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Daniel Rotrosen, M.D.
Acting Director, DAIT, NIAID
NIAID is moving ahead with major plans to expand tolerance research. Helped by a $4.5 million leg up from the NIH director’s fund, the initiative strives to bring to fruition basic research advances. Bolstering tolerance research has been in the works for a while. Two years ago, NIAID invited Dr. Jeff Blustone, to present his perspective at an Institute retreat, where he correctly predicted that tolerance research was on the verge of realizing clinical gains.
Tolerance is emerging as a major therapeutic goal for many immune diseases and transplantation with spin-offs to other areas. A strong basic science foundation has propelled research from mice to primates at unparalleled speed. Many biological agents, such as antibodies to costimulatory molecules, are available for clinical study, and success has been shown already in nonhuman primates.
Dr. Rotrosen presented Council with NIAID’s research tolerance plan, developed with input from the research community, interest groups, and industry. Panelists recommended a mechanism- rather than disease-based approach of basic, exploratory, and developmental research, including work in nonhuman primates. Relying on both solicited and unsolicited research, studies will explore transplantation, asthma, allergy, and autoimmune diseases. Developing markers showing early induction, maintenance, and loss of tolerance will be key. Following the group’s advice, NIAID is already working closely with industry on ideas for new projects.
Tolerance Research Plan: Capsule of Recommendations of Two Expert Panels
- Create a network of basic and clinical investigators and programs
- Foster multi-institutional and multi sector partnerships and approaches.
- Ensure scientific and administrative flexibility
- Study underlying mechanisms in non-human primates and in the clinic
- Support basic research to expand knowledge of the molecular basis of tolerance
- Focus on the most appropriate approaches for clinical trials
- Incorporate developmental work to identify and validate surrogate markers
- Ensure adequate research resources, including training investigators
To set the stage for a tolerance network, NIAID published an RFP in November, Collaborative Network for Clinical Research on Immune Tolerance. The single contract will integrate four components into a collaborative network. Cosponsored with Juvenile Diabetes Foundation International (JDFI), it will focus on kidney and islet transplantation, asthma and allergy, and autoimmune diseases. Find the RFP on the web at http://www.niaid.nih.gov/publications/immune/rfp1.htm.
A consortium of institutions will accelerate research to treat immune-mediated diseases, conduct clinical trials, study mechanisms of tolerance induction and loss as part of trials, and develop assays of tolerance induction and loss. Several hundred people have showed interest, including major players in the field. The RFP was published in November; award will be made at the end of the fiscal year.
In addition to the RFP, NIAID is jump starting its new efforts with the NIH funds to support three unsolicited P01s in basic mechanisms of tolerance induction and kidney transplantation in nonhuman primates. The Institute is also cosponsoring a phase I clinical trial with biotech company Biogen, Inc. that will begin shortly and are supplementing three NIAID grants to study the mechanisms of kidney graft maintenance in clinical trials.
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