Partner's Blog - June 2022

Thanks for visiting the June 2022 Partner's Blog!

Thank you for visiting the June 2022 Partner's Blog! I hope that you find the featured information helpful.

The Corporate Affiliates Program provides an exciting opportunity for companies to support the work of the American Society of Transplantation (AST) and receive tangible benefits throughout the year. The following companies are members of the 2022 Corporate Affiliate Program (CAP).

For additional partner information, check out AST Partner Connect.

Richard Formica
AST Development Chair

What's News With Our Partners:

At ATC 2022, CareDx showcased a record-breaking number of scientific abstracts with over 50 oral and scientific poster presentations. In the first oral presentation of the OKRA study results, with data from over 50 centers, the value of multi-modality KidneyCare® was highlighted, including AlloSure®, AlloMap®, and AI-based tools. To see the data, explore our abstract website today.

The Transplant Company™ also proudly announced that it has delivered over 200,000 AlloMap® or AlloSure® results for over 30,000 heart transplant recipients.¹

At the ISHLT Annual Meeting, CareDx hosted over 25 oral presentations and posters covering the latest innovations in heart and lung transplant surveillance. Notably, oral presentations covering interim findings from the SHORE observational study were presented, highlighting the value of multimodality testing for assessing the risk of rejection and de novo donor-specific antibodies (dnDSA) in heart transplant recipients. See the full list of abstracts on our press release here.

CareDx announced the publication² of new data demonstrating that AlloMap® Kidney gene-expression profiling predicts the probability of allograft rejection for both antibody-mediated rejection (ABMR) and T cell-mediated rejection (TCMR). Published in Biomarkers in Medicine, the data including the multi-center, prospective OKRA (Outcomes of KidneyCare in Renal Allografts) Study, shows that AlloMap Kidney can reliably discriminate rejection from quiescence in kidney transplant patients with a negative predictive value of 95%. The results are consistent with previously published clinical validation study results.³To read the publication, click here.

CareDx plans to expand its growing multimodality portfolio with AiKidney™, a new allograft risk assessment clinical decision support tool, in development, that includes AlloSure® and other transplant metrics. AiKidney delivers information about a patient’s current risk of rejection and a prognosis of allograft survival at three, five, and seven years. AiKidney can be used for informing clinical management decisions and to help clinicians predict the long-term impact of treatments. To learn more about AiKidney, visit our website.

CareDx data of on file. March 7, 2022.
Cheung R, Xu H, Jin X, et al. Validation of a gene expression signature to measure immune quiescence in kidney transplant recipients in the CLIA setting. Biomarkers in Medicine. Published Online: 29 Apr 2022. https://doi.org/10.2217/bmm-2022-0113
Akalin E, Weir MR, Bunnapradist S, et al. Clinical Validation of an Immune Quiescence Gene Expression Signature in Kidney Transplantation. Kidney360. December 2021, 2 (12) 1998-2009; DOI: https://doi.org/10.34067/KID.0005062021

CSL Behring is pleased to share that our ongoing pivotal Phase III clinical trial IMAGINE (Clazakizumab for the Treatment of Chronic Active Antibody Mediated Rejection in Kidney Transplant Recipients) leverages clazakizumab, a humanized monoclonal antibody targeting interleukin-6 (IL-6) for the potential treatment of chronic active antibody-mediated rejection (AMR), the leading cause of long-term rejection in kidney transplant recipients. For any questions about our IMAGINE trial, or suggestions for additional clinical trial sites, please see this link to the IMAGINE trial at ClinicalTrials.gov and reach out to us directly at James.Lee2@cslbehring.com.

Watch our recent symposium, Guiding Difficult Treatment Decisions for Transplant Recipients. During this panel discussion, we presented case studies of how leading physicians use biomarker guidance to improve patient outcomes in challenging and complicated contexts. Listen to a discussion regarding the practical uses of the OmniGraf® rejection biomarker panel, the inSIGHT™ t cell diagnostic assay, and other novel biomarkers, including their application in managing post-transplant patient care. Presenters included: Dr. John Friedewald, Dr. Nicolae Leca, Dr. Suphamai Bunnapradist, Dr. Gaurav Gupta, and Dr. Adnan Khan.
Register for our upcoming webinar, The PCR Advantage: How the Biomark™ HD System Enhances the TruGraf® Gene Expression Test for Kidney Rejection.

On Thursday, June 30 at 12:00 P.M. ET, come learn how our recent move to the Fluidigm Biomark HD platform has improved specimen collection, assay speed, and accuracy–dramatically improving the sensitivity of the TruGraf test.

Get To Know Lung Bioengineering

Lung Bioengineering is dedicated to making more donor organs available for transplant. This is why we built a 360° Ex Vivo Lung Perfusion service to preserve and reassess organs for transplant that may otherwise be discarded.

Our unique service model is a frontier of change for the betterment of transplantation, tailored to meet each of its partners’ unique needs by bringing together all of the components of EVLP under one roof - from logistics and technology to data and resources.

Lung Bioengineering’s work is powered by expertise paired with cutting edge technology. Our team of experts are on hand 24/7, 365 days per year to make more donor organs available for evaluation. Our cloud-based audio-visual system allows for remote, real-time data every step of the way, providing all the tools needed to make optimal decisions.

Watch our recent Boston symposium on demand HERE. Dr. Philip Halloran presented new Prospera data from his Trifecta study, the largest multisite, prospective, fully biopsy-matched cohort with dd-cfDNA analysis for kidney transplant recipients conducted to date. New data demonstrated that a dual threshold test—based on donor fraction and estimated amount of donor-derived cfDNA (dd-cfDNA) — can significantly improve the identification of active rejection, compared to either variable alone.
Transplant rejection can be missed. Adding Prospera to your toolkit can help prevent this. Transplant recipients often have a complex set of risk factors for transplant rejection. Regularly scheduled testing with Prospera identifies out-of-baseline trends that may indicate larger transplant issues, enabling physicians and patients to quickly tailor healthcare with the most current data. Explore some case studies HERE and see how Prospera can have a positive impact for any patient type.
A new published study that analyzed the first 1,000 Renasight tests revealed a high diagnostic yield, spanning common and rare genetic conditions. The clinical utility of genetic testing in the transplant nephrology setting is multi-faceted and may include:
Improved prognostication and post-transplant recurrence information.
Appropriate counseling and testing of at-risk relatives, including potential donor candidates.
Inclusion in clinical trials
Learn more about Renasight
Kidney Disease: Improving Global Outcomes (KDIGO) Controversies Conference advises practitioners to "Think Genetic." In May 2022, KDIGO published an executive conclusions paper stating, "Given the important contribution of genetic variants to CKD, practitioners with CKD patients are advised to 'think genetic.'" Renasight provides a comprehensive approach to incorporating genetic testing into daily practice. Conveniently, Renasight comes with unparalleled access to board-certified genetic counselors and patient and provider support services. Get started today
Next-Level insights for next-level care with Renasight. Renasight is a genetic test that uses next-generation sequencing (NGS) and other methodologies to identify germline genetic factors causing or contributing to kidney disease from a patient’s blood or buccal sample. The test identifies certain autosomal dominant, autosomal recessive and X-linked disorders, and the APOL1 risk allele. Providers can use Renasight to identify a genetic predisposition, clarify a clinical diagnosis, determine the etiology of an unknown kidney disease, and to help inform medical management. Additionally, genetic counseling and familial testing can be offered based on the test result. Learn more about Renasight.

MAT-US-2204024-v1.0-06/2022
At ATC 2022, Sanofi hosted a booth activity designed to raise awareness of the issues that may contribute to disparities in transplantation. The participants in our mirror photobooth were encouraged share their picture using #Pledge2Reflect on social media for a donation of $25 per mention. Together, we raised $20,000 for the AST and ASTS in support their efforts to address inequities in transplantation.

To learn more about AST's diversity, equity, and inclusion initiatives, click here.

Click here for more information on Sanofi’s partnership with the transplant community

Findings from a new exploratory analysis of data from Takeda's Phase 3 SOLSTICE study were presented at the April Tandem Transplantation & Cellular Therapy Meetings.[i] The analysis is part of Takeda's ongoing research to explore new ways to improve the lives of transplant recipients.
Takeda recently announced their partnership with PatientsLikeMe (PLM), the world’s largest real-world patient data platform, on a new initiative, The Post-transplant Experience Study: Patient and Care Partner Experience with Post-transplant Effects on Quality of Life. The study is now recruiting participants for initial interviews, which will help to inform Takeda’s work with the transplant community and broaden PLM’s digital health management platforms for patients. Learn more about participating in the study here and about the Takeda and PLM partnership here.
This June, Takeda recognized National Cytomegalovirus (CMV) Awareness Month through the development of, “Fast Facts on post-transplant CMV,” which aims to draw attention to this common, yet rarely discussed virus that affects hundreds[ii] of transplant recipients. This is the first in a series of “Pop-Up Videos,” which will feature educational content on topics like CMV, transplantation and organ donation. The videos will be shared on Takeda’s YouTube, Twitter and LinkedIn channels.

[i] Hirji I, et al. Healthcare resource utilization in transplant recipients with cytomegalovirus infection refractory/resistant to treatment receiving LIVTENCITY versus investigator assigned therapy: Exploratory analysis of a Phase 3 trial. In: The 2022 Tandem Transplantation & Cellular Therapy (TCT) Meetings Of ASTCT and CIBMTR. 2022. Abstract 52.

[ii] Azevedo LS, et al. Clinics (Sao Paulo). 2015;70:515–23; 2. Felipe CR, et al. J Bras Nefrol. 2017;39:413–23; 3. Peffault De Latour R, et al. J Med Virol. 2020. doi: 10.1002/jmv.25895. Online ahead of print;

We are excited to report that a Phase 1 study of VEL‐101 has dosed its first participant. VEL‐101 is a novel investigational drug for kidney transplant immunosuppression. A previous Phase 1 study investigated intravenous administration of VEL‐101. In the current study, VEL‐101 will be administered subcutaneously exploring the possibility of at‐home self‐administration of this novel investigational medication. See our full press release: https://lnkd.in/g4AnzYPg
New episodes of the Kidney Transplant Conversations podcast are now available! This podcast is a unique collaboration between kidney transplant providers, recipients, caregivers, advocacy groups, and medical societies. Each episode features diverse voices and experiences related to donating, receiving, and caring for this gift of life. To stay connected, informed, and inspired, listen to Kidney Transplant Conversations here or on any major streaming platform.

Verici Dx presented performance in a prospective, blinded multi-center trial which establishes a new industry standard in detection of acute kidney transplant rejection and paves way for US commercial launch in 2022.

The study design and successful outcomes were well received at American Transplant Congress 2022; the poster was presented and referenced during the closing session of the “What’s new / What’s hot” roundup. The full poster is available at https://vericidx.com/clinical

A novel prospective validation trial of blood-based RNA signature assay to predict rejection post kidney transplant

Tuteva™ is a quantitative blood-based transcriptomic signature able to correlate an acute rejection risk score with rejection phenotype based on histopathology in the kidney biopsy, representing a level of evidence which has not yet existed in biomarker transplant biology.
The Tuteva™ study highlights the utilization of an all-comers patient population rather than a specific subgroup to provide an inclusion of diverse populations and broad diversity in care management practices while allowing blinding to protect from introduction of biases; thereby producing robust and reliable results for clinical integration.
The Tuteva™ study was purposefully designed this way to capture the clinical reality of all types of rejection, including sub-clinical, borderline, T Cell-mediated, and antibody-mediated rejection across 14 international transplant centers. The results reflect the wide clinical applicability of the test for comprehensive commercial adoption in a real-world setting
Validation in an all-comers cohort 1 that is independent of the training set and representing all forms and levels of rejection which is essential to the assessment of expected test performance in translational clinical care settings to support medical management decision making.

Check out all of our CAP partners: