Partners' Blog - September 2023

Thanks for visiting the September 2023 Partner's Blog!

Thank you for visiting the September 2023 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 2023 Corporate Affiliate Program (CAP).

For additional partner information, check out AST Partner Connect.

Alex Wiseman
AST Development Chair

What's News With Our Partners:

Atara, a pioneer of off‐the‐shelf allogeneic T‐cell immunotherapies, currently has a tabelecleucel clinical trial enrolling patients with Epstein-Barr virus (EBV)-associated diseases.

EBVision (NCT04554914) is a multinational, multicohort, open‐label Phase 2 study to assess the efficacy and safety of tabelecleucel in participants with EBV-associated diseases, including those with EBV+ post-transplant lymphoproliferative disease (PTLD) for whom first‐line treatment is inappropriate, as well as patients with newly diagnosed first‐line inappropriate EBV+ central nervous system (CNS) PTLD or relapsed or refractory (R/R) EBV+ CNS PTLD.

For more information, please visit clinicaltrials.gov or email clinicaltrials@atarabio.com

Revolutionizing Transplant Management with Eurofins Transplant Diagnostics

Transplant management is a complex and continuous process that requires precise matching, early detection, and intuitive monitoring. From pre-transplant protocols and screenings to post-transplant diagnostics and rejection monitoring, the journey never stops. These crucial steps improve patient outcomes. That's where Eurofins Transplant Diagnostics (ETD) comes in. By harnessing the power of artificial intelligence and innovative technologies, ETD is redefining transplant testing and delivering breakthrough solutions that empower both patients and providers. Comprised of four key divisions within Eurofins, (Eurofins CellTX, Eurofins Donor & Product Testing, Eurofins Viracor, and Eurofins Transplant Genomics) Eurofins Transplant Diagnostics covers every critical step in the transplant journey. Together, these key clinical and diagnostic sectors make up Eurofins Transplant Diagnostics. Let's dive deeper into the company overview of ETD to understand how they contribute to this groundbreaking field.

Eurofins CellTX: Revolutionizing Cell Therapy Solutions Eurofins CellTX is a critical division of Eurofins Transplant Diagnostics that specializes in providing innovative solutions for cell therapy. With the rapid advancements in regenerative medicine and cellular therapies, Eurofins CellTX plays a pivotal role in ensuring the safety, quality, and efficacy of these groundbreaking treatments. Through state-of-the-art testing and analysis, Eurofins CellTX enables the characterization, potency assessment, and release testing of cellular products, ensuring they meet the rigorous standards necessary for successful transplantation. By leveraging their expertise in cell biology, immunology, and molecular diagnostics, Eurofins CellTX empowers researchers, clinicians, and biopharmaceutical companies to advance the field of cell therapy and bring life-changing treatments to patients in need.

Eurofins Donor and Product Testing: Ensuring Transplant Safety Eurofins Donor and Product Testing is a crucial division of Eurofins Transplant Diagnostics that focuses on ensuring the safety and quality of transplant-related products and donor testing. With a comprehensive range of testing services, Eurofins Donor and Product Testing helps mitigate the risk of disease transmission, infection, and adverse reactions in transplantation. By thoroughly screening and testing donors and transplant products, Eurofins Donor and Product Testing ensures compliance with regulatory standards and provides healthcare professionals with critical information to make informed decisions regarding transplant suitability. Their dedication to accuracy, reliability, and efficiency makes them an indispensable partner in safeguarding the well-being of transplant patients and optimizing transplant outcomes.

Eurofins Viracor: Advancing Precision and Early Detection, Eurofins Viracor is a vital component of Eurofins Transplant Diagnostics, specializing in advanced testing solutions to support precision and early detection in transplant management. A leader in infectious disease testing and immunology, Viracor focuses on supporting pre- to post-transplant management. By utilizing cutting-edge technologies and expert analysis, Viracor provides accurate and timely results that enable healthcare professionals to make informed decisions throughout the transplant process. Their commitment to innovation and comprehensive testing services have established them as a leading authority in the field of transplant diagnostics. Specifically dedicated to this special population, Eurofins Viracor delivers comprehensive, accurate results with fast turnaround times. 

Eurofins Transplant Genomics: Pioneering personalized diagnostics, Eurofins Transplant Genomics, is at the forefront of personalized treatment strategies for transplant patients. Working alongside the transplant community and within the Eurofins family, TGI is commercializing a suite of tests to improve the quality of life for transplant recipients. TGI is committed to improving organ transplant outcomes worldwide through innovative tests that detect early signs of graft injury, differentiate among actionable causes, and enable the optimization of therapy. Leveraging the power of genomics and molecular profiling, Transplant Genomics aims to optimize patient outcomes by tailoring treatment plans based on individual genetic markers. By identifying genetic signatures related to immune system function and response, Transplant Genomics enables healthcare providers to make informed decisions regarding immunosuppressive therapies and post-transplant monitoring. This personalized approach not only enhances patient care but also helps mitigate the risk of organ rejection, ultimately improving long-term transplant success rates.

By bringing these 4 entities together to work in partnership, Eurofins Transplant Diagnostics is revolutionizing transplant management by offering comprehensive solutions across the entire transplantation journey and optimizing transplant outcomes. Eurofins Transplant Diagnostics is committed to accuracy and reliability, ensuring precise matching, early detection, and personalized treatment for transplant patients. By combining advanced technologies, artificial intelligence, and expert analysis, Eurofins Transplant Diagnostics provides healthcare professionals with the answers they need to make informed decisions and navigate the complexities of transplant management. Through their unwavering commitment to innovation and patient-centric care, Eurofins Transplant Diagnostics is paving the way for a future where successful transplant outcomes are within reach for more individuals in need.

Eurofins Transplant Diagnostics …a step ahead in transplant testing.

Mallinckrodt Pharmaceuticals is pleased to announce that TERLIVAZ® (terlipressin) is now available for patients in the United States. TERLIVAZ is the first and only FDA-approved treatment to improve kidney function in adults with hepatorenal syndrome (HRS) involving rapid reduction in kidney function,1 an acute and life-threatening condition.² Please see Limitation of Use below.

TERLIVAZ is available through a network of independent distributors for hospital purchasing. To learn more, visit our website.

INDICATION AND LIMITATION OF USE

TERLIVAZ is indicated to improve kidney function in adults with hepatorenal syndrome with rapid reduction in kidney function.

Patients with a serum creatinine >5 mg/dL are unlikely to experience benefit

IMPORTANT SAFETY INFORMATION

WARNING: SERIOUS OR FATAL RESPIRATORY FAILURE

TERLIVAZ may cause serious or fatal respiratory failure. Patients with volume overload or with acute-on-chronic liver failure (ACLF) Grade 3 are at increased risk. Assess oxygenation saturation (e.g., SpO2) before initiating TERLIVAZ.
Do not initiate TERLIVAZ in patients experiencing hypoxia (e.g., SpO2 <90%) until oxygenation levels improve. Monitor patients for hypoxia using continuous pulse oximetry during treatment and discontinue TERLIVAZ if SpO2 decreases below 90%.

Contraindications

TERLIVAZ is contraindicated:

In patients experiencing hypoxia or worsening respiratory symptoms.
In patients with ongoing coronary, peripheral, or mesenteric ischemia.

Warnings and Precautions

Serious or Fatal Respiratory Failure: Obtain baseline oxygen saturation and do not initiate TERLIVAZ in hypoxic patients. Monitor patients for changes in respiratory status using continuous pulse oximetry and regular clinical assessments. Discontinue TERLIVAZ in patients experiencing hypoxia or increased respiratory symptoms. Manage intravascular volume overload by reducing or discontinuing the administration of albumin and/or other fluids and through judicious use of diuretics. Temporarily interrupt, reduce, or discontinue TERLIVAZ treatment until patient volume status improves. Avoid use in patients with ACLF Grade 3 because they are at significant risk for respiratory failure.
Ineligibility for Liver Transplant: TERLIVAZ-related adverse reactions (respiratory failure, ischemia) may make a patient ineligible for liver transplantation, if listed. For patients with high prioritization for liver transplantation (e.g., MELD ≥35), the benefits of TERLIVAZ may not outweigh its risks.
Ischemic Events: TERLIVAZ may cause cardiac, cerebrovascular, peripheral, or mesenteric ischemia. Avoid use of TERLIVAZ in patients with a history of severe cardiovascular conditions or cerebrovascular or ischemic disease. Discontinue TERLIVAZ in patients who experience signs or symptoms suggestive of ischemic adverse reactions.
Embryo-Fetal Toxicity: TERLIVAZ may cause fetal harm when administered to a pregnant woman. If TERLIVAZ is used during pregnancy, the patient should be informed of the potential risk to the fetus.

Adverse Reactions
The most common adverse reactions (≥10%) include abdominal pain, nausea, respiratory failure, diarrhea, and dyspnea.

Please see full Prescribing Information, including Boxed Warning, by clicking here.

References

TERLIVAZ® (terlipressin). Prescribing Information. Mallinckrodt Hospital Products Inc.
Hepatorenal Syndrome. National Organization for Rare Disorders website. Accessed October 18, 2022. https://rarediseases.org/rare-diseases/hepatorenal-syndrome/

Mallinckrodt, the “M” brand mark and the Mallinckrodt Pharmaceuticals logo are trademarks of a Mallinckrodt company. Other brands are trademarks of a Mallinckrodt company or their respective owners. © 2022 Mallinckrodt. US-2201145 11/2022

New ProActive Study Interim Data highlights Prospera Transplant Rejection Surveillance Use, presented at ATC 2023. Listen to our new audio and video on demand podcast, Inside the ProActive Study, where we interviewed our PIs on their experience in the study, use of the Prospera test for surveillance and its impact on their kidney transplant patients. Our guests include: Dr. Yasir Qazi from Providence Transplant Center, Dr. Matthew Cooper from the Medical College of Wisconsin, Dr. Daniel Brennan from  the Johns Hopkins Transplant Center and Dr. Milagros Samaniego-Picota from Henry Ford Health.

Notable highlights include: 

Predicted Antibody Mediated Rejection (ABMR) up to 4 months and T Cell-Mediated Rejection (TCMR) up to 2 months in advance of biopsy-proven rejection
86.9% of clinically stable patients had donor-derived cell-free DNA levels (dd-cfDNA) persistently <1% 
Patients with biopsy-proven rejection showed a 60x median elevation in dd-cfDNA % vs baseline, compared to just 1.3x median elevation in the non-rejection group 

Now covered by Medicare, Prospera Heart and Prospera Lung are validated and clinically available to the transplant community. Prospera identifies rejection with exceptional performance from a single test, eliminating the need to combine two tests for each patient.

In August 2023, Prospera Lung was featured in a new publication highlighting the first real-world assessment of clinical utility of dd-cfDNA combined with post-lung transplant standard of practice, inclusive of surveillance flexible bronchoscopy procedures.

Prospera demonstrated strong performance (AUC-ROC of 0.783) in detecting acute lung allograft dysfunction (ALAD) and further suggested that longitudinal monitoring with dd-cfDNA% may allow for earlier detection and intervention.
Investigators in the study predicted that the use of invasive surveillance procedures (bronchoscopy/TBBx) could be reduced by ~50%  when implementing Prospera Lung into their clinical practice.
Read the full study Girgis et al., J Medicine & Research (MAR) Pulmonology

Sanofi is proud to share an educational presentation focused on the economic benefits of increasing access to kidney transplant and preemptive kidney transplant (PKT), including real-world outcomes

Did you know that PKT offers substantial clinical benefits and economic advantages, including lower health care resource utilization and approximately 60% average savings vs non-PKT?^3-5,* Legislation resulting from the AAKH and CMS payment models ETC and KCC expands access to and provides incentives for kidney transplant, specifically PKT.^6,7

Utilization of the Centers for Medicare and Medicaid Services Kidney Disease Education benefit has demonstrated increases in both pre-end-stage renal disease waitlisting and PKT.¹ With this early education, there is also a higher likelihood of a patient undergoing living donor kidney transplant.²

Want to know more? Please have your transplant administrator or program director contact Sanofi Transplant Value & Access Director Todd Black at Todd.Black@sanofi.com, or schedule a call with your Sanofi Transplant Network Manager.

AAKH, Advancing American Kidney Health; CMS, Centers for Medicare and Medicaid Services; ETC, End-Stage Renal Disease Treatment Choices; KCC, Kidney Care Choices. *Average total medical cost of care from transplant evaluation to 1-year post-transplant from an evaluation of members from a large commercial health plan who were referred for solid organ transplantation.4

References: 1. Johansen KL, et al. J Am Soc Nephrol. 2020;31(suppl):18. 2. Massey EK, et al. Nephrol Dial Transplant. 2016;31(5):823-830. 3. Dean P, et al. Am J Transplant. 2018;18(suppl 4):467. 4. Irwin FD, et al. Transplant Rev (Orlando). 2016;30(2):71-76. 5. Abecassis M, et al. Clin J Am Soc Nephrol. 2008;3(2):471-480. 6. Lentine KL, Mannon RB. Kidney360. 2020;1(6):557-560. 7. Kshirsagar AV, et al. Clin J Am Soc Nephrol. 2022;17(7):1082-1091.

Takeda launched a Fast Facts on the Transplant Community video to educate patients, caregivers and healthcare professionals on key facts regarding transplant, including different types of transplants and Takeda’s commitment to supporting this community, especially individuals facing post-transplant cytomegalovirus (CMV) infection.

IDWeek 2023 will be taking place in Boston between October 11 – 15. Takeda will be sponsoring an educational session, titled, “Tackling the Problem Head On: Key Considerations for CMV in the post-transplant Setting” in addition to having commercial and medical booths onsite.

New clinical validation results VericiDx, a developer of advanced clinical diagnostics for organ transplant, announced in July another successful validation result from its prospective, blinded, international multi-center clinical validation study.

Clarava™ is the first pre-transplant prognostic test to enable measurement of a patient's immune response to assess the risk of early kidney graft rejection. The validation study represents a significant demonstration of Clarava™ as a predictive test capable of informing a clear, actionable response from clinicians.

Verici Dx is on track to make Clarava™ available by the end of 2023. 

The Clarava™ study, which included a broad and diverse group of 122 patients preparing to receive a deceased donor (DD) kidney transplant with a range of rejection outcomes across 13 centers, demonstrated a statistically significant AUC result of 0.719 AUC result, with a sensitivity of 78% and specificity of 64%, identifying patients that are at increased risk for a kidney rejection event in the critical first 60 days post-transplant. Study data analysis of the clinical performance of Clarava™ demonstrated differentiation of high-risk and low-risk patient groups, determining that patients of high risk were approximately six times (OR = 6.133) more likely to have a rejection than those of low risk.

Whilst DDs provide the majority of kidney transplants, the Company will be also be exploring further samples drawn from Living Donor (LD) transplant recipients, in addition to assessing the anticipated combination of using our pre-transplant test, Clarava™ in conjunction with our post-transplant test, Tutivia™.

Clarava™ is the only pre-transplant test of its kind that can risk stratify patients based on their likely immune response to a transplanted organ. This allows clinicians to identify patients most likely to require increased monitoring, including adjustments in the type, dose, and duration of immunosuppressive agents. Existing approaches to assess rejection risk are standardized and typically based on the recipient's race, age, previous transplant history and whether they have antibodies against common donor antigens. As reported, the Clarava™ personalized risk assessment is especially important for the expanding DD transplant population.

Tutivia™ is our first commercially available test, which can identify Early Acute Rejection, for use by all kidney transplant centers in the US.

Tutivia™ is our proprietary blood-based transcriptomic signature test that is set to deliver on the high standards clinicians expect from biomarkers. Using a simple blood draw, Tutivia™ delivers Early, Personalized, Dynamic, and Reliable results for all post-kidney transplant patients, providing clinicians with a risk score for early acute rejection.

Click on the link https://vericidx.com/tutivia/ to learn how Tutivia helps clinicians make earlier informed decisions to manage their kidney transplant patients.

VericiDx, Renalytix, AST, and ASN, partnered to create the Dr. Barbara T. Murphy, MB, BAO, BCh, endowed lectureship. This lectureship commemorates Dr. Murphy and her legacy of transplant immunology by recognizing advances in kidney transplantation. Dr. Flavio Vincenti, MD will present at the ASN Kidney Week 2023 in Philadelphia, Saturday, November 4th, 2023, from 12:00-12:30pm in room 115, during the Basic/Clinical Science Session, New Look at Antibody-Mediated Rejection. Dr Vincenti will be discussing Novel therapeutic Targets to Control Humoral Responses in Desensitization and ABMR.

To learn more about VericiDx, our commitment to the transplant community, and our kidney transplant technology platform, click on the link here to go to our website. https://vericidx.com.

Check out all of our CAP partners: