Immunovative Therapies, Ltd.(ITL) announced the start of a phase IIb study of CryoVax, a next generation immunotherapy cancer vaccine product, for patients with chemotherapy-refractory (third line) metastatic colorectal cancer (mCRC). The trial is being conducted by Banner MD Anderson Medical Center, in Phoenix, AZ, which is partnered with the world renowned University of Texas MD Anderson Cancer Center in Houston, TX, Recruitment in the trial is underway, and the first volunteers have received their initial vaccine doses. Enrollment is expected to be completed by the end of July 2017.
CryoVax is a next generation immunotherapy designed to provide immune-mediated tumour killing effects for the remaining 85% of mCRC patients that fail to respond to checkpoint inhibition immunotherapy. The CryoVax next generation immunotherapy regimen is designed to create "hot" tumours in these patients and then naturally block checkpoint molecule expression. Patients are first immunized against patented bioengineered immune cells called AlloStim which are derived from healthy, intentionally mis-matched, donor cells. A vaccine is then created within the body which customizes the immune response to the patient's own tumour.
Vaccines contain a source of tumour antigens and an adjuvant to modulate the immune response. The tumour antigens for the CryoVax vaccine are derived from the release of the inner contents of tumours (i.e., heat shock proteins) killed by extreme cold, a technique called "cryoablation". Intratumoural injection of AlloStim cells into the microenvironment of the cryoablation lesion containing dead tumour cells serves as an adjuvant. This creates an in-situ, personalized, anti-cancer vaccine. Subsequent IV infusions of the AlloStim® cells cause the movement of immune cells from the circulation into the tumour lesions. This movement of immune cells is predicted to create 'hot' tumours. The highly inflammatory conditions created by the subsequent rejection of the mis-matched AlloStim cells serves to naturally down-regulate checkpoint molecules on tumour cells. This combination of hot tumours and down-regulation of checkpoint molecules is a formula known to enable immune-mediate tumour killing of mCRC tumours.
Dr Michael Har-Noy, CEO of Immunovative Therapies, Ltd. and inventor of the CryoVax anti-tumour vaccine regimen stated: "anti-tumour vaccines have had difficulties in translating into effective therapies in the clinic and mCRC has been particularly resistant to immunotherapy. The CryoVax vaccine regimen has a unique mechanism of action and shows promise as a next generation immunotherapy. We will be studying various AlloStim® dosing frequencies and closely monitoring the interaction of host immune cells with the tumour cells in each of the cohorts of this clinical trial. This information should serve to determine if this customized in-situ vaccine approach will benefit mCRC patients."
The volunteers in this study will be sequentially enrolled into six groups (A through F) that will receive different dosing frequency schedules of AlloStim. All subjects receive cryoablation of a selected tumour lesion followed by intratumoural injection of AlloStim to create a customized in-situ vaccine. Subjects are required to undergo multiple biopsy and CT scan procedures and provide multiple blood samples over time. These materials are analyzed sequentially in order to study how the interaction of the mCRC tumours with the immune system changes over time.
Dr. Madappa Kundranda, MD, PhD, the Principle Investigator on this study stated:" there is a clear need for alternative treatment options for chemotherapy-refractory mCRC tumours. We feel very fortunate to be chosen as the first institution in the United States to have the opportunity to evaluate the novel CryoVax vaccine technology and to provide this clinical trial option to our patient population. Response to chemotherapy treatments relies upon evaluation of changes in tumour size, however often times it is difficult to evaluate response to immunotherapy using these techniques. Immune responses can result in swollen tumours that appear larger but actually contain decreased tumour burden, initial pseudo-progression followed by response sometimes even months later, or stable disease that translates to increased survival. The incorporation of sophisticated immunomonitoring exploratory end-points and longitudinal biopsies and CT scans taken simultaneously in the trial design provides an unprecedented opportunity to understand the immune mechanisms involved in mCRC and to learn how different frequencies of CryoVax vaccine administration affects these parameters. We are confident that this trial will significantly add to our knowledge regarding the interaction of the immune system with chemotherapy-resistant tumours."
Subscribe to PharmaTutor News Alerts by Email
