Veloxis doses first patient in Phase 2 RENGEVITY-201 of pegrizeprument (VEL-101)
- First participant dosed in Phase 2 RENGEVITY-201 evaluating pegrizeprument for prevention of organ rejection in kidney transplant recipients.
- Randomized, multicenter, partially blinded active-control trial enrolling up to 120 de novo kidney transplant recipients randomized 1:1:1 to two pegrizeprument dose arms or tacrolimus; all receive rATG, corticosteroids and mycophenolate.
- Primary objectives are to evaluate safety, pharmacokinetics and pharmacodynamics of pegrizeprument.
- Pegrizeprument is a pegylated monoclonal antibody fragment that blocks CD28‑mediated T‑cell costimulation while sparing CTLA‑4; FDA granted orphan designations for liver (Dec 2025) and heart (Mar 2026) transplant indications.
Clinical milestone
Veloxis has dosed the first participant in RENGEVITY-201, its Phase 2 study of pegrizeprument (VEL-101) for prevention of organ rejection in kidney transplant recipients.
Study design and objectives
RENGEVITY-201 is a randomized, multicenter, partially blinded, active-control trial. Up to 120 de novo kidney transplant recipients will receive rATG with corticosteroids and mycophenolate and be randomized 1:1:1 to one of two pegrizeprument dose arms or to tacrolimus. The study will evaluate safety, pharmacokinetics and pharmacodynamics.
Drug profile and mechanism
Pegrizeprument is a pegylated monoclonal antibody fragment that binds CD28 and blocks CD28‑mediated effector‑T cell costimulation without blocking CTLA‑4, permitting CTLA‑4‑mediated immunosuppressive functions; the molecule is positioned as a maintenance immunosuppressive therapy to prevent acute rejection in solid organ transplant recipients.
Regulatory and licensing history
The FDA granted orphan drug designation to pegrizeprument for prevention of organ rejection in liver transplant recipients (December 2025) and for prophylaxis of heart allograft rejection (March 2026). Veloxis licensed pegrizeprument (also known as FR104) from OSE Immunotherapeutics in April 2021 with worldwide development, manufacturing and commercialization rights for transplant indications.
Source: Asahi Kasei