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Equillium to Present Translational Data on Itolizumab for Acute Graft-Versus-Host Disease at 61st American Society of Hematology (ASH) Annual Meeting and Exposition
[November 26, 2019]

Equillium to Present Translational Data on Itolizumab for Acute Graft-Versus-Host Disease at 61st American Society of Hematology (ASH) Annual Meeting and Exposition


LA JOLLA, Calif., Nov. 26, 2019 (GLOBE NEWSWIRE) -- Equillium, Inc. (Nasdaq: EQ), a clinical-stage biotechnology company leveraging deep understanding of immunobiology to develop products to treat severe autoimmune and inflammatory disorders, today announced that data supporting the role of the CD6-ALCAM pathway as a relevant target for patients with acute graft-versus-host disease (aGVHD) along with details of the EQUATE Phase 1b/2 trial design will be presented at the 61st American Society of Hematology (ASH) Annual Meeting and Exposition being held from December 7-10, 2019 in Orlando, Florida.  

Data demonstrating itolizumab efficiently inhibits T cell responses in samples taken from patients with aGVHD received the ASH Abstract Achievement Award. Additionally, data supporting itolizumab as a potential systemic treatment that can modulate pathogenic T effector cell activity in an in vivo model of disease has been published online-only in Blood, the journal of ASH.

“Today, approximately 30-70 percent of patients receiving allogeneic hematopoietic stem cell transplant (HSCT) with standard GVHD prophylaxis regimens are diagnosed with aGVHD, a multisystem disorder that occurs when the transplanted immune system attacks host tissues. aGVHD is a leading cause of non-relapse mortality in patients undergoing allogeneic HSCT and yet no approved therapies are currently available,” said Dr. Jerome Ritz, Executive Director of the Connell and O’Reilly Families Cell Manipulation Core Facility at Dana-Farber Cancer Institute and Professor of Medicine at Harvard Medical School. “We look forward to further research on the EQUATE trial, which advances the pioneering work conducted over a decade ago at Dana-Farber by myself and Dr. Robert Soiffer that elucidated the role of CD6+ T effector cells in the development of aGVHD.”

“These data demonstrating the capabilities of CD6 blockade to efficiently inhibit T effector cell responses further supports our ongoing EQUATE Phase 1b/2 trial of itolizumab for front-line treatment in patients with aGVHD,” added Stephen Connelly, Ph.D., chief scientific officer of Equillium.  “As the first clinical study to examine the effects of an anti-CD6 therapy in patients with aGVHD, the EQUATE trial is designed to evaluate the safety and activity of itolizumab in these patients.  We look forward to sharing the supporting translational data and study design at the ASH Annual Meeting and Exposition and providing future updates on our programs as we progress.” 

Below are the abstract titles that have been selected for poster presentations. Full text of the abstracts can be found on the confernce website. Information from the ASH poster presentations are under embargo until Monday, December 9, 2019 at 10:00 AM ET. Once the posters are made public, they will be available in the Investors section of Equillium’s website.



Poster Presentations
Title: Equate, a Phase 1b/2 Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of a Novel Targeted Anti-CD6 Therapy, Itolizumab, in Subjects with Newly Diagnosed Acute Graft Versus Host Disease ?
First Author: John Koreth, MBBS, DPhil
?Date and Time: Monday, December 9, 2019 from 6:00 PM to 8:00 PM ET
Session: 722. Clinical Allogeneic Transplantation: Acute and Chronic GVHD, Immune Reconstitution: Poster III
Publication Number: 4516

Title: Anti-CD6 Monoclonal Antibody Itolizumab Efficiently Inhibits T Cell Proliferation after in Vitro TCR Stimulation in the Setting of Acute Graft Versus Host Disease ?
First Author: Benedetta Rambaldi, M.D. 
?Date and Time: Monday, December 9, 2019 from 6:00 PM to 8:00 PM ET
Session: 722. Clinical Allogeneic Transplantation: Acute and Chronic GVHD, Immune Reconstitution: Poster III
Publication Number: 4517
*Dr. Rambaldi received an ASH Abstract Achievement Award for this work.


Online-Only Publication
Title: Itolizumab as a Potential Therapeutic for the Prevention and Treatment of Graft vs. Host Disease
First Author: Cherie Ng, Ph.D.
Publication Date: November 13, 2019
Section: 701. Experimental Transplantation: Basic Biology, Pre-Clinical Models
Published in: Blood – Volume 134, Issue Supplement_1

About Equillium
Equillium is a biotechnology company leveraging deep understanding of immunobiology to develop 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 novel immune checkpoint receptor CD6. CD6 plays a central role in modulating the activity and trafficking of T cells that drive a number of immuno-inflammatory diseases. Itolizumab is a clinically-validated therapeutic that has demonstrated a favorable safety and tolerability profile. Equillium acquired rights to itolizumab through an exclusive partnership with Biocon Limited. Equillium believes that itolizumab has the potential to be a best-in-class disease modifying therapeutic and is advancing itolizumab into clinical development in the following severe immuno-inflammatory disorders: uncontrolled asthma, acute graft-versus-host disease, and lupus nephritis. 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 Equillium’s plans for developing itolizumab and the potential benefits of itolizumab for aGVHD. Risks that contribute to the uncertain nature of the forward-looking statements include uncertainties related to the completion of clinical trials and whether the results from clinical trials will validate and support the safety and efficacy of itolizumab for aGVHD. 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
+1-858-412-5302
ir@equilliumbio.com

Media Contact
Cammy Duong
Canale Communications
+1-619-849-5389
cammy@canalecomm.com

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