Dutch biotech starts liquidation after ending PhIII in GVHD

27 Jan 2023
endpts.com
Phase 3Fast TrackOrphan DrugCell TherapyDrug Approval
A 13-year-old Dutch biotech is going through a liquidation process after an unexpected end to its Phase III trial testing whether its combination of two monoclonal antibodies was superior to Incyte’s Jakafi. Xenikos had hoped to prove its investigational therapy, named T-Guard, was better than Jakafi at garnering a complete response in patients experiencing life-threatening complications in which new cells from a hematopoietic stem cell transplant begin to fight the body. Jakafi was approved for the indication, steroid-refractory acute graft-versus-host disease, in May 2019. But Xenikos flashed a stop sign this week in an update to the Phase III study on the US clinical trials database, saying it had terminated the testing because the study “met the protocol defined stopping boundary for Day 60 mortality when comparing mortality between the T-Guard and ruxolitinib [Jakafi] arms.” In an interview, Xenikos founder and CEO Ypke van Oosterhout said the biotech hadn’t expected the outcome. The drug developer, which he said has let most employees go, is still going through the results with its trial partners, including the Blood and Marrow Transplant Clinical Trials Network. He said it was too early to provide details about the future of the asset. T-Guard combines two monoclonal antibodies going after CD3 and CD7 on T cells and NK cells. The antibodies hook up to an immunotoxin with the goal of stopping the activated T cells from producing new proteins. FDA and EU assigned it orphan drug status and the US regulator also gave it fast track designation. Xenikos had aimed to enroll 246 patients in the trial, but only a dozen were actually brought into the study. Patients in the T-Guard group received an IV infusion over the course of four hours for four times in one week. In the Jakafi group, patients took the oral drug twice a day until day 56. Data from the first 150 patients were expected to form the basis for a biologics license application to the FDA, and data from all patients in the study were anticipated to support an approval request in the EU, Xenikos had previously guided. The biotech had tried running a single-arm Phase III in the US in 2019, but the FDA placed a hold on it after the first three patients died within 30 days of the trial start. Xenikos said the FDA conducted an “in-depth investigation” that “found no reason to stop further development of T-Guard.” After meeting with the FDA, the parties hashed out the new Phase III trial, which also included sites in the EU. Financing for the private biotech had come from the likes of RA Capital and Medicxi, via a $30 million Series B in 2018. Another €40 million came via convertible debt in fall 2021 , and just last month Xenikos had announced funding from the European Innovation Council. Social: Shutterstock
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