Remestemcel-L Reduces Inflammatory Biomarkers Predictive of High Mortality in Acute Graft Versus Host Disease
December 07 2020 - 6:00AM
Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in
allogeneic cellular medicines for inflammatory diseases, today
announced results presented at the 62nd annual
meeting American Society of Hematology (ASH), which
provide in vivo biomarker evidence linking
remestemcel-L’s immunomodulatory activity to survival outcomes in
children with steroid-refractory acute graft versus host disease
(SR-aGVHD). The results were presented on December 6,
2020 by the Phase 3 trial’s lead investigator and pediatric
transplant physician, Dr Joanne Kurtzberg, the Jerome Harris
Distinguished Professor of Pediatrics and Professor of Pathology,
and Director, Pediatric Blood and Marrow Transplant Program at Duke
University Medical Center.
Key conclusions were:
- Clinically meaningful overall responses and survival in
children with SR-aGVHD treated with remestemcel-L were associated
with significant reductions in certain biomarkers of inflammation
which have been validated as predictors of mortality risk
- These biomarkers provide evidence of in vivo bioactivity of
remestemcel-L in pediatric SR-aGVHD, where children under 12 are at
high-risk for mortality, with no approved therapies in the United
States
- The durable reductions in blood levels of certain biomarkers
associated with inflammatory diseases of the gut suggest that these
could be more generally reflective of remestemcel-L activity in
vivo in other inflammatory bowel diseases such as Crohn’s disease
and ulcerative colitis
Blood levels of soluble suppression of
tumorigenicity 2 (ST2)1,2 and MAGIC Biomarker Score (MBS)3,4,
validated biomarkers that predict high mortality in SR-aGVHD and
active gut inflammation more broadly, were measured at baseline and
sequentially over 180 days in 40 of the 54 children with SR-aGVHD
who received at least four weeks of remestemcel-L treatment in the
single-arm Phase 3 trial. Both the elevated baseline levels of
ST2 and MBS were significantly reduced after remestemcel-L
treatment at Days 100, 160 and 180 (all timepoints p<0.001 for
both markers). This was accompanied by significant reductions in
activated circulating T cells. Day 100 survival was 74% in the
54 remestemcel-L children with SR-aGVHD (89% with Grade C/D
disease), which compares very favourably with a mortality
approaching 70-90% in children of similar severity treated with
other therapies.
Dr Kurtzberg said: “These results support the
bioactivity of remestemcel-L in treating the severe inflammation in
children with acute graft versus host disease refractory to
steroids and provide evidence linking the immunomodulatory
properties of remestemcel-L with the excellent responses and
survival we see when treating these desperately ill children.”
About Remestemcel-L Remestemcel-L
is an investigational therapy comprising culture-expanded
mesenchymal stromal cells derived from the bone marrow of an
unrelated donor. Remestemcel-L is thought to have immunomodulatory
properties to counteract the cytokine storms that are implicated in
various inflammatory conditions by downregulating the production of
pro-inflammatory cytokines, increasing production of
anti-inflammatory cytokines, and enabling recruitment of naturally
occurring anti-inflammatory cells to involved tissues.
About Mesoblast Mesoblast Limited
(Nasdaq:MESO; ASX:MSB) is a world leader in developing allogeneic
(off-the-shelf) cellular medicines. The Company has leveraged its
proprietary mesenchymal lineage cell therapy technology platform to
establish a broad portfolio of commercial products and late-stage
product candidates. Mesoblast has a strong and extensive global
intellectual property portfolio with protection extending through
to at least 2040 in all major markets. The Company’s proprietary
manufacturing processes yield industrial-scale, cryopreserved,
off-the-shelf, cellular medicines. These cell therapies, with
defined pharmaceutical release criteria, are planned to be readily
available to patients worldwide. For more information, please see
www.mesoblast.com, LinkedIn: Mesoblast Limited and Twitter:
@Mesoblast
References 1. Reichenbach DK et
al. Bloo`d. 2015 May 14;125(20):3183-92. 2. Vander Lugt MT et
al. New Engl J Med. 2013 Aug 8 369:529-39. 3. Hartwell MJ et
al. JCI Insight. 2017;2(3):e89798. 4. Major-Monfried H et al.
Blood. 2018;131(25):2846‐2855.
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For more information, please contact:
Media |
|
Julie
Meldrum |
Kristen
Bothwell |
T: +61 3
9639 6036 |
T: +1 917
613 5434 |
E:julie.meldrum@mesoblast.com |
E:kbothwell@rubenstein.com |
Investors |
|
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Greenway |
Paul
Hughes |
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2060 |
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9639 6036 |
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