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.
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.
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.
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
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/