Apogenix is exploring partnerships with pharmaceutical and biotechnology companies as well as collaborations with leading academic institutions in order to advance the preclinical and clinical development and commercialization of its proprietary drug candidates targeting members of the TNF superfamily and TNF receptor superfamily. The TNF/TNF receptor superfamilies comprise more than a dozen proteins that play a crucial role in the regulation of the immune response, making them attractive immunotherapy targets.
Our most advanced immunotherapy candidate asunercept is being developed for the treatment of solid tumors, malignant hematological diseases, and viral infections, such as COVID-19. It has delivered outstanding results in clinical trials in glioblastoma and myelodysplastic syndromes to date.
Apogenix’ proprietary HERA-ligand technology platform delivers single-chain fusion proteins which activate TNF superfamily receptors, thereby stimulating the anti-tumor immune response. Apogenix’ unique protein architecture offers clear advantages over other biologics such as antibodies and has the potential for broad application in oncology.
For more information regarding partnering opportunities, please contact:
Juergen Gamer, Ph.D.
VP Business Development
Phone: +49 (0) 6221 586080
Asunercept – a CD95 ligand inhibitor – is currently being developed for the treatment of cancer and viral infections, such as COVID-19. The excellent safety and tolerability of asunercept has been demonstrated in both animal models and clinical trials. Clinical trials in glioblastoma (GB) and myelodysplastic syndromes (MDS) have shown outstanding results, and a pivotal phase II/III trial in glioblastoma is currently being planned.
Given the urgent need for COVID-19 treatments, asunercept will be evaluated in two controlled phase II clinical trials in hospitalized moderate to severe COVID-19 patients. There is a strong scientific rationale of using asunercept to block CD95L-mediated epithelial lung damage and a high interest from international key opinion leaders. Patient recruitment is scheduled to begin in Q2/2020 and final data is expected in Q1/2021.
With asunercept, Apogenix targets commercially attractive indications characterized by a high unmet medical need. GB and MDS, our initial target indications, are so-called orphan diseases with very few effective treatment options. Asunercept was granted orphan drug status for the treatment of glioma and MDS in the EU and for the treatment of GB and MDS in the US. It has also been awarded PRIME designation by the European Medicines Agency (EMA) for the treatment of GB.
In a randomized controlled phase II trial in recurrent GB, treatment with asunercept in combination with radiotherapy has shown significant improvements in progression-free survival and quality of life as well as a positive trend in overall survival compared to treatment with radiotherapy alone, demonstrating the potential efficacy of asunercept in the treatment of recurrent GB.
Final results of a phase I trial with asunercept for the treatment of MDS reveal an increase in erythrocyte precursor cells and a marked reduction of transfusion frequency in MDS patients, which is an indication of the efficacy of asunercept in the treatment of MDS.
The CD95 system, which is inhibited by asunercept, plays an important role in the progression of other solid tumors beyond GB, underlining the tremendous potential of asunercept in a broad range of oncology indications.
HERA-Ligand Technology Platform
The Apogenix team has developed the unique, patent-protected HERA-ligand technology for the development of novel receptor agonists that target different TNFSF-dependent signaling pathways, which play a crucial role in the regulation of the immune response. Apogenix’ TNFSF receptor agonists overcome the structural limitations of other biologics targeting TNFSF pathways, such as antibodies.
Through their unique molecular architecture, Apogenix’ single-chain fusion proteins combine high efficacy with defined, adjustable pharmacokinetics. These properties are especially important for activators of immune cells in order to stimulate an immune response against cancer cells.
Apogenix has successfully developed novel TRAIL receptor agonists based on this technology platform, which have demonstrated excellent anti-tumor efficacy in a large number of preclinical studies. The TRAIL receptor agonist program was successfully out-licensed to AbbVie in 2014. Other TNFSF receptor agonists including CD40, CD27, GITR, HVEM, and 4-1BB agonists are currently in preclinical development.