Company: NCEL
Filing Date: 2025-02-05
Form Type: F-3
Source: 0001213900-25-010223
Chunk: 30

Company: NewcelX Ltd.
Filing Date: 2025-02-05
Form: F-3
Chunk 30
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 Encap-IsletRx (INTERACT).

Drug administration strategies

The use of allogeneic islets
in clinical settings requires to ensure their long-term function in the patient without being destroyed by patient’s immune system
The Company 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 IsletRx cells.

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iTOL-102

iTOL-102 are human pluripotent (embryonic) stem-cell derived islet-like clusters mixed with iTOL-100 (biotinylated PEG microgels with surface bound SA-FasL). iTOL-102 consists of IsletRx Pluscells and iTOL-100 prepared for delivery into the omentum, a part of the stomach of diabetic patients. The therapeutic goal for iTOL-102 is to provide an easily administered, low risk, treatment via a minimally invasive procedure with long-term glucose responsiveness, that can treat diabetes without the need for chronic immunosuppression or exogenous insulin supplementation. Data from initial proof-of-concept studies with iTOL-102 in diabetic mouse models demonstrated supportive efficacy and safety results of iTOL-102.

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Encap-IsletRx Plus

Microencapsulation of cells within semi-permeable hydrogels represents an immune isolation strategy for cell-based therapies without the need for systemic immunosuppression. Studies have demonstrated that the microencapsulation process does not hinder the function of islets, and the insulin is efficiently secreted in response to elevated blood glucose levels, using similar doses of islets as used in the Edmonton protocol. Preclinical studies have demonstrated long-term Encap-IsletRx Plusfunctionality, in terms of continuous balanced glucose levels, in immunocompetent mice without immunosuppressive treatment. The microencapsulation provides a physical barrier that protects the IsletRx Plusfrom the host immune system. Kadimastem’s aim for Encap-IsletRx Plusis an easily administered, low risk, minimally invasive procedure in which encapsulated islets with long-term glucose responsiveness can treat diabetes without the need for immunosuppression or exogenous insulin supplementation.

In-Scaffold-IsletRx Plus

Although alginate microcapsules provide immuno-isolation, their surgical retrievability might be difficult