Memo Therapeutics AG, a biotechnology company developing therapeutic antibodies, said the US Food and Drug Administration (FDA) had granted a fast-track designation for AntiBKV, an MTx primary antibody therapy that targets BK polyomavirus (BKV) infection commonly seen in kidney transplant patients.
AntiBKV has successfully completed phase I clinical studies and following FDA approval has begun to actively recruit patients for its critical phase II/III clinical trials.
The FDA’s fast-track process has been designed to facilitate the development and accelerate the review of drugs to treat serious conditions and meet unmet medical needs. This means an important new drug has the potential to get to patients earlier. There are currently no therapies to treat BKV infection.
“Receiving Fast Track designation from the FDA is a significant achievement for Memo, validating the potential of AntiBKV and accelerating its development. We believe AntiBKV can be a first and best-in-class treatment option for kidney transplant patients suffering from BKV infection,” said Karsten Fischer, chief executive officer of Memo Therapeutics.
“AntiBKV showed very promising results in our phase I trial. We recently started recruiting for a very important phase II/III clinical trial in the US and plan for the next BLA submission in 2024. We hope to be able to offer patients much needed therapeutic options by 2025 at the latest.”
BKV infection mostly occurs in childhood and remains dormant in healthy individuals. However, BKV infection poses a significant threat after kidney transplantation, with serious adverse effects on graft function and ultimately patient survival. Due to the immunosuppressive drug regimen that transplant patients receive, BKV reactivation is triggered in 40 to 50% of kidney transplant recipients.
Up to 10% then develop BKV-associated nephropathy, which is the main cause of graft loss. There are currently no disease-modifying therapies available to treat BKV infection; it can only be treated by lowering the immunosuppression. However, this significantly increases the risk of graft rejection reactions, leading to impaired function and longevity, or graft failure.
About Therapy Memos
Memo Therapeutics is a Swiss late-stage biotech company developing best-in-class therapeutic antibodies to transform the lives of patients with viral infections and cancer.
In addition to AntiBKV, the MTx line comprises additional infectious disease-focused therapeutic antibodies, such as cytomegalovirus (CMV), an undisclosed immuno-oncology target, as well as a partnership with Ono Pharmaceutical.