Since the company's foundation in 2005, the Apogenix team has developed a promising portfolio of innovative immuno-oncology therapeutics for the treatment of cancer and viral infections. Apogenix' drug candidates target different TNFSF-dependent signaling pathways, thereby restoring the anti-tumor immune response in cancer patients and reducing lymphopenia and inflammatory cell death in patients with viral infections.
The company’s lead immunotherapy candidate asunercept is in clinical development for solid tumors and hemato-oncological indications, with a pivotal phase II/III study planned for glioblastoma. Given the urgent need for COVID-19 treatments, Apogenix intends to rapidly evaluate asunercept in hospitalized moderate to severe COVID-19 patients. Based on a strong scientific rationale of using asunercept to block CD95L-mediated epithelial lung damage, Apogenix will start two controlled phase II studies in Q2/2020 with final data expected in Q1/2021.
In recurrent glioblastoma, the most frequent and aggressive brain tumor, asunercept has demonstrated significant improvements in progression-free survival and quality of life as well as a positive trend in overall survival in a controlled phase II proof of concept trial. This milestone was achieved only six years after the initial publication of preclinical data that laid the foundation for the use of asunercept to treat this devastating disease.
Asunercept has also been evaluated in a phase I trial for the treatment of myelodysplastic syndromes (MDS), a stem cell disorder that can lead to severe anemia. Forty percent of patients showed a marked reduction of transfusion frequency during the duration of the trial.
Asunercept ’s unique mode of action supports its significant potential for the treatment of other solid tumors beyond glioblastoma.
In addition, Apogenix’ scientific team has developed the proprietary HERA-ligand technology platform for the development of novel fusion proteins. These fusion proteins offer clear therapeutic advantages over other biologics such as antibodies and have the potential for broad application in oncology.
Apogenix has successfully out-licensed its first program based on this technology platform – TRAIL receptor agonist APG880 (ABBV-621) and derivatives – to Abbvie. In March 2017, AbbVie initiated a clinical phase I study with ABBV-621 in patients suffering from solid tumors, non-Hodgkin's lymphoma (NHL) or acute myeloid leukemia (AML).