ORYX GmbH & Co. KG
ORYX to present positive clinical data with oncolytic virus ParvOryx in combination with immune activators at the Third CRI-CIMT-EATI-AACR Conference

Press Release

ORYX to present positive clinical data with oncolytic virus ParvOryx in combination with immune activators at the Third CRI-CIMT-EATI-AACR Conference

Munich (Germany), September 6, 2017: ORYX, a translational medicine company focused on oncolytic virotherapy and cancer vaccines, today announced that positive clinical data for its oncolytic virus, ParvOryx, in combination with immune activators will be presented at the “Third CRI-CIMT-EATI-AACR International Cancer Immunotherapy Conference: Translating Science into Survival” taking place September 6-9, 2017 in Mainz, Germany.

The abstract “Viro-immunotherapy with oncolytic parvovirus H-1 in combination with bevacizumab and PD-1 checkpoint blockade shows safety and objective anti-tumor response in patients with recurrent glioblastoma,” will be presented during “Poster Session B” on September 8 from 6:00pm to 8:00pm and is available for download on the conference website.

Based on results from a phase I/IIa trial in which the oncolytic H-1 parvovirus (H-1PV), ParvOryx, showed evidence of inducing immune responses in patients with recurrent glioblastoma, ORYX investigated the enhancement of ParvOryx treatment with immune activators. Under a compassionate use program, eight patients with recurrent or primary glioblastoma were treated with ParvOryx plus bevacizumab and a checkpoint inhibitor (nivolumab or pembrolizumab).

Seven patients were treated with intratumoral and intravenous injections of ParvOryx and one patient with intravenous injection only. All patients then received bevacizumab and nivolumab or pembrolizumab. In all eight patients, the combination treatment was shown to be safe. Side effects were attributed to bevacizumab (impaired wound healing) or the checkpoint inhibitors (hepatitis and thyroiditis). Magnetic resonance imaging (MRI) showed marked and rapid tumor regression in all eight patients within four to eight weeks after injection. The objective radiological response according to RANO (Response Assessment in Neuro-Oncology) criteria was between 49% and 96%, accompanied by clinical improvement in all symptomatic patients.

Dr. Karsten Geletneky, Department of Neurosurgery, Darmstadt Medical Center, commented: “Treatment with ParvOryx in combination with bevacizumab and checkpoint inhibitors in these patients was shown to be safe and induced unexpectedly consistent clinical and radiological responses. Even though the observations were derived from non-trial patients, the data is very encouraging to further investigate this novel concept in malignant glioma therapy.”

About ParvOryx
ParvOryx (Parvovirus H1) is a wild type rat oncolytic virus that infects and lyses tumor cells in a wide variety of cancers, including glioblastoma multiforme, pancreatic cancer, breast cancer, lung cancer, melanoma, lymphoma, pediatric tumors such as neuroblastoma and medulloblastoma, prostate cancer and renal cancer, as well as tumor stem cells. ParvOryx (parvus), the smallest among all oncolytic viruses, is able to pass the blood brain barrier. The special properties of ParvOryx allow for both intratumoral and intravenous administration as well as repeated application (boosters). Unlike other natural or modified oncolytic viruses currently under investigation, H-1PV does not affect normal cells and is not pathogenic for humans. The virus exerts a cytotoxic/oncolytic effect, resulting in dysregulation of cell transcription, cell cycle arrest, shut off of cell replication, activation of cellular stress response and induction of cell death. In addition, viral oncolysis induces a strong tumor-specific immune response leading to the recognition and elimination of minimal residual disease (bystander effect). ParvOryx can turn an immunogenic “cold” into a “hot” tumor by profoundly changing its microenvironment, making the tumor vulnerable to a variety of immuno-oncological approaches.

ParvOryx successfully completed a Phase I/IIa trial to treat glioblastoma multiforme in 18 patients with recurrent or progressive disease. A dose-escalation Phase I/IIa pilot study for the treatment of metastatic pancreatic cancer with ParvOryx monotherapy is currently ongoing, with topline data expected in Q4 2017.

About ORYX
ORYX is a privately held Munich-based biotech company. ORYX is developing three highly innovative drug candidates for the treatment of cancer, originating from leading research institutions like the German Cancer Research Center (DKFZ) and the University of Heidelberg. The ORYX clinical development portfolio consists of an oncolytic virus and two therapeutic cancer vaccines. ORYX holds exclusive, worldwide licenses for all its development projects. For more information, please visit: www.oryx-medicine.com

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