Encellin Partners with Breakthrough T1D to Advance Immune-Protected Cell Therapy for Type 1 Diabetes

SAN FRANCISCO & NEW YORK & MONTREAL — Encellin, Inc., a clinical-stage biotechnology company developing Encapsulated Cell Replacement Therapy (ENCRT), today announced a partnership with Breakthrough T1D, the leading global Type 1 Diabetes (T1D) research and advocacy organization, and an award through its Industry Discovery and Development Partnership (IDDP) program to support the advancement of Encellin’s ENCRT-103-hPI clinical program in T1D.

The new trial (NCT07680673) will bring ENCRT-103-hPI, Encellin’s immune-protected implant configuration, into the clinic. ENCRT-103-hPI builds on the successful completion of NCT06408311, Encellin’s first-in-human Phase 1 study, which demonstrated non-fibrotic tissue integration, vascularization, and viable human islets within retrieved ENC-201 implants. NCT07680673 is designed to test whether this next-generation implant can safely support and protect transplanted islets in people with T1D, and will be conducted in Canada. The planned study will assess safety, tolerability, and local tissue response, including vascular integration around the implant, the ENCRT membrane’s ability to exclude immune cells, and survival of the donor islets.

For people living with T1D, replacing the insulin-producing cells lost to the disease has the potential to address the underlying disease rather than continually managing its consequences. Today, however, islet transplantation requires systemic immunosuppression to protect transplanted cells. Encellin is developing ENCRT with the long-term goal of enabling cell replacement therapies that can survive and function while being protected from the immune system, without the need for immunosuppression.

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“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 at Breakthrough T1D. “Breakthrough T1D is committed to advancing approaches to help overcome this barrier.