On January 13, 2023 Equillium, Inc. (Nasdaq: EQ), a clinical-stage biotechnology company focused on developing novel therapeutics to treat severe autoimmune and inflammatory disorders, reported that an abstract was accepted for oral presentation at the Transplantation & Cellular Therapy Meetings of the American Society of Transplantation and Cellular Therapy, and the Center for International Blood & Marrow Transplant Research (Press release, Equillium, JAN 13, 2023, View Source [SID1234626231]). The Hybrid meetings will take place virtually and in person at the Orlando World Center Marriott, Orlando, Florida, February 15 – 19, 2023.
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Title: Final Safety and Efficacy Results from EQUATE, an Open-Label Study Evaluating Itolizumab, a Novel Targeted anti-CD6 Therapy, in Newly Diagnosed Acute Graft-Versus-Host Disease
Presenting Author: Dr. John Koreth, associate professor of medicine, Dana Farber Cancer Institute, Harvard Medical School
Abstract ID Number: 36
Assigned Session: Oral Abstract – Session E: GVHD – Clinical
Date and Time: Thursday, February 16, 2023, 2:30 PM
The abstract highlights positive final study results, including long-term follow-up data for up to one year, from EQUATE (NCT03763318), a Phase 1b study of itolizumab in combination with corticosteroids (CS) to treat subjects with newly diagnosed severe acute graft-versus-host disease (aGVHD). The data demonstrate promising outcomes in subjects with severe aGVHD, and Equillium has since initiated EQUATOR (NCT05263999), a Phase 3 study of itolizumab as a potential initial therapy for aGVHD in combination with CS.
About Graft-Versus-Host Disease (GVHD)
GVHD is a multisystem disorder that is a common complication of allogeneic hematopoietic stem cell transplants (allo-HSCT) caused by the transplanted immune system recognizing and attacking the recipient’s body. Symptoms of GVHD include rash, itching, skin discoloration, nausea, vomiting, diarrhea, and jaundice, as well as eye dryness and irritation.
GVHD is the leading cause of non-relapse mortality in cancer patients receiving allo-HSCT, and its risk limits the number and type of patients receiving HSCT. GVHD results in high morbidity and mortality, with five-year survival of approximately 53% in patients who respond to steroid treatment and mortality as high as 95% in patients who do not respond to steroids. There are no approved treatments for first-line aGVHD. Published literature (MacMillan et al., 2015) describes background response rates to high-dose steroid administration in severe high-risk patients as 43% overall response and 27% complete response.
About the EQUATE Study
The EQUATE study is a Phase 1b/2 trial to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and clinical activity of itolizumab for first-line treatment in patients who present with aGVHD (NCT03763318). The Phase 1b part of the trial is an open-label dose escalation study in adult patients who present with high-risk aGVHD and typically respond poorly to steroids. The Phase 1b data will inform selection of the dose to be used in the next phase of development for the program.
About Itolizumab
Itolizumab is a clinical-stage, first-in-class anti-CD6 monoclonal antibody that selectively targets the CD6-ALCAM signaling pathway to selectively downregulate pathogenic T effector cells while preserving T regulatory cells critical for maintaining a balanced immune response. This pathway plays a central role in modulating the activity and trafficking of T cells that drive a number of immuno-inflammatory diseases.