ORYX Presents Positive Phase I/IIa Data with Therapeutic Vaccine MicOryx
ORYX 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(R) 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 high 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."
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