News Release

Equillium Presented New Data and Insights on the CD6-ALCAM Pathway in Uncontrolled Asthma at the European Respiratory Society International Congress 2020

September 17, 2020

LA JOLLA, Calif., Sept. 17, 2020 (GLOBE NEWSWIRE) -- Equillium, Inc. (Nasdaq: EQ), a clinical-stage biotechnology company developing itolizumab to treat severe autoimmune and inflammatory disorders, today announced that data supporting the CD6-ALCAM pathway as a relevant target for therapeutic intervention in patients with uncontrolled asthma was presented in an oral presentation and two posters at the virtual European Respiratory Society (ERS) International Congress 2020 held September 7-9, 2020.

The role of the CD6-ALCAM pathway in modulating T cell activity and trafficking has been suspected in the pathogenesis of multiple autoimmune and inflammatory diseases. The work presented at ERS provides insight into novel roles for CD6 on innate lymphoid cells, as well as the potential interplay between CD6+ T cells and lung smooth muscle cells in modulating bronchomotor tone. These findings suggest the CD6-ALCAM pathway may contribute in multiple ways to asthma pathology. Furthermore, data presented demonstrated that elevated levels of soluble ALCAM were observed in the sputum of patients with severe asthma and high sputum eosinophils.  Additional studies are ongoing to characterize this in different phenotypes of asthma patients as a potential biomarker.

“These data provide additional insight into the role of the CD6-ALCAM pathway in inflammatory responses observed in patients with asthma and how it contributes to disease pathogenesis,” said Rey Panettieri, M.D., vice chancellor for translational medicine and science director, Rutgers Institute for Translational Medicine and science professor of medicine, Robert Wood Johnson Medical School Emeritus Professor of Medicine, University of Pennsylvania. “Uncontrolled asthma is a complex, heterogenous and dynamic disease with many patients still not achieving symptom control with current standard of care. There is a critical need for novel therapies that can more broadly modulate the different underlying immune pathways to address this patient population.” 

Stephen Connelly, Ph.D., chief scientific officer of Equillium, added, “This data further validates CD6 as a therapeutic target that may selectively modulate pathogenic effector cell activity and underscores the compelling opportunity to provide a new potential therapy that selectively targets the CD6-ALCAM pathway.  These data support Equillium’s ongoing clinical development of itolizumab for the treatment of patients with moderate-to-severe uncontrolled asthma.”

Summarized below are the abstracts that were selected for presentation. The ERS abstracts are available online at the conference website. The posters are available under Posters and Presentations on Equillium’s website.

Oral Presentation

Title: CD6-ALCAM Pathway is Elevated in Patients with Severe Asthma
Presenting Author: Manali Mukherjee, Ph.D.
Session: 487
Channel: 2

E-Poster Presentations

Title: CD6 is highly expressed in fatal asthma patients and may modulate bronchomotor tone
First Author: Cynthia Koziol-White, Ph.D.
Session: 47

Title: CD6 Is Expressed On Human Airway and Blood ILCs and Is Upregulated by Epithelial Alarmins IL-33 and TSLP
First Author: Taylor Doherty, M.D.
Session: 64

About Uncontrolled Asthma
Asthma is a complex and highly prevalent inflammatory lung disease, characterized by reversible airway obstruction and chronic inflammation that, in severe cases, can significantly impact patient quality of life. Asthma is estimated to affect 26 million people in the United States – with a subset of that population exhibiting eosinophilic and non-eosinophilic asthma (Th2 or non-Th2, respectively), which impacts distinct phenotypes and disease severity. Preclinical data has demonstrated that modulating the CD6-ALCAM pathway has the potential to inhibit the activation and trafficking of both Th2 and Th17 effector T cells. Therefore, Equillium is evaluating itolizumab in uncontrolled moderate to severe asthma, regardless of eosinophilia level, to assess the breadth of its clinical utility.

About the EQUIP Study
The EQUIP study is a Phase 1b randomized, double-blind, placebo-controlled study to evaluate the safety and tolerability of itolizumab in patients with uncontrolled moderate-to-severe asthma (NCT04007198). The primary endpoints of the study are to evaluate safety and tolerability of itolizumab in patients, and the secondary endpoints include characterizing pharmacokinetics (PK), pharmacodynamics (PD), PK/PD relationship and clinical activity of itolizumab.

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’s initial product candidate, itolizumab (EQ001), 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. Equillium acquired rights to itolizumab through an exclusive partnership with Biocon Limited.  Itolizumab is currently marketed by Biocon in India under the trade name “ALZUMab” for the treatment of chronic plaque psoriasis, and in July 2020, received emergency use approval in India to treat cytokine release syndrome (CRS) in COVID-19 patients with moderate-to-severe acute respiratory distress syndrome (ARDS).

Equillium believes that itolizumab has the potential to be a best-in-class disease modifying therapeutic in several indications and is developing itolizumab (EQ001) in multiple severe immuno-inflammatory disorders – acute graft-versus-host disease, uncontrolled asthma, and lupus nephritis – and is planning to submit an investigational new drug application for the treatment of COVID-19 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. 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 moderate-to-severe uncontrolled asthma with itolizumab, Equillium’s business strategy, Equillium’s plans and expected timing for developing itolizumab, including the expected timing of further results from the EQUIP study, the potential for the ongoing EQUIP trial to show safety or efficacy, and potential benefits of itolizumab. Risks that contribute to the uncertain nature of the forward-looking statements include: Equillium’s plans and product development, including the initiation, restarting and completion of clinical trials and the reporting of data therefrom, including a clinical trial of patients with COVID-19; 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 uncertainties 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 Contact
Christine Zedelmayer, Chief Operating Officer
+1-858-412-5302
ir@equilliumbio.com

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