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 publication
of an article that reviews data in both experimental models and in
humans that suggest a key role of type 1 invariant NKT (iNKT) cell
activation in the progression of inflammatory cascades leading to
recruitment of neutrophils and activation of the inflammasome,
macrophages, fibroblasts, and, ultimately, fibrosis. The manuscript
titled, “Type 1 invariant natural killer T cells in chronic
inflammation and tissue fibrosis,” has been published in Frontiers
in Immunology.1
Natural killer T (NKT) cells are innate-like T
cells that share properties of both NK cells and T lymphocytes. NKT
cells are pre-loaded with cytokine message and respond quickly in
immune responses, but also help to maintain and propagate chronic
long term immune responses. They interact with and influence the
activity of other cell types and are a functional link between the
innate and adaptive immune systems. iNKT are pro-inflammatory
effector T cells that accumulate in many models of chronic fibrotic
diseases such as idiopathic pulmonary fibrosis (IPF), lupus
nephritis and NASH. Type 2 NKT cells are anti-inflammatory
regulatory T cells that can reset unwanted immune responses that
contribute to many autoimmune disorders such as systemic lupus
erythematosus, multiple sclerosis and rheumatoid arthritis. GRI has
a robust portfolio of patented drug candidates that regulate NKT
cells.
“There remains a significant unmet need with no
existing therapeutic solutions that halt disease progression of
fibrotic diseases such as IPF and NASH. This review provides
valuable insight and is a step forward in attaining a better
understanding of the cellular and molecular mechanisms involved in
progressive fibrotic disease. I am encouraged by the emerging
experimental evidence that iNKT cells play an important role in
chronic inflammation and fibrosis. I look forward to the continued
advancements toward a potential therapeutic and ultimately address
this significant unmet need for a solution for chronic inflammation
and tissue fibrosis,” commented Dr. Cormac McCarthy, Associate
Professor of Medicine at University College Dublin, School of
Medicine. and Consultant Respiratory Physician at St. Vincent's
University Hospital.
“We continue to establish a growing body of data
highlighting the positive effect of targeting the immune response
earlier in the inflammatory cascade to interrupt disease
progression. Our belief in the potential of our NKT platform
technology continues to build and we remain focused on leveraging
its potential to develop novel biomarkers and therapeutic targets
that differentiate stages of fibrosis progression,” commented Marc
Hertz, PhD, Chief Executive Officer of GRI Bio. “Supported by this
compelling emerging data in experimental models of fibrosis, our
team continues to make solid progress in the advancement of our
lead programs, GRI-0621 and GRI-0803. We believe GRI is poised to
interrupt disease progression and importantly, provide benefit to
patients.”
Emerging evidence suggests that iNKT-associated
mechanisms contribute to type 1, type 2 and type 3 immune pathways
mediating tissue fibrosis, including IPF. IPF is a rare chronic
progressive pulmonary disease with abnormal scarring of the lung
blocking the movement of oxygen into the bloodstream. Currently, no
therapeutic solution exists that halt disease progression of IPF
and a better understanding of the cellular and molecular mechanisms
involved in progressive fibrotic disease is necessary for the
development of new therapeutic interventions.
Key Highlights
- iNKT cells are involved in the
regulation of all three, type 1, type 2 and type 3 cytokine
associated fibrotic pathways. The cross regulation of iNKT cell
subsets as well as mechanisms that dictate whether type 1, type 2,
or type 3 immunity predominates during the progression of lung
fibrosis in IPF are not clear. However, based on data from disease
models, inhibition of iNKT cells, including NKT1, NKT2 and NKT17
subsets, is likely to inhibit type 1, 2 and 3 key cytokine pathways
driving fibrosis in IPF.
- Consistent with the experimental
data, iNKT cells are chronically activated and secrete
significantly higher levels of proinflammatory cytokines in NASH,
severe alcoholic hepatitis, lupus nephritis and accumulate in IPF
patients in comparison to healthy volunteers.
- Neutrophil accumulation into
fibrotic liver tissue is dependent on the activation of iNKT cells.
This is due to the inhibition of the upregulation of several
cytokines and chemokines, including MIP-1, MIP-2, IL-6, and
osteopontin that are involved in the neutrophil infiltration into
tissues following injury.
- Targeting an immune pathway that
can facilitate a re-balancing of downstream pathways, and restoring
immune homeostasis, may be crucial for an effective treatment
strategy for fibrosis. As covered in this published NKT review
manuscript, the blocking of an earlier upstream pathway, such as
iNKT cell activation, may dampen all three key cytokine-associated
pathways and ultimately may lead to the development of novel
therapeutic strategies in IPF.
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 date2 and previous
trials with the oral formulation, GRI-0621 has been shown to
improve fibrosis in multiple disease models and improve LFTs and
other markers of inflammation and injury in patients. The Company
remains on track to launch its Phase 2a biomarker study evaluating
GRI-0621 for the treatment of IPF before year end 2023.
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
initiation or completion of clinical trials, the potential benefits
and impact of the Company’s product candidates and the related
timing of regulatory approvals, if any, evaluations and judgements
regarding the Company’s intellectual property position, the ability
of the Company to achieve the milestones presented and the timing
of such milestones, any implication that the results or preliminary
results of earlier or prior clinical trials will be representative
or indicative of future clinical trials, estimates regarding the
funding necessary to fund the Company’s planned operations and any
estimate or implication as to potential market size or potential
revenue. 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 their
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 its ability to serve those markets, either alone or in
partnership with others; (9) inaccuracy in the Company’s estimates
regarding expenses, future revenue, capital requirements and needs
for and the ability to obtain additional financing; (10) the
Company’s ability to protect and enforce its intellectual property
portfolio; and (10) 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 and Quarterly Report on Form 10-Q filed with the SEC on May 15,
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. This press release also contains
estimates and other statistical data made by independent parties
and by the Company relating to market size and growth and other
data about its industry. This data involves a number of assumptions
and limitations, and you are cautioned not to give undue weight to
such estimates.
Investor Contact:JTC Team, LLCJenene
Thomas(833) 475-8247GRI@jtcir.com
1 Front. Immunol., 25 September 2023, Sec. T
Cell Biology, Volume 14 - 2023 |
https://doi.org/10.3389/fimmu.2023.12605032 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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