Veloxis Pharmaceuticals’ VEL-101 Granted FDA Fast Track Designation

February 17, 2022 |

3 min read

Veloxis Pharmaceuticals Inc., an Asahi Kasei company, today announced that VEL-101, a novel investigational maintenance immunosuppressive agent being developed for prophylaxis of renal allograft rejection in patients receiving a kidney transplant, was granted fast track designation by the U.S. Food & Drug Administration (FDA).

CARY, N.C., Feb. 17, 2022 /PRNewswire/ -- Veloxis Pharmaceuticals Inc., an Asahi Kasei company, today announced that VEL-101, a novel investigational maintenance immunosuppressive agent being developed for prophylaxis of renal allograft rejection in patients receiving a kidney transplant, was granted fast track designation by the U.S. Food & Drug Administration (FDA). Fast track designation is granted by the FDA to facilitate the development and expedite the review of drugs that treat serious conditions and fill an unmet medical need.

This designation shows that the FDA recognizes the serious need to improve outcomes in kidney transplant recipients.

“We are encouraged to receive fast-track designation for VEL-101 because it shows that the FDA recognizes the serious need to improve outcomes in kidney transplant recipients,” said Mark Hensley, CEO of Veloxis. “Veloxis is committed to developing innovative therapeutics in an effort to improve the lives of the thousands of individuals who receive kidney transplants every year.”

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 found on T cells that acts as natural brakes on the body’s immune responses. VEL-101 is, therefore, expected to impact immune function both directly by blocking CD28-mediated T cell activation, and indirectly through preservation of CTLA-4 mediated immunoregulatory function.

“Despite short-term improvements in outcomes, long-term kidney transplant outcomes have not improved in part due to the challenges of maintaining long-term immunosuppression,” said Dr. Ulf Meier-Kriesche, Veloxis’s chief scientific officer and transplant nephrologist. “By receiving fast track designation for the VEL-101 clinical development program, we hope that more frequent interactions with the FDA and potential rolling regulatory submissions may shorten the time it will take to make VEL-101 available for kidney transplant recipients.”

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, an Asahi Kasei company, is a fully integrated specialty pharmaceutical company committed to improving the lives of transplant patients. Headquartered in Cary, N.C., 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 Health Care. 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. J Immunol 2016; 197:4593-4602

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SOURCE Veloxis Pharmaceuticals