Munich (Germany): ORYX, a translational medicine company focused on oncolytic virotherapy and cancer vaccines, today provided an update on the development strategy for oncolytic virus ParvOryx, a wild type rat oncolytic parvovirus (H-1PV). So far, two Phase I/IIa clinical trials in recurrent glioblastoma (rGBM) and metastatic, inoperable pancreatic cancer have been completed successfully. Moreover, in a follow-up program in patients with recurrent glioblastoma, metastatic colorectal cancer and NSCLC, the enhancement of efficacy of ParvOryx in combination with immune modulators like bevacizumab alone or together with immune checkpoint inhibitors was investigated. The combination treatment was well tolerated by all patients and led to objective tumor response and significantly prolonged survival times.
On the basis of compelling safety, tolerability and efficacy data stemming from both the rGBM trial and from the follow-up program, ORYX requested meetings with the regulatory authorities both in the EU and US to discuss pivotal studies with ParvOryx in combination with bevacizumab for the treatment of recurrent glioblastoma multiforme (rGBM).
In a scientific advice meeting with EMA and in a pre-IND type B meeting with the FDA, the path forward to further clinical studies and potential approval in Europe and the US was discussed. ORYX received positive feedback and endorsement from both agencies to evaluate its proposed plans for pivotal studies.
“We appreciate this very positive feedback and helpful guidance from both regulatory authorities,” commented Dr. Bernard Huber, CEO and Founder of ORYX. “Our clinical results for ParvOryx so far have been very promising. We have not only proven the excellent safety profile of the oncolytic virus but also succeeded in validating the mode of action of ParvOryx in two different tumor types, inoperable metastatic pancreatic cancer and glioblastoma. We see recurrent glioblastoma multiforme as a gateway indication into a range of other solid cancers for which we expect ParvOryx to have extraordinary potential, both as monotherapy and in combination with antibody-based therapeutics. We are looking forward to taking ParvOryx through pivotal trials together with a strong pharma partner and are excited that EMA and the FDA endorse our pivotal development strategy.
Furthermore, we are very happy that Prof. Timothy Cloughesy, Director of Neuro-Oncology, UCLA, and one of the world’s leading specialists for the treatment of brain tumors, has agreed to head a future US trial with ParvOryx as Principal Investigator.”
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.
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
For further information, please contact:
ORYX GmbH & Co. KG
Dr. Bernard Huber
Chief Executive Officer
ORYX GmbH & Co. KG
Dr. Dr. Sven Rohmann