Background

With an estimated number of 21,167 surgeries in 2018 in the US, kidney transplants represent the leading intervention for organ replacement. Among kidney transplant recipients, BK polyomavirus (BKPyV) reactivation is common. Reactivation is frequently subclinical, although it may manifest with acute kidney injury (AKI), and is a risk factor for premature allograft loss. Reduction of immunosuppression is the only intervention with the accompanying risk of organ rejection There is no specific antiviral or immunomodulatory therapy sufficiently effective for routine use. New approaches are needed to prevent and treat the occurance of BKV infection.

Technology Overview

BK polyomavirus (BKPyV) is a small DNA virus that establishes lifelong infection in the renal tubular and uroepithelial cells of most of the world’s population. For the majority, infection is quiescent and benign. However, in immunocompromised patients, BKPyV can reactivate, and in some, lead to BKPyV-associated nephropathy (BKPyVAN). Among kidney transplant recipients, BKPyV primarily causes tubulointerstitial nephritis and ureteral stenosis. Mount Sinai has developed a preventive/therapeutic approach to BKPyVAN for treating patients prior and during kidney transplant with neutralizing human antibodies against BKPyV.

Stage of Development

Mount Sinai has generated a panel of human BKV monoclonal antibodies with neutralizaton potentcy in the nano/pico molar range (in vitro data)

Benefits

A safe approach to reduce attrition from BKPyV-associated nephropathy (BKPyVAN)

Applications

Prevent and treat BKPyV-associated nephropathy (BKPyVAN) in patients who received a kidney transplant.
Prevent and treat BKPyV infection causing hemorrhagic cystitis and polyomavirus associated nephropathy in bone marrow transplant patients.

Neutralizing Human Antibodies Against BK Virus

IP Status