Partner's Blog - October 2021

Thanks for visiting the October 2021 Partner's Blog!

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 2021 Corporate Affiliate Program (CAP):

What's News With Our Partners:

Atara Biotherapeutics, Inc. (@Atarabio) is a leading allogeneic T-cell immunotherapy company leveraging its novel allogeneic Epstein Barr virus (EBV) T-cell platform to develop therapies for patients with serious diseases including solid tumors, hematologic cancers, and autoimmune diseases. Atara’s pipeline includes tabelecleucel in Phase 3 development for EBV-driven post-transplant lymphoproliferative disease (PTLD) and in earlier stages of development for other EBV-associated diseases, ATA188 for progressive forms of multiple sclerosis, and next-generation CAR T therapies for solid tumors and hematologic cancers.
Atara is now enrolling participants in the ALLELE study, a multicenter, open-label, phase 3 study of tabelecleucel for solid organ or allogeneic hematopoietic cell transplant subjects with Epstein-Barr virus-associated post-transplant lymphoproliferative disease (EBV⁺ PTLD) after failure of rituximab or rituximab and chemotherapy. For more information about this study, please visit https://www.clinicaltrials.gov/ct2/show/NCT03394365.
Atara is also enrolling participants in the ATA-129-EBV-205 study, an open-label, single-arm, multi-cohort, phase 2 study to assess the efficacy and safety of tabelecleucel in subjects with Epstein-Barr virus-associated diseases. For more information about this study, please visit https://www.clinicaltrials.gov/ct2/show/NCT04554914.

CareDx is excited to announce the first ever publication with AlloSure Kidney and AlloMap Kidney data combined. The multi-center study published in Kidney360 shows that KidneyCare, CareDx’s multimodality solution combining AlloMap Kidney gene expression profiling (GEP) and AlloSure Kidney donor-derived cell-free DNA (dd-cfDNA) has enhanced accuracy with an AUC of 0.894 and contribute independent signals to inform on different aspects of allograft rejection. Read the full article here.

CareDx is proud to announce that AlloSure Lung is now commercially available for use in all lung transplant patients. AlloSure Lung is now the first clinically validated and broadly available non-invasive direct marker of organ health and can help guide treatment decisions for lung transplant recipients. Two clinical validation studies and further published data on utility have demonstrated that AlloSure Lung can rule-out allograft injury related to rejection or chronic lung allograft dysfunction (CLAD).^1,2,3

AlloSure has been successfully validated across solid organ transplant, with 60+ publications in kidney , heart and now lung transplantation, and over 200,000 tests performed to date across these organ groups. With cases of COVID-19 once again rising, ISHLT and CDC guidelines recommend the use of non-invasive monitoring of lung allograft health whenever feasible. To get started with AlloSure lung, please visit our website.

A landmark longitudinal study by OrganX showed that AlloSure Kidney is more accurate than current standards of care, including estimated glomerular filtration rate (eGFR) or donor specific antibody (DSA) testing, in detecting allograft rejection. In an analysis of paired-biopsy results of 1,196 kidney patients taken from 2013 to 2018, the study conclusively demonstrated that AlloSure® Kidney showed independent and incremental predictive capability when compared to standard of care patient monitoring. Alexandre Loupy, MD PhD, the principal study investigator, said “Our data confirms that AlloSure Kidney can more accurately gauge the risk of immunologic events, giving more accurate information earlier than the standard of care.” Read the full study here.

CareDx shared an interim analysis from KOAR, the prospective, multicenter study of AlloSure clinical utility in the surveillance setting. Watch the interim analysis video with Dr. Stanley Jordan of Cedars-Sinai here that highlights the preliminary data from the first 1000 patients, including that:

AlloSure accurately discriminated rejection from no-rejection in surveillance and for-cause use, allowing for earlier intervention
AlloSure surveillance potentially enables optimization of biopsies
AlloSure accurately identified subclinical rejection
One-year graft survival was excellent in patients managed with AlloSure surveillance over the UNOS comparator

RemoTraC, CareDx’s mobile phlebotomy service for at-home blood draws, continues to be a safe and convenient option for patients. To date, over 150 transplant centers and nearly 10,000 patients have benefitted from the service that provides a full panel of transplant lab tests. To learn more, go to https://caredx.com/contact-us/ and select “other”.

References

1. Sayah et. al. (2020). Plasma Donor-derived Cell-free DNA Levels Are Increased During Acute Cellular Rejection After Lung Transplant: Pilot Data. Transplantation Direct, 6(10)
2. Khush, K. K. et. al. (2021). Donor-derived, cell-free DNA levels by next-generation targeted sequencing are elevated in allograft rejection after lung transplantation. ERJ Open Research, 7(1).
3. Levine et al. (2020). Single Center “Snapshot” Experience With Donor-Derived Cell-Free DNA After Lung Transplantation. Biomarker Insights, 15, 1177271920958704

CSL Behring is a global biotherapeutics leader driven by its promise for over 100 years to save lives. Our mission now is to address unmet patient needs before, during, and after transplantation, to enable patients to get the very most out of the gift of life. .

CSL Behring is now enrolling participants in the study, Clazakizumab for the Treatment of Chronic Active Antibody Mediated Rejection in Kidney Transplant Recipients (IMAGINE). IMAGINE is a randomized, double-blind, placebo-controlled, Phase 3, multicenter study of 350 kidney transplant recipients with chronic active antibody-mediated rejection. For more information or to find a trial site, please visit NCT03744910

In June 2021, the Swedish New Therapies Council recommended the use of Idefirix^® (imlifidase) as desensitization treatment for highly sensitized kidney transplant patients. The recommendation was provided by the New Therapies Council in Sweden.
As of August 1st, 2021, Idefirix^® is reimbursable and available in the Netherlands.
Imlifidase is an investigational product in the US and is not yet approved for any indication. Idefirix^® (imlifidase) has received conditional approval by the European Commission for use in highly sensitized kidney transplant patients in the European Union (EU) and the United Kingdom (UK).
Following US FDA interactions, the U.S. trial design for a randomized, controlled trial of imlifidase in highly sensitized kidney transplant patients was announced in late June 2021. The new study will target 64 patients with the highest unmet medical need in the U.S., with the first patient expected to be included in H2 2021, as previously planned.
The publication “Outcomes at 3 years post-transplant in imlifidase-desensitized kidney transplant patients”, (Kjellman C, et al.) has been published in the American Journal of Transplantation (published on July 8, 2021, https://doi.org/10.1111/ajt.16754). It presents a pooled analysis of three-year follow-up data in crossmatch positive patients who received imlifidase prior to kidney transplantation. After the three-year follow up, 84% of patients had a functioning allograft, patient survival was 90%, and mean estimated glomerular filtration rate (eGFR) was 55 mL/min/1.73m².
In addition to the above study, the following publications have been published:
- “Beyond CPRA: Identifying Sensitized Kidney Candidates with Markedly Low Access to Deceased Donor Transplantation by Granular CPRA and Blood Type” (Maldonado AQ, et al.) on OBM Transplantation (published on June 3, 2021, doi:10.21926/obm.transplant.2102143)
- “IgM Single Antigen Bead HLA-assay is affected by imlifidase through the cleavage of IgG but not IgM” (Runström A, et al.) on the Journal Transplant Immunology (published on July 13, 2021, https://doi.org/10.1016/j.trim.2021.101436).
- “Imlifidase for the treatment of anti-HLA antibody-mediated processes in kidney transplantation” (Huang E, et al.) on the American Journal of Transplantation (published September 1, 2021, https://doi.org/10.1111/ajt.16828)
At the European Society for Organ Transplantation (ESOT) Congress, held in Milan, Italy, between August 29 and September 1, 2021, Hansa Biopharma presented the two following abstracts:
- “Rabbit anti-thymocyte globulin as induction therapy following desensitization with imlifidase”, (Runström A, et al.) aimed to determine the most appropriate time to initiate rabbit anti-thymocyte globulin therapy (rATG) after transplantation enabled by imlifidase.
- “Patterns of IgG rebound after imlifidase treatment” (Maldonado AQ, et al.), examining the patterns and timing of rebound after imlifidase treatment.
Hansa Biopharma hosted a virtual symposium on June 30, 2021 titled "Clinical case Studies with Imlifidase in Kidney Transplantation", with attendance from more than 120 transplant physicians representing around 80 transplant centers.

Be part of Immucor’s kSORT®clinical studies! Interested in monitoring your transplant patients with kSORT? We are looking for collaborators for our clinical study program! kSORT is a non-invasive gene expression assay that enables enhanced post-transplant surveillance and monitors immune quiescence for transplant patients. It provides the ability for clinicians to assess patients for organ rejection via a simple blood test versus the current standard of care which is an invasive biopsy. kSORT is available exclusively as a Laboratory Developed Test (LDT) through Immucor DX, the company’s CLIA certified and CAP accredited independent clinical laboratory. Visit www.ksort.immucor.com for more information about this exciting opportunity.
Immucor’s next generation of LIFECODES® Non-HLA Antibody kit is available! See beyond the limits of your existing workflow and expand your testing capabilities with Immucor’s Non-HLA Antibody kit. Click here to see our new panel that now includes 28 new antigens for a total of 60! https://view.highspot.com/viewer/5fa955dd8117172260869a7f Join Immucor in a scientific partnership through LEAP, LIFECODES® Early Adopter Program. LEAP gives laboratories access to discounted LIFECODES® Non-HLA kits in exchange for data sharing. Collaborate with us to drive publications using the LIFECODES® Non-HLA Antibody kits!
Immucor is a proud partner and gold sponsor of the 18th International HLA & Immunogenetics Workshop, May 2022 in Amsterdam, The Netherlands. We invite you to participate in the exciting projects that aim to better understand and define HLA epitopes and clinical relevance of non-HLA antibodies in the absence of donor-specific HLA antibodies. Click here for more information: https://view.highspot.com/viewer/6148ea094c07b68e210885ce
Immucor is a preferred partner of PIRCHE! Immucor is committed to uncovering new frontiers in epitope matching. Immucor’s integration tool provides automated data transfer to the PIRCHE matching modules with a simple click of a button! Utilizing the PIRCHE service REST, PIRCHE scores are transferred back to the tool. To learn more about using PIRCHE with Immucor’s MATCH IT! Antibody Software or MIA FORA NGS software or to arrange a demo contact your local Immucor representative or visit us on www.immucor.com.

Announcing the completion of the VALID study: Natera is excited to announce the completion of the largest validation study of a commercial cell-free DNA test in lung transplantation. The VALID study (Validation for Allograft Lungs Implementing Donor-derived cell-free DNA) has been accepted as a late-breaking abstract for presentation at the American College of Chest Physicians (ACCP) international online meeting, CHEST 2021. Click here to learn more information.
Introducing Prospera Heart: Learn more about Natera's newest product, Prospera Heart - a single, noninvasive dd-cfDNA blood test for heart transplant monitoring. Join Dr. Michael Olymbios, Medical Director for Heart Transplant at Natera, as he discusses Prospera Heart and the latest clinical validation data. Click Here
Introducing Prospera Kidney with Quantification: Check out the latest JASN publication on Natera's latest enhancement, Prospera Kidney with Quantification -- the only cfDNA test that provides absolute quantity of dd-cfDNA, total cfDNA along with fraction of dd-cfDNA on every report for kidney transplant recipients.

o Explore further at: https://www.natera.com/info/prospera-with-quantification/

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.

Disparities in Kidney Transplantation: By the Numbers
Learn more about disparities in kidney transplantation faced by underrepresented minorities.

The future of transplantation starts with you - the providers. As your partner in transplant, we proudly stand by your side.

To learn more and access a downloadable infographic PDF, please visit the Sanofi AST PartnerConnect page.

Takeda announced that, on October 7, 2021, the FDA Antimicrobial Drugs Advisory Committee (AMDAC) voted unanimously to recommend the use of maribavir (TAK-620) for the treatment of refractory cytomegalovirus (CMV) infection and disease with or without genotypic resistance (R/R) to conventional antiviral therapies, based on data from the phase 2 and phase 3 TAK-620-303 (SOLSTICE) trials. The New Drug Application (NDA) for maribavir is currently under Priority Review by the FDA. The FDA will consider the vote as part of its review of the NDA and is not bound by the AMDAC’s recommendation. If approved, maribavir will become the first approved treatment for post-transplant R/R CMV, one of the most common viral infections for transplant recipients . The result of years of research, maribavir is Takeda’s first potential therapeutic agent for this community and is part of Takeda’s commitment to addressing the special needs of transplant patients and their health teams.
As part of a growing effort to build greater awareness of transplant health, Takeda recently launched a comprehensive patient education website, understandcmvtransplant.com. This unique resource provides patients and their care partners with easy access to often overlooked CMV information to help throughout their journey, from early exposure to the virus through post-transplant recovery. The site is organized for both hematopoietic stem cell and solid organ transplant patients, providing practical recommendations for managing CMV, like the downloadable Talking with Your Transplant Team guide . Patients and their families can also learn more about Takeda’s commitment to transplant health by reading profiles and commentary on Takeda.com, like the recent post, Opportunities to help patient outcomes through post-transplant infection mitigation.

[1] Final Takeda Release: FDA Advisory Committee Recommends Use of Investigational Drug Maribavir (TAK-620) to Treat Post-Transplant Recipients with Cytomegalovirus (CMV) Infection and Disease Refractory to Treatment
[2] With or Without Resistance. October 7, 2021 Takeda website: Understandcmvtransplant.com

We are excited to announce the recent launch of a new podcast series called Kidney Transplant Conversations. The podcast is a unique collaboration between kidney transplant providers, recipients, caregivers, advocacy groups, and medical societies. At its highest level, Kidney Transplant Conversations focuses on quality healthcare delivery, highlighting the innovative approaches kidney transplant recipients and providers are applying to improve care.

The series also addresses health disparities in renal transplant and discusses what can be done to close the gaps. These discussions include important explorations of inclusion, diversity, equity, and access. Each episode features diverse voices and experiences related to donating, receiving, and caring for this gift of life.

Kidney Transplant Conversations is available NOW on all major streaming platforms. To stay connected, informed, and inspired:

Listen to the latest episode through your favorite streaming service or directly on the Kidney Transplant Conversations website
Subscribe to Kidney Transplant Conversations so you never miss an episode
Share Kidney Transplant Conversations with others Suggestions for future guests or topics?
Please email Rolf Taylor at rolf.taylor@projectadvocacy.com.

Check out all of our CAP partners: