JDRF Funding Opportunity: Therapeutic Development and Early Clinical Testing of T Cell Targeted Immunotherapies for the Treatment of Type 1 Diabetes

Here is the announcement from JDRF:

"JDRF REQUESTS EXPRESSIONS OF INTEREST FOR: THERAPEUTIC DEVELOPMENT AND EARLY CLINICAL TESTING OF T CELL TARGETED IMMUNOTHERAPIES FOR THE TREATMENT OF TYPE 1 DIABETES.

PURPOSE

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 towardsregulatory approval of novel therapeutic candidates.

BACKGROUND

Type 1 diabetes (T1D) is a chronic autoimmune disorder in which auto-reactive T cells mediate the destruction of insulin-producing pancreatic ?-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 autoreactive 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.

OBJECTIVE/SCOPE

Examples of pertinent topics include, but are not limited to: 

-IND-enabling studies of clinical candidates, including GLP/tox, studies if justified.

-Pre-clinical mechanistic and/or efficacy studies of candidate therapeutics in appropriate animal models (effectiveness in two orthogonal models is desirable).

-Optimization of lead candidate molecules.

-Pilot clinical studies to demonstrate proof-of-mechanism or effectiveness for existing clinicalstage drugs to define the expected MOA of different types of T cell targeted therapies.

To help ensure reproducibility and reliability of results, applicants are encouraged to work with appropriate Contract Research Organizations (CROs). A list of CROs with relevant expertise is available upon request. Projects involving parties with complementary expertise are highly encouraged to submit to this RFA. Applicants are strongly encouraged to consult Subject Matter Experts (SME) while preparing their EOIs. This may include solicitation of scientific, clinical, regulatory and commercial advice. A clear vision of the Target Product Profile (TPP) of a therapeutic candidate is a plus. This RFA is not intended to support: projects involving approved repositioned therapies not targeting Treg or Teff function, research on biomarker identification, studies without potential for near term translation, or for informing future clinical approaches, and discovery efforts.

Introduction meeting: Aug. 10 at 11am-12pm ET

Letter of Intent: Oct. 8, 2018

Full Proposal Deadline: Jan. 7, 2019"

More information: http://grantcenter.jdrf.org/rfa/therapeutic-development-and-early-clinical-testing-of-t-cell-targeted-immunotherapies-for-the-treatment-of-type-1-diabetes/