News Release

Equillium Presents Multiple Posters at the 104th Annual Meeting of the American Association of Immunologists

May 17, 2021

Research highlights itolizumab’s novel mechanism of action and its effect on modulating T cell responses through inhibition of the CD6-ALCAM pathway

The development of a pharmacodynamic biomarker assay to monitor target engagement and fate of CD6 on T cells in patients treated with itolizumab

LA JOLLA, Calif., May 17, 2021 (GLOBE NEWSWIRE) -- Equillium, Inc. (Nasdaq: EQ) a clinical-stage biotechnology company developing itolizumab to treat severe autoimmune and inflammatory disorders, today announced that three posters detailing the novel mechanistic activity of itolizumab were presented at the 2021 American Association of Immunologists (AAI) Annual Meeting held May 10-15, 2021.

“As leaders in CD6 biology, we are proud to be presenting important research that continues to advance the field and provide greater insight into the importance of the CD6-ALCAM pathway and its role in the pathogenesis of T cell mediated diseases,” said Stephen Connelly, Ph.D., chief scientific officer of Equillium. “This series of posters highlight itolizumab’s potent and broad inhibition of T cell activity, how itolizumab mechanistically inhibits those T cells – through a loss of CD6 – and that we now have an assay to monitor the loss of CD6 on T cells in patients as a pharmacodynamic biomarker.”

Angelina R. Bisconte, Senior Director of Translational Biology & Biomarker Development, Precision for Medicine, added, “There is little doubt that the CD6-ALCAM pathway is important in modulating T cell activity. Historically, measuring cell-based receptor engagement and fate in patients has been very challenging.   We are delighted to have incorporated our unique expertise and collaborated in the development of this pharmacodynamic biomarker assay. The data that Equillium has generated using this assay in both acute graft-vs-host disease and systemic lupus erythematosus are impressive and highlight the importance of such tools in the development of immune-modulatory therapies.”

Itolizumab-induced Antigenic Modulation of CD6 Inhibits T Cell Activity (#929)
Details ex-vivo data demonstrating that treatment of effector T cells with itolizumab, the company’s novel first-in-class monoclonal antibody, resulted in a significant decrease in pro-inflammatory cytokine secretion from Th1, Th2 and Th17 cells, whose excessive activity is implicated in numerous autoimmune and inflammatory diseases. This study characterizes the CD6-ALCAM pathway as a key regulator of pathogenic effector T cell function and supports the use of itolizumab in treating autoimmune and inflammatory diseases.

Blockade of the CD6-ALCAM Pathway Modulates Effector T Cell Function (#836)
Highlights new mechanistic findings for itolizumab in the modulation of CD6 receptor levels by inducing loss of CD6 from the T cell surface. CD6 high T cells have increased pathogenic potential, treatment with itolizumab results in CD6 low T cells that are hyporesponsive to stimulation, have lower levels of activation markers and reduced proinflammatory cytokine secretion. These data demonstrate that modulation of surface levels of CD6 by itolizumab results in reduced pathogenic T cell activity.

An Assay to Monitor the Engagement and Modulation of CD6 on T cells as a Clinical Biomarker of Treatment with Itolizumab (#976)
Describes the development and validation of a pharmacodynamic biomarker assay to sensitively quantify CD6 receptor engagement and fate in patients treated with itolizumab. The resulting assay is used to facilitate the determination of an optimal therapeutic dose of itolizumab in autoimmune and inflammatory diseases.

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 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. 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 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 new leadership team members to integrate and 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" in Equillium’s Annual Report on Form 10-K for the year ended December 31, 2020, and elsewhere in Equillium's filings and reports with the SEC. 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 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