Home Therapeutic relationship Veloxis Pharmaceuticals Announces Dosing of First Participant in Phase I Study of VEL-101, an Investigational New Drug for Kidney Transplant Immunosuppression

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

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CARY, North Carolina, May 18, 2022 /PRNewswire/ — Veloxis Pharmaceuticals A/S, Inc., an Asahi Kasei Company, today announced that the first participant has received a dose in a Phase 1 study of VEL-101 [NCT05238493]. VEL-101 is an investigational novel maintenance immunosuppressive agent under development for the prevention of acute rejection in kidney transplant recipients.



“The dosing of our first participant in this study is a monumental milestone for Veloxis…”


“The dosing of our first participant in this study is a monumental milestone for Veloxis and our growth as a global pharmaceutical development company,” said Mark Hensley, CEO of Veloxis. “This milestone demonstrates how our relationship with Asahi Kasei Group enables us to deliver on our promise to improve the lives of transplant patients by developing innovative therapies.


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


The previous Phase 1, randomized, double-blind, placebo-controlled study of VEL-101 evaluated single and multiple ascending IV doses of VEL-101 in healthy participants. The ongoing Phase 1 study will provide important data after SC administration before proceeding to studies in the kidney transplant population. A SC route of administration is being investigated to possibly support self-administration at home.


“We are excited to initiate the development of VEL-101 with this study in healthy participants in United States. The Phase 1 study will primarily provide data on the safety and tolerability of the investigational drug when administered subcutaneously and in a non-weight-based fixed-dose format,” states Tunde Otulana MD, Veloxis Chief Medical Officer. “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 and blocks CD28-mediated costimulation of effector T cells, without blocking CTLA-4, an important protein receptor found on T cells that acts as a natural brake on responses body’s immune systems. VEL-101 should therefore have a dual mechanism of action where, directly, it blocks CD28-mediated T cell activation and, indirectly, it enables CTLA-4-mediated immunosuppressive functions. VEL-101 will be developed for the prevention of acute rejection in kidney transplant recipients and potentially in recipients of other solid organs.


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


About the VEL-101 Clinical Program
VEL-101 has been evaluated in a first-in-man study to assess the safety, pharmacokinetics, pharmacodynamics, and potency of IV administrations in healthy subjects (read the study here1). VEL-101, a CD28 antagonist pegylated monoclonal antibody fragment, selectively attenuates CD28 co-stimulation while sparing the CTLA-4 co-inhibitory signal. The net effect of CD28 antagonism is downregulation of 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. Under the licensing agreement, Veloxis Pharmaceuticals, Inc. has obtained worldwide rights to develop, manufacture and commercialize VEL-101 for all transplantation 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. Based at Cary, North Carolina, United States, Veloxis is focused on the development and worldwide commercialization of medicines used by transplant patients and patients with serious related diseases. For more information, visit www.veloxis.com.


About Asahi Kasei:
The Asahi Kasei Group contributes to the life and lives of people around the world. Since its founding in 1922 with ammonia and cellulose fiber businesses, Asahi Kasei has grown steadily through proactive transformation of its business portfolio to meet the ever-changing needs of every age. With more than 40,000 employees worldwide, the company contributes to a sustainable society by providing solutions to global challenges through its three business segments: Hardware, Homes and Healthcare. Its healthcare businesses include devices and systems for acute intensive care, dialysis, therapeutic apheresis, transfusion and manufacturing of biotherapeutic products, as well as pharmaceuticals and diagnostic reagents. For more information, 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



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SOURCEVeloxis Pharmaceuticals