Amplyx Announces Upcoming Virtual Data Presentations at 62nd American Society of Hematology (ASH) Annual Meeting

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 62^nd 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

About MAU868
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

READ FULL TEXT

Michael N. Dudley, Pharm.D.

President and Chief Executive Officer
Qpex Biopharma, Inc.

Dr. Dudley has over 30 years of experience in antiinfective drug research, development, and commercialization. In 2018, he co-founded Qpex Biopharma which raised $33M in Series A financing and acquired the preclinical infectious disease programs from The Medicines Company. He has overseen the development and regulatory approval of 3 antibiotics, most recently a beta-lactamase inhibitor combination product from a new chemical class (vaborbactam) discovered in the company laboratories. The antibiotic product Vabomere™ advanced from discovery to FDA approval in 2017 in less than 8 years. He lead the negotiation for multiple contracts from public-private partnerships (e.g., BARDA of the US Government; Innovative Medicines Initiative for the EU) for a combined total of over $190 million funding to advance antimicrobial agents in development in the US and Europe. Prior to co-founding Qpex, he was Chief Scientific Officer and co-founder of Rempex Pharmaceuticals that was acquired by the Medicines Company (MDCO) in 2013, where he remained as the co-leader of the Infectious Disease Business Unit of MDCO. Prior to Rempex, he held VP/SVP/CSO positions of increasing responsibility at the biotech companies Mpex Pharmaceuticals (acquired by Aptalis in 2011), Diversa Corporation, and Microcide Pharmaceuticals. Prior to his career in pharmaceutical industry, he held full-time academic appointments that included Professor of Pharmacy and Chairman of the Department of Pharmacy Practice at the University of Rhode Island College of Pharmacy (URI), and Adjunct Professor of Medicine, Brown University School of Medicine at Roger Williams Medical Center in Providence, RI. As an academic researcher, he conducted preclinical and clinical research in antibacterial, antifungal, and antiviral agents, including pioneering work on PK-PD approaches for several classes of antiinfectives. Dr. Dudley has published over 130 scientific papers and book chapters describing the evaluation and clinical use of antiinfective agents and treatment of infectious diseases. He has served as an invited speaker at several FDA and EMA workshops, international meetings on infectious diseases, and advisor to several companies. He has served as an Editor for the journal Antimicrobial Agents and Chemotherapy and numerous other editorial and advisory boards. He completed undergraduate work at Pepperdine University and his Doctor of Pharmacy (PharmD) from the University of California San Francisco (UCSF), completed at residency at UCSF, and a fellowship in infectious diseases at Hartford Hospital.

Amplyx Announces Upcoming Virtual Data Presentations at 62nd American Society of Hematology (ASH) Annual Meeting

René Russo, PharmD, BCPS

René Russo, PharmD, BCPS

Roger J. Pomerantz, M.D., F.A.C.P.

Christine Ann Miller

Graham G. Lumsden

Marco Taglietti, M.D.

Ankit Mahadevia

Jeffrey Stein, Ph.D.

Evan Loh, M.D.

Michael Dunne, M.D

Ciara Kennedy, Ph.D.

Ted Schroeder

Kevin Finney

Manos Perros, Ph.D.

David Roblin

Stephen Conafay

Christopher J. Burns, Ph.D.

Michael N. Dudley, Pharm.D.

Ramani Varanasi

Corey Fishman

Felix Faupel

Adrian Nivoliez