GRI Bio Presents Translational Data Demonstrating Connection Between NKT Cells and the Pathogenesis of Idiopathic Pulmonary Fibrosis (IPF) at the 2023 Pittsburgh-Ireland International Lung Conference
19 Octubre 2023 - 7:45AM
GRI Bio, Inc. (NASDAQ: GRI) (“GRI Bio” or the “Company”), a
biotechnology company advancing an innovative pipeline of Natural
Killer T (“NKT”) cell modulators for the treatment of inflammatory,
fibrotic and autoimmune diseases, today announced the presentation
of translational data at the 2023 Pittsburgh-Ireland International
Lung Conference: Precision Medicine in Lung Diseases: From Cellular
Mechanisms to Clinical Phenotypes held October 16-17, 2023 at the
RCSI University of Medicine and Health Sciences in Dublin, Ireland.
The abstract titled “Altered NKT cell populations in the airways of
patients with IPF,” was presented in a poster presentation by
collaborator Emily Calamita of Dr. Adam Byrne’s laboratory.
IPF is a rare chronic progressive pulmonary
disease with abnormal scarring of the lung blocking the movement of
oxygen into the bloodstream. Natural killer T (NKT) cells are a
subset of innate-like T lymphocytes that recognize lipid antigens,
by expressing the T-cell receptor (TCR) Vα24-Jα18 chain. Upon
activation, NKT cells produce numerous cytokines, including those
that have been shown to drive IPF pathogenesis. In animal models of
lung fibrosis, NKT cells have been shown to drive IPF pathology.
However, their role in human IPF remains unknown.
“There remains an urgent need to understand the
mechanism underlying IPF. These data add to our growing belief in
the key role of NKT cells in the pathogenesis of IPF and bolsters
our confidence in GRI-0621’s ability to provide a much-needed
therapeutic option for patients,” commented Marc Hertz, PhD, Chief
Executive Officer of GRI Bio. “Supported by a growing body of data,
we are on track to launch our Phase 2a biomarker study before year
end to evaluate GRI-0621 as a potential treatment option for this
devastating disease.”
For the translational study, surface and
intracellular flow cytometry of cells isolated from bronchoalveolar
lavage (BAL) and blood of healthy donors and IPF patients was
conducted to characterize their NKT cell compartment.
Key Findings:
- In the BAL of IPF patients, a
significant increase in the number of NKT cells was observed in
comparison to healthy controls.
- Numbers of NKT cells correlated
positively with the number of airway macrophages (AMs) in IPF
BAL.
- Increased expression of NKT-IFNγ
was also observed in the BAL of IPF patients relative to
controls.
- The number of NKT cells positively
correlated with the number of airway macrophages in IPF patients.
However, the correlation with lung function parameters did not
reach significance in this small study.
GRI Bio’s lead program, GRI-0621 is a small
molecule RAR-βɣ dual agonist that inhibits the activity of
human type 1, iNKT cells. In preliminary trials to date1 and
previous trials with the oral formulation, GRI-0621 has been shown
to improve fibrosis in multiple disease models and improve liver
function tests and other markers of inflammation and injury in
patients.
GRI is developing and repurposing GRI-0621 as a
once-daily oral capsule for the treatment of IPF with the potential
to expand into additional fibrotic indications. The Company plans
to leverage the 505(b)(2) regulatory pathway and to launch a Phase
2a biomarker study evaluating GRI-0621 for the treatment of IPF.
The Company is on track to launch its Phase 2a biomarker study of
GRI-0621 before year-end.
About GRI Bio, Inc.
GRI Bio is a clinical-stage biopharmaceutical
company focused on fundamentally changing the way inflammatory,
fibrotic and autoimmune diseases are treated. GRI Bio’s therapies
are designed to target the activity of NKT cells, which are key
regulators earlier in the inflammatory cascade, to interrupt
disease progression and restore the immune system to homeostasis.
NKT cells are innate-like T cells that share properties of both NK
and T cells and are a functional link between the innate and
adaptive immune responses. Type I invariant NKT (“iNKT”) cells play
a critical role in propagating the injury, inflammatory response,
and fibrosis observed in inflammatory and fibrotic indications. GRI
Bio’s lead program, GRI-0621, is an inhibitor of iNKT cell activity
and is being developed as a novel oral therapeutic for the
treatment of idiopathic pulmonary fibrosis, a serious disease with
significant unmet need. The Company is also developing a pipeline
of novel type 2 NKT agonists for the treatment of systemic lupus
erythematosus. Additionally, with a library of over 500 proprietary
compounds, GRI Bio has the ability to fuel a growing pipeline.
Forward Looking Statements
This press release contains “forward-looking
statements” within the meaning of the “safe harbor” provisions of
the Private Securities Litigation Reform Act of 1995.
Forward-looking statements may be identified by the use of words
such as “anticipate,” “believe,” “contemplate,” “could,”
“estimate,” “expect,” “intend,” “seek,” “may,” “might,” “plan,”
“potential,” “predict,” “project,” “target,” “aim,” “should,”
“will,” “would,” or the negative of these words or other similar
expressions. These forward-looking statements are based on the
Company’s current beliefs and expectations. Forward-looking
statements include, but are not limited to, statements regarding:
the Company’s expectations with respect to development and
commercialization of the Company’s product candidates, the timing
of initiation or completion of clinical trials, the potential
benefits and impact of the Company’s clinical trials and product
candidates and any implication that the data or results observed in
preclinical trials or earlier studies or trials will be indicative
of results of later studies or clinical trials. Actual results may
differ from the forward-looking statements expressed by the Company
in this press release and consequently, you should not rely on
these forward-looking statements as predictions of future events.
These forward-looking statements are subject to inherent
uncertainties, risks and assumptions that are difficult to predict,
including, without limitation: (1) the inability to maintain the
listing of the Company’s common stock on Nasdaq; (2) changes in
applicable laws or regulations; (3) the inability of the Company to
raise financing in the future; (4) the success, cost and timing of
the Company’s product development activities; (5) the inability of
the Company to obtain and maintain regulatory clearance or approval
for its respective products, and any related restrictions and
limitations of any cleared or approved product; (6) the inability
of the Company to identify, in-license or acquire additional
technology; (7) the inability of the Company to compete with other
companies currently marketing or engaged in the development of
products and services that the Company is currently developing; (8)
the size and growth potential of the markets for the Company’s
products and services, and their respective ability to serve those
markets, either alone or in partnership with others; (9) the
failure to achieve any milestones or receive any milestone payments
under any agreements; (10) inaccuracy in the Company’s estimates
regarding expenses, future revenue, capital requirements and needs
for and the ability to obtain additional financing; (11) the
Company’s or Aardvark’s ability to protect and enforce its
intellectual property portfolio, including any newly issued
patents; and (12) other risks and uncertainties indicated from time
to time in the Company’s filings with the U.S. Securities and
Exchange Commission (the “SEC”), including the risks and
uncertainties described in the “Risk Factors” section of the
Company’s most recent Annual Report on Form 10-K filed with the SEC
on February 24, 2023 and subsequently filed reports.
Forward-looking statements contained in this announcement are made
as of this date, and the Company undertakes no duty to update such
information except as required under applicable law.
Investor Contact:JTC Team, LLCJenene
Thomas(833) 475-8247GRI@jtcir.com
1 I. Maricic et al., Differential Activation of
Hepatic Invariant NKT Cell Subsets Plays a Key Role in Progression
of Nonalcoholic Steatohepatitis. J Immunol 201,
3017-3035 (2018), Tazoral™ for the Treatment of Moderate to Very
Severe Plaque Psoriasis Briefing Document, Allergan
(https://wayback.archive-it.org/7993/20170405104812/https://www.fda.gov/ohrms/dockets/ac/04/briefing/2004-4062B1_01_Allergan-Background.pdf)
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