Asunercept (APG101), an inhibitor of the CD95 ligand, significantly extended the survival of recurrent glioblastoma patients included in a Phase 2 trial, according to Apogenix, the investigational therapy’s maker.
Five years after entering the trial, 7 percent of patients who received the medicine along with re-irradiation were still alive, compared to none of the patients who received re-irradiation alone.
Apogenix is now working closely with the European regulatory agency to submit a marketing authorization application (MAA) for conditional approval of asunercept in the treatment of recurrent glioblastoma by the end of 2019.
Asunercept is a fully human fusion protein that is designed to inhibit the CD95 ligand, which plays an important role in the progression of solid tumors.
Depending on the type of target cell (immune or tumor cell), the interaction between the CD95 ligand and the CD95 receptor induces either apoptotic cell death or invasive growth of cells.
Thus, asunercept has a dual role. For one, it activates the immune system and prevents cancer cells from escaping immune surveillance. For another, asunercept inhibits invasive growth in tumor cells.
In November 2017, following a priority medicine (PRIME) designation asunercept received in Europe for the treatment of glioblastoma, Apogenix had a kick-off meeting with the European Medicines Agency (EMA) where the company presented its plan to make asunercept available to patients with recurrent glioblastoma as soon as possible.
At that meeting, Apogenix highlighted the five-year overall survival (OS) rate for patients with recurrent glioblastoma treated with asunercept in a Phase 2 trial was 7 percent, versus 0 percent in patients treated with radiotherapy alone.
“We are excited about the support that Apogenix is receiving from the EMA in the PRIME process,” Harald Fricke, MD, chief medical officer of Apogenix, said in a press release.
Apogenix’s Chinese licensing partner, CANbridge, recently announced the approval of an investigational new drug (IND) application in China for a pivotal Phase 2/3 clinical trial testing asunercept for the treatment of recurrent glioblastoma in China.
Glioblastoma is a type of tumor that arises from astrocytes — the star-shaped cells that constitute the supportive tissue, or “glue-like” tissue of the brain. These tumors are the most aggressive kind of brain tumors.
The study will assess the effectiveness and safety of weekly re-radiation therapy in combination with asunercept. The primary objective of this study is to determine overall survival. The study’s first patient is expected to be enrolled later this year.
“We are also very pleased with the progress our Chinese licensing partner CANbridge is making in the clinical development of asunercept in China. The clinical and safety data from CANbridge’s phase II/III trial with asunercept in China and our phase II trial in Europe will help both sides ensure that patients suffering from recurrent glioblastoma can benefit from this novel treatment option as fast as possible,” said Fricke.
Asunercept has orphan drug status for the treatment of glioblastoma and myelodysplastic syndromes (MDS) in both the United States and Europe.