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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, Xenikos announces in a press release, was led by Veloxis Pharmaceuticals, with participation from existing investors, Medicxi, RA Capital Management, Oost NL and Sanquinnovate. In connection with the financing, Veloxis will obtain two sequential call options to acquire the company and a Board seat.

Xenikos will use the proceeds of the financing to initiate a registrational Phase 3 clinical trial in the US and EU, which is designed to evaluate the efficacy and safety of their flagship product T-Guard® for the treatment of steroid-refractory acute graft-versus-host disease (SR-aGVHD) in patients following allogeneic stem cell transplantation versus ruxolitinib. T-Guard is designed to reset the body’s immune system safely and swiftly in life-threatening T cell-mediated conditions, including transplant-related rejection, acute solid-organ rejection and severe autoimmune disease.

Effective new treatments

“Today’s announcement highlights Veloxis’ confidence in T-Guard’s potential in acute graft-versus-host disease,” said Dr. Ypke van Oosterhout, Xenikos’ CEO. “Effective new treatments for this severe and often fatal condition are urgently needed, and we believe that T-Guard can fill this void. With their expertise and experience developing and commercializing innovative therapies for transplant patients, Veloxis is an ideal partner to help bring T-Guard to the market following completion of our Phase 3 clinical trial, which we plan to resume during the second half of 2021.”

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    “Veloxis is committed to addressing unmet needs in transplantation and improving outcomes in transplant patients,” said Craig A. Collard, CEO of Veloxis. “Finding ways to combat acute GVHD, and SR-aGVHD in particular is critical to this mission. We are excited to make this strategic investment in Xenikos in hopes of bringing T-Guard through the final phase of development and explore other life cycle opportunities in transplantation such as acute rejection treatment or prevention for solid organ transplant patients.”

    Xenikos successfully completed a Phase 1/2 study for the second-line treatment of SR-aGVHD in patients following hematopoietic stem cell transplantation, showing that just one week of T-Guard treatment induced a remarkably high complete response rate and a doubling of the six-month overall survival rate, as compared to institutional historical controls. These results were published in the peer-reviewed journal Biology of Blood and Marrow Transplantation. T-Guard has been granted Orphan Drug Designation status in both the EU and the US.

    T-Guard®: Helping Reset the Body’s Immune System

    T-Guard is designed to safely and swiftly reset the body’s immune system in life-threatening T cell‒mediated conditions, including transplant-related rejection, acute solid-organ rejection, and severe autoimmune disease. T Guard consists of a unique combination of toxin-conjugated monoclonal antibodies that target CD3 and CD7 molecules on immune cells. Preclinical and early clinical testing have shown that T-Guard can specifically identify and eliminate mature T cells and NK cells with tolerable treatment-related side effects. Importantly, T-Guard’s action is short-lived, thereby significantly reducing the patient’s vulnerability to opportunistic infections compared to currently available therapies. In a Phase 1/2 study, just one week of T-Guard treatment induced a remarkably high complete response rate and a doubling of the 6-month overall survival rate as compared to institutional historical controls in patients being treated second-line for steroid-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. Nov 2018). T-Guard has been granted Orphan Drug Designation in both the EU and the US, and a randomized Phase 3 registration trial evaluating T-Guard for the treatment of SR-aGVHD is expected to commence in the second half of 2021.

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