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Studiesfurther validateongoing clinicaldevelopment of itolizumab for the treatmentofsystemiclupuserythematosus and lupusnephritis


GlobeNewswire Inc | Nov 4, 2020 08:35AM EST

November 04, 2020

Studiesfurther validateongoing clinicaldevelopment of itolizumab for the treatmentofsystemiclupuserythematosus and lupusnephritis

LA JOLLA, Calif., Nov. 04, 2020 (GLOBE NEWSWIRE) -- Equillium, Inc. (Nasdaq: EQ) a clinical stage biotechnology company developing novel immune modifying therapies for severe immune-inflammatory diseases, today announced that data will be presented demonstrating that modulation of the CD6-ALCAM pathway with itolizumab improves kidney and skin pathology in mouse models of systemic lupus erythematosus (SLE). The data will be presented virtually at the 2020 American College of Rheumatology (ACR) Virtual Convergence on November 7, 2020.

The posters will be made available in the publications section of the Equillium website at 9 a.m. ET on Saturday, November 7. The studies provide further insight into the role of the CD6-ALCAM pathway in lupus nephritis, specifically in the pathogenesis of glomerulonephritis and in the wider context of systemic lupus. The findings establish that CD6 and ALCAM are over-expressed on T cells and antigen-presenting cells in models of lupus during disease. Importantly, the work highlights the role that the CD6-ALCAM pathway plays in promoting disease by creating an inflammatory environment that recruits other cells such as neutrophils and inflammatory macrophages, and that this can be ameliorated by blocking CD6.

Chaim Putterman, M.D., professor, department of rheumatology, Albert Einstein College of Medicine stated, Evidence of increased CD6-ALCAM signaling in the kidneys of lupus nephritis patients and the corresponding efficacy of CD6 blockade in animal models support the therapeutic potential for itolizumab as a new immuno-modulatory treatment for people experiencing lupus nephritis - a very serious manifestation of lupus for which there are currently no treatments approved by the U.S. Food and Drug Administration.

The CD6-ALCAM pathway plays an important role in both the activity and trafficking of pathogenic T-cells that drive autoimmune disease, and our studies underscore the therapeutic potential of blocking this to treat multiple lupus pathologies, added Stephen Connelly, Ph.D., chief scientific officer of Equillium. These results provide further validation and are supportive of our ongoing clinical trials of itolizumab in lupus patients where we believe targeting the CD6-ALCAM pathway could provide therapeutic benefit to those with the disease.

Postersat American College of Rheumatology Virtual Convergence

Title: CD6 Modulation Ameliorates Kidney and Skin Disease in a Spontaneous Murine Lupus ModelAbstract ID 909191First Author: Samantha A. ChalmersDate: Saturday, November 7Time: 9:00 11:00 a.m. ET

Title: Amelioration of Immune Complex-Mediated Glomerulonephritis via CD6 ModulationAbstract ID: 909165Author Samantha A. ChalmersDate Saturday, November 7Time 9:00 11:00 a.m. ET

About Itolizumab

Itolizumab is a clinical-stage, first-in-class 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. Itoluzumab is currently being evaluated in multiple clinical trials in patients with severe diseases, including acute graft-versus-host disease (aGVHD), lupus nephritis and uncontrolled asthma. Equillium acquired rights to itolizumab through an exclusive partnership with Biocon Limited. Itolizumab is marketed in India under the trade name ALZUMAb for the treatment of chronic plaque psoriasis and has received emergency use approval in India to treat cytokine release syndrome in COVID-19 patients with moderate to severe acute respiratory distress syndrome.

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 COVID-19, aGVHD, lupus nephritis and uncontrolled asthma. For more information, visitwww.equilliumbio.com.

Forward Looking StatementsStatements 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. Because such statements are subject to risks and uncertainties, 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 lupus nephritis or lupus erythematosuswith itolizumab, Equilliums business strategy, Equilliums plans and expected timing for developing itolizumab, the potential benefits of itolizumab and the potential for any of Equilliums ongoing or planned clinical trials to show safety or efficacy. Risks that contribute to the uncertain nature of the forward-looking statements include: potential delays in the commencement, enrollment and completion of clinical trials and the reporting of data therefrom; the risk that studies will not be completed as planned; uncertainties related to Equilliums capital requirements; Equilliums plans and product development, including the initiation, restarting and completion of clinical trials and the reporting of data therefrom; uncertainties caused by the recent restarting of the EQUIP and EQUALISE clinical trials after a pause; whether the results from clinical trials will validate and support the safety and efficacy of itolizumab; changes in the competitive landscape; 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 United States Securities and Exchange Commission. 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.

Investor ContactChristine Zedelmayer, Chief Operating Officer+1-858-412-5302ir@equilliumbio.com

Media ContactKatherine Carlyle SmithSenior Account AssociateCanale Communications805-907-2497katherine.smith@canalecomm.com







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