Veloxis Pharmaceuticals Selected to Present at the 2024 American Transplant Congress in Philadelphia

CARY, N.C., U.S.A. (May 30, 2024) – Veloxis Pharmaceuticals, Inc. (Veloxis), a fully integrated specialty pharmaceutical company, is pleased to announce the presentation of VEL-101 research at the 2024 American Transplant Congress (ATC). VEL-101 (also known as FR104) is a novel investigational maintenance immunosuppressive agent being developed for prevention of acute rejection in kidney transplant recipients. Taking place June 1-5 in Philadelphia, ATC is the joint annual meeting of the American Society of Transplant Surgeons and the American Society of Transplantation.

An abstract titled “Safety, Pharmacokinetics, and Pharmacodynamics of Fixed-Dose, Subcutaneous (SQ) Administration of VEL-101, an Anti-CD28 Pegylated Monoclonal Antibody Fragment, in Healthy Participants” will be presented on Tuesday, June 4 as a rapid fire oral abstract with a seven-minute presentation followed by a three-minute question and answer session.

The presentation will include data from a Veloxis-sponsored Phase 1 dose escalation study in healthy participants evaluating safety and pharmacokinetics of VEL-101 following intravenous and SQ administration, presented by Dr. Simon Tremblay, Senior Director of Clinical Development and Clinical Development Lead for VEL-101 at Veloxis.

“We are pleased to share data supporting the potential for non-weight based, fixed dose, subcutaneous administration of VEL-101, which will facilitate dose selection in preparation for a Phase 2 study in kidney transplant recipients,” says Dr. Tunde Otulana, Chief Medical Officer at Veloxis. “Veloxis is proud to be contributing to the advancement of patient-focused transplant science.”

Two additional VEL-101 abstracts, supported by OSE Immunotherapeutics, were also accepted as rapid fire oral presentations. The first, titled “First Use of FR104 an Anti-CD28 Molecule in Human Kidney Transplantation, Interim Analysis,” a Phase 1/2 clinical trial in kidney transplant recipients, will be presented by Professor Gilles Blancho, Head of the Institute of Urology and Nephrology Transplantation (ITUN) at the University Hospital in Nantes/Nantes University. The second, titled “Combined Blockade of the CD154 and CD28 Co-Stimulation Pathways Attenuates Pathogenic Alloimmunity and Prolongs Survival in Cynomolgus Cardiac Allografts,” will be presented by Dr. Kohei Kinoshita from the Center for Transplantation Sciences, Massachusetts General Hospital.

“On behalf of the authors and contributors from the VEL-101 development team, I am thrilled that the American Transplant Congress has selected VEL-101 abstracts to be presented this year,” says Mark Hensley, Chief Executive Officer at Veloxis. “The acceptance of VEL-101 research led by Veloxis, OSE and other investigators at this event is indicative of the strong interest in bringing novel therapies to transplant patients and the potential contribution VEL-101 may make if approved. This represents an important step for Veloxis as we strive to grow our impact in the global transplant community.”

The ATC, which brings together transplant physicians and surgeons, advanced practice providers, scientists, nurses, organ procurement personnel, pharmacists and allied health professionals, provides a forum for exchange of new scientific and clinical information related to solid organ and tissue transplantation. Each year, the Congress selects over 1,500 of the top research abstracts from authors across the nation to present. In being selected for their research and development of VEL-101, Veloxis is proud to be recognized amongst the most innovative and groundbreaking research programs in transplantation nationwide.

About VEL-101

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 naturally helps keep the body's immune responses in check. 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 is being developed for prevention of acute rejection in recipients of kidney transplants and potentially in recipients of other solid organs.

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 Veloxis.com.

About OSE Immunotherapeutics

OSE Immunotherapeutics is an integrated biotechnology company focused on developing and partnering therapies to control the immune system for immuno-oncology and immuno-inflammation. Based in Nantes (Head Office) and Paris, OSE Immunotherapeutics has 65+ employees and is listed on Euronext Paris. For further information, please visit OSE-immuno.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 48,000 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 Health Care. Its Health Care operations include devices and systems for acute critical care, dialysis, therapeutic apheresis, and manufacture of biotherapeutics, as well as pharmaceuticals and diagnostic reagents. For further information, please visit Asahi-Kasei.com.