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Veloxis Pharmaceuticals Announces Dosing of the First Patient by partner Xenikos in the Global Phase 3 Study Evaluating T-Guard®

Cary, North Carolina, United States – June 28, 2022 – Veloxis Pharmaceuticals, an Ashai Kasei company, today announced dosing of the first patient in a global pivotal Phase 3 clinical study [NCT04934670] designed to evaluate T-Guard® versus ruxolitinib for the treatment of patients with Grade III or IV steroid-refractory acute graft-versus-host disease (SR-aGVHD) following allogeneic hematopoietic stem cell transplant (allo-HSCT). T-Guard is currently being developed by Xenikos B.V., a privately-held biotechnology company that develops innovative immunotherapies for treating patients with severe immune disease and post-transplant rejection.


Veloxis Pharmaceuticals Announces Dosing of the First Participant in a Phase I Study of VEL-101

CARY, N.C., U.S.A. (May 18, 2022) – 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.


Veloxis Pharmaceuticals, Inc. Initiates Phase 1 Study of ART-123 in the U.S. and Japan

CARY, N.C., U.S.A. (March 28, 2022) – Veloxis Pharmaceuticals, Inc., an Asahi Kasei company, today announced initiation of study drug dosing in ART-123.PN101, a phase 1 study designed primarily to assess the safety and tolerability of ART-123 (thrombomodulin alfa) in metastatic colorectal cancer patients receiving chemotherapy that includes Oxaliplatin. The ART-123.PN101 study is being conducted jointly with Asahi Kasei Pharma Corp. in the United States and Japan.


Veloxis Pharmaceuticals’ VEL-101, A Novel Investigational Maintenance Immunosuppressant, Granted FDA Fast-Track Designation

Cary, North Carolina, USA, February 17, 2022 – 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.


Xenikos Secures €40 Million in Convertible Debt Financing, Veloxis Pharmaceuticals Joins as Strategic Investor

NIJMEGEN, the Netherlands, Sept. 8, 2021 /PRNewswire/ — Xenikos B.V., a clinical-stage biopharmaceutical company currently developing a novel therapy for treating immune related disorders, announced today the closing of €40 million in convertible debt consisting of two equal tranches of €20 million. The financing was led by Veloxis Pharmaceuticals, with participation from existing investors, Medicxi, RA


OSE Immunotherapeutics and Veloxis Pharmaceuticals Enter Into Global License Agreement to Develop, Manufacture, and Commercialize FR104, a CD28 Antagonist, in the Organ Transplantation Market

Agreement expands Veloxis’s product portfolio and the continued commitment to improving the lives of transplant patients. OSE Immunotherapeutics to receive up to €315 million in potential milestones, including a €7 million upfront, and tiered royalties on sales. PDF Version Nantes, France – Cary, NC, United States, April 26, 2021 – 6:00PM CET — OSE Immunotherapeutics (ISIN:


Transplant Therapeutics Consortium Receives Acceptance of Letter-of-Intent for iBox Scoring System as a Reasonably Likely Surrogate Endpoint from the Biomarker Qualification Program

Collaboration between the transplant community, industry, and regulatory agencies develops biomarker aimed to streamline the development of novel therapies intended to improve long-term outcomes for kidney transplant recipients. PDF Version Cary, NC, June 18, 2020 — Critical Path Institute (C-Path) announced Wednesday, June 17, that its Transplant Therapeutics Consortium (TTC), of which Veloxis Pharmaceuticals is a member,