Company: NCEL
Filing Date: 2025-02-10
Form Type: F-3
Source: 0001213900-25-011823
Chunk: 31

Company: NewcelX Ltd.
Filing Date: 2025-02-10
Form: F-3
Chunk 31
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 method.

These delivery options are
in various development stages. The most advanced is iTOL-102, currently at the pre-IND stage. Preclinical development studies were conducted
to support regulatory submissions for iTOL-102 (pre-IND) and Encap-IsletRx (INTERACT).

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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.

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 cells 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 functionality, in terms of continuous balanced glucose levels, in immunocompetent
mice without immunosuppressive treatment. The microencapsulation provides a physical barrier that protects the IsletRxfrom
the host immune system. Kadimastem’s aim for Encap-IsletRx is an easily administered, low risk,