Company: NCEL
Filing Date: 2025-09-03
Form Type: F-4/A
Source: 0001213900-25-084157
Chunk: 421

Company: NewcelX Ltd.
Filing Date: 2025-09-03
Form: F-4/A
Chunk 421
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otent (embryonic) stem cell -derivedpancreatic islet -likecell clusters (IsletRx Plus); encapsulated in alginate microgels, intended for intra -peritonealimplantation. The alginate microencapsulation enables implanting of IsletRx Pluscells without the need of chronic immunosuppression treatment. Still, IsletRx Pluscells are not in direct contact with the vasculature, and may suffer from hypoxia and loss of function due to fibrosis. The 213 retrievability of microencapsulated IsletRx Pluscells is a regulatory concern, as there is very limited data about the safety of stem cells -derivedislets. Preclinical efficacy studies using Encap -IsletRx Plusdemonstrated prolong anti -diabeticeffect, with physiological secretion of human insulin in a glucose dependent manner. In -Scaffold-IsletRx PlusHuman pluripotent (embryonic) stem cell -derivedpancreatic islet -likecell clusters (IsletRx Plus); encapsulated in alginate microgels embedded in electro spun polycaprolactone membrane, intended for subcutaneous implantation. The alginate microencapsulation enables implanting of IsletRx Pluscells without the need of chronic immunosuppression treatment. The embedding of the microcapsules in a membrane makes it a retrievable solution and obviates the regulatory concern. POC studies using In -Scaffold-IsletRx Plusdemonstrated that 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