GRI Bio Presents Encouraging Preclinical Data Indicating Oral Administration of GRI-0803 Inhibited Lupus Nephritis and Significantly Improved Overall Survival in Animal Models
07 August 2023 - 10:35PM
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 preclinical data from its GRI-0803 development program at The
Autoimmunity Conference hosted by FASEB held July 30-August 3, 2023
in Southbridge, MA.
GRI-0803 is the Company’s novel activator of
human type 2 NKT cells in development for the treatment of
autoimmune disorders, with an initial focus on SLE, the most common
form of lupus, is an autoimmune disease in which the immune system
attacks its own tissue and organs.
As part of the conference, Albert Agro, PhD,
Chief Medical Officer of GRI Bio presented preclinical data from
its GRI-0803 asset in development in an abstract titled, "Type 2
NKT cells directed immune regulatory mechanism in lupus nephritis,"
in the Novel Translational and Clinical Treatments for Autoimmune
Disease session held on August 3, 2023.
Dr. Agro commented, “We remain highly encouraged
by the animal model data that we observed in connection with
GRI-0124 and the second-generation type 2 NKT cell agonist,
GRI-0803. Oral administration of type 2 NKT cell agonists have been
observed to inhibit animal models of lupus nephritis, proteinuria,
and to significantly improve overall survival in these animal
models.”
“Our growing body of data gives us further
confidence in GRI Bio’s approach to play an important role in the
treatment of SLE, especially given there have been only two drugs
approved for this indication in more than 50 years. We are excited
by GRI-0803’s potential and are working in earnest to complete our
IND-enabling studies to position us to commence our Phase 1a/b
study early next year,” added Dr. Agro.
Natural killer T (NKT) cells recognize lipid
antigens presented by CD1d molecules and can be categorized into
two subsets: type 1 or invariant (iNKT) and type 2 NKT cells. Type
2 NKT cells recognize lipids such as sulfatide or
lysophosphatidylcholine (LPC), and their activation results in
cross-regulation of iNKT cells, tolerization of DC resulting in a
net positive effect during inflammatory diseases. iNKT cells play a
pathogenic role in a murine model of lupus in (NZB x NZW) F1 or
BWF1 mice and are also activated in lupus patients as demonstrated
by the increased release of the pro-inflammatory cytokine IFNɣ.
Interestingly, anti-glycosphingolipid antibody responses have been
found in lupus patients and sulfatide is enriched in kidney
glomeruli.
The Company has investigated the role of type 2
NKT cells in the spontaneous development of lupus in BWF1 mice.
Results from the studies found that both iNKT and type 2 NKT cells
accumulate in kidney tissues with progression of disease in BWF1
mice. Type 2 NKT cell activation leads to a significant inhibition
of nephritis in these mice. A clinically relevant structural analog
of LPC, GRI-0124 also binds to CD1d, activates type 2 NKT cells and
upon oral administration induces inhibition of proteinuria,
anti-dsDNA antibodies as well as infiltration of CD4+/CD8+ T cells
and B cells into kidney of BWF1 mice. These studies suggest a key
role for a type 2 NKT cell-based immune regulatory mechanism in the
control of lupus.
Based on the data demonstrated to date, GRI Bio
plans to evaluate GRI-0803 in a hybrid designed Phase 1 program.
Healthy volunteers (SAD trial) and patients with SLE (MAD trial)
will be assessed to examine the safety and tolerability of
GRI-0803. A number of biomarkers will be evaluated in the MAD to
validate the role of NKT 2 cell activation in SLE. The Company is
working to complete IND-enabling studies for GRI-0803 and file an
IND in 2024.
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
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statements” within the meaning of the “safe harbor” provisions of
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the Company’s expectations with respect to development and
commercialization of the Company’s product candidates, the
initiation or completion of clinical trials, , any implication or
statement indicating that the results or data from earlier
development or preclinical development will be indicative of later
results in clinical trials, the timing of continued preclinical or
clinical development, the potential benefits and impact of the
Company’s product candidates, and any estimate or implication as to
potential market size or potential revenue. Actual results may
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to identify, in-license or acquire additional technology; (7) the
inability of the Company to compete with other companies currently
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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
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for and the ability to obtain additional financing; (10) the
Company’s ability to protect and enforce its intellectual property
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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 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
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Investor Contact:JTC Team,
LLCJenene Thomas(833) 475-8247GRI@jtcir.com
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