The Israel-U.S. Binational Industrial Research and Development Foundation has approved another milestone-based funding payment for the continued development of iTOL-102, a novel cell therapy targeting a potential cure for Type 1 diabetes without requiring lifelong immunosuppression. The approval follows a successful Type B Pre-IND meeting with the U.S. Food and Drug Administration in February 2025, marking significant regulatory progress for the collaborative program between Kadimastem Ltd., iTolerance Inc., and NLS Pharmaceutics Ltd.
Regulatory Milestone Drives Continued Investment
The BIRD Foundation's approval of a fifth disbursement amounts to approximately NIS 564,400 ($166,000 USD), bringing total support from the foundation to nearly NIS 3 million ($882,352 USD) to date. The milestone payment reflects the program's recent scientific and regulatory achievements, particularly the constructive FDA guidance received during the Pre-IND meeting that enables the companies to advance toward initiating First-in-Human clinical trials.
"We believe that the BIRD Foundation's decision to release this additional tranche of funding is a strong endorsement of the remarkable scientific and regulatory progress we've achieved with iTolerance," said Ronen Twito, Executive Chairman and CEO of Kadimastem. "Our successful Pre-IND meeting with the FDA marks a pivotal step on the path to clinical development, and we are energized by the potential of iTOL-102 to redefine what is possible for patients with Type 1 diabetes."
Innovative Combination Therapy Approach
iTOL-102 represents a novel approach combining two complementary technologies. Kadimastem's IsletRx technology provides a scalable, stem cell-derived source of insulin-producing islet-like cells, while iTolerance's proprietary iTOL-100 immunomodulatory platform addresses the immunological challenges of cell transplantation. This combination aims to overcome the traditional requirement for chronic systemic immunosuppression in transplant-based diabetes therapies.
In preclinical studies, the combined therapy demonstrated functional insulin secretion and disease reversal in diabetic animal models. The product has undergone testing at the Diabetes Research Institute at the University of Miami and is regarded as a potential breakthrough in transplant-based diabetes therapies.
Clinical Development Pathway
The companies are currently preparing for safety toxicology studies and the initiation of clinical trial submissions based on FDA guidance received during the Pre-IND meeting. The regulatory pathway established through this interaction positions iTOL-102 for advancement into human clinical testing.
"We believe that the continued support from the BIRD Foundation, especially following our productive Pre-IND meeting with the FDA, is a strong validation of the significant progress we've made in developing iTOL-102," said Anthony Japor, CEO of iTolerance. "This milestone brings us another step closer to offering a functional cure for patients living with Type 1 diabetes—without the burden of lifelong immunosuppression."
Strategic Collaboration Framework
The iTOL-102 program operates within a broader strategic framework that includes NLS Pharmaceutics' proposed merger with Kadimastem. Alex Zwyer, Chief Executive Officer of NLS Pharmaceutics, noted that the milestone "further reinforces the strong scientific and strategic rationale behind our proposed merger with Kadimastem" as the merged company prepares to initiate key clinical studies in diabetes.
The collaboration leverages the expertise of multiple organizations: Kadimastem's clinical-stage biotechnology platform for allogeneic cell therapies derived from human embryonic stem cells, iTolerance's regenerative medicine focus on immunomodulatory technologies, and NLS Pharmaceutics' development experience in complex therapeutic areas.
Technology Platform Foundations
Kadimastem's IsletRx technology represents part of the company's broader portfolio of "off-the-shelf" cell therapies derived from human embryonic stem cells. The company's lead products include AstroRx for ALS treatment alongside IsletRx for Type 1 diabetes. iTolerance's iTOL-100 platform specifically addresses the challenge of enabling tissue or cell transplantation without chronic systemic immunosuppression, a critical limitation in current transplant-based approaches.
The continued BIRD Foundation support and FDA engagement signal growing confidence in the therapeutic potential of this combined approach to address the significant unmet medical need in Type 1 diabetes treatment.
