Company: NCEL
Filing Date: 2025-02-10
Form Type: F-3
Source: 0001213900-25-011823
Chunk: 30

Company: NewcelX Ltd.
Filing Date: 2025-02-10
Form: F-3
Chunk 30
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(embryonic) stem cell-derived pancreatic islet-like cell clusters (IsletRx); mixed with SA-FasL Microgels (iTOL-100), intended
for omental implantation. The iTOL100 enables implanting of IsletRx cells without the need of chronic immunosuppression
treatment. Thus, IsletRx cells are in direct contact with the omental vasculature, ensuring proper engraftment and function.
Preclinical efficacy studies using iTOL-102 demonstrated prolonged anti-diabetic effect, 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-IND package.

Encap-IsletRx Plus
Human pluripotent (embryonic) stem cell-derived pancreatic islet-like cell clusters (IsletRx); encapsulated in alginate
microgels, intended for intra-periotenal implantation. The alginate microencapsulation enables implanting of IsletRx cells
without the need of chronic immunosuppression treatment. Still, IsletRx cells 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 cells
is a regulatory concern, as there is very limited data about the safety of stem cells-derived islets. Preclinical efficacy studies using
Encap-IsletRx demonstrated prolong anti-diabetic effect, with physiological secretion of human insulin in a glucose dependent
manner.

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In-Scaffold-IsletRx Plus
Human pluripotent (embryonic) stem cell-derived pancreatic islet-like cell clusters (IsletRx); encapsulated in alginate
microgels embedded in electro spun polycaprolactone membrane, intended for subcutaneous implantation. The alginate microencapsulation
enables implanting of IsletRx cells 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
demonstrated that microencapsulated IsletRx cells maintain their identity and capability to secrete insulin in immunodeficient
mice. Next planned studies aim to test the anti-diabetic effect of this delivery