Encellin and Breakthrough T1D Planning Phase 1 of Immune-Protected Cell Therapy for Type 1 Diabetes

Key Points

• Encellin and Breakthrough T1D are partnering to advance ENCRT-103-hPI, which contains primary donor islets inside a retrievable, immune-protective implant.
• A planned Phase 1 study in Canada will evaluate safety, tissue response, immune-cell exclusion, and donor islet survival.
• Breakthrough T1D will provide $2.5 million over 24 months through its Industry Discovery and Development Partnership program.

Encellin has announced a partnership with Breakthrough T1D to advance ENCRT-103-hPI for type 1 diabetes (T1D). The collaboration includes an award through Breakthrough T1D’s Industry Discovery and Development Partnership program.

ENCRT-103-hPI consists of primary donor islets contained within Encellin’s implant device, ENC-103-CED. The quarter-sized device provides a soft, pillow-like enclosure designed to contain the cells and prevent immune cells from reaching them. The retrievable implant is placed in the upper arm or abdomen.

Planned Phase 1 Study

The Phase 1 study, NCT07680673, is planned for adults with T1D in Canada. Eligibility is open to patients on a standard-of-care islet infusion waitlist and those who are not. Participation will not preclude enrollment in future Encellin trials.

The study will last approximately 4.5 months, with the implant remaining in place for four months. Participants will follow a standard-of-care follow-up schedule during the implant period.

The study will assess:

• Safety and tolerability
• Local tissue response
• Vascular integration around the implant
• The ENCRT membrane’s ability to exclude immune cells
• Survival of transplanted donor islets

The program follows Encellin’s first-in-human Phase 1 study, NCT06408311. Encellin reported non-fibrotic tissue integration, vascularization, and viable human islets within retrieved ENC-201 implants.

Cell Protection Approach

Islet transplantation is intended to replace the insulin-producing cells lost in T1D. Current islet transplantation requires systemic immunosuppression to protect transplanted cells. Encellin is developing encapsulated cell replacement therapy (ENCRT) with the long-term goal of allowing transplanted cells to survive and function while remaining protected from the immune system without systemic immunosuppression.

“People with Type 1 Diabetes manage their disease every hour of every day. Our vision is a future where replacing the cells lost to T1D and protecting them instead of suppressing the patient’s immune response can become a practical therapeutic option for many more people,” said Crystal Nyitray, PhD, founder and CEO of Encellin. “This study represents an important step toward that goal. We are grateful to Breakthrough T1D for sharing that vision and for supporting the careful clinical work required to determine whether an immune-protected cell replacement approach can ultimately deliver meaningful benefit to people living with T1D.”

“Islet Cell replacement has enormous potential to transform the lives of people with Type 1 Diabetes, but protecting transplanted insulin-producing cells from the immune system without the need for immune suppressive drugs remains one of the field’s central challenges,” said Asja Guzman, Associate Director of Cell Therapy Research at Breakthrough T1D. “Breakthrough T1D is committed to advancing approaches to help overcome this barrier. Encellin’s clinical program provides an opportunity to validate a retrievable, immune-protective device can safely support the long-term function of transplanted islets in people with T1D, and we are pleased to collaborate in this next stage of development.”

Want to keep up on regenerative medicine? Get the weekly newsletter here.