Collaboration supports IND-enabling development and a planned Phase 1/2a first-in-human clinical study in type 1 diabetes

CARY, N.C. and NEW YORK, March 24, 2026 /PRNewswire/ -- Continuity Biosciences and Breakthrough T1D, the leading global type 1 diabetes (T1D) advocacy organization, today announced a strategic collaboration to advance Continuity's NICHE^® cell-therapy platform toward a planned first-in-human clinical study for people living with T1D.

The effort is supported through Breakthrough T1D's Industry Discovery and Development Partnership (IDDP) program, which funds research projects aimed at accelerating promising therapeutic programs for the treatment, cure, and prevention of T1D.

If successful, the NICHE platform could represent a new delivery paradigm for cell-based therapies in T1D by enabling direct cell vascularization and localized immune protection while minimizing systemic immunosuppression.

The collaboration brings together Continuity's expertise in implantable, precision-controlled drug delivery systems with Breakthrough T1D's global leadership in accelerating innovation across the T1D ecosystem. The program will support IND-enabling development and a planned Phase 1/2a first-in-human clinical study of NICHE -- an implantable, retrievable, and refillable extrahepatic cell-therapy platform designed to address two key challenges limiting islet transplantation: graft vascularization and immune protection.

NICHE integrates a prevascularized graft chamber for insulin-producing cells with a dedicated drug reservoir capable of delivering localized immunomodulatory agents directly to the graft microenvironment. By combining insulin-producing cells with localized immune protection, the platform is designed to restore the body's ability to produce insulin while protecting those cells from immune attack. This precision-controlled approach enables targeted immune modulation while minimizing systemic exposure, with the goal of improving graft durability and long-term therapeutic outcomes.

"This collaboration reflects our conviction that the future of type 1 diabetes will be shaped not only by breakthrough cell therapies, but by how effectively those therapies can be delivered, protected, and sustained over time," said Ramakrishna Venugopalan, PhD, MBA, Co-Founder and Chief Executive Officer of Continuity Biosciences. "Breakthrough T1D has played a critical role in catalyzing progress across the field. Together, we are advancing both the science and the disciplined clinical pathway necessary to translate innovation into scalable impact for patients."

The staged development program is designed to establish concept feasibility and safety before advancing to full combination-product capabilities incorporating localized immune modulation in preclinical models. The planned Phase 1/2a study will evaluate device safety, vascularization, and islet viability in adults with long-standing T1D.

"As a co-founder of Continuity, my focus has been translating breakthrough delivery science into clinically practical and scalable technologies," said Alessandro Grattoni, PhD, Co-founder and Chief Scientific Advisor of Continuity Biosciences. "NICHE was engineered to create a controlled, prevascularized environment where therapeutic cells can survive and function while localized immunotherapy helps protect those cells from immune attack. Our goal is to enable durable cell therapies that could ultimately restore the body's ability to produce insulin."

"The development of safe and effective cell therapies that can one day lead to cures for type 1 diabetes is a key priority for Breakthrough T1D," said Asja Guzman, PhD, Breakthrough T1D Associate Director of Cell Therapy Research. "Addressing the immune rejection after transplantation remains a challenge. We are excited to work with Continuity on this new approach to keeping transplanted cells healthy and protected from immune rejection with localized rather than broad immunosuppression."

Together, the collaboration will advance a new generation of technology designed to serve as infrastructure for next-generation cell therapies, helping make durable cell-based therapies for T1D a clinical reality.

About Continuity Biosciences

Continuity Biosciences is a clinical-stage biotechnology company developing implantable and device-enabled platform technologies at the intersection of drug delivery, biologics, and medical devices. The company's platforms are designed to overcome key translational barriers in cell therapy and oncology by enabling localized, precision-controlled drug delivery while minimizing systemic toxicity. Its pipeline includes the NICHE^® platform for Type 1 Diabetes and an oncology portfolio of intratumoral delivery technologies, including its iontophoretic (IOP) system advancing toward first-in-human clinical studies in pancreatic cancer.

Learn more at
www.continuitybiosciences.com

About Breakthrough T1D, Formerly JDRF

As the leading global type 1 diabetes research and advocacy organization, Breakthrough T1D helps make everyday life with type 1 diabetes better while driving toward cures. We do this by investing in the most promising research, advocating for progress by working with government to address issues that impact the T1D community, and helping educate and empower individuals facing this condition.

Learn more at
www.breakthrought1d.org

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