Partnership Between Continuity Biosciences and Breakthrough T1D for NICHE® Cell Therapy Platform Advancement

Introduction

In a groundbreaking move in the field of diabetes research, Continuity Biosciences and Breakthrough T1D have announced a strategic collaboration that aims to advance the NICHE® cell therapy platform towards its first clinical study in human subjects suffering from type 1 diabetes (T1D). This partnership is seen as a significant step in not only improving the lives of those affected by diabetes but also in accelerating the development of innovative therapies that could potentially change the landscape of T1D treatment.

Collaboration Goals

The collaboration is particularly focused on the IND (Investigational New Drug) application and the upcoming phase 1/2a clinical trial. The NICHE® platform promises to transform how cell therapies are administered, offering a novel approach that ensures direct vascularization and localized immune protection while reducing the need for systemic immunosuppression. This is crucial as it minimizes potential side effects associated with traditional therapies.

Key Features of the NICHE® Platform

NICHE® integrates a pre-vascularized graft chamber for insulin-producing cells with dedicated drug reservoirs capable of delivering localized immunomodulators directly to the graft's microenvironment. By combining insulin-producing cells with localized immune protection, the platform is designed to restore the body’s ability to produce insulin while simultaneously shielding those cells from autoimmune attacks. This targeted immunomodulation aims to enhance graft durability and achieve better long-term therapeutic outcomes.

Ramakrishna Venugopalan, co-founder and CEO of Continuity Biosciences, emphasized the transformative potential of this collaboration: "The future of type 1 diabetes will not only hinge on revolutionary cell therapies but also on how effectively these therapies can be administered and maintained over time. Together with Breakthrough T1D, we are advancing both the science and the clinical pathway necessary to translate innovation into a meaningful impact for patients."

Research and Development Path

The phased development program aims to establish the feasibility and safety of the novel concept before moving on to fully integrated combination products that incorporate localized immune modulation in preclinical models. The upcoming phase 1/2a study will specifically assess the safety of the device, graft vascularization, and the viability of Langerhans islets in adults with chronic T1D.

Alessandro Grattoni, co-founder and senior scientific advisor of Continuity Biosciences, noted the program’s objective: "Our goal is to create a controlled, pre-vascularized environment where therapeutic cells can survive and function effectively, while localized immunotherapy protects them from immune attacks. We aim to enable sustainable cell therapies that could ultimately restore the body’s insulin production capabilities."

Importance of Targeted Immunosuppression

Asja Guzman, Deputy Director of Cellular Therapy Research at Breakthrough T1D, highlighted the partnership's focus on addressing the critical challenge of immune rejection post-transplantation: "Developing safe and effective cellular therapies that could one day lead to a cure for type 1 diabetes is paramount. We are excited to collaborate with Continuity to explore this novel approach to keeping transplanted cells healthy and protected from immune rejection through localized immunosuppression rather than systemic approaches."

Through this collaboration, both organizations aim to propel a new generation of technologies designed to lay the groundwork for next-gen cellular therapies, thereby making sustainable therapies for T1D a clinical reality.

About the Collaborating Organizations

Continuity Biosciences is a clinical-stage biotechnology company that develops implantable, device-activated technology platforms at the intersection of drug delivery, biologics, and medical devices. Their NICHE® platform for type 1 diabetes, along with their portfolio of tumor delivery technologies, underscores their commitment to overcoming key barriers in cellular therapy and oncology.

For more details, visit Continuity Biosciences.

Breakthrough T1D, formerly known as JDRF, is the leading global organization dedicated to type 1 diabetes research and advocacy. Their mission is to enhance the everyday lives of those affected by T1D while driving research efforts aimed at finding a cure. Learn more at Breakthrough T1D.