Encellin Announces Interim Clinical Results Showing First-in-Human Non-Fibrotic Engraftment and Viable Encapsulated Human Islets in Subjects with Type 1 Diabetes

SAN FRANCISCO--(BUSINESS WIRE)--Encellin, a biotechnology company pioneering Encapsulated Cell Replacement Therapy (ENCRT), today announced interim clinical results from its ongoing Phase 1 investigational trial (NCT06408311) in study subjects with Type 1 Diabetes. Analyses of explants from the initial five subjects at prespecified timepoints demonstrated non-fibrotic engraftment with robust vascularization around the ENCRT implant after a 4-month implantation. Importantly, in the initial evaluated explant Encellin observed viable islets, providing the first clinical support that therapeutic cells can persist within the ENCRT implant in humans.

These early findings represent the first reported human evidence suggesting that Encellin’s proprietary ENCRT can potentially be used to mitigate fibrosis, a challenge that has historically limited encapsulated approaches. Moreover, the presence of viable encapsulated human islets suggests that by addressing the fibrotic response, the local microenvironment created by the ENCRT may be capable of supporting living therapeutic cells in the human body, an important step towards the development of cell-based therapies for patients with Type 1 Diabetes.

“These findings represent an exciting milestone for our team and the field,” said Crystal Nyitray, PhD, CEO and Founder of Encellin. “While much work remains, these findings suggest that Encellin’s proprietary ENCRT approach may be capable of supporting cell therapies in humans. If confirmed in larger studies, these observations provide an important foundation for the continued development of ENCRT in Type 1 Diabetes and, over time, other endocrine indications.”

“Outside the body, we can now engineer cells in all sorts of ways. For example, we can engineer them to be little factories producing medicines like hormones and therapeutic peptides in response to outside signals,” said Alex Morgan, Partner at Khosla Ventures. “However, what we can’t currently do is easily keep these foreign cells alive inside the human body. Showing that foreign cells can be kept alive for months within these implanted packets points to a possible future where instead of needing to take medications via an injection or pill, they are just made within us, as needed, from universal cell lines. Demonstration that non-fibrotic, vascularized integration can be achieved and foreign cell viability sustained is a key milestone toward this goal, although there is still a lot of work ahead.”

The Phase 1 trial is designed to evaluate the safety and tolerability of ENCRT devices containing therapeutic cell cargo. Specifically, in this case, subjects were patients with Type 1 Diabetes implanted with allogeneic islets. While analyses are ongoing, these initial observations show early supportive human evidence of non-fibrotic, vascularized integration of ENCRT with viable encapsulated human islets—important foundations for future encapsulated cell-based therapies. Beyond Type 1 Diabetes, Encellin is exploring its ENCRT platform in additional endocrine and metabolic indications, assessing its potential as a modular and scalable solution with the long-term vision of enabling cell-based therapies across multiple diseases.

About Encellin

Encellin is a biotechnology company developing transformative cell therapies using its proprietary Encapsulated Cell Replacement Therapy (ENCRT) platform. ENCRT is an investigational device designed to protect therapeutic cells from immune rejection, enable vascular integration, and eliminate the need for lifelong immunosuppression. Encellin’s lead program is focused on Type 1 Diabetes, with additional programs in parathyroid disorders and other endocrine diseases. Encellin is backed by leading investors including Khosla Ventures and Endurance 28, who share the company’s vision of enabling safe, durable, and accessible cell-based therapies.

Forward-Looking Statements

This press release contains forward-looking statements regarding the potential benefit of the ENCRT platform, including its ability to address fibrosis, immune protection, viability of human cells, and potential applications in Type 1 Diabetes and other endocrine or metabolic diseases, development plans and vision for future programs or potential therapeutic applications. The ENCRT platform’s development for use with allogeneic islets in patients with Type 1 Diabetes is being evaluated in clinical studies, and its safety and effectiveness for this use has not been established. These statements are based on current expectations and are subject to risks and uncertainties including risks associated with early-stage clinical development, the possibility of unfavorable preclinical or clinical results, regulatory review and approval process, manufacturing challenges, and the ability to advance programs as planned. Actual results may differ materially from those expressed or implied. Encellin undertakes no obligation to update forward-looking statements contained in this press release as a result of new information or future events.

Media Contact
Encellin Communications
press@encellin.com

Investor Contact
Encellin
investors@encellin.com