Veloxis Pharmaceuticals Announces Dosing of the First Participant in a Phase I Study of VEL-101, a Novel Investigational Drug for Kidney Transplant Immunosuppression

CARY, N.C., May 18, 2022 /PRNewswire/ -- Veloxis Pharmaceuticals, Inc., an Asahi Kasei company, today announced that the first participant has been dosed in a Phase 1 Study of VEL-101 [NCT05238493]. VEL-101 is a novel investigational maintenance immunosuppressive agent being developed for prevention of acute rejection in kidney transplant recipients.

"Dosing our first participant in this study is a monumental step for Veloxis and our growth as a global pharmaceutical development company," said Mark Hensley, chief executive officer of Veloxis. "This milestone demonstrates how our relationship with the Asahi Kasei Group is enabling us to deliver on our promise to improve the lives of transplant patients by developing innovative therapeutics."

The study will assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of single ascending doses of VEL-101 or placebo when administered subcutaneously (SC) or intravenously (IV). Approximately 56 healthy participants will be enrolled and will undergo monitoring for 50 days.

VEL-101's prior Phase 1, randomized, double-blind, placebo-controlled study evaluated single and multiple ascending IV doses of VEL-101 in healthy participants. The current Phase 1 study will provide important data following SC administration before proceeding to studies in the kidney transplant population. A SC route of administration is being studied to potentially support self-administration at home.

"We are excited to initiate the development of VEL-101 with this study in healthy participants in the United States. The Phase 1 study will primarily provide data on the safety and tolerability of the investigational drug when administered using a subcutaneous route of administration and in a non-weight based fixed dose format," says Tunde Otulana MD, chief medical officer of Veloxis. "The study will also generate data to support the selection of an appropriate dose-range to incorporate into the next study, which will be a Phase 2 proof of concept study in de novo kidney transplant patients."

VEL-101 is a pegylated monoclonal antibody fragment that binds to and blocks CD28-mediated effector-T cell costimulation, without blocking CTLA-4, an important protein receptor found on T cells that acts as a natural brake on the body's immune responses. VEL-101 is, therefore, expected to have a dual-mechanism of action where in a direct manner, it blocks CD28-mediated T cell activation, and in an indirect way, it allows for CTLA-4 mediated immunosuppressive functions. VEL-101 will be developed for prevention of acute rejection in recipients of kidney transplants and potentially in recipients of other solid organs.

About the Study (NCT05238493)
VEL-101 is being studied in a Phase 1, randomized, double blind, placebo controlled, dose escalation study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of VEL-101 administered intravenously or subcutaneously in healthy participants. The primary objective is to assess the safety and tolerability of single ascending doses of VEL-101 when administered subcutaneously or intravenously. Approximately 56 participants will be enrolled in all the cohorts.

About the VEL-101 Clinical Program
VEL-101 has been evaluated in a first-in-human study to assess the safety, pharmacokinetics, pharmacodynamics, and potency of IV administrations in healthy subjects (read about the study here¹). VEL-101, a pegylated monoclonal antibody fragment CD28 antagonist, selectively blunts CD28 co-stimulation while sparing the CTLA-4 co-inhibitory signal. The net effect of CD28 antagonism is downregulating effector T cells while potentially promoting regulatory T-cell (Treg) activity.

VEL-101, also known as FR104, was licensed by Veloxis Pharmaceuticals, Inc. from OSE Immunotherapeutics in April 2021. As part of the license agreement, Veloxis Pharmaceuticals, Inc. obtained worldwide rights to develop, manufacture, and commercialize VEL-101 for all transplant indications.

About Veloxis Pharmaceuticals
Veloxis Pharmaceuticals, Inc, an Asahi Kasei company, is a fully integrated 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 www.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 40,000 employees around the world, the company contributes to 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, dialysis, therapeutic apheresis, transfusion, and manufacture of biotherapeutics, as well as pharmaceuticals and diagnostic reagents. For further information, please visit www.asahi-kasei.com.

¹ Poirier N et al. First-in-Human Study in Healthy Subjects with FR104, a Pegylated Monoclonal Antibody Fragment Antagonist of CD28. J. Immunol. 2016

SOURCE Veloxis Pharmaceuticals