Equillium Announces Data Suggesting Soluble ALCAM as a Potential Biomarker of Disease Severity in Lupus Nephritis at ACR Convergence 2022

Rhea-AI Summary

Equillium, Inc. (Nasdaq: EQ) presented key research at ACR Convergence, indicating that urinary soluble ALCAM (sALCAM) may serve as a biomarker for disease severity in lupus nephritis (LN), potentially aiding in treatment response assessment. This study aligns urinary ALCAM levels with existing measures of LN, suggesting a less invasive alternative to kidney biopsies. Dr. Maple Fung highlighted its significance for patient monitoring. Itolizumab, Equillium's first-in-class monoclonal antibody, targets the CD6-ALCAM pathway and is currently undergoing clinical studies for its effectiveness in treating severe autoimmune disorders.

Positive

• Research indicates urinary sALCAM could be a non-invasive biomarker for disease severity in lupus nephritis.
• The study correlates urinary ALCAM with conventional lupus nephritis measures, enhancing clinical assessment.
• Itolizumab, Equillium's lead candidate, shows promise in treating lupus nephritis as it works through the CD6-ALCAM pathway.

Negative

• None.

LA JOLLA, Calif.--(BUSINESS WIRE)-- Equillium, Inc. (Nasdaq: EQ), a clinical-stage biotechnology company focused on developing novel therapeutics to treat severe autoimmune and inflammatory disorders with high unmet medical need, today announced that a poster presentation was given over the weekend at ACR Convergence, the annual meeting of the American College of Rheumatology. The presentation highlighted that levels of urinary soluble ALCAM (sALCAM) could be a potential biomarker of disease severity in lupus nephritis (LN) and indicative of a patient’s response to treatment. The meeting, the world’s premier rheumatology conference, is taking place November 10 – 14, 2022 at the Pennsylvania Convention Center in Philadelphia, Pennsylvania.

“The findings from this research represent an important step in the clinical development of itolizumab, which targets the CD6-ALCAM pathway and provides further support for its potential to be a meaningful therapy for lupus nephritis patients,” said Dr. Maple Fung, nephrologist and senior vice president of clinical development at Equillium. “Lupus nephritis is a serious illness that can lead to devastating long term complications including end stage kidney disease. A potential biomarker that can be diagnostic in a less invasive manner than a kidney biopsy, such as a urine sample, would be a tremendous advancement in the field. If that same biomarker could be indicative of response to treatment, it could be a breakthrough in the diagnosis and follow-up care for patients with this complex disease.”

Title: Urine ALCAM is a Strong Predictor of Lupus Nephritis
First Author: Dalena Chu, Associate Scientist, Equillium, Inc.
Session Title: SLE – Diagnosis, Manifestations, and Outcomes Poster II: Manifestations
Poster Number: 1478

Key Highlights, Summary and Conclusions from Presentation:

• Research demonstrated that urine ALCAM is a biomarker of disease severity in LN that could be indicative of disease progression and/or response to treatment
• Urine ALCAM correlates with currently accepted measures of LN, including UPCR (urine protein-to-creatinine ratio) and renal SLEDAI (systemic lupus erythematosus disease activity index)
• Data suggests that urine ALCAM reflects changes in LN and could potentially be used in combination with other measures to inform clinicians of a patient’s disease early on, without invasive measures

About Systemic Lupus Erythematosus (SLE) / Lupus Nephritis (LN)

Systemic lupus erythematosus is an autoimmune disease in which the immune system attacks its own tissues, causing widespread inflammation and tissue damage in the affected organs. It can affect the joints, skin, brain, lungs, kidneys, and blood vessels. Lupus nephritis is a serious complication of SLE, occurring in approximately 30% – 60% of individuals with SLE. In LN, the body’s own immune system attacks the kidneys, causing inflammation and significantly reducing kidney function over time.

About Itolizumab

Itolizumab is a clinical-stage, first-in-class anti-CD6 monoclonal antibody that selectively targets the CD6-ALCAM pathway. This pathway plays a central role in modulating the activity and trafficking of T cells that drive a number of immuno-inflammatory diseases. Equillium acquired rights to itolizumab through an exclusive partnership with Biocon Limited.

About Equillium

Equillium is a clinical-stage biotechnology company leveraging a deep understanding of immunobiology to develop novel therapeutics to treat severe autoimmune and inflammatory disorders with high unmet medical need. The company’s pipeline consists of the following novel immunomodulatory assets targeting immuno-inflammatory pathways. Itolizumab, a first-in-class monoclonal antibody that targets the CD6-ALCAM signaling pathway which plays a central role in the modulation of effector T cells, is currently in a Phase 3 study for patients with acute graft-versus-host disease (aGVHD) and is in a Phase 1b study for patients with lupus/lupus nephritis. EQ101 is a first-in-class tri-specific cytokine inhibitor that selectively targets IL-2, IL-9, and IL-15. Equillium is currently enrolling patients in a Phase 2 proof-of-concept study of EQ101 for patients with alopecia areata. EQ102 is a bi-specific cytokine inhibitor that selectively targets IL-15 and IL-21. Equillium is currently enrolling patients in a Phase 1 study of EQ102, including healthy volunteers and celiac disease patients.

For more information, visit www.equilliumbio.com.

Forward Looking Statements

Statements contained 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 may be identified by the use of words such as "anticipate", "believe", “could”, “continue”, "expect", "estimate", “may”, "plan", "outlook", “future” and "project" and other similar 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 outside of the Company’s control, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include but are not limited to statements regarding the potential for any of Equillium’s ongoing or planned clinical studies to show safety or efficacy, and Equillium’s plans and expected timing for developing its product candidates and potential benefits of its product candidates. Risks that contribute to the uncertain nature of the forward-looking statements include: uncertainties related to the abilities of the leadership team to perform as expected; Equillium’s ability to execute its plans and strategies; risks related to performing clinical studies; the risk that interim results of a clinical study do not necessarily predict final results and that one or more of the clinical outcomes may materially change as patient enrollment continues, following more comprehensive reviews of the data, and as more patient data become available; potential delays in the commencement, enrollment and completion of clinical studies and the reporting of data therefrom; the risk that studies will 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 from clinical studies will validate and support the safety and efficacy of Equillium’s product candidates; changes in the competitive landscape; uncertainties related to Equillium’s capital requirements; and having to use cash in ways or on timing other than expected and the impact of market volatility on cash reserves. These and other risks and uncertainties are described more fully under the caption "Risk Factors" and elsewhere in Equillium's filings and reports, which may be accessed for free by visiting EDGAR on the SEC web site at http://www.sec.gov and on the Company’s website under the heading “Investors.” Investors should take such risks into account 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 such statements to reflect events that occur or circumstances that exist after the date on which they were made.

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Investor Contact

Michael Moore

Vice President, Investor Relations & Corporate Communications

619-302-4431

ir@equilliumbio.com

Source: Equillium, Inc.

FAQ

What is the significance of urinary soluble ALCAM in lupus nephritis for Equillium (EQ)?

Urinary soluble ALCAM may serve as a biomarker for disease severity in lupus nephritis, helping in treatment response assessment.

What are the current clinical studies involving itolizumab by Equillium (EQ)?

Itolizumab is in Phase 3 studies for acute graft-versus-host disease and Phase 1b for lupus nephritis.

When was the research on urinary ALCAM presented by Equillium (EQ)?

The research was presented at ACR Convergence from November 10-14, 2022.

What is lupus nephritis and its relevance to Equillium (EQ)?

Lupus nephritis is an autoimmune condition affecting kidney function and occurs in 30%-60% of systemic lupus erythematosus patients.