Preclinical and clinical data on anti-BKV monoclonal antibody MAU868 highlights promise of ongoing clinical development program for transplant patients
SAN DIEGO – Dec. 3, 2020 – Amplyx Pharmaceuticals, a clinical-stage biopharmaceutical company developing innovative therapies for debilitating and life-threatening diseases in patients with compromised immune systems, announced today that clinical and preclinical data for its Phase 2 program, MAU868, will be presented at the 62nd American Society of Hematology (ASH) Annual Meeting & Exposition, taking place virtually on December 5-8, 2020.
The ASH abstracts are available at www.hematology.org. Details of the virtual presentations are as follows:
Title: “Preclinical Characterization of MAU868, a Novel Neutralizing Antibody Targeting BK Virus”
Abstract Number: 1475
Presenter: Atul Sathe, Novartis Institutes for BioMedical Research
Session: 721. Clinical Allogeneic Transplantation: Conditioning Regimens, Engraftment, and Acute Transplant Toxicities: Poster I
Date and Time: Saturday, December 5, 2020: Available virtually from 7:00 AM-3:30 PM PST
Title: “A First-in-Human Study of MAU868, a Novel Neutralizing Antibody Against BK Virus”
Abstract Number: 2367
Presenter: Steven J. Kovacs, Novartis Institutes for BioMedical Research
Session: 721. Clinical Allogeneic Transplantation: Conditioning Regimens, Engraftment, and Acute Transplant Toxicities: Poster II
Date and Time: Sunday, December 6, 2020: available virtually from 7:00 AM-3:30 PM PST
MAU868, a novel human monoclonal antibody that potently neutralizes the BK virus, which can cause significant morbidity and mortality in transplant patients. Antibodies to BKV are found in approximately 80 to 90% of adults worldwide, indicating previous infection or exposure to the virus. A weakened immune system may result in BKV reactivation and cause serious disease. In patients who have had kidney transplant, BKV can lead to the loss of the transplanted kidney. BKV reactivation in the bladder can also cause hemorrhagic cystitis. Severe cases require bladder irrigation, clot evacuation, blood transfusion, stenting and nephrostomy. There are currently no approved treatments for renal nephropathy or hemorrhagic cystitis caused by BKV.
MAU868 potently neutralizes all four major genotypes of BKV at sub-nanomolar concentrations and has a high barrier to resistance in vitro. MAU868 also has neutralizing activity against the closely related JC virus, the cause of progressive multifocal leukoencephalopathy
MAU868 is currently being evaluated in a multicenter, randomized, double-blind, placebo-controlled Phase 2 clinical trial to assess the safety, pharmacokinetics, and efficacy for the treatment of BK viremia in kidney transplant recipients at centers in the US and Canada. The study’s primary objectives are to assess the safety of MAU868 in this patient population and to evaluate the efficacy of MAU868 in reducing BKV plasma viral load.
About Amplyx Pharmaceuticals
Amplyx Pharmaceuticals is developing innovative therapies for patients with compromised immune systems, including cancer and transplant patients, and the critically ill. The company’s two lead products are fosmanogepix (APX001), a first-in-class antifungal, for the treatment of life-threatening fungal infections caused by pathogens such as Candida, Aspergillus and rare molds, and MAU868, a novel human monoclonal antibody that potently neutralizes the BK virus, which can cause significant morbidity and mortality in transplant patients. For more information, please visit www.amplyx.com