Company: NCEL
Filing Date: 2025-06-23
Form Type: F-4/A
Source: 0001213900-25-056787
Chunk: 387

Company: NewcelX Ltd.
Filing Date: 2025-06-23
Form: F-4/A
Chunk 387
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 with an immunomodulatory microgel to reverse Type 1 diabetes (T1D). The results demonstrated that the combination of iTOL -100engineered microgel developed by iTolerance and IsletRx stem cell -derivedislets developed by Kadimastem, iTOL -102, can restore normoglycemia in a model of diabetes. Accordingly, the companies are working on submitting a pre -INDpackage in the third quarter of 2025. Encap-IsletRx Plus Microencapsulation of cells within semi -permeablehydrogels represents an immune isolation strategy for cell -basedtherapies 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 211 Encap -IsletRxPlusfunctionality, in terms of continuous balanced glucose levels, in immunocompetent mice without immunosuppressive treatment. The microencapsulation provides a physical barrier that protects the IsletRxPlus from the host immune system. Kadimastem’s aim for Encap -IsletRxPlusis an easily administered, low risk, minimally invasive procedure in which encapsulated islets with long -termglucose responsiveness can treat diabetes without the need for immunosuppression or exogenous insulin supplementation. A pre -INDsubmission is planned for the third quarter of 2025, respectively Encap -IsletRxPlus. In-Scaffold-IsletRx Plus Although alginate microcapsules provide immuno -isolation, their surgical retrievability might be difficult. To ensure removal of IsletRx cells if needed, it is possible to implant them in a bioengineered device to enable it. The device is a 3D printed scaffold containing encapsulated IsletRxPlus cells. The 3D printing process, called melt electrospinning writing is a relatively novel solvent -lessprocess that enables the design and fabrication of micrometer -thinfibers with highly controllable architectures and patterns manufactured at the University of Queensland, Australia. Preclinical results demonstrated that encapsulated islets placed in scaffolds and implanted subcutaneously or intraperitoneally, produced human insulin and maintained viability and identity for study duration (~3 months). Current Future studies aim to optimize this delivery strategy. In these studies, a dose response study is planned