Pure Transplant Solutions, LLC and Oxford Immunotec, Ltd. Announce Exclusive Sublicense Agreement to Support Commercialization of Novel B Cell Measurement Assay for Early Detection of Tissue Injury and Prevention of Organ Rejection

AUSTIN, Texas -- Pure Transplant Solutions, LLC (PTS), a developer of novel HLA based transplant diagnostics, and Oxford Immunotec, Ltd. (OI), a global diagnostics company part of PerkinElmer Inc., today announce an exclusive sublicense agreement in which PTS will obtain exclusive commercial rights to issued patents protecting a novel assay originally developed by Dr. Oriol Bestard, M.D., Ph.D., that measures antibody-secreting B cells. Oxford Immunotec exclusively licensed the patented technology in 2015 from the Bellvitge Biomedical Research Institute (IDIBELL) in Barcelona, Spain, where Dr. Bestard performed his research.

"We are thrilled to add this assay to our portfolio of diagnostic solutions," said Blake Harlan, President of Pure Transplant Solutions. "This assay, when combined with our proprietary HLA tetramer technology, offers a powerful new diagnostic tool for transplant physicians that we expect will improve patient care and extend graft life."

"We are excited about the potential for Pure Transplant Solutions to apply our B-Cell assay technology to new diagnostic solutions in transplant medicine," commented Dr. Peter Wrighton-Smith, CEO of Oxford Immunotec.

The enabling results of the B cell measuring technology were originally published in The Kidney International in a study co-authored by Dr. Bestard and showed the efficacy of the B cell technology in identifying patients at high risk for rejection that were not identified by other serological tests. The 70-patient study included patients on a waiting list for kidney transplantation as well as kidney transplant recipients undergoing antibody-mediated rejection.

Independently, PTS has continued to expand its portfolio of soluble HLA reagents including monomers and tetramers. Today, PTS has one of the largest selections of Class I and Class II proteins which are offered to researchers for Research Use Only through the company's website http://www.hlaprotein.com/.

When used with original assay technology, the combined assay offers a powerful and enhanced diagnostic tool that is complementary to existing assays such as the Panel of Reactive Antibodies (PRA) test and the Donor Specific Antibody (DSA) test, which represent the standard of care for the assessment of the likelihood of an antibody-driven rejection event in transplant patients. The PRA and DSA tests depend on the identification of antibody levels to foreign Human Leucocyte Antigens (HLA) in the blood. Because these levels fluctuate or the antibodies disappear entirely for various reasons, patients at-risk for rejection are often missed.

The enhanced B cell addresses this problem by directly measuring the underlying B cells themselves, which have the potential to rapidly react to a donor organ and produce antibodies that contribute to acute rejection. By measuring these specific foreign HLA antibody-secreting B cells, the test is able to identify such sensitized patients regardless of the presence of circulating antibodies, potentially identifying at-risk patients missed by the PRA and DSA tests.

NOTES:

[1]Lúcia M et al. Preformed circulating HLA-specific memory B cells predict high risk of humoral rejection in kidney transplantation. Kidney International advance online publication, July 15, 2015; doi:10.1038/ki.2015.205

Definitions

HLA - Human Leucocyte Antigens - Proteins on the surface of cells that are responsible for regulation of the immune system and particularly responsible for the ability of the immune system to recognize self from non-self.

PRA Test - Panel of Reactive Antibody test - An immunological laboratory blood test that assesses the extent to which the patient on the transplant waiting list will react, via pre-existing antibodies, to non-self. Any PRA score indicates that the patient has a higher risk of antibody mediated graft rejection.

DSA Test - Donor Specific Antibody test - An immunological laboratory blood test that assesses the presence of antibodies in the transplant patient that are generated specifically against the donor's HLA type. The presence of DSA indicates that the patient has a higher risk of antibody-mediated allograft rejection. Pre-transplant, the DSA test indicates which donor HLA types may not be tolerated or would carry a higher risk of antibody-mediated graft rejection. Post-transplant, persistence or appearance of DSA may indicate a high risk of ongoing or future antibody mediated graft rejection.

About Pure Transplant Solutions, LLC

Pure Transplant Solutions, LLC was founded in 1999 in order to leverage the leading research in HLA protein of parent company, Pure Protein, LLC, into solutions to address a growing list of needs in organ transplantation. Learn more: https://www.puretransplant.com/.

About Pure Protein, LLC

Pure Protein, LLC is a biotechnology company funded and managed by Emergent Technologies, Inc. that is focused on the development and commercialization of proprietary technologies related to the human leukocyte antigen (HLA) system, formed and exclusively licensed from the University of Oklahoma. Pure Protein, in conjunction with its affiliates and subsidiaries, aims to bring novel therapies and diagnostic tools to patients across a wide range of application areas spanning from therapeutic development in the fields of oncology, autoimmunity, and infectious disease, to antibody mediated rejection in transplantation.

Through its new ecommerce website, www.hlaprotein.com, Pure Protein now offers academic and commercial researchers the ability to purchase individual HLA reagents to detect, profile, and monitor allele-specific immune responses, as well as HLA peptide epitope binding services to aide in improving the design of vaccination and therapeutic targeting strategies.

About Oxford Immunotec, Ltd.

Oxford Immunotec is a global diagnostics company and part of PerkinElmer Inc. We bring energy and invention to a world in need of diagnostic truth. We are uniquely placed as the only company in the world offering regulated ELISPOT assays for T cell measurement, with approval around the globe. Our leading product, the T-SPOT.TB test, is used for diagnosing infection with Tuberculosis, the world's largest cause of death from infectious disease. Oxford Immunotec is an experienced manufacturer of IVD tests, operating under a fully audited Quality Management System, ensuring rigorous batch control. The company has manufactured in excess of 20 million clinical T cell tests for TB infection.

The T-SPOT.TB test has been approved for sale in over 50 countries, including the United States (where it has received pre-market approval from the Food and Drug Administration), Europe (where it has obtained a CE mark), as well as Japan and China. The recently released T-SPOT.COVID test is CE marked in Europe for clinical use to detect the T cell immune response to SARS-CoV-2 (www.tspotcovid.com). Oxford Immunotec is headquartered near Oxford, U.K. and in Marlborough, MA. Additional information can be found at www.oxfordimmunotec.com.

About PerkinElmer

PerkinElmer enables scientists, researchers and clinicians to address their most critical challenges across science and healthcare. With a mission focused on innovating for a healthier world, we deliver unique solutions to serve the diagnostics, life sciences, food and applied markets. We strategically partner with customers to enable earlier and more accurate insights supported by deep market knowledge and technical expertise. Our dedicated team of about 15,000 employees worldwide is passionate about helping customers work to create healthier families, improve the quality of life, and sustain the wellbeing and longevity of people globally. The Company reported revenue of approximately $3.8 billion in 2020, serves customers in 190 countries, and is a component of the S&P 500 index. Additional information is available at https://www.perkinelmer.com/.

Related link: https://www.puretransplant.com/

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