The First Orally Delivered Cell Therapy for the Treatment of Inflammatory Bowel Disease

We are developing the first oral cell therapy for the treatment of inflammatory bowel disease [IBD]. Current standard of care reaches only 1/3 of patients. There is an increasing incidence without a known cure. Cell therapy is considered the next generation IBD therapy. However, while cell-based therapies are very promising and some initial successes have been reported in cancer immunotherapies and other human diseases, they are expensive and can only be administered by injection at a hospital or clinic. Access is limited to those who can afford them and can make a trip to the hospital or clinic.

We will solve these issues and advance cell-based therapeutics by engineering a new oral cell delivery mechanism. We believe most would prefer an oral pill to an injection. Live bacteria are already delivered in this way for the treatment of Clostridium difficile and to restore a healthy gut. We also already know that locally applied cell-based medicines have revolutionized the way inflammatory bowel disease is treated. With our oral cell delivery technology, we will deliver the live anti-inflammatory cells directly to the inflamed gut. 

The CIRM-funded DISC2 efforts helped to establish that our oral anti-inflammatory cell therapy platform works in animal models of IBD. In our next step, we will continue to gather the information needed to begin discussions with the FDA towards our first in man clinical studies. To this end, we will apply for a CIRM TRAN1 grant to fund the next studies that help discover the best way to safely manufacture and test our clinical oral cell therapy product prior to the clinical trial. We anticipate that we will file an FDA application for the first clinical trial within a year of completion of those studies.