Equillium Announces Publication of Abstract for European Hematology Association Annual Meeting

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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 that the European Hematology Association (EHA) has published an abstract highlighting the EQUATOR Phase 3 study in acute graft-versus-host disease (aGVHD) in first-line treatment.

Title:

ECUADOR: ROTATING DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED PHASE 3 STUDY OF ITOLIZUMAB IN COMBINATION WITH CORTICOSTERIDS FOR THE INITIAL TREATMENT OF ACUTE GRAFT-VERSUS-HOST DISEASE

Abstract code:

PB2196

Author:

John Koreth, associate professor of medicine, Harvard Medical School, et. Al.

The abstract discusses acute graft versus host disease (aGVHD) which is a major cause of morbidity and mortality after allogeneic hematopoietic stem cell transplantation (allo-GCSH) and there is no first-line treatment approved, where corticosteroids remain the standard of care. Itolizumab, a humanized IgG1 monoclonal antibody that binds to CD6 and blocks interaction with activated leukocyte cell adhesion molecule (ALCAM) to inhibit effector T cell activity and trafficking to target organs, represents a promising therapeutic approach to treat aGVHD, as suggested by the safety and efficacy results of the Phase 1b EQUATE study (NCT03763318). These results and the benefit/risk profile led to the enrolling Phase 3 EQUATOR study, a randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of itolizumab in combination with corticosteroids for the first-line treatment of aGVHD.

For more information and access to the abstract, visit the EHA Open Access Library.

About the EQUATOR study

The Phase 3 multicenter, randomized, double-blind, placebo-controlled study (NCT05263999) will compare the efficacy and safety of itolizumab administered intravenously versus placebo (randomized 1:1) as a treatment first-line therapy in up to 200 adult and adolescent patients with Grade III-IV aGVHD or Grade II aGVHD with lower gastrointestinal involvement, in combination with high doses of corticosteroids, the current standard of care. The primary endpoint of the study is complete response rate at day 29; key secondary endpoints include overall response rate at day 29 and durability of complete response rate from day 29 to day 99.

According to the study protocol, patients should receive itolizumab within 3 days of the first high-dose corticosteroid administration with a treatment period of 1 to 99 days and a follow-up period of 100 to 365 days. Approximately 200 eligible subjects who receive 2 mg/kg methylprednisolone or equivalent on Day 1 will be randomized in a 1:1 ratio to the following two treatment groups:

  1. Group A: Itolizumab, initial dose of 1.6 mg/kg followed by 6 doses of 0.8 mg/kg once every 2 weeks (q2w), plus systemic corticosteroids (100 subjects)

  2. Group B: Placebo, 7 doses every 2 weeks, plus systemic corticosteroids (100 subjects)

An independent data monitoring board will regularly review the safety data, and an interim analysis is planned after approximately 100 subjects complete the Day 29 assessments for futility and efficacy.

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 corticosteroid therapy and up to 95% mortality in patients who do not respond to corticosteroids. There are no approved treatments for first-line aGVHD. The published literature (MacMillan et al., 2015) describes background response rates to high-dose corticosteroid 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 expected to include normal healthy volunteers and 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 manner 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, which may be viewed free of charge by visiting EDGAR on the SEC’s website. at http://www.sec.gov and on the Company’s website under “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.

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