#USA #Cary, NC #Breakthrough T1D #Continuity Biosciences #NICHE®

Collaboration to Advance NICHE® Cell Therapy Platform

Continuity Biosciences and Breakthrough T1D have announced a strategic collaboration aimed at advancing the NICHE® cell therapy platform toward its first human clinical study for individuals living with Type 1 Diabetes (T1D). This partnership leverages Breakthrough T1D's Industry Discovery and Development Partnership (IDDP) program, which supports research projects designed to accelerate promising therapeutic programs for the treatment, cure, and prevention of T1D.

The NICHE® platform represents a potential shift in how cellular therapies are administered for T1D, emphasizing direct cellular vascularization and localized immune protection while minimizing systemic immunosuppression. The collaboration merges Continuity's expertise in precision-controlled, implantable drug delivery systems with Breakthrough T1D's leadership in innovation throughout the T1D ecosystem.

The key aim of this partnership is to support the development work that will enable the submission of an Investigational New Drug (IND) application and initiate a Phase 1/2a clinical study for the NICHE® platform. This system is designed to tackle two significant challenges limiting islet transplantation: graft vascularization and immune protection.

NICHE® integrates a pre-vascularized graft chamber for insulin-producing cells with a drug reservoir capable of administering localized immunomodulatory agents directly into the graft's microenvironment. By combining insulin-producing cells with localized immune protection, this platform aims to restore the body's ability to produce insulin while simultaneously shielding these cells from immune attacks. Such a precision-based approach allows for targeted immune modulation, reducing systemic exposure, ultimately improving graft durability and long-term therapeutic outcomes.

Dr. Ramakrishna Venugopalan, co-founder and CEO of Continuity Biosciences, emphasized that this collaboration underscores the belief that the future of T1D management will not only depend on innovative cellular therapies but also on their effective administration, protection, and sustained maintenance. He noted, “Advancements in T1D treatment have been fundamental to driving progress in this area. Together, we are advancing both scientific understanding and the rigorous clinical pathway necessary to translate innovation into scalable patient impact.”

The staged development program aims to establish the feasibility and safety of the concept before progressing to the full capabilities of the combined product. This will incorporate localized immune modulation in preclinical models. The anticipated phase 1/2a study will evaluate device safety, vascularization, and islet viability in adults with long-standing Type 1 Diabetes.

Dr. Alessandro Grattoni, co-founder and Chief Scientific Officer of Continuity Biosciences, stated, “As a co-founder of Continuity, I have focused on translating scientific advancements in drug delivery into clinically practical and scalable technologies. NICHE® is designed to create a controlled and pre-vascularized environment where therapeutic cells can survive and function, while localized immunotherapy helps protect them from immune attack. Our goal is to enable durable cell therapies that could eventually restore the body's ability to produce insulin.”

Asja Guzman, PhD, Associate Director of Cellular Therapy Research at Breakthrough T1D, highlighted the importance of developing safe and effective cell therapies that could one day cure Type 1 Diabetes. She explained, “Addressing immune rejection post-transplant remains a challenge. We are excited to collaborate with Continuity on this novel approach to keep transplanted cells healthy while protecting them from immune rejection through localized rather than generalized immunosuppression.”

Together, this collaboration aims to drive a new generation of technology that is designed to serve as an infrastructure for next-generation cellular therapies, ultimately helping to turn durable cellular therapies for Type 1 Diabetes into a clinical reality.

About Continuity Biosciences

Continuity Biosciences is a clinical-stage biotechnology company developing implantable and device-based technology platforms at the intersection of drug delivery, biologics, and medical devices. The company's platforms are specifically designed to overcome major translational barriers in cell therapies and oncology by enabling the localized and precise delivery of drugs while minimizing systemic toxicity. Its product portfolio includes the NICHE® platform for Type 1 Diabetes and an oncology portfolio of intratumoral delivery technologies, including its iontophoretic system (IOP), which is progressing toward first-in-human clinical studies for pancreatic cancer.

About Breakthrough T1D (formerly JDRF)

As the leading global organization focused on research and advocacy for Type 1 Diabetes, Breakthrough T1D aims to improve daily life for individuals living with T1D while driving the search for cures. It achieves this by investing in the most promising research, collaborating with governments to address T1D community challenges, and helping to educate and empower those affected by the disease.