NLS Pharmaceutics Advances iTOL-102 Program with New Funding and FDA Support for Type 1 Diabetes Therapy

NLS Pharmaceutics Ltd., a Swiss biopharmaceutical company specializing in central nervous system disorders, has made significant strides in its iTOL-102 diabetes program. Recently, the Israel-U.S. Binational Industrial Research and Development Foundation (BIRD Foundation) approved a funding milestone that supports the collaboration between NLS, Kadimastem, and iTolerance in developing innovative therapies for Type 1 diabetes.

This breakthrough funding is a testament to the progress made in this initiative, especially after a successful Type B Pre-Investigational New Drug (Pre-IND) meeting with the U.S. Food and Drug Administration (FDA) back in February 2025. The FDA provided constructive guidance, paving the way for the next steps in the clinical development of iTOL-102, a potential functional cure for Type 1 diabetes that offers a unique advantage by eliminating the need for lifelong immunosuppressive drugs.

The BIRD Foundation's latest funding allocation amounts to approximately NIS 564,400 (around $166,000 USD), contributing to the total support of near NIS 3 million (approximately $882,352 USD) that has been awarded to date. Leaders from both Kadimastem and iTolerance expressed their optimism regarding the ongoing backing from the BIRD Foundation, highlighting its role in validating the promising nature of the projects they are working on together.

Ronen Twito, the Executive Chairman and CEO of Kadimastem, stated that the release of additional funds signifies the remarkable scientific and regulatory advancements achieved in collaboration with iTolerance. He praised the successful Pre-IND meeting as pivotal, reinforcing their commitment to the clinical development of iTOL-102.

Similarly, Anthony Japor, CEO of iTolerance, recognized the BIRD Foundation's support as vital for progressing toward the development of a viable treatment for Type 1 diabetes without the burden of lifelong immunosuppression. Together with Kadimastem, they aim to transform how this chronic disease is managed, potentially improving the lives of countless patients.

The technology behind iTOL-102 combines Kadimastem's IsletRx technology, which generates stem cell-derived insulin-producing islet-like cells, with iTolerance's iTOL-100 platform for immunomodulation. This collaboration aims to offer an innovative approach to treating diabetes, as preclinical studies have already demonstrated insulin secretion and the reversal of diabetes symptoms in animal models.

As they prepare for safety toxicology studies and the initiation of human clinical trials, NLS Pharmaceutics is also celebrating another achievement: Dr. Eric Konofal, their Chief Scientific Officer, has been nominated for the esteemed Prix Galien award in the biotech sector. Dr. Konofal's contributions to pediatric sleep medicine, including groundbreaking work on narcolepsy, have drawn attention and recognition from the international scientific community.

In summary, the partnership among NLS Pharmaceutics, Kadimastem, and iTolerance showcases a strong commitment to advancing the understanding and treatment of Type 1 diabetes. With continued support from organizations like the BIRD Foundation, the team is well-positioned to initiate clinical trials that could lead to revolutionary changes in diabetes therapy. As they move forward, all eyes will be on their upcoming studies and the potential impacts of this innovative approach on future diabetes treatments.

Topics Health)

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