Veloxis Pharmaceuticals to Present at 2025 World Transplant Congress

CARY, N.C., July 30, 2025 /PRNewswire/ -- Veloxis Pharmaceuticals, Inc. (Veloxis), an Asahi Kasei company and a global specialty pharmaceutical company, is pleased to announce it will present new preclinical data at the upcoming World Transplant Congress (WTC) on pegrizeprument (also known as VEL-101), a novel subcutaneous CD28 co-stimulation blocker being developed as maintenance immunosuppression in kidney transplantation.

The abstract, titled "Subcutaneous Administration of a CD28 Co-stimulation Blocker Demonstrates Efficacy in an NHP Model of Kidney Allotransplantation," will be presented on Tuesday, August 5 at 4:30 PM PST as an oral abstract by Daniel Schuster, MD, MS, General Surgery Resident at Duke University Medical Center.

The study evaluated subcutaneous pegrizeprument administration in a non-human primate model of renal transplantation and found that pegrizeprument monotherapy significantly increased rejection-free survival when compared to animals that did not receive immunosuppression (P=0.0128). Additionally, the combination of pegrizeprument and standard of care immunosuppression resulted in similar overall and rejection-free survival when compared to animals treated with tacrolimus and standard of care immunosuppression (P=0.6714), while resulting in less donor specific antibodies and showing a potentially improved safety profile compared to tacrolimus–based immunosuppression. These findings support the ongoing development of pegrizeprument administered subcutaneously as a novel immunosuppressive therapy with the goal of improving long term transplant outcomes.

"This study, conducted in a stringent nonhuman primate model of kidney transplantation, demonstrates clear efficacy of pegrizeprument in preventing rejection while potentially reducing the overall burden of immunosuppression in these animals," said Allan D. Kirk, MD, PhD, Chair of Surgery at Duke University. "Additionally, subcutaneous administration was well tolerated and represents an innovative approach to delivery of immunosuppression. I'm very happy to see this agent progressing through clinical trials."

Stacy Wheeler, Chief Executive Officer at Veloxis, stated "The World Transplant Congress brings together the brightest minds in transplantation, and we are incredibly proud to have research on pegrizeprument featured at this year's congress." She added "The selection of our data for presentation reflects the meaningful progress we are making toward delivering innovative immunosuppressive therapies. It's an exciting milestone for Veloxis as we continue our mission to improve long-term outcomes for transplant recipients around the world."

The 2025 World Transplant Congress, taking place August 2-6 in San Francisco, is a premier global event dedicated to advancing the science and medicine of transplantation. Jointly organized by the American Society of Transplant Surgeons, the American Society of Transplantation, and The Transplantation Society, the congress brings together leading clinicians, researchers and healthcare professionals for scientific sessions, educational workshops, and networking opportunities to advance innovation and address key challenges in organ transplantation. In addition to presenting new data, Veloxis will have a presence at the conference at booth #501.

About pegrizeprument (also known as VEL-101)
Pegrizeprument is a pegylated monoclonal monovalent antibody fragment that binds to and blocks CD28-mediated effector-T cell costimulation, without blocking CTLA-4, an important protein found on T cells that naturally helps keep the body's immune responses in check. Pegrizeprument is, therefore, expected to have a dual-mechanism of action where, in a direct manner, it blocks CD28-mediated T cell activation, and indirectly, it allows for CTLA-4 mediated immunosuppressive functions. Also known as FR104, pegrizeprument was licensed by Veloxis from OSE Immunotherapeutics in April 2021. As part of the license agreement, Veloxis obtained worldwide rights to develop, manufacture, and commercialize pegrizeprument for all transplant indications. Pegrizeprument is being developed for the prevention of acute rejection in recipients of kidney transplants and potentially in recipients of other solid organs.

About Veloxis Pharmaceuticals, Inc.
Veloxis Pharmaceuticals, Inc., an Asahi Kasei company, is a global specialty pharmaceutical company committed to improving the lives of transplant patients. Headquartered in Cary, North Carolina, USA, Veloxis is focused on the global development and commercialization of medications utilized by transplant patients and by patients with serious related diseases. For further information, please visit Veloxis.com.

About Asahi Kasei
The Asahi Kasei Group contributes to life and living for people around the world. Since its foundation in 1922 with ammonia and cellulose fiber business, Asahi Kasei has consistently grown through the proactive transformation of its business portfolio to meet the evolving needs of every age. With more than 50,000 employees worldwide, the company contributes to a sustainable society by providing solutions to the world's challenges through its three business sectors of Material, Homes, and Healthcare. Its Healthcare operations include devices and systems for acute critical care, therapeutic apheresis, and manufacture of biotherapeutics, as well as pharmaceuticals. For further information, please visit asahi-kasei.com.

SOURCE Veloxis Pharmaceuticals