February 13, 2012
Transplant RFP Update: ITN Invites Two Full Applications for Spring NSC Meeting
This past summer the ITN issued a Request for Proposals (RFP) for clinical trials designed to induce tolerance using combined therapeutic cell transfer and solid organ transplantation. This RFP was an effort to corral innovative strategies from the transplant community to identify novel and promising clinical trials to further explore the use of mixed chimerism as a tolerance induction strategy.
The ITN received numerous high-quality submissions in response to the RFP, and is engaging with investigators to gather additional information about the proposed trials. Following initial discussions the ITN has invited two full applications to be vetted by the NSC at the spring meeting. These two Full Applications include:
1) "High-dose post-transplantation cyclophosphamide as a means of achieving hematopoietic chimerism and long-term renal allograft tolerance" (Lode Swinnen, Johns Hopkins University)
2) "Alemtuzumab, costimulation blockade and sirolimus: a tolerogenic canvas for antigen (MSC) delivery" (Allan Kirk, Emory University)
Two Allergy Trials to be Discussed at Spring NSC Meeting
A preliminary protocol for a trial using Amgen's anti-TSLP agent in combination with antigen will be presented at the upcoming spring meeting for NSC review and feedback. This study will be led by Jon Corren (UCLA) and is a collaborative project between ITN and Amgen.
Additionally, the NSC will review a Full Application from Mark Larche (McMaster University) to study the mechanisms of tolerance induced by a cat peptide vaccine.
Update from ITN Autoimmunity Subgroup
Over the past few months the ITN's Autoimmunity Assessment Group (Bill St. Clair, Alan Krensky, Jim Krueger, Olaf Stuve, David Fox) has been discussing combination therapy approaches to induce tolerance in various autoimmune indications. At the spring meeting Bill St. Clair will provide an update on the group's activities and the priority combination projects identified.
Pipeline Updates
ITN Planning Mechanistic Pilot for Kuendig Study
The NSC approved a Full Application from Thomas Kuendig at the fall meeting to conduct the mechanistic portion of a cat allergen vaccine study. In advance of full study development the ITN plans to conduct a small pilot to determine whether exposure chamber antigen challenges can produce robust measurements for mechanistic assays. If the Larche Full Application is approved, the plan is to coordinate this pilot to accommodate both studies.
Diamond Combination Study in Feasibility Analysis
A combination trial of rituximab (anti-CD20) plus belimumab (anti-BAFF) in lupus nephritis (Betty Diamond; Full Application approved at the fall 2011 meeting) is with the ITN's Clinical Trials Group for a feasibility analysis, and discussions with industry partners regarding level of support are underway.
Request for Proposals - Combination Therapy Trials in Allergy and Asthma
In conjunction with the upcoming American Academy of Allergy, Asthma, and Immunology (AAAAI) conference (March 2-6), the ITN is issuing a Request for Proposals for studies that combine allergen-specific approaches with other immunomodulatory agents, as well as assays to investigate allergen-specific mechanisms of clinical tolerance. The RFP will be distributed to all meeting delegates.
Publications
Recent ITN published manuscripts:
Feng: "Complete immunosuppression withdrawal and subsequent allograft function among pediatric recipients of parental living donor liver transplants" (Journal of the American Medical Association, 2012)
Burlingham (Newell): "Donor-specific indirect pathway analysis reveals a B cell-independent signature which correlates with graft status in kidney transplant recipients" (American Journal of Transplantation, 2011)
Monach (Specks): "Circulating markers of vascular injury and angiogenesis in ANCA-associated vasculitis" (Arthritis and Rheumatism, 2011)
Monach (Specks): "Circulating angiopoieitin-2 as a biomarker in ANCA-associated vasculitis" (PLoS ONE)
Upcoming abstract presentations:
Shamji (Durham): "Interluekin-35 suppresses allergen-specific Th2 response in patients with grass pollen induced seasonal allergic rhinitis" (American Academy of Allergy, Asthma, and Immunology, March 2-6, 2012)
Shamji (Durham): "Effects of nasal allergen challenge on T cell signature in peripheral blood in patients with severe seasonal allergic rhinitis (American Academy of Allergy, Asthma, and Immunology, March 2-6, 2012)
Shamji (Durham): "IgE-facilitated peanut-allergen binding to B cells (IgE-FAB peanut): a diagnostic biomarker for peanut allergy?" (American Academy of Allergy, Asthma, and Immunology, March 2-6, 2012)
Announcements
Upcoming NSC Meetings:
April 24-25, 2012 in Chicago, IL
October 23-24, 2012 in Washington, DC
ITN Process Overview at April NSC Meeting
For new NSC members (and anyone who is interested) the ITN will host an informal breakfast session preceding the start of the spring NSC meeting to review the ITN's pipeline development process and the NSC's role in shaping the pipeline. More information about this morning session will be available close to the meeting.
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