NIJMEGEN, the Netherlands, September 8, 2021 / PRNewswire / – Xenikos BV, a clinical-stage biopharmaceutical company currently developing a new therapy for the treatment of immune disorders, today announced the closing of € 40 million convertible debt consisting of two equal tranches of 20 million euros. Funding was led by Veloxis Pharmaceuticals, with participation from existing investors, Medicxi, RA Capital Management, Oost NL and Sanquinnovate. As part of the financing, Veloxis will obtain two sequential purchase options to acquire the company and a seat on the board of directors.
Xenikos will use the proceeds from the funding to launch a Phase 3 registration clinical trial in the US and EU, which is designed to assess the efficacy and safety of their flagship product T-Guard® for the treatment of acute steroid-refractory graft-versus-host disease (SR-aGVHD) in patients after allogeneic stem cell transplantation versus ruxolitinib. T-Guard is designed to safely and quickly reset the body’s immune system under potentially life-threatening T cell-mediated conditions, including transplant-related rejection, acute solid organ rejection, and auto- matic diseases. severe immune systems.
Under the terms of this agreement, Xenikos will receive the first tranche on signature and will retain the right to draw down the second tranche by meeting certain criteria. Concurrent with the issuance of each tranche of convertible debt, Veloxis will receive a call option, each becoming active upon the release of its associated tranche, giving Veloxis the exclusive option to exercise its right to acquire all of the securities. outstanding shares of Xenikos. The options may be exercised for a limited period of time after i) the successful completion of the safety portion of the Phase 3 study, which is expected to be completed in 2022, or ii) the successful completion of the futility of the phase 3 study, which is expected to be completed in 2023.
“Today’s announcement highlights Veloxis’ confidence in T-Guard’s potential in acute graft-versus-host disease,” said Dr Ypke van Oosterhout, CEO of Xenikos. “New, effective treatments for this serious and often fatal disease are urgently needed, and we believe T-Guard can fill this void. With its expertise and experience in the development and commercialization of innovative therapies for transplant patients, Veloxis is an ideal partner to help bring T-Guard to market following the completion of our Phase 3 clinical trial, which we plan to resume in the second half of 2021. “
“Veloxis is committed to addressing unmet transplant needs and improving outcomes in transplant patients,” said Craig A. Collard, CEO of Veloxis. “Finding ways to control acute GVHD, and SR-aGVHD in particular, is essential for this mission. We are excited to make this strategic investment in Xenikos in the hopes of bringing T-Guard through the final stages of development and exploring other lifecycle opportunities. in transplantation, such as the treatment of acute rejection or prevention in patients who have had a solid organ transplant. “
Xenikos has successfully completed a phase 1/2 study for the second-line treatment of SR-aGVHD in patients after hematopoietic stem cell transplantation, showing that a single week of treatment with T-Guard induced a rate of remarkably high complete response and a doubling of the six-month overall survival rate, compared to historical institutional controls. These results were published in the peer-reviewed journal Biology of blood and marrow transplantation. T-Guard has been granted orphan drug status in the EU and the United States.
T-Guard®: Help reset the body’s immune system
T-Guard is designed to quickly and safely reset the body’s immune system under life-threatening T-cell mediated conditions, including transplant-related rejection, acute solid organ rejection, and disease severe autoimmune. T Guard is a unique combination of monoclonal antibodies conjugated to toxins that target CD3 and CD7 molecules on immune cells. Preclinical and early clinical testing has shown that T-Guard can specifically identify and eliminate mature T cells and NK cells with tolerable treatment-related side effects. It is important to note that the action of T-Guard is short-lived, which significantly reduces the patient’s vulnerability to opportunistic infections compared to currently available therapies. In a phase 1/2 study, a single week of treatment with T-Guard induced a remarkably high complete response rate and a doubling of the overall survival rate at 6 months compared to historical institutional controls in patients treated in second line for corticosteroids. refractory acute graft versus host disease (SR-aGVHD) following hematopoietic stem cell transplantation (HSCT). These results were published in the peer-reviewed journal Biology of Blood and Marrow Transplantation (Groth, et al. november 2018). T-Guard has achieved orphan drug designation in the EU and US, and a phase 3 randomized registration trial evaluating T-Guard for the treatment of SR-aGVHD is expected to begin in the second half of 2021.
Xenikos develops innovative immunotherapies based on conjugated antibodies. This new therapeutic approach enables the immune system to be reset in patients who have severe immune disease or who have developed post-transplant rejection. A Phase 3 randomized registration trial evaluating the company’s flagship product, T-Guard® for the treatment of acute steroid-refractory graft-versus-host disease (SR-aGVHD) should begin in the United States and Europe in the second half of 2021.
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 direct commercialization of immunosuppressive drugs in the United States, the expansion of partnerships for markets around the world and the acquisition of assets used in transplant patients and by medical specialties adjacent. For more information, please visit www.veloxis.com.
About Asahi Kasei
The Asahi Kasei Group contributes to the lives and the lives of people around the world. Since its founding in 1922 with ammonia and cellulose fiber businesses, Asahi Kasei has grown steadily through the 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 of materials, homes and healthcare. Its healthcare business includes devices and systems for acute intensive care, dialysis, therapeutic apheresis, transfusion, and the manufacturing of biotherapeutics, as well as pharmaceuticals and diagnostic reagents. For more information, please visit www.asahi-kasei.com.
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SOURCE Veloxis Pharma