Pleasanton, CA, and San Francisco, CA, April 14, 2016 – Transplant Genomics Inc. (“TGI”) and Quark Pharmaceuticals, Inc. (“Quark”) today announced their joint intent to pursue a discovery and development collaboration involving the use of TGI’s TruGraf™ blood test in a Phase 3 clinical trial involving patients being treated for delayed graft function (DGF) with Quark’s proprietary drug candidate QPI-1002. Under the agreement, TGI would be Quark’s preferred provider of gene expression profiling services related to their clinical trial.
The primary objective of the Quark/TGI collaboration will be to understand individual patient responses to QPI-1002 as a function of time and gene expression in pathways of immune response injury post transplant. Results can be correlated with the extensive pre-clinical data created by Quark on the therapy’s molecular mechanism. The secondary objective will be to explore potential surrogate endpoints using the possible predictive value of genomic profiling for longer term outcomes post transplant.
“We’re excited TGI has this powerful technology for understanding the arc of post transplant ischemia reperfusion and immune events leading to the longer term consequences of rejection and graft loss ” said Dr. Elizabeth Squiers, Deputy Chief Medical Officer of Quark. “TGI’s TruGraf blood test offers a less invasive means to understand these events and to unlock the potential for future and clinically meaningful endpoints.”
Dr. Roy First, Chief Medical Officer of TGI, commented “This study could highlight an additional use of TGI’s core technology beyond the diagnostic testing we are currently commercializing. We are thrilled to have an opportunity to work with Quark on this important Phase 3 trial of an exciting novel drug candidate with the potential to shorten or avoid DGF, an unmet medical need. If the success of their phase 2 study continues such could potentially expand the population of transplantable organs while reducing costs by avoiding this common medical complication.” No other terms of the collaboration between TGI and Quark are being disclosed at this time.
About Delayed Graft Function (DGF)
DGF results from ischemia-reperfusion injury to the graft tissue associated with transplantation procedure when blood flow is re-established to the kidney following transplantation and initiates a chain of events that can lead to severe renal damage. DGF not only significantly increases the risk of delayed allograft rejection, but also adds to the cumulative cost of renal transplantation by increasing the time of hospital stay, the number of tests and the use of dialysis facilities. The increasing shortage of suitable kidney donors led to the necessity of incorporating expanded criteria donor kidneys (mainly from older deceased donors) into the donor pool. However, such kidneys are at increased risk of DGF. There is no currently marketed drug therapy for the prevention or treatment of DGF.
QPI-1002, the first systemic siRNA drug to enter human clinical trials and to complete a well-controlled clinical trial with clinical efficacy endpoints that was conducted in hundreds of patients. It is an investigational drug designed to temporarily inhibit the expression of the pro-apoptotic gene, p53, to protect normal cells from acute injury. Preclinical studies have shown that p53-targeted siRNAs can protect kidneys from ischemia/reperfusion injury in a variety of clinically relevant animal models. QPI-1002 has been granted Orphan Drug designation in the USA and Europe for the prevention of DGF in kidney transplant patients. Under an August 2010 agreement, Novartis has an exclusive worldwide license option for the development and commercialization QPI-1002.
About Quark Pharmaceuticals, Inc.
Quark Pharmaceuticals, Inc., is one of the world leaders in novel therapeutic RNAi discovery and development. The Company’s fully integrated drug development platform spans from therapeutic target identification to drug development. Quark has three siRNA product candidates in clinical development in five different disease indications of which four are in Phase II. Quark’s Joint venture in China, Kunshan Ribo-Quark Pharmaceutical Inc, and its strategic partner in India, Biocon Limited, are part of Quark’s world wide clinical studies network. Quark is headquartered in Fremont, California and operates research and development facilities in Boulder, Colorado and Ness-Ziona, Israel. For additional information please visit: www.quarkpharma.com
About Transplant Genomics Inc.
Transplant Genomics Inc. (TGI) is a molecular diagnostics company committed to improving organ transplant outcomes, with an initial focus on kidney transplant recipients. Working with the transplant community, TGI is commercializing a suite of tests enabling diagnosis and prediction of transplant recipient immune status. Test results will support clinicians with information to optimize immunosuppressive therapy, enhance patient care and improve graft survival. Test services are offered through TGI’s CLIA lab in Pleasanton, CA. www.transplantgenomics.com