Equillium Announces Abstract Accepted for Oral Presentation at the Transplantation & Cellular Therapy Meetings of ASTCT and CIBMTR
14 January 2023 - 12:00AM
Business Wire
Equillium, Inc. (Nasdaq: EQ), a clinical-stage biotechnology
company focused on developing novel therapeutics to treat severe
autoimmune and inflammatory disorders, today announced that an
abstract was accepted for oral presentation at the Transplantation
& Cellular Therapy Meetings of the American Society of
Transplantation and Cellular Therapy, and the Center for
International Blood & Marrow Transplant Research. The Hybrid
meetings will take place virtually and in person at the Orlando
World Center Marriott, Orlando, Florida, February 15 – 19,
2023.
Title: Final Safety and Efficacy Results from EQUATE, an
Open-Label Study Evaluating Itolizumab, a Novel Targeted anti-CD6
Therapy, in Newly Diagnosed Acute Graft-Versus-Host Disease
Presenting Author: Dr. John Koreth, associate professor of
medicine, Dana Farber Cancer Institute, Harvard Medical School
Abstract ID Number: 36 Assigned Session: Oral
Abstract - Session E: GVHD - Clinical Date and Time:
Thursday, February 16, 2023, 2:30 PM
The abstract highlights positive final study results, including
long-term follow-up data for up to one year, from EQUATE
(NCT03763318), a Phase 1b study of itolizumab in combination with
corticosteroids (CS) to treat subjects with newly diagnosed severe
acute graft-versus-host disease (aGVHD). The data demonstrate
promising outcomes in subjects with severe aGVHD, and Equillium has
since initiated EQUATOR (NCT05263999), a Phase 3 study of
itolizumab as a potential initial therapy for aGVHD in combination
with CS.
About Graft-Versus-Host Disease (GVHD)
GVHD is a multisystem disorder that is a common complication of
allogeneic hematopoietic stem cell transplants (allo-HSCT) caused
by the transplanted immune system recognizing and attacking the
recipient’s body. Symptoms of GVHD include rash, itching, skin
discoloration, nausea, vomiting, diarrhea, and jaundice, as well as
eye dryness and irritation.
GVHD is the leading cause of non-relapse mortality in cancer
patients receiving allo-HSCT, and its risk limits the number and
type of patients receiving HSCT. GVHD results in high morbidity and
mortality, with five-year survival of approximately 53% in patients
who respond to steroid treatment and mortality as high as 95% in
patients who do not respond to steroids. There are no approved
treatments for first-line aGVHD. Published literature (MacMillan et
al., 2015) describes background response rates to high-dose steroid
administration in severe high-risk patients as 43% overall response
and 27% complete response.
About the EQUATE Study
The EQUATE study is a Phase 1b/2 trial to evaluate the safety,
tolerability, pharmacokinetics, pharmacodynamics and clinical
activity of itolizumab for first-line treatment in patients who
present with aGVHD (NCT03763318). The Phase 1b part of the trial is
an open-label dose escalation study in adult patients who present
with high-risk aGVHD and typically respond poorly to steroids. The
Phase 1b data will inform selection of the dose to be used in the
next phase of development for the program.
About Itolizumab
Itolizumab is a clinical-stage, first-in-class anti-CD6
monoclonal antibody that selectively targets the CD6-ALCAM
signaling pathway to selectively downregulate pathogenic T effector
cells while preserving T regulatory cells critical for maintaining
a balanced immune response. This pathway plays a central role in
modulating the activity and trafficking of T cells that drive a
number of immuno-inflammatory diseases.
About Equillium
Equillium is a clinical-stage biotechnology company leveraging a
deep understanding of immunobiology to develop novel therapeutics
to treat severe autoimmune and inflammatory disorders with high
unmet medical need. The company’s pipeline consists of the
following novel first-in-class immunomodulatory assets targeting
immuno-inflammatory pathways. EQ101: a tri-specific cytokine
inhibitor that selectively targets IL-2, IL-9, and IL-15; currently
under evaluation in a Phase 2 proof-of-concept study of patients
with alopecia areata. EQ102: a bi-specific cytokine inhibitor that
selectively targets IL-15 and IL-21; currently under evaluation in
a Phase 1 study to include healthy volunteers and celiac disease
patients. Itolizumab: a monoclonal antibody that targets the
CD6-ALCAM signaling pathway which plays a central role in the
modulation of effector T cells; currently under evaluation in a
Phase 3 study for patients with acute graft-versus-host disease
(aGVHD) and a Phase 1b study for patients with lupus/lupus
nephritis. Equillium acquired rights to itolizumab through an
exclusive partnership with Biocon Limited and has entered a
strategic partnership with Ono Pharmaceutical Co., Ltd. for the
development and commercialization of itolizumab under an exclusive
asset purchase agreement.
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 of Equillium’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 benefit of
treating patients with aGVHD with itolizumab and Equillium’s plans
for developing itolizumab. Risks that contribute to the uncertain
nature of the forward-looking statements include: Equillium’s
ability to execute its plans and strategies; risks related to
performing clinical studies; whether the results from clinical
studies will validate and support the safety and efficacy of
Equillium’s product candidates; and risks related to Ono’s
financial condition, willingness to continue to fund the
development of itolizumab, and decision to exercise, if ever, its
option to purchase itolizumab or terminate the asset purchase
agreement. These and other risks and uncertainties are described
more fully under the caption “Risk Factors” and elsewhere in
Equillium’s filings and reports, which may be accessed for free by
visiting the Securities and Exchange Commission’s website at
www.sec.gov and on Equillium’s website under the heading
“Investors.” 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, except as required by law.
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Investor & Media Contact Equillium, Inc. Michael
Moore Vice President, Investor Relations Officer & Head of
Corporate Communications 619-302-4431 ir@equilliumbio.com
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