Advancing the platform toward first-in-hunam study in type 1 diabetes
Continuity Biosciences and Breakthrough T1D have formed a strategic collaboration to advance Continuity’s Niche cell-therapy platform toward a planned first-in-human clinical study for people living with Type 1 Diabetes (T1D).
The effort is supported by Breakthrough T1D’s Industry Discovery and Development Partnership (IDDP) program, which funds research projects that accelerate 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 facilitating direct cell vascularisation and localised immune protection while reducing systemic immunosuppression.
The collaboration combines Continuity’s expertise in implantable, precision-controlled drug delivery systems with Breakthrough T1D’s experience 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 the challenges of graft vascularisation and immune protection that limit islet transplantation.
Niche integrates a prevascularised graft chamber for insulin-producing cells with a dedicated drug reservoir that can deliver localised immunodulatory agents to the graft microenvironment. By combining insulin-producing cells with localised immune protection, the platform can help restore the body’s ability to produce insulin while protecting those cells from immune attack. This precision-controlled approach allows targeted immune modulation while decreasing systemic exposure, aiming to enhance graft durability and long-term therapeutic outcomes.
Ramakrishna Venugopalan, co-founder and CEO of Continuity Biosciences, said, “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. Breakthrough T1D has played a critical role in catalysing 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 has been developed to establish concept feasibility and safety before advancing to full combination-product capabilities, incorporating localised immune modulation in preclinical models. The planned Phase 1/2a study will analyse device safety, vascularisation, and islet viability in adults with long-standing T1D.
Alessandro Grattoni, co-founder and chief scientific advisor of Continuity Biosciences, said, “As a co-founder of Continuity, my focus has been translating breakthrough delivery science into clinically practical and scalable technologies. Niche was engineered to create a controlled, prevascularised environment where therapeutic cells can survive and function while localised 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.”
Asja Guzman, Breakthrough T1D associate director of Cell Therapy Research, said, “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. 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 localised rather than broad immunosuppression.”
