MUNICH--(BUSINESS WIRE)--ORYX, a translational medicine company focused on oncolytic virotherapy and cancer vaccines, today announced positive findings from 16 patients treated with the oncolytic virus, ParvOryx, in combination with Avastin(R) (bevacizumab) and with immune checkpoint inhibitors Keytruda(R) or Opdivo(R) under compassionate use programs. These promising results have encouraged ORYX to prepare a controlled clinical study, which will be discussed with regulatory authorities.
Seven patients suffering from glioblastoma multiforme (GBM) who had experienced a second relapse following treatment with ParvOryx in a completed Phase I/IIa study were treated with ParvOryx plus Avastin(R) following surgery. In the seven ParvOryx/Avastin(R)-treated patients, median overall survival (mOS) was prolonged to 25.9 months compared to the ParvOryx monotherapy study mOS (15.9 months).
Additionally, nine GBM patients with either primary, diffuse primary, single recurrent or double recurrent GBM were treated with ParvOryx in combination with an immune checkpoint inhibitor alone (1) or in combination with Avastin(R) and an immune checkpoint inhibitor (8) without prior surgery. All nine patients responded with objective tumor regression already after 6-8 weeks. The tumor load was reduced by 45-96% as measured by RANO (Response Assessment in Neuro-Oncology) criteria. Follow-up is ongoing.
Two patients relapsed (26 and 47 weeks) after virotherapy, while receiving constant treatment with Avastin(R) and an immune checkpoint inhibitor. Treatment with ParvOryx together with the resumption of combination therapy with Avastin(R) and the checkpoint inhibitor led to rapid regression of the tumor mass and disease control.
Dr. Michael Dahm, ORYX's Chief Medical Officer, said: "Although these data are preliminary and uncontrolled, they are highly encouraging. We look forward to evaluating ParvOryx in combination with Avastin(R) or with Avastin(R) plus an immune checkpoint inhibitor in a controlled clinical trial setting."
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.
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
Avastin(R) is a registered trademark of Genentech, Inc., a member of the Roche Group. Keytruda(R) (pembrolizumab) is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. Opdivo(R) (nivolumab) is a registered trademark of Bristol-Myers Squibb Company.