Kadimastem and iTolerance Achieve Key Milestone with FDA for Type 1 Diabetes Treatment

Collaborative Milestone in Diabetes Treatment

In an encouraging step towards addressing Type 1 Diabetes, Kadimastem Ltd. and iTolerance Inc. have successfully completed a pre-IND (Investigational New Drug) meeting with the U.S. Food and Drug Administration (FDA). This milestone, achieved on February 24, 2025, highlights the collaborative efforts between the two companies in developing iTOL-102, a groundbreaking treatment that aims to cure diabetes without requiring lifelong immune suppression.

Understanding iTOL-102

iTOL-102 integrates Kadimastem’s IsletRx cells, derived from allogenic human stem cells, with iTolerance’s immunomodulator, iTOL-100. This combination represents a promising innovation in the treatment landscape for Type 1 Diabetes, as it has shown potential in reversing the disease in preclinical studies by inducing immune tolerance against the transplanted cells.

In particular, IsletRx cells possess the unique capability of secreting insulin, which can address the critical shortage of donor islets currently faced by patients. Kadimastem's focus on creating a scalable source of these insulin-producing cells is crucial for effective diabetes management.

Advances and FDA Insights

Both companies expressed their optimism following the meeting with the FDA, with Ronen Twito, Kadimastem's Executive Chairman and CEO, emphasizing the positive collaboration with the regulatory agency. This engagement provided essential feedback on the preclinical and clinical development plans, facilitating the design of upcoming safety and toxicology studies crucial for progressing toward human trials.

Dr. Anthony Japour, CEO of iTolerance, reinforced the significance of the FDA’s guidance, noting that it validates their mission to deliver transformative therapies to individuals with Type 1 Diabetes. The focus is on eliminating lifelong immune suppression typically required after the transplantation of allogenic cells—a common drawback in current treatments.

Collaborative Efforts and Future Directions

Kadimastem and iTolerance’s partnership is further strengthened through funding from the Israel-U.S. Binational Industrial Research and Development Foundation, indicating significant institutional support for this innovative project. The recent evaluation at the Diabetes Research Institute in Miami identified iTOL-102 as a potential breakthrough in transplantation, showcasing the efficacy of combining tolerance-inducing agents with stem cell-derived pancreatic islets.

They anticipate that advancements made through this collaboration will pave the way for regulatory approvals, leading to human trials of iTOL-102. As they adapt their development strategies based on the FDA's suggestions, Kadimastem and iTolerance remain committed to bringing forth a solution capable of radically transforming diabetes treatment.

The Path Ahead

Both companies now aim to incorporate FDA feedback as they refine their plans for subsequent studies, focusing on ensuring the safety and effectiveness of the treatment before advancing into human clinical trials. The implications of a successful iTOL-102 could change the lives of millions affected by Type 1 Diabetes, alleviating the burdens of daily management and long-term health complications due to the disease.

Conclusion

The progress made by Kadimastem and iTolerance underscores the potential for innovative therapies in the realm of regenerative medicine. As they continue to navigate the complexities of development and regulation, the medical community and patients alike eagerly await the results of their endeavors, hopeful for a future where diabetes can be effectively managed or perhaps even cured.