DGAP-News: ORYX GmbH & Co. KG
/ Key word(s): Study results
30.10.2019 / 11:00
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Press Release
ORYX Announces Positive Phase I/IIa Data for Oncolytic Virus ParvOryx Demonstrating Safety, Anti-tumor Effects, Partial Responses and Prolonged Overall Survival in Metastatic, Inoperable Pancreatic Cancer
Munich (Germany), October 30, 2019: ORYX, a translational medicine company focused on oncolytic virotherapy and cancer vaccines, today published positive clinical trial results from a dose-escalating Phase I/IIa trial with oncolytic virus ParvOryx in metastatic, inoperable pancreatic cancer.
ParvOryx, a wild type rat oncolytic parvovirus (H-1PV), was evaluated in an open label study in seven patients with metastatic, inoperable pancreatic cancer. The patients received ParvOryx at three increasing dose levels, partly administered intravenously on four consecutive days, followed by an intrametastatic injection into a single liver metastasis after 6 to 13 days. After virotherapy, patients were treated with gemcitabine. Primary endpoint of the trial evaluated safety and tolerability of ParvOryx. Secondary endpoints included anti-tumor effects and cellular immune response, plus overall survival. To identify immunological and molecular signatures of responses, three serial liver biopsies (before, during, and after virotherapy) allowed for in-depth analyses of pathological tumor characteristics, tumor-infiltrating immune cells, quantification of cytokines and chemokines, and investigation of viral replication and tropism.
ParvOryx was safe at all dose levels and no maximum tolerated dose was reached. Two patients showed a partial response to virotherapy and prolonged overall survival times (326 and 555 days). These patients showed favorable immunological signatures, like changes in the tumor microenvironment and induction of specific immune responses. Preliminary and final data were presented by Prof. Guy Ungerechts, principal investigator of the ParvOryx02 study, at the Oncolytic Virus Immunotherapy Summit in London (March 20-21, 2019) and at the International Oncolytic Virus Conference at the Mayo Clinic Center in Rochester (October 9-12, 2019), respectively.
“We are pleased to present these positive data for ParvOryx, which confirm the promising results of previous trials with glioblastoma patients,” commented Dr. Dr. Michael Dahm, CMO of ORYX. “With the successful completion of this trial, we have validated the mode of action of ParvOryx in another tumor type, inoperable metastatic pancreatic cancer, and have once more proven the excellent safety profile of the oncolytic virus. These clinical trial results are fully in line with our expectation that ParvOryx holds exceptional potential to treat a whole range of solid tumors.”
In a previous phase I/IIa trial with 18 patients with primary or recurrent glioblastoma, ParvOryx also showed changes in the tumor microenvironment and induction of specific immune responses.
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.
About ORYX
ORYX is a privately held Munich-based biotech company that 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. The Company holds exclusive, worldwide licenses for all its development projects. For more information, please visit: www.oryx-medicine.com
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