Celularity Inc. (Nasdaq: CELU) (“Celularity”), a biotechnology
company developing placental-derived allogeneic cell therapies and
biomaterial products, announced results from an exploratory
analysis of Phase 1 data evaluating alterations in gene and protein
signatures associated with reduced inflammation and fistula
formation resulting from therapy with mesenchymal‐like adherent
stromal cells (MLASCs) in adult patients with Crohn’s disease (CD).
These data were presented at the 26th Annual Meeting of the
American Society of Gene & Cell Therapy, which is being held
May 16-20th in Los Angeles.
(Placental‐Derived Mesenchymal‐Like Adherent Stromal Cell
(MLASC) Therapy Results in Alterations in Gene and Protein
Signatures Associated with Inflammation and Fistula Formation in
Patients with Crohn’s Disease, Kilcoyne, et al., Poster Session
1111.)
In this study, two patient groups were evaluated: patients who
responded to MLASC therapy (n=12) and patients who received placebo
(n=12). For each of the 24 patients, mRNA gene expression data and
proteomics data were provided at early pre‐treatment, at
pre‐treatment baseline, at early post‐treatment) and at later
post‐treatment.
The results of this analysis showed that in CD, MLASC treatment
resulted in alterations in gene and protein signatures associated
with inflammation and fistula formation. This analysis provides
some insight into pathways associated with severity of CD and
suggests that gene and protein profiling of blood plasma might be
useful for assessing disease severity and treatment response. It
also suggests that MLASCs may be a potential therapeutic option in
both managing the disease but also, importantly, in limiting
fistula formation.
“Crohn’s disease is a devastating condition for patients, and we
believe these data help us begin to see the potential role that
cell therapy may play in its treatment,” said Robert J. Hariri,
M.D., Ph.D., Celularity’s CEO, Chairman and Founder. “Furthermore,
these results validate our decision to progress our novel
genetically modified allogeneic placental-derived MLASC, APPL-01,
in Crohn’s disease, where this cell therapy candidate has the
potential to make a significant difference. Celularity’s unique
technology platform is grounded in our use of the post-partum
placenta as the source of cells and biomaterials, enabling
independent but complementary product opportunities in cellular and
regenerative medicine. We’re moving forward with confidence to
assess the potential immunomodulatory and pro-regenerative
therapeutic benefits of MLASCs as we advance the development of
therapeutic options for patients.”
About Crohn’s Disease
Crohn’s disease (CD) is a chronic idiopathic inflammatory bowel
disease. The goal of treatment is to control the inflammation and
induce a clinical remission and reduce the incidence of the
associated fistula formation, which has proved challenging.
Fistulae, caused by epithelial‐to‐mesenchymal transition (EMT),
occur in up to 50 percent of patients and often require surgery.
Transforming growth factor‐beta (TGF‐β) is the most important
inducer of EMT as it regulates invasion via loss of epithelial and
gain of mesenchymal markers.
About MLASCs
MLASC are proprietary culture expanded, undifferentiated
mesenchymal‐like adherent stromal cells derived from full term
placental tissue that have immuno‐modulatory and anti‐inflammatory
properties. Depending on the environment in which they are located,
MLASCs secrete numerous factors and thus act paracrine and
autocrine, performing trophic, immunomodulatory, and antimicrobial
effects.
About Celularity
Celularity Inc. (Nasdaq: CELU) headquartered in Florham Park,
N.J., is a biotechnology company leading the next evolution in
cellular and regenerative medicine by developing allogeneic
cryopreserved off-the-shelf placental-derived cell therapies,
including therapeutic programs using mesenchymal-like adherent
stromal cells (MLASCs), T-cells engineered with CAR (CAR T-cells),
and genetically modified and unmodified natural killer (NK) cells.
These therapeutic programs target indications in autoimmune,
infectious and degenerative diseases, and cancer. In addition,
Celularity develops, manufactures, and commercializes innovative
biomaterial products also derived from the postpartum placenta.
Celularity believes that by harnessing the placenta’s unique
biology and ready availability, it can develop therapeutic
solutions that address significant unmet global needs for
effective, accessible, and affordable therapies.
To learn more, visit celularity.com
Forward-Looking Statements
This press release includes “forward-looking statements” within
the meaning of The Private Securities Litigation Reform Act of
1995, as well as within the meaning of Section 27A of the
Securities Act of 1933, as amended, and Section 21E of the
Securities Exchange Act of 1934, as amended. All statements other
than statements of historical facts are “forward-looking
statements,” including those relating to future events. In some
cases, you can identify forward-looking statements by terminology
such as “anticipate,” “believe,” “can,” “contemplate,” “continue,”
“could,” “estimate,” “expect,” “forecast,” “intends,” “may,”
“might,” “outlook,” “plan,” “possible,” “potential,” “predict,”
“project,” “seek,” “should,” “strive,” “target,” “will,” “would”
and the negative of terms like these or other comparable
terminology, and other words or terms of similar meaning. The
forward-looking statements in this press release include express or
implied statements regarding progressing APPL-001 into clinical
studies and its potential for Crohn’s disease, the benefits of
Celularity’s approach to cellular medicine, and Celularity’s
ability to advance its technology platform to develop therapeutic
options for patients, among others. Many factors could cause actual
results to differ materially from those described in these
forward-looking statements, including but not limited to: the
inherent risks in biotechnological development, including with
respect to the development of novel biomaterial products and
cellular therapies, and the clinical trial and regulatory approval
process; and risks associated with Celularity’s current liquidity,
as well as developments relating to Celularity’s competitors and
industry, along with those risk factors set forth under the caption
“Risk Factors” in Celularity’s annual report on Form 10-K filed
with the Securities and Exchange Commission (SEC) on March 31,
2023, and other filings with the SEC. These risks and uncertainties
may be amplified by current economic situations, including
inflation, supply chain issues and overall economic uncertainty. If
any of these risks materialize or underlying assumptions prove
incorrect, actual results could differ materially from the results
implied by these forward-looking statements. There may be
additional risks that Celularity does not presently know, or that
Celularity currently believes are immaterial, that could also cause
actual results to differ from those contained in the
forward-looking statements. In addition, these forward-looking
statements reflect Celularity’s current expectations, plans, or
forecasts of future events and views as of the date of this
communication. Subsequent events and developments could cause
assessments to change. Accordingly, forward-looking statements
should not be relied upon as representing Celularity’s views as of
any subsequent date, and Celularity undertakes no obligation to
update forward-looking statements to reflect events or
circumstances after the date hereof, whether as a result of new
information, future events or otherwise, except as may be required
under applicable securities laws.
Celularity Contact:Paul Graves, Chief
Communications OfficerCelularity Inc.paul.graves@celularity.com
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