Deadlines are 5:00 PM (Eastern). No extensions will be granted.
Please click on the “RFA ANNOUNCEMENT” link in the upper right corner for complete information.
The purpose of this request for applications (RFA) is to facilitate faster translation of important type 1 diabetes (T1D) related research findings into viable immune therapeutic candidates for human testing. This RFA intends to specifically support late stage preclinical development of promising candidate immune drug and biologic therapies. It is JDRF’s hope that projects successfully completed under this RFA will attract external partners for large scale trials towards regulatory approval of novel therapeutic candidates.
Type 1 diabetes (T1D) is a chronic autoimmune disorder in which auto-reactive T cells mediate the destruction of insulin-producing pancreatic β-cells, leading to lifelong dependence on exogenous insulin. To date, there are no approved immunotherapies for the prevention or treatment of T1D. Immune therapies that have shown promising results in T1D trials have included therapies aimed at enhancing the number and/or function of regulatory T cells (Treg) as well as those aimed at disabling or ablating auto-reactive effector T cells (Teff). To maximize efficacy and patient impact in T1D, a variety of Treg and Teff targeted therapies will be essential. To this end, in addition to pre-clinical development of novel lead candidates, existing clinical grade T cell targeted product candidates from industry pipelines may increase the number of therapies evaluated in T1D.
There are inherent challenges in translating findings from preclinical models to human T1D, especially with respect to the dose, route, and frequency of administration to result in clinically meaningful outcomes. These challenges make it difficult to compare candidate therapies head to head. There is therefore a dire need for standardized high quality preclinical testing of promising therapies. This RFA seeks proposals both from for-profit and non-profit sectors involving T cell targeted product candidates that require late stage pre-clinical development and also encourages projects to test clinical-stage compounds in proof-of-mechanism clinical trials in T1D.