LA JOLLA, Calif.–(BUSINESS WIRE)–Equillium, Inc. (Nasdaq: EQ), a clinical-stage biotechnology company focused on developing novel therapies to treat serious autoimmune and inflammatory disorders with high unmet medical need, announced today an oral presentation at the 2022 National Congress of the Italian Society of Experimental Hematology in Rome, Italy. Presentation analyzes immune reconstitution data from 95 adult patients who underwent allogeneic hematopoietic cell transplants at the Dana-Farber Cancer Institute between September 2018 and January 2020, demonstrating the ability of itolizumab to inhibit pathogenic T-cell proliferation in patients with an acute graft versus host disease. disease (aGVHD).
“The translational work presented specifically characterizes CD6 expression levels and demonstrates the suppressive effect of itolizumab on CD4 and CD8 T cell activity from transplant patients with aGVHD,” said Jerome Ritz, MD, executive director of the Connell and O’Reilly Family Cell. Core Facility Manipulation at the Dana-Farber Cancer Institute and Professor of Medicine at Harvard Medical School. “The data highlight the important role of the CD6-ALCAM pathway in modulating effector T cell function and further support progress toward a Phase 3 study of itolizumab in front-line aGVHD.
Itolizumab is a first-in-class anti-CD6 monoclonal antibody that selectively targets the CD6-ALCAM pathway, which plays a central role in modulating the activity and trafficking of pathogenic T cells responsible for a number immuno-inflammatory diseases.
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Presentation ID: |
No. 14 |
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Category: |
Immunotherapy and transplantation |
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Title of abstract: |
Inhibition of the CD6-ALCAM T-cell co-stimulation pathway using the anti-CD6 monoclonal antibody itolizumab for the treatment of acute graft-versus-host disease following cell transplantation hematopoietic strains |
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First author: |
Benedetta Rambaldi, MD, Medical Researcher, Dana-Farber Cancer Institute, Department of Hematological Malignancies and Harvard Medical School |
Main highlights, summary and conclusions of the oral presentation:
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Reconstituted CD6+ T cells early after transplant
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Itolizumab inhibits T cell proliferation and activation in patients with aGVHD
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Itolizumab demonstrates pathway specificity by inhibiting T cell proliferation in the presence of ALCAM-Fc and anti-CD3 antibodies, with no effect in the presence of anti-CD3 antibodies alone
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Functional inhibition of the CD6-ALCAM pathway may be a novel therapeutic strategy for the treatment of aGVHD, and translational data support the recently initiated EQUATOR Phase 3 study of itolizumab in the first-line setting
The presentation is available on the Presentations page of the Equillium website.
About Graft versus Host Disease (GVHD)
GVHD is a multisystem disease that is a common complication of allogeneic hematopoietic stem cell (allo-GCSH) transplants 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 dryness and irritation of the eyes.
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 causes high morbidity and mortality, with a five-year survival of approximately 53% in patients who respond to steroid treatment and mortality of up to 95% in patients who do not respond to steroids. There are no approved treatments for first-line aGVHD. The 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 itolizumab
Itolizumab is a first-in-class, clinical-stage anti-CD6 monoclonal antibody that selectively targets the CD6-ALCAM signaling pathway to selectively downregulate pathogenic effector T cells while preserving critical regulatory T cells to maintain of a balanced immune response. This pathway plays a central role in modulating the activity and trafficking of T lymphocytes which lead to a number of immuno-inflammatory diseases. Equillium acquired the rights to itolizumab through an exclusive partnership with Biocon Limited.
About Equillium
Equillium is a clinical-stage biotechnology company that leverages a deep understanding of immunobiology to develop novel therapies to treat serious autoimmune and inflammatory disorders with high unmet medical need. The Company’s pipeline includes the following novel immunomodulatory actives targeting immune-inflammatory pathways. Itolizumab, a first-in-class monoclonal antibody that targets the CD6-ALCAM signaling pathway that plays a central role in modulating effector T cells, is currently in a Phase 3 study for patients with acute graft versus host disease (aGVHD) and is being studied in a Phase 1b study for patients with lupus/lupus nephritis. EQ101, a first-in-class trispecific cytokine inhibitor that selectively targets IL-2, IL-9 and IL-15, is Phase 2-ready and expected to begin enrolling patients in a clinical trial. alopecia areata in the second half of 2022 EQ102, a bispecific cytokine inhibitor that selectively targets IL-15 and IL-21, is ready for clinical development and is expected to begin enrolling patients in a Phase 1 study to include patients with celiac disease in the second half of 2022.
For more information, visit www.equilliumbio.com.
Forward-looking statements
Statements in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by the use of words such as as “anticipate”, “believe”, “could”, “continue”, “expect”, “estimate”, “may”, “plan”, “outlook”, “future” and “project” and other expressions that predict or indicate future events or trends or that are not statements of historical matters. Because such statements are subject to risks and uncertainties, many of which are beyond the Company’s control, actual results may differ materially from those expressed or implied by such forward-looking statements. These statements include, but are not limited to, statements regarding the potential benefit of treating patients with aGVHD or lupus/lupus nephritis with itolizumab, Equillium’s plans and the expected timeline for the development of the ‘itolizumab, including the expected timeline to launch, complete and announce further results from EQUATE, EQUIP, EQUALIZE and EQUATOR, Equillium’s plans and the expected timeline for the development of EQ101 and EQ102 , including the expected timeline for the initiation, completion and announcement of the results of the Phase 2 and Phase 1 studies, respectively, the potential for any ongoing or planned clinical studies of Equillium studies to demonstrate safety or efficacy, Equillium’s anticipated timeline for regulatory review and comment, and Equillium’s plans and anticipated timeline for the development of its product candidates and the potential benefits of its product candidates. Risks that contribute to the uncertain nature of forward-looking statements include: uncertainties relating to the management team’s ability to perform as expected; Equillium’s ability to execute its plans and strategies; risks associated with conducting clinical studies; the risk that the interim results of a clinical study may not necessarily predict the final results and that one or more of the clinical results may change materially as patient recruitment continues, following more comprehensive reviews of the data and as more patient data becomes available; potential delays in the initiation, recruitment and completion of clinical studies and the reporting of data arising therefrom; the risk that studies may not be completed as planned; Equillium’s plans and product development, including the initiation and completion of clinical studies and the reporting of data therefrom; whether the results of the clinical studies will validate and support the safety and efficacy of Equillium’s product candidates; changes in the competitive landscape; uncertainties relating to Equillium’s capital requirements; and having to use cash in a way or at a time other than expected and the impact of market volatility on cash reserves. These and other risks and uncertainties are described in more detail under “Risk Factors” and elsewhere in Equillium’s documents and reports, available free of charge by visiting EDGAR on the SEC’s website at address http://www.sec.gov and on the Company’s website under the heading “Investors”. Investors should consider these risks and should not rely on forward-looking statements when making investment decisions. All forward-looking statements contained in this press release speak only as of the date on which they were made. Equillium undertakes no obligation to update these statements to reflect events that occur or circumstances that exist after the date on which they were made.
