Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 2554 |
| INN | Dafsolimab setaritox, grisnilimab setaritox |
| Status | Terminated |
| Drug code(s) | T-Guard; SPV-T3a + WT1 |
| Brand name | None |
| mAb sequence source | mAb murine |
| General Molecular Category | Immunoconjugate, Immunotoxin, Mixture |
| Format, general category | Full length Ab fusion |
| Format details | None |
| Isotype (Fc) | IgG2a, IgG2b |
| Light chain isotype | kappa, lambda |
| Linker | None |
| Ave. DAR | None |
| Conjugated/fused moiety | Ricin A |
| Discovery method/technology | None |
| Target(s) | CD3, CD7 |
| Indications of clinical studies | Graft vs host disease |
| Primary therapeutic area | Immune-mediated / inflammatory disorders |
| Most advanced stage of development (global) | Terminated at Phase 3 |
| Status | Inactive |
| Start of clinical phase (IND filing or first Phase 1) | July 01, 2012 |
| Start of Phase 2 | |
| Start of Phase 3 | November 21, 2019 |
| Date BLA/NDA submitted to FDA | |
| Year of first approval (global) | None |
| Date of first US approval | |
| INN, US product name | None |
| US or EU approved indications | None |
| Company | Xenikos |
| Licensee/Partner | None |
| Comments about company or candidate | The Phase 3 NCT04934670 study is terminated (January 25, 2023) "The study met the protocol defined stopping boundary for Day 60 mortality when comparing mortality between the T-Guard and ruxolitinib arms". Xenikos also announced it on their website (https://www.xenikos.com/) that the company has decided to cease operations."It is also currently being explored whether T-Guard can be further developed for other clinical indications." June 27, 2022: Xenikos B.V., a privately-held biotechnology company that develops innovative immunotherapies for treating patients with severe immune disease and post-transplant rejection, announced enrollment of the first patient in a global pivotal Phase 3 clinical study 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 NCT04934670 Phase 3 due to start in Sep 2021. Assuming a positive outcome from the new Phase 3 study, Xenikos expects the data from this study to support the submission of a Biologics License Application (BLA) in the US based on Day 28 data from the first 150 patients. Aug 2020: Phase 3 study terminated (Initiated a new randomized trial per discussion with FDA); no information found for this new study. NCT04128319 Phase 3 study recruiting as of Nov 21, 2019. Oct 2019: The FDA granted fast track designation to T-Guard for treatment of patients who develop steroid-refractory acute graft-versus-host disease after allogeneic stem cell transplantation. June 11, 2019 - The Dutch company Xenikos B.V., which develops innovative immunotherapies for treating patients with severe immune disease and post-transplant rejection, announced today that the U.S. Food and Drug Administration (FDA) has approved an investigational new drug (IND) application to initiate a U.S.-based clinical Phase 3 registration trial in order to test the efficacy of T-Guard for treating steroid-refractory acute graft-versus-host disease (SR-aGVHD) in patients following allogeneic stem cell transplantation. This single-arm, multi-center Phase 3 trial (BMT CTN 1802) is designed to evaluate the efficacy and safety of T-Guard in 47 patients who receive an allogeneic stem cell transplantation and subsequently develop SR-aGVHD. The primary endpoint of the study will be the complete response rate at day 28, and key secondary endpoints will include the duration of complete response and overall survival rate at six months. The trial will be conducted in the U.S. by the Blood and Marrow Transplant Clinical Trials Network (BMT CTN), funded by the National Heart, Lung, and Blood Institute (NHLBI) and the National Cancer Institute (NCI), which are co-funding the trial. Drawing on its vast network of leading transplant centers throughout the U.S., the BMT CTN is expected to be able to quickly recruit patients for the trial, thereby helping bring T-Guard to market as quickly as possible. May 15, 2018 - Xenikos B.V., a clinical-stage biopharmaceutical company currently developing a novel therapy for treating acute graft-versus-host disease (aGVHD), announced today the receipt of USD 30 million from a Series B financing. Two new investors in the Company - Medicxi and RA Capital Management – participated in the financing round. The funds will be used to advance the development of Xenikos’ lead compound, T-Guard, including conducting clinical Phase 3 registration trials in the US and EU, arranging commercial-scale production, and submitting the relevant applications for market approval. December 11, 2017 - Xenikos B.V. today reported that detailed efficacy and safety data from a clinical phase I/II trial with T-Guard for the second-line treatment of steroid-resistant acute graft-versus-host disease (GVHD) were presented at the 59th Annual Meeting of the American Society of Hematology (ASH) in Atlanta, GA. The Company is planning to initiate a pivotal multi-center global active-controlled trial, comparing T-Guard with best-available therapy for steroid-resistant acute GVHD in the first half of 2018. January 3rd, 2017- Xenikos B.V., focused on the development of innovative immunotherapies for the treatment of patients suffering from serious immune diseases or rejection after transplantation, announced today that it has been awarded a EUR 1 million innovation credit extension by the Netherlands Enterprise Agency (Rijksdienst voor Ondernemend Nederland, RVO), part of the Dutch Ministry of Economic Affairs. The funding is to support the next steps in the development of product candidate, T-Guard, which is in clinical Phase 1/2 testing for the treatment of steroid-resistant acute graft versus host disease (GVHD). T-Guard consists of a combination of two toxin-loaded anti-T-cell antibodies . NCT02027805 Phase 1 study completed as of Nov 2016; Company is seeking to out-license asset. T-Guard was discovered and developed in the Hematology Department of the Radboud University Nijmegen Medical Center in Nijmegen |
| Full address of company | Wilhelminasingel 14, 6524 AL Nijmegen Europe Netherlands https://www.xenikos.com/ |
Targets activated T and NK cells. Dafsolimab setaritox is an immunoglobulin G2B-kappa, anti-[CD3E (CD3 epsilon, Leu-4)], Mus musculus monoclonal antibody conjugated to aglycosylated ricin toxin A (RTA); grisnilimab setaritox is an immunoglobulin G2A-lambda, anti-[CD7 (CD7 antigen (p41),GP40, LEU-9, TP41, Tp40)], Mus musculus monoclonal antibody conjugated to ricin toxin A (RTA)
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |