Partner's Blog - April 2021

 

Dear Valued Member:

In this ever-changing environment, it’s comforting to know that we are in this together and that we will continue to work toward advancing the field of transplantation. As we look ahead to the next six months, we look forward to hosting ATC and our Fellows Symposium virtually. Our ability to adapt has made it possible to continue to offer these important meetings to the transplant community, and the opportunities to connect our partners to AST members. Another exciting venture the AST Partner Connect, which is a platform that allows you to engage with our partners directly, request more information on a product and/or service, or find out more about trials they may be running. I’d like to thank our Corporate Partners for providing the following information so that we can remain connected, engaged, and educated. I continue to appreciate all your help and support during these times of change and uncertainty. I look forward to working together to bring the most valuable resources to the transplant community.

Stay safe and healthy,

Anil Chandraker, MD, FASN, FRCP
AST Development Chair

 

 

View all Partner's Blog updates

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 2020 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.

  • Clinical Transplantation published “Single-Center Utilization of Donor-Derived Cell-Free DNA Testing in the Management of Heart Transplant Patients.” Dr. Keerthi Gondi et al. concluded that testing with HeartCare “yielded a significant reduction in endomyocardial biopsy volume by re-classifying Gene expression profiling (+) patients into a lower risk group, without reduction in acute rejection detection.” HeartCare is now commercially available for heart transplant patients.
  • The AlloCare patient app helps patients at every step of their transplant journey. From medication management to vitals tracking, this app has everything a patient will need before and after transplant. More information here.
    • More than 150 centers use RemoTraC – CareDx’s home-based blood draw service for transplant patients that includes AlloSure® and AlloMap®, along with a panel of routine tests. For more information contact remotrac@caredx.com.

TransplantLyfe.com, a new online platform created by Lyfebulb in collaboration with CSL Behring, invites visitors to set up an account to be part of a positive community for transplant candidates, transplant recipients and care partners. The site offers resources, discussion forums, and find-a-friend to chat with community members. Dr. Karin Hehenberger founded Lyfebulb, a platform for various online patient communities, and is herself a transplant recipient who received both a donated kidney and a pancreas. In addition to creating online communities, Lyfebulb has a track record of organizing innovation challenges for several serious diseases. The challenges seek out-of-the-box ideas from people who are living with the conditions and their loved ones. The 2021 Innovation Challenge for transplant recipients offers a $25,000 top prize and a winner will be announced May 13.

 

  •  Following the conditional approval by the European Commission for Idefirix® (imlifidase) for use in highly sensitized kidney transplant patients in the European Union (EU), the commercial launch in the EU countries is underway as planned. National level reimbursement processes are ongoing in the early launch countries. Preparations for a Post Approval Efficacy study (phase III) to confirm efficacy and safety in the intended patient population is proceeding as planned and aim at including the first patients during 2021.
  • Imlifidase is an investigational product in the US and is not yet approved for any indication. However, Hansa is truly committed to develop imlifidase also for the patients in the US and has an ongoing dialogue with the U.S. Food and Drug Administration (FDA) about a new, randomized controlled phase III study. The study aims at investigating imlifidase mediated desensitization of highly sensitized kidney transplant patients in comparison to standard of care. Assuming agreement is reached with the FDA on the study design in the coming months, Hansa will initiate the study during 2021.
  • Beyond the four completed phase 2 studies in kidney transplantation, Hansa is also conducting a prospective, observational long-term follow-up study of patients treated with imlifidase prior to kidney transplantation to measure long-term graft survival in patients who have undergone kidney transplantation after imlifidase administration. The 2-year follow-up data demonstrates graft survival of 90% for 31 patients post imlifidase treatment with a median eGFR of 61.5 ml/min and an AMR frequency that was comparable with less sensitized patients. Reference: Lorant T, et al. Presented at the American Transplant Congress, June 2020. ClinicalTrials.gov Identifier: NCT02224820
  • Hansa is proud to be part of AST’s Living Donor Circle of Excellence, which aims to eliminate the financial costs of living organ donation by recognizing companies who support living donation through providing lost wages.


  •  Immucor is excited to announce that Palmetto MolDX has finalized a local coverage determination (LCD) for Molecular Testing for Solid Organ Allograft Rejection. The policy change, which takes effect June 6, 2021, will enable patients to benefit from Immucor’s kSORT, an innovative, non-invasive gene expression assay designed to better monitor and support the health of solid organ transplant recipients. kSORT is a 15-gene RNA expression-based assay designed for enhanced post-transplant graft surveillance and immune quiescence monitoring in solid organ transplant patients. Utilizing a proprietary algorithm, the kSORT assay evaluates the change in expression of specific genes, several of which are associated with pathways involved in immune activation. kSORT is available exclusively through Immucor DX, the company’s CLIA certified and CAP accredited independent clinical laboratory as a Laboratory Developed Test (LDT). To read the full press release click here
  • Present a Case Study at ASHI! Submit a case study to Immucor for a chance to present to a small audience of fellow laboratorians at our booth at ASHI! If your case study is selected, then Immucor will sponsor your partial travel expenses associated with attending ASHI as a speaker on Immucor’s behalf. All cases have the chance to be featured during Immucor's Virtual HLA Antibody Workshops! Send us any interesting or unique case studies you may have encountered. Have an antibody reacting “funny” or with unusual characteristics you would like us to present? Send it to us! All case studies will be anonymous and remember patient privacy regulations and to anonymize you submission. Contact your Immucor sales representative or marketinginformation@immucor.com to submit your case study today!
  • Save the Date for Immucor’s 2021 Virtual HLA Scientific Symposium! Our Virtual Symposium will be held on Tuesday June 22nd and Wednesday June 23rd from 11:00am – 1:30pm EST. We have an amazing line up of speakers featuring our two Keynote speakers, Annette Jackson from Duke University and Michael Mengel from the University of Alberta. The symposium will also feature presentations from Anat Tambur from Northwestern University Transplant Immunology Lab, Julie Houp from The University of Alabama, Rajalingam Raja from UCSF and Massimo Mangiola from NYU Langone. You will not want to miss this! Click here to pre-register for this event.
  • Immucor is now 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.
  • Immucor’s next generation of LIFECODES® Non-HLA Antibody kit is now available! See beyond the limits of your existing workflow and expand your testing capabilities with Immucor’s Non-HLA Antibody kit. We are proud to sponsor the Non-HLA antigens in organ transplantation project coordinated by Dr. Henry G. Otten (The Netherlands) and Dr. Elaine F. Reed (USA) at the 18th International HLA & Immunogenetics Workshop May 2022 in Amsterdam, The Netherlands. Click here to see our new panel that now includes 28 new antigens for a total of 60! 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!
     



On October 26, 2020, Mallinckrodt participated in an end of review meeting with the U.S. Food and Drug Administration (FDA) to discuss the Complete Response Letter issued on September 11, 2020 for our new drug application (NDA) for the investigational agent terlipressin to treat adults with hepatorenal syndrome type 1 (HRS-1).

Mallinckrodt had a Type A Meeting with the FDA on January 29, 2021, where both parties engaged in constructive dialogue in an effort to clarify a possible path to U.S. approval. Based on recent discussions with the FDA, Mallinckrodt continues to explore a potential regulatory path forward regarding the NDA with the expectation of additional clarity in 2021. Clinical Update Mallinckrodt continues to support research efforts involving acute kidney injury in patients with cirrhosis.


To show our appreciation to your transplant nurses, Natera’s Nurse Education Workshops (NEW) offers complimentary, comprehensive educational opportunities focused on genetic testing and technology. These classroom style workshops will enable coordinators to be confident and prepared when providing patient education on the clinical utility of molecular diagnoses and rejection assessment. Natera is an approved provider by the American Board of Transplant Coordinators. Schedule a workshop for your team or learn more by contacting us at txcoord@natera.com

Natera's Genetics in Fellowship Training (GIFT) is an educational program for transplant nephrology and general nephrology fellows to provide the latest information on donor-derived cfDNA testing and broad panel genetic testing. The program is unbranded and thus far, 17 programs have participated in the one hour introductory presentation provided by one of our nephrologist medical directors. For more information or to schedule a presentation, contact nephfellows@natera.com.

Stay up to date on the latest information about genetics in nephrology through free CME-accredited learning modules. A series of modules below are available now with Neera K. Dahl, MD, as the Program Chair. Visit the Learning Center to start viewing.

  • Module 1: Fundamentals of Genetic Medicine of Non-Geneticists - Melissa Stosic, MS, CGC
  • Module 2: Challenges and Opportunities in Kidney Genetics - Eric Wallace, MD
  • Module 3: Practical Applications of Genetic Testing in Nephrology - Moumita Baurua, MD
  • Module 4: Genetic Testing in FSGS and Nephrotic Syndrome - Martin Pollak, MD
  • Module 5: Genetics of Kidney Disease - Ali Gharavi, MD
  • Module 6: The Role of Genetic Testing in Kidney Transplant - Anil Chandraker, MD

Do you carry hidden biases?

That was the question posed during Professor Mahzarin Banaji’s Outsmarting Human Minds Satellite Symposium presentation, supported by Sanofi during Cutting Edge of Transplantation.

Professor Banaji discussed implicit bias in our daily lives and steps we can take to mitigate its impact on our decision-making. Visit Outsmarting Human Minds to increase your awareness about implicit biases and the mind’s blind spots.

To help drive meaningful action, the anonymous Implicit Association Tests can help you explore your own possible hidden biases and consider how they might affect the care you provide to your transplant patients. By identifying biases, we can help reduce their effects during patient treatment to optimize care.

Click here to take the Implicit Association Tests. Reference: Chapman E, et al. J Gen Intern Med. 2013;28(11):1504–1510.
Reference:
Chapman E, et al. J Gen Intern Med. 2013;28(11):1504–1510.
 
 
Mahzarin R. Banaji
Richard Clarke Cabot Professor of Social Ethics
Department of Psychology, Harvard University



Veloxis Pharmaceuticals, Inc. is pleased to announce the availability of a new on-demand webinar. Join a leading expert for a discussion of strategies and best practices to optimize recruitment, engagement, and care of living donors. This program also explores emerging approaches to optimize renal allograft matches and exchange. To view the webinar, please click the link below:

Strategies to Optimize Kidney Transplantation Opportunities

 

Check out all of our CAP partners: