ORYX GmbH & Co. KG
ORYX to Present Positive Clinical Data for Oncolytic Virus ParvOryx in Combination with Immune Modulators at CIMT Annual Meeting 2018

Press Release

ORYX to Present Positive Clinical Data for Oncolytic Virus ParvOryx in Combination with Immune Modulators at CIMT Annual Meeting 2018

Munich (Germany), May 16, 2018: 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 modulators in recurrent glioblastoma will be presented at the 16^th Annual Meeting of the Association for Cancer Immunotherapy (CIMT), taking place in Mainz, Germany, on May 15 – 17, 2018.

The abstract “High rate of objective anti-tumor response in 9 patients with primary or recurrent glioblastoma after viro-immunotherapy with oncolytic parvovirus H-1 in combination with bevacizumab and PD-1 checkpoint blockade” will be presented by Dr. Karsten Geletneky, Department of Neurosurgery, Darmstadt Medical Center, on Wednesday, May 16, from 03:30 PM to 6:30 PM (CEST) as part of the “Improving Immunity” session and discussed on Thursday, May 17, from 11:45 AM – 01:00 PM (CEST) in the “Clinical Trials” short talk session.

In a successfully completed phase I/IIa trial the oncolytic H-1 parvovirus (H-1PV) ParvOryx showed changes in the tumor microenvironment and induction of immune responses in patients with recurrent glioblastoma. The enhancement of ParvOryx’ efficacy in combination with immune modulators was investigated under a compassionate use program. Nine patients with primary (n=2) or recurrent (n=7) glioblastoma were treated with ParvOryx in combination with bevacizumab (Avastin^(R), an angiogenesis inhibitor) and either pembrolizumab or nivolumab (Keytruda^(R) or Opdivo^(R), PD-1 checkpoint inhibitors).

Seven patients were treated with intratumoral and intravenous injection of ParvOryx and two patients by intravenous injection only. The combination treatment was well tolerated by all nine patients. Resonance imaging (MRI) showed objective tumor response in seven of nine patients (78%), thereof two complete responses.

“We are very pleased to present this highly promising data of ParvOryx in combination with immune modulators at CIMT”, commented PD Dr. Karsten Geletneky, Head of the Department of Neurosurgery, Darmstadt Medical Center. “Combination therapy is an emerging concept to improve the clinical effects of oncolytic virus based anti-cancer strategies. The objective tumor responses in 78% of glioblastoma patients treated with ParvOryx and immune modulators represent a high response rate in this very difficult to treat tumor entity. We are convinced that the positive findings from non-trial patients support further systematic clinical development of this novel concept for malignant glioma therapy.”

The abstract is currently available on the CIMT website at: http://www.meeting.cimt.eu/program

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 cross the blood brain barrier. The special properties of ParvOryx allow for both intratumoral and intravenous administration as well as repeated application. 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) in animal models. 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 study for the treatment of metastatic pancreatic cancer with ParvOryx monotherapy is currently ongoing, with topline data expected in the second half of 2018.

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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