Transplant Genomics Inc (TGI), a molecular diagnostic company, and Quark Pharmaceuticals, Inc, a clinical-stage pharmaceutical company, 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 commercialising. 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.

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 commercialisation QPI-1002.