Continuity Biosciences Partners with Breakthrough T1D to Advance Novel Cell Therapy Platform for Type 1 Diabetes
Key Insights
Continuity Biosciences (search) and Breakthrough T1D (search) announced a strategic collaboration to advance the NICHE (search)® cell-therapy platform toward a planned Phase 1/2a first-in-human clinical study for type 1 diabetes (search).
The NICHE (search) platform is an implantable, retrievable, and refillable extrahepatic cell-therapy system designed to address key challenges in islet transplantation through direct cell vascularization and localized immune protection.
The collaboration is supported through Breakthrough T1D (search)'s Industry Discovery and Development Partnership program, which funds promising therapeutic programs for T1D (search) treatment, cure, and prevention.
Continuity Biosciences (search) and Breakthrough T1D (search), the leading global type 1 diabetes (search) advocacy organization, announced a strategic collaboration to advance Continuity's NICHE (search)® cell-therapy platform toward a planned first-in-human clinical study for people living with type 1 diabetes. The collaboration 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 (search).
Revolutionary Platform Design
The NICHE (search) platform represents an implantable, retrievable, and refillable extrahepatic cell-therapy system designed to address two key challenges limiting islet transplantation: graft vascularization and immune protection. The platform integrates a prevascularized graft chamber for insulin-producing cells (search) with a dedicated drug reservoir capable of delivering localized immunomodulatory agents directly to the graft microenvironment.
By combining insulin-producing cells (search) 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.
Clinical Development Strategy
The collaboration will support IND-enabling development and a planned Phase 1/2a first-in-human clinical study. 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 (search).
"This collaboration reflects our conviction that the future of type 1 diabetes (search) 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 (search). "Breakthrough T1D (search) 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."
Addressing Key Therapeutic Challenges
Alessandro Grattoni, PhD, Co-founder and Chief Scientific Advisor of Continuity Biosciences (search), emphasized the platform's engineering approach: "NICHE (search) 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 collaboration addresses a critical unmet need in type 1 diabetes (search) treatment. "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 (search)," 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."
Potential Clinical Impact
If successful, the NICHE (search) platform could represent a new delivery paradigm for cell-based therapies in T1D (search) 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 (search)'s global leadership in accelerating innovation across the T1D ecosystem.
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 (search) a clinical reality. Continuity Biosciences (search) is a clinical-stage biotechnology company developing implantable and device-enabled platform technologies at the intersection of drug delivery, biologics, and medical devices, with platforms designed to overcome key translational barriers in cell therapy and oncology by enabling localized, precision-controlled drug delivery while minimizing systemic toxicity.