Company: NCEL
Filing Date: 2025-07-18
Form Type: F-4/A
Source: 0001213900-25-065783
Chunk: 419

Company: NewcelX Ltd.
Filing Date: 2025-07-18
Form: F-4/A
Chunk 419
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 microencapsulated IsletRx Pluscells maintain their identity and capability to secrete insulin in immunodeficient mice. Next planned studies aim to test the anti -diabeticeffect of this delivery method. Kadimastem expects to submit a pre -INDpackage in the third quarter of 2025. These delivery options are in various development stages. The most advanced is iTOL -102, currently at the Pre -INDstage. Preclinical development studies were conducted to support regulatory submissions for iTOL -102(Pre -IND) and Encap -IsletRx Plus(INTERACT). Drug administration strategies The use of allogeneic islets in clinical settings requires to ensure their long -termfunction in the patient without being destroyed by patient’s immune system. Kadimastem utilizes several technologies to protect the islets from the recipient’s immune system, which will eliminate the implant rejection risk, without the need to administer immunosuppressive drugs to weaken the patient’s immune system and ensure long term function of IsletRxPlus cells. 213 iTOL-102 iTOL -102are human pluripotent (embryonic) stem -cellderived islet -likeclusters mixed with iTOL -100(biotinylated PEG microgels with surface bound SA -FasL). iTOL -102consists of IsletRxPlus cells and iTOL -100prepared for delivery into the omentum, a part of the stomach of diabetic patients. The therapeutic goal for iTOL -102is to provide an easily administered, low risk, treatment via a minimally invasive procedure with long -termglucose responsiveness, that can treat diabetes without the need for chronic immunosuppression or exogenous insulin supplementation. Data from initial proof -of-conceptstudies with iTOL -102in diabetic mouse models demonstrated potential efficacy and safety results of iTOL -102. In January 2024, iTolerance and Kadimastem held a meeting with the FDA (INTERACT) to discuss safety, functionality and planning regarding the development of the joint iTOL -102project. In June 2024, The Diabetes Research Institute at the University of Miami Miller School of Medicine presented the results of iTOL -102POC study in the American Diabetes Association’s 84th Scientific Sessions that highlights the potential of human, stem cell -derivedislets combined with an immunomodulatory microgel to reverse Type 1 diabetes (T1D). The results demonstrated that the combination of iTOL -100