The study, led by Dr. Tim Greten at the National Cancer Institute (NCI), is being conducted as part of a Cooperative Research and Development Agreement (CRADA) with the NCI, part of the National Institutes of Health (NIH).
Under the CRADA, SillaJen will collaborate with Dr. Greten to evaluate the combination of SillaJen's lead clinical candidate, Pexa-Vec in combination with durvalumab (anti-PDL1 antibody) and, in a separate treatment group, with both durvalumab and tremelimumab (anti-CTLA4 antibody) in patients with refractory metastatic CRC.
The aim of the trial will be to test if the combination of oncolytic virus and immune checkpoint inhibitor therapy can activate the immune system to fight cancer and overcome self-tolerance to colon cancer.
Further, in depth assessment of tumor biopsies, and other collected patient samples, will be conducted to assess the immune modulating potential of Pexa-Vec given concurrently with checkpoint inhibitor therapy.
SillaJen CEO Eun Sang Moon said: "We are pleased to be working with Dr. Greten at the NCI. He is a leading researcher in the area of cancer immunotherapy. Obviously, we hope this collaboration can improve the treatment options for patients with incurable colon cancer.
Dr. Greten is a Senior Investigator in the Thoracic and Gastrointestinal Oncology Branch of NCI's Center for Cancer Research and a recognized expert in GI Oncology and tumor immunology. Dr. Greten received his training in medical oncology, gastroenterology and hepatology in Germany and has been performing basic and translational research studies in tumor immunology for more than 20 years. He is currently studying novel immune-based approaches to treat patients with gastrointestinal tumors.
SillaJen chief medical officer James Burke said: “We are excited that this clinical trial has started. Cancer immunotherapy is significantly impacting multiple cancer types, and we hope this trial will provide further understanding about how our immunotherapy might help patients with CRC, particularly given the limited treatment options available to this patient population.”
Under the terms of the CRADA, Dr. Greten will recruit and treat patients at the NCI on the jointly developed protocol, and NCI will handle the operational aspects of this trial. SillaJen will supply Pexa-Vec for the clinical trial, while tremelimumab and durvalumab will be provided by a third party to NCI under a separate CRADA.
This CRADA will provide SillaJen access to NCI's scientific and clinical expertise to facilitate development of Pexa-Vec for the benefit of public health.