disease."
"The CD95 ligand, which is inhibited by asunercept, plays an important role in inducing life-threatening lymphopenia and pulmonary epithelial cell death, which leads to pneumonia and acute respiratory distress syndrome (ARDS) in COVID-19 patients," continued Thomas Hoeger. "With lymphopenia and ARDS being complications of other viral infections, Asunercept could represent a new therapeutic approach to viral infections beyond COVID-19."
Apogenix is a privately held company developing innovative immunotherapeutic agents to treat cancer and viral infections such as COVID-19. The company's immunotherapeutic pipeline targets a variety of signaling pathways dependent on the tumor necrosis factor (TNF) superfamily to restore anti-tumor immune responses in cancer patients and to reduce lymphopenia and inflammatory cell death in patients with viral infections. Checkpoint Inhibitor Asunercept, the company's lead immunotherapy candidate, is in late-stage clinical development and has been awarded PRIME (PRIority MEdicines) by the European Medicines Agency for the treatment of glioblastoma. Based on its proprietary technology platform for the construction of novel receptor agonists of the TNF superfamily (HERA ligands), Apogenix develops CD40, CD27, GITR, HVEM and 4-1BB receptor agonists for cancer immunotherapy. The TRAIL receptor agonist program has been assigned to AbbVie. AbbVie is conducting a Phase I study of the TRAIL receptor agonist ABBV-621 in patients with solid tumors, non-Hodgkin's lymphoma, or acute myeloid leukemia.
Apogenix's lead immunotherapy candidate, Asunercept, is a fully human fusion protein consisting of the extracellular domain of the CD95 receptor and the Fc domain of an IgG1 antibody. It is being developed to treat solid tumors, haematological malignancies, and viral infections such as COVID-19. Asunercept has been recognized as an orphan drug for the treatment of glioblastomas and myelodysplastic syndromes (MDS) in both the EU and the USA and as PRIME (PRIority MEdicines) by the European Medicines Agency for the treatment of glioblastomas. Asunercept is exclusively licensed to CANbridge Life Sciences under a development and commercialization license for China, Macau, Hong Kong and Taiwan.
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SOURCE: Apogenix via EQS Newswire
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