Kidney transplantation

Global Kidney Summit Honors Former HHS Secretary Alex M. Azar

Retrieved on: 
Tuesday, June 27, 2023
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WASHINGTON, June 26, 2023 /PRNewswire/ -- The American Association of Kidney Patients (AAKP), the largest independent kidney patient organization in the nation, today announced that The Honorable Alex M. Azar II, former Secretary of the U.S. Department of Health and Human Services (HHS), will receive the inaugural Kidney Leadership and Innovation Award at the patient-led 5thAnnual Global Summit on Kidney Disease Innovations.

Key Points: 
  • WASHINGTON, June 26, 2023 /PRNewswire/ -- The American Association of Kidney Patients (AAKP), the largest independent kidney patient organization in the nation, today announced that The Honorable Alex M. Azar II, former Secretary of the U.S. Department of Health and Human Services (HHS), will receive the inaugural Kidney Leadership and Innovation Award at the patient-led 5thAnnual Global Summit on Kidney Disease Innovations .
  • Founded in 2019, the Global Summit is a partnership of AAKP and the George Washington University School of Medicine and Health Sciences (GWU/SMHS).
  • Further, the Global Summit encourages all participants to collaborate to achieve more common sense regulatory and payment policies that align, and not hinder, rapid innovations in kidney care that will save more lives.
  • Secretary Azar and his team actively engaged all kidney community stakeholders, particularly kidney patients, to gain insights on the barriers and opportunities for innovations in kidney care.

Makana™ Wins KidneyX Artificial Kidney Prize to Continue Development of Its Line of Genetically Engineered Donor Pigs for Use in Kidney Transplantation

Retrieved on: 
Monday, June 26, 2023
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Makana™ Therapeutics, a global leader in the field of xenotransplantation, announced today that it has been awarded an Artificial Kidney Phase II Prize from KidneyX to continue development of its genetically engineered donor pigs for use in kidney transplantation.

Key Points: 
  • Makana™ Therapeutics, a global leader in the field of xenotransplantation, announced today that it has been awarded an Artificial Kidney Phase II Prize from KidneyX to continue development of its genetically engineered donor pigs for use in kidney transplantation.
  • Makana is working to solve the organ shortage crisis by making genetically modified pigs for use as organ donors for human recipients.
  • “Through this prize competition, KidneyX is seeking to advance a field that has seen little progress in more than 60 years.
  • We are honored to have been chosen as a KidneyX Phase II Prize Winner.”
    Makana has demonstrated compelling results in xenotransplantation.

Memo Therapeutics AG Starts U.S. Pivotal Phase II/III Clinical Trial with AntiBKV for Treatment of BKV Infection in Renal Transplant Patients

Retrieved on: 
Thursday, June 22, 2023
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Phase II/III trial of AntiBKV, MTx’s antibody therapeutic that targets BK polyomavirus (“BKV”) infection in renal transplant patients.

Key Points: 
  • Phase II/III trial of AntiBKV, MTx’s antibody therapeutic that targets BK polyomavirus (“BKV”) infection in renal transplant patients.
  • “The start of this U.S. pivotal Phase II/III clinical trial with AntiBKV is a significant milestone for us.
  • We believe that AntiBKV, with its 100x more potent neutralization capacity than benchmark antibodies, has great potential to help renal transplant patients.
  • The Phase II part is a randomized, placebo-controlled trial designed to evaluate the therapeutic efficacy of AntiBKV in 60 renal transplant patients with BK viremia.

SAB Biotherapeutics Presents Positive IND-Enabling GLP Toxicology Study for SAB-142, a Novel Immunotherapeutic for Type 1 Diabetes at FOCIS 2023

Retrieved on: 
Wednesday, June 21, 2023
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SIOUX FALLS, S.D., June 21, 2023 (GLOBE NEWSWIRE) -- SAB Biotherapeutics (Nasdaq: SABS), (SAB), a clinical-stage biopharmaceutical company with a novel immunotherapy platform that produces specifically targeted, high-potency, fully-human multi-target immunoglobulin (hIgG) antibodies (fully-human polyclonal antibodies) without the need for human donors, today announced the presentation of positive safety and pharmacologic data from a GLP toxicology study for SAB-142, a first in class fully human immunotherapeutic being developed for delaying onset and progression of Type 1 Diabetes (T1D), at the Federation of Clinical Immunology Societies (FOCIS) in Boston. Results from the IND-enabling GLP tox study confirmed that SAB-142 affects the same subsets of immune cells associated with T1D as commercially available rabbit-derived anti-thymocyte globulin (rATG) in vivo.

Key Points: 
  • SAB-142's unique multi-target strategy can be directed at the multiple immunological cell subsets associated with T1D and other autoimmune diseases.
  • SAB will present a poster titled, “Safety and Pharmacodynamic Effects of Novel Fully Human Anti-Thymocyte Polyclonal IgG Antibodies in an IND Enabling GLP Toxicology Study.
  • In the in vivo study conducted under GLP conditions, SAB-142 was administered at three dose levels of 1, 5, and 10 mg/kg.
  • More information on SAB’s T1D candidate, SAB-142, can be found on the pipeline page of SAB’s website: SAB-142: Type 1 Diabetes .

Natera Announces Data from the ProActive Study that Supports Prospera™ Kidney as an Early Indicator of Transplant Rejection

Retrieved on: 
Monday, June 5, 2023
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The Company’s presence at ATC includes three oral presentations, several posters, and a symposium led by medical experts in kidney transplantation.

Key Points: 
  • The Company’s presence at ATC includes three oral presentations, several posters, and a symposium led by medical experts in kidney transplantation.
  • “We’re excited to unveil new data at ATC that reinforces dd-cfDNA as a leading indicator of transplant rejection,” said Suphamai Bunnapradist, MD, MS, professor of medicine, David Geffen School of Medicine at UCLA.
  • “The ProActive study demonstrates that Prospera Kidney provides highly accurate and early insight into allograft health using a non-invasive tool.
  • 86.9% of stable kidney transplant recipients had dd-cfDNA persistently below 1%, further supporting Prospera as a reliable indicator of allograft stability.

National Kidney Registry Removes Disincentives to Living Donation, Adds Dependent Care and Home Blood Draws to Donor Shield

Retrieved on: 
Thursday, June 1, 2023
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The maximum Donor Shield reimbursement is nearly three times higher than the government-sponsored program, which limits the maximum donor reimbursement to $6,000.

Key Points: 
  • The maximum Donor Shield reimbursement is nearly three times higher than the government-sponsored program, which limits the maximum donor reimbursement to $6,000.
  • "We are thrilled to add dependent care and home blood draws to the comprehensive protections and support already offered by Donor Shield," said Michael Lollo, the National Kidney Registry's Chief Strategy Officer and a living kidney donor.
  • "With the addition of dependent care and the home blood draw service, Donor Shield has eliminated, to the maximum extent possible, all disincentives to living donation."
  • "We utilize Donor Shield for all the living kidney donors, direct and kidney paired donation, at our center," said Dr. Kandaswamy, Director of Kidney Transplant at the University of Minnesota, one of the largest users of Donor Shield.

Hansa Biopharma announces positive reimbursement decision for Idefirix (imlifidase) in Belgium as desensitization treatment for highly sensitized patients in kidney transplantation

Retrieved on: 
Thursday, June 1, 2023
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LUND, Sweden, June 1, 2023 /PRNewswire/ -- Hansa Biopharma, "Hansa" (Nasdaq Stockholm: HNSA), a pioneer in enzyme technology for rare immunological conditions, today announced that it has attained reimbursement in Belgium for its first-in-class treatment, Idefirix, for the desensitization treatment of highly sensitized adult patients prior to kidney transplant from a deceased donor.

Key Points: 
  • LUND, Sweden, June 1, 2023 /PRNewswire/ -- Hansa Biopharma, "Hansa" (Nasdaq Stockholm: HNSA), a pioneer in enzyme technology for rare immunological conditions, today announced that it has attained reimbursement in Belgium for its first-in-class treatment, Idefirix, for the desensitization treatment of highly sensitized adult patients prior to kidney transplant from a deceased donor.
  • Idefirix is available for eligible highly sensitized patients starting today, June 1, 2023.
  • Idefirix is the first and only product approved for use in highly sensitized patients waiting for a kidney transplant in Belgium.
  • Including Belgium, we now have positive access and reimbursement decisions in twelve countries in Europe – a testament to our commitment to ensure access to Idefirix for highly-sensitized patients waiting for a kidney transplant.

Eledon Pharmaceuticals Reports First Quarter 2023 Operating and Financial Results

Retrieved on: 
Thursday, May 11, 2023
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IRVINE, Calif., May 11, 2023 (GLOBE NEWSWIRE) -- Eledon Pharmaceuticals, Inc. (“Eledon”) (NASDAQ: ELDN) today reported its first quarter operating and financial results and reviewed recent business highlights.

Key Points: 
  • ET
    IRVINE, Calif., May 11, 2023 (GLOBE NEWSWIRE) -- Eledon Pharmaceuticals, Inc. (“Eledon”) (NASDAQ: ELDN) today reported its first quarter operating and financial results and reviewed recent business highlights.
  • “Eledon made significant progress this year in advancing the clinical development of tegoprubart as well as securing financing for its future development.
  • Eledon ended the first quarter with approximately $46.5 million in cash and cash equivalents, which excludes the $35.0 million received in the recent financing during the second quarter.
  • Eledon will hold a conference call today, May 11, 2023 at 4:30 pm Eastern Time to discuss first quarter results.

Horizon Therapeutics plc Announces First Patient Enrolled in Phase 2 Trial Evaluating Daxdilimab for the Treatment of Lupus Nephritis

Retrieved on: 
Tuesday, May 2, 2023
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LN is a rare, autoimmune and inflammatory condition of the kidney and represents a common organ manifestation of systemic lupus erythematosus (SLE), a multisystem autoimmune disease.

Key Points: 
  • LN is a rare, autoimmune and inflammatory condition of the kidney and represents a common organ manifestation of systemic lupus erythematosus (SLE), a multisystem autoimmune disease.
  • Between 31 and 60 percent of SLE patients live with LN1 and in the United States, Horizon estimates that approximately 60,000 patients with LN are appropriate for treatment with novel therapies, including biologics.
  • There is a need to identify a more specific medicine for those with proliferative LN.”
    Approximately 210 participants who meet trial eligibility are expected to be enrolled.
  • As a part of our commitment to addressing better treatment options for autoimmune diseases, we are currently evaluating daxdilimab in SLE as well as a variety of other conditions.”

Memo Therapeutics AG Receives FDA Fast Track Designation for AntiBKV as Treatment of BKV Infection in Renal Transplant Patients

Retrieved on: 
Tuesday, May 2, 2023
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Memo Therapeutics AG (“MTx”), a biotech company developing best-in-class therapeutic antibodies, announced today that the U.S. Food and Drug Administration (“FDA”) has granted Fast Track designation to AntiBKV, MTx’s lead antibody therapeutic that targets BK polyomavirus (“BKV”) infection commonly seen in renal transplant patients.

Key Points: 
  • Memo Therapeutics AG (“MTx”), a biotech company developing best-in-class therapeutic antibodies, announced today that the U.S. Food and Drug Administration (“FDA”) has granted Fast Track designation to AntiBKV, MTx’s lead antibody therapeutic that targets BK polyomavirus (“BKV”) infection commonly seen in renal transplant patients.
  • “Receiving Fast Track designation from the FDA is a significant achievement for Memo, validating the potential of AntiBKV and expediting its development.
  • We believe AntiBKV could be a first- and best-in-class treatment option for kidney transplant patients suffering from BKV infection,” said Dr. Karsten Fischer, Chief Executive Officer of Memo Therapeutics AG.
  • Due to the immunosuppressive drug regimen transplant patients receive, reactivation of BKV is triggered in 40 to 50% of kidney transplant recipients.