iTolerance, Inc. and Kadimastem Ltd. announced they have submitted a meeting request to the INTERACT committee of the U.S Food and Drug Administration (FDA) for iTOL-102, which is under development as a potential cure for Type 1 diabetes without the need for chronic immunosuppression. This is the first of a three-step process, with the goal of designing and commencing an FDA-approved clinical study of iTOL-102. The second step would be to submit a pre-IND application based on the feedback from the INTERACT meeting, followed by an IND application to begin clinical trials at locations worldwide.

In May 2023, the companies announced their research collaboration agreement to co-develop and commercialize a breakthrough and innovative regenerative technology to cure diabetes without the need for chronic Immunosuppression and received a grant in the aggregate amount of USD 1 million from the Binational Israel-U.S. Industrial R&D (BIRD) Foundation. As part of the agreement, the companies are considering expanding their cooperation and advancing the development of iTOL-102 which combines Kadimastem's advanced cell product for the treatment of diabetes called IsletRx, and iTolerance's iTOL-100 immunomodulatory technology. The purpose of the meeting would be to present the iTOL-102 development program and specifically discuss the chemistry, manufacturing and control (CMC) program, the definitive proof of concept study design in light of preliminary data, and general plans for non-clinical safety and clinical development.