Munich (Germany): ORYX, a translational medicine company focused on oncolytic virotherapy and cancer vaccines, reported positive Phase I/IIa clinical trial results of therapeutic vaccine MicOryx to treat advanced microsatellite instable (MSI-H) colorectal cancer at the 2015 Annual Meeting of the American Society of Clinical Oncology (ASCO).
The MicOryx vaccine was evaluated in the open label, single center trial that included 22 advanced MSI-H colorectal cancer patients (UICC stage III or IV), who had received standard chemotherapy. Results for the Phase I/IIa trial of MicOryx plus Montanide® ISA-51 VG adjuvant in patients showed that MicOryx strongly induced T cell (mainly CD4-positive) and humoral immune responses in all patients vaccinated. No frameshift peptide (FSP) antigen-associated severe adverse events were observed. The primary Phase I clinical trial endpoint was safety and toxicity (6 patients). The Phase IIa clinical trial evaluated the induction of cellular and humoral immune responses against MicOryx (16 patients) assessed by CT or MRI scans according to RECIST.
Dr. Bernard Huber, CEO and Founder of ORYX, said: “These MicOryx Phase I/IIa results open up a new therapeutic approach for the treatment of colorectal cancer, now that we have shown the therapeutic vaccine is safe and induces a strong humoral and cellular immune response in patients. The results are fully in line with our expectations based on the preclinical data. FSP vaccination holds great potential as a novel adjuvant treatment option in MSI-H colorectal cancer patients and for cancer prevention in Lynch syndrome mutation carriers. In addition, MicOryx might treat other indications like endometrial cancers and upper urinary tract cancers.”
The poster "Vaccination of MSI-H colorectal cancer patients with frameshift peptide antigens: A phase I/IIa clinical trial", was presented by Dr. Miriam Reuschenbach, research fellow at the German Cancer Research Center in Heidelberg, at the 2015 Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago.
ORYX is a privately held Munich based biotech company. ORYX develops 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, world-wide licenses for all its development projects. For more information please visit: www.oryx-medicine.com
For further information, please contact:
Dr. Bernard Huber
Chief Executive Officer
ORYX GmbH & Co. KG
Executive Director MC Services AG
Dr. Dr. Sven Rohmann