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Transplant Genomics Inc. Announces Exclusive License to Patent Rights Co-Owned by The Scripps Research Institute and Northwestern University

July 14, 2014

Company to Develop and Commercialize Genomics-Based Tests to Improve Organ Transplant Outcomes

BROOKLINE, Mass.--(BUSINESS WIRE)-- Transplant Genomics Inc. (TGI) announced that it has obtained an exclusive license to patent rights co-owned by The Scripps Research Institute and Northwestern University that provide the foundation for clinical tests to improve management of organ transplant recipients, with the potential to extend lives and reduce costs of associated healthcare. TGI intends to develop and commercialize tests that use genomic markers of transplant graft status as part of a surveillance program to detect and respond to early signs of graft injury.

This licensing agreement provides TGI with access to a broad portfolio of intellectual property related to kidney and liver transplant diagnostics, including immune status monitoring and optimization. TGI’s scientific founders, Dr. Michael Abecassis (Northwestern Medicine) and Dr. Daniel Salomon (The Scripps Research Institute), have been recognized for their work on discovery and validation of novel biomarkers of graft and immune status for solid-organ transplants.

“The scientific founders of TGI have uniquely combined biomarker discovery with clinical validation and insight to set the stage for high-impact collaborations designed to move the transplant field forward,” explained Stanley Rose, PhD, President & CEO of Transplant Genomics and a kidney transplant recipient. “Working with the transplant community, TGI will bring these vital advances in biomarkers of transplant status from bench to clinic. Clinicians will be able to access clear, actionable information to optimize immunosuppression therapy to improve graft survival.”

TGI’s first test will be used to routinely monitor kidney transplant recipients, indicating when treatment or biopsy is required based on analysis of a patient’s blood. As described in a study involving seven transplant centers recently published in the American Journal of Transplantation,1 peripheral blood gene expression profiling was used to classify kidney graft recipients into three key categories of graft status (acute rejection, acute dysfunction no rejection, and stable graft performance) with very high predictive accuracy. Ongoing prospective studies will reveal how far in advance of dysfunction these signatures can be detected, and whether they can be used to monitor the effectiveness of treatment. The need for such improved tests is highlighted by the fact that more than 15% of kidney transplant patients with normal serum creatinine levels, the most commonly used indicator of graft injury, show signs of rejection when their grafts are analyzed by protocol biopsy up to one year post-transplant.2-4

“TGI’s tests could be used for serial patient monitoring in stable patients with good kidney function to better inform decisions about immunosuppression,” stated Michael Abecassis, MD, MBA, Founding Director and Chief Clinical Advisor of TGI and Founding Director of the Comprehensive Transplant Center at Northwestern University’s Feinberg School of Medicine. “The test will also find a major and immediate application in circumstances where a sudden elevation in creatinine is noted by the clinician and a biopsy is not possible because of logistical issues.”

“The danger of subclinical acute organ rejection is well recognized as a significant cause of late graft loss but nearly impossible to diagnose since doing serial biopsies is not feasible,” explained Dan Salomon, MD, Founding Director and Chief Scientific Advisor of TGI and Professor at The Scripps Research Institute. “A minimally invasive blood test could be used to predict clinical rejection, to diagnose subclinical rejection, and to monitor treatment to assure clinicians that the therapy was fully effective.” TGI is committed to making minimally invasive tests commercially available to transplant recipients for this purpose, delivering on the promise of clinical application of biomarker discovery.

About Transplant Genomics Inc.

Transplant Genomics is a molecular diagnostics company committed to improving organ transplant outcomes. Working with the transplant community, TGI will bring vital advances in diagnosis and prediction of transplant status from bench to clinic, supporting clinicians with clear, actionable information to optimize immunosuppression therapy, enhance patient care and improve graft survival. Tests will be made commercially available through a CLIA lab, with an initial focus on kidney transplantation.

For more information, go to www.TransplantGenomics.com.

1. Kurian SM, Williams AN, Gelbart T, et al. Molecular classifiers for acute kidney transplant rejection in peripheral blood by whole genome gene expression profiling. Am J Transplant2014;5(14):1164-1172.

2. Rush D, Somorjai R, Deslauriers R, Shaw A, Jeffery J, Nickerson P. Subclinical rejection—a potential surrogate marker for chronic rejection—may be diagnosed by protocol biopsy or urine spectroscopy. Ann Transplant 2000;5(2):44-49.

3. Moreso F, Ibernon M, Goma M, et al. Subclinical rejection associated with chronic allograft nephropathy in protocol biopsies as a risk factor for late graft loss. Am J Transplant 2006;6(4):747-752.

4. Nankivell BJ. Subclinical renal allograft rejection and protocol biopsies: quo vadis? Nat Clin Pract Nephrol 2008;4(3):134-135.




For Transplant Genomics Inc.

Ed Stevens, 727-412-1541

edstevenspr@comcast.net

Source: Transplant Genomics Inc.


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