Strong Quality of Life Data for Apogenix' Asunercept Published in Journal of Neuro-Oncology

Asunercept Plus Radiotherapy Significantly Prolongs Time to Deterioration of Quality of Life Compared to Radiotherapy Alone in Patients with Recurrent Glioblastoma

Heidelberg, Germany, November 7, 2019 - Apogenix, a biopharmaceutical company developing next generation immuno-oncology therapeutics, announced today that a shows that in patients with recurrent glioblastoma, treatment with asunercept in combination with radiotherapy is associated with a statistically significant prolongation in time to deterioration of quality of life beyond progression of the disease compared to treatment with radiotherapy alone.

In a proof-of-concept phase II clinical trial in patients with recurrent glioblastoma, treatment with asunercept in combination with radiotherapy has demonstrated clinical efficacy compared to treatment with radiotherapy alone, including 6-month progression-free survival in 20.7% of patients treated with asunercept plus radiotherapy compared to 3.8% of patients treated with radiotherapy alone. Quality of life was an important secondary endpoint of the trial, and the recent analysis shows the time to deterioration of quality of life based on data from this clinical trial.

In glioblastoma patients, disease progression is generally associated with a deterioration of overall quality of life, neurological and neurocognitive functions, and the capacity to perform daily activities. This includes sleep disruption, inability to concentrate, depression, and impaired professional, personal, and social lives. In recurrent glioblastoma patients treated with asunercept and radiotherapy, overall quality of life was maintained for 166 days before deterioration, versus 107 days in patients treated with radiotherapy alone. Physical functioning was maintained for 183 days before deterioration in patients treated with asunercept plus radiotherapy, compared to 89 days in patients who received only radiotherapy.

"Given the poor prognosis of glioblastoma patients with currently available treatment options, quality of life maintenance is an important clinical outcome in addition to therapeutic goals such as progression-free and overall survival in order to preserve neurological functions and sustain the capacity to perform daily activities," said Thomas Hoeger, Ph.D., Chief Executive Officer of Apogenix. "It is remarkable that in recurrent glioblastoma patients who received
asunercept in combination with radiotherapy, time to deterioration was even prolonged beyond progression of the disease, particularly with regards to overall quality of life, physical functioning, and neurological status. This was not the case in patients treated with radiotherapy alone in this study, nor was it demonstrated in other clinical studies in similar patient populations."

About Apogenix
Apogenix is a private company developing innovative immuno-oncology therapeutics for the treatment of solid tumors and hematological malignancies. The company's pipeline of immuno-oncology drug candidates targets different tumor necrosis factor (TNF) superfamily-dependent signaling pathways, thereby restoring the immune response against tumors. Checkpoint inhibitor asunercept, the company's lead immuno-oncology candidate, is in late-stage clinical development with PRIME (PRIority MEdicines) designation by the European Medicines Agency for the treatment of glioblastoma. Based on its proprietary technology platform for the construction of novel TNF superfamily receptor agonists (HERA-ligands), Apogenix develops CD40, CD27, GITR, HVEM, and 4-1BB receptor agonists for cancer immunotherapy. The TRAIL receptor agonist program was outlicensed to AbbVie. AbbVie has initiated a phase I trial with TRAIL receptor agonist ABBV-621 in patients suffering from solid tumors, non-Hodgkin's lymphoma, or acute myeloid leukemia.

About Asunercept
Apogenix' lead immuno-oncology candidate asunercept is a fully human fusion protein that consists of the extracellular domain of the CD95 receptor and the Fc domain of an IgG1 antibody. It is being developed for the treatment of solid tumors and hematological malignancies. Asunercept was granted orphan drug designation for the treatment of glioblastoma and myelodysplastic syndromes (MDS) in both the EU and the US and 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.

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^[1] Wick W, Krendyukov A, Junge K, Höger T and Fricke H (2019). Longitudinal analysis of quality of life following treatment with Asunercept plus reirradiation versus reirradiation in progressive glioblastoma patients. J Neurooncol. doi: 10.1007/s11060-019-03320-x