Equillium Announces Multiple Abstracts Accepted for Presentation at ACR Convergence 2021

Rhea-AI Summary

Equillium, Inc. (Nasdaq: EQ) has announced that three abstracts will be presented at the ACR Convergence from November 3-10, highlighting the use of itolizumab for treating systemic lupus erythematosus (SLE) and lupus nephritis. The abstracts report on safety results from the Phase 1b EQUALISE study, pharmacodynamic markers, and the potential role of urinary ALCAM as a biomarker for renal disease activity. Itolizumab is a first-in-class monoclonal antibody targeting the CD6-ALCAM pathway, aimed at managing severe autoimmune disorders.

Positive

• Three abstracts accepted for presentation at ACR Convergence, showcasing itolizumab's potential in lupus treatment.
• Interim safety results from the Phase 1b EQUALISE study show promise for continued evaluation.
• Urinary ALCAM levels significantly correlated with renal disease activity, indicating a potential biomarker.

Negative

• None.

LA JOLLA, Calif.--(BUSINESS WIRE)-- Equillium, Inc. (Nasdaq: EQ), a clinical-stage biotechnology company developing itolizumab to treat severe autoimmune and inflammatory disorders with high unmet medical need, today announced that three abstracts were accepted for presentation at ACR Convergence, the annual meeting of the American College of Rheumatology. The meeting, the world’s premier virtual rheumatology experience, will take place online November 3 - 10.

Title: Itolizumab, a Novel anti-CD6 Therapy, in Systemic Lupus Erythematosus Patients: Interim Safety Results from the Phase 1b EQUALISE Dose-escalation Study
First Author: Dr. Kenneth Kalunian, Professor, Medicine, UCSD School of Medicine
Session Title: SLE – Treatment Poster (1732–1772)
Session Type: Poster Session D
Date and Time: 8:30 am – 10:30 am ET, Tuesday, November 9, 2021
Abstract Number: 1750

The abstract highlights itolizumab (subcutaneous delivery) safety and tolerability, as well as PK/PD data from patients with active or inactive systemic lupus erythematosus (SLE) in the TYPE A portion of the EQUALISE study, supporting continued evaluation of itolizumab in SLE, lupus nephritis (LN) and other chronic autoimmune diseases. The ongoing Part B portion of the study will assess the safety and efficacy of itolizumab in patients with active proliferative LN.

Title: Itolizumab-induced Modulation of Cell Surface CD6 Is a Pharmacodynamic Marker of Drug Activity in SLE Patients
First Author: Dalena Chu, Senior Research Associate, Equillium, Inc.
Session Title: SLE – Treatment Poster (1732–1772)
Session Type: Poster Session D
Date and Time: 8:30 am – 10:30 am ET, Tuesday, November 9, 2021
Abstract Number: 1766

The abstract outlines pharmacodynamic data from the Type A portion of the EQUALISE study in which subcutaneous delivery of itolizumab induces dose-dependent loss of cell surface CD6 on T cells (with maximal loss occurring at 1.6 mg/kg), leading to inhibition of T effector cell activity.

Title: Soluble Urine ALCAM Reflects Renal Disease Activity in Lupus Nephritis
First Author: Dalena Chu, Senior Research Associate, Equillium, Inc.
Session Title: SLE – Diagnosis, Manifestations, & Outcomes Poster I: Diagnosis (0323–0356)
Session Type: Poster Session A
Date and Time: 8:30 am – 10:30 am ET, Saturday, November 6, 2021
Abstract Number: 0353

The abstract highlights data demonstrating significantly elevated urinary ALCAM levels in patients with LN compared to control subjects without kidney disease (p<0.001). The urinary ALCAM levels varied based on the pathologic classification of LN. Over the course of the study urinary ALCAM levels declined as proteinuria improved, suggesting its potential role as a biomarker to monitor disease activity over time.

About the EQUALISE Study

The EQUALISE study is a Phase 1b open-label proof-of-concept multiple ascending-dose clinical study of itolizumab in patients with systemic lupus erythematosus and lupus nephritis. The study is evaluating the safety and tolerability of subcutaneous delivery of itolizumab in patients with systemic lupus erythematosus and lupus nephritis. The treatment period for patients with systemic lupus erythematosus is two weeks in duration, while treatment for patients with active proliferative lupus nephritis is 24 weeks in duration.

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 effector 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 deep understanding of immunobiology to develop novel products to treat severe autoimmune and inflammatory disorders with high unmet medical need. Equillium is developing itolizumab for multiple severe immuno-inflammatory diseases, including acute graft-versus-host-disease (aGVHD), lupus/lupus nephritis and uncontrolled asthma.

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 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 benefit of treating patients with aGVHD, uncontrolled asthma, or lupus/lupus nephritis with itolizumab, Equillium’s plans and expected timing for developing itolizumab including the expected timing of initiating, completing and announcing further results from the EQUATE, EQUIP, and EQUALISE studies, the potential for any of Equillium’s ongoing or planned clinical studies to show safety or efficacy, statements regarding the impact of new leadership team members, Equillium’s anticipated timing of regulatory review and feedback, Equillium’s cash runway, and Equillium’s plans and expected timing for developing itolizumab and potential benefits of itolizumab. 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 itolizumab; 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 with the SEC. 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20210930005329/en/

Investor Contact

Michael Moore

Vice President, Investor Relations & Corporate Communications

619-302-4431

ir@equilliumbio.com

Media Contacts

Aljanae Reynolds

Wheelhouse Life Science Advisors

areynolds@wheelhouselsa.com

Source: Equillium, Inc.

FAQ

What are the key findings of Equillium's itolizumab study presented at ACR Convergence?

Equillium presented three abstracts highlighting itolizumab's safety and potential as a treatment for lupus and lupus nephritis.

When will the ACR Convergence event take place?

The ACR Convergence will occur online from November 3 to 10.

What is the significance of urinary ALCAM in lupus nephritis according to Equillium's findings?

Urinary ALCAM levels were found to reflect renal disease activity and varied with the pathologic classification of lupus nephritis.

What is itolizumab and how is it used?

Itolizumab is a first-in-class anti-CD6 monoclonal antibody developed for treating severe autoimmune disorders, including lupus.