Company: NCEL
Filing Date: 2025-03-31
Form Type: F-4/A
Source: 0001213900-25-026428
Chunk: 279

Company: NewcelX Ltd.
Filing Date: 2025-03-31
Form: F-4/A
Chunk 279
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 laboratory conditions, in 142 several stages, by adding chemical and/or biological agents in controlled timings to the pluripotent stem cell culture. Induction of differentiation processes of pluripotent stem cells into islet -likecell clusters, under laboratory conditions is conducted in a stirred suspension bioreactor under conditions that mimic the development of the pancreatic islets. Enrichment:Kadimastem has developed an enrichment technology which it believes improves safety and efficacy of IsletRx cells. The IsletRx cells are enriched for insulin secreting cells, designated as IsletRxPlus, and formulated as the drug substance. Delivery:Several delivery strategies were developed to obviate the need for life -longimmunosuppressive treatment while enabling the long -termfunction of IsletRxPlus cells. These strategies include immune tolerance, microencapsulation in polymer, and scaffolding using electrospinning of polycaprolactone. The cellular component in all products is the same, IsletRx Pluscells. Products description iTOL -102Human pluripotent (embryonic) stem cell -derivedpancreatic islet -likecell clusters (IsletRx Plus); mixed with SA -FasLMicrogels (iTOL -100), intended for omental implantation. The iTOL100 enables implanting of IsletRx Pluscells without the need of chronic immunosuppression treatment. Thus, IsletRx Pluscells are in direct contact with the omental vasculature, ensuring proper engraftment and function. Preclinical efficacy studies using iTOL -102demonstrated prolonged anti -diabeticeffect, with physiological secretion of human insulin in a glucose dependent manner. These results, along with the proof of concept, or POC, studies with an iTOL100 component, have led to submission of a Pre -INDpackage. Encap -IsletRx PlusHuman pluripotent (embryonic) stem cell -derivedpancreatic islet -likecell clusters (IsletRx Plus); encapsulated in alginate microgels, intended for intra -periotenalimplantation. 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 retrievability of microencapsulated IsletRx Pluscells is a regulatory concern