Date: 2015-03-04
Type of information: Completion of the trial
phase: 1-2a
Announcement: completion of the trial
Company: Oryx (Germany)
Product: MicOryx/Montanide® ISA-51 VG
Action
mechanism: peptide/therapeutic vaccine.
Disease: advanced microsatellite instable (MSI-H-) colorectal cancer
Therapeutic area: Cancer - Oncology
Country: Germany
Trial
details: In this trial, patients with advanced microsatellite unstable (MSI-H) colorectal cancer will be vaccinated with three so called frame shift peptides (FSPs), AIM2(-1), HT001(-1) and TAF1B(-1) combined with Montanide® ISA-51 VG. By this, an immune response directed against MSI-induced FSPs that are shared by the majority of MSI-H colorectal cancers can be induced. The aim is to show that vaccination against MSI-induced FSPs is safe and can induce or enhance immune responses against MSI-H colorectal cancer-associated antigens.(NCT01461148)
Latest
news: * On March 4, 2015, Oryx, a translational medicine company focused on oncolytic virotherapy and cancer vaccines, announced the successful completion of a Phase I/IIa trial of the therapeutic vaccine MicOryx to treat advanced microsatellite instable (MSI-H-) colorectal cancer patients in an open label, single center trial that included 22 patients (UICC stage III or IV), who had received standard chemotherapy. Phase I of the trial evaluated safety and toxicity as the primary endpoint (6 patients). Phase IIa addressed the induction of cellular and humoral immune responses against MicOryx (16 patients) assessed by CT or MRI scans according to RECIST. The vaccine was safe and induced humoral and cellular immune responses. Full data from the trial will be presented at upcoming scientific conferences. Several cancers arise from the lack of DNA mismatch repair (MMR) resulting in the accumulation of thousands of single deletions or insertions at coding microsatellites. These mutations lead to the inactivation of specific proteins and the expression of frameshift peptides (FSPs). These FSPs are tumor-specific antigens, which are constantly expressed. In patients with MSI-H colorectal cancer, humoral and cellular immune responses against FSPs occur spontaneously. In healthy people such immune responses are not observed. Dr. Bernard Huber, CEO and Founder of ORYX, said: \"This is the first of a series of three clinical trials ongoing at ORYX to report successful completion this year.\"
