Equillium Announces Poster Presentation at the Annual Meeting of the European Society for Blood and Marrow Transplantation
April 24 2023 - 7:00AM
Business Wire
Itolizumab in combination with systemic
corticosteroids was associated with high rates of overall clinical
response
Response at Day 29 was associated with improved
progression-free survival through 1 year
Itolizumab is being evaluated in pivotal Phase
3 EQUATOR study in first-line acute graft-versus-host disease
Equillium, Inc. (Nasdaq: EQ), 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, today announced that an
ePoster presentation highlighting data from the EQUATE study in
acute graft-versus-host disease (aGVHD) was given yesterday at the
49th Annual Meeting of the European Society for Blood and Marrow
Transplantation.
The presentation, given by Dr. Corey Cutler, associate professor
of medicine, Dana Farber Cancer Institute, Harvard Medical School,
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 aGVHD. The data
demonstrate promising outcomes in subjects with severe aGVHD.
Equillium has since initiated EQUATOR (NCT05263999), a pivotal
Phase 3 study of itolizumab as a potential initial therapy for
aGVHD in combination with CS.
“The full data set from the EQUATE study suggests that
itolizumab has potential clinical value for the treatment of
aGVHD,” said Dr. Cutler. “There are no drugs approved in the
first-line setting of this potentially lethal condition, so I am
encouraged to see rapid and durable responses demonstrating high
progression-free survival through one year, as well as responders
to itolizumab treatment having a clinically meaningful reduction in
the use of corticosteroids of ninety-nine percent at six
months.”
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. Corey Cutler Poster Number: P322
Key Highlights, Summary and Conclusions from
Presentation:
- Itolizumab treatment in combination with systemic
corticosteroids was associated with rapid and durable high rates of
overall clinical response
- Response at Day 29 was associated with improved
progression-free survival through 1 year
- Itolizumab was safe and well tolerated in severe aGVHD
patients
- Itolizumab offers a favorable benefit-risk profile that
supports evaluation in the pivotal Phase 3 study (EQUATOR
NCT05263999), which has been initiated for the first-line treatment
of aGVHD
The oral presentation is available on the Presentations page of
Equillium’s website.
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 was a Phase 1b 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
was an open-label dose escalation study in adult patients who
present with high-risk acute graft-versus-host disease (aGVHD) and
typically respond poorly to steroids. The Phase 1b data informed
the selection of the dose being used in the EQUATOR pivotal Phase 3
study.
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 clinical 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 first-in-human clinical 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 clinical study of patients
with acute graft-versus-host disease (aGVHD) and a Phase 1b
clinical study of 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 option and 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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20230424005161/en/
Investor & Media Contact Equillium, Inc. Michael
Moore Vice President, Investor Relations Officer & Head of
Corporate Communications 619-302-4431 ir@equilliumbio.com
Equillium (NASDAQ:EQ)
Historical Stock Chart
From Apr 2024 to May 2024
Equillium (NASDAQ:EQ)
Historical Stock Chart
From May 2023 to May 2024