GRI Bio (NASDAQ: GRI) Bolsters Patent Portfolio
27 Giugno 2023 - 2:45PM
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 provided an update to the
progress of its patent portfolio development.
Most recently, the Company received notice that
the United States Patent and Trademark Office (USPTO) has issued
U.S. Patent No. 11,660,309 entitled, “Prevention and treatment of
inflammatory conditions,” covering methods for the prevention and
treatment of inflammatory conditions. More specifically, the patent
covers the prevention and treatment of inflammatory and fibrotic
conditions through the administration of a Retinoic Acid Receptor
(RAR) agonist that inhibits type 1 invariant NKT (iNKT) cells, and
at its broadest covers the administration of an RAR agonist that
inhibits the activity of iNKT cells in a subject.
GRI-0621 is the Company’s small molecule RAR-βɣ
dual agonist candidate that inhibits the activity of human iNKT
cells. In clinical trials/pre-clinical studies with GRI-0621,
reduced aminotransferases and other LFTs in patients and improved
fibrosis in multiple disease models were observed. GRI is
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 launch a Phase 2a biomarker study evaluating GRI-0621
for the treatment of IPF in the second half of 2023.
“Establishing a strong global patent estate for
our innovative pipeline continues to be an area of focus for the
Company as we continue to advance development. We are pleased to
have been issued this latest U.S. patent for GRI-0621 which extends
our patent coverage to 2032 and which we believe provides further
validation of our differentiated approach. Over the course of the
past year, we have significantly added to our patent estate,
underscoring our commitment to advance much needed treatment
options for inflammatory, fibrotic and autoimmune diseases,"
commented Marc Hertz, Ph.D., Chief Executive Officer of GRI
Bio.
Additionally, over the course of the past year,
the Company has bolstered its IP protection with the issuance of
several U.S. and ex-U.S. patents for the GRI-0621, GRI-0803,
GRI-0124, and GRI-0729 development programs:
GRI-0621
- Russian Patent No. RU2789326
- Brazilian Patent No.
BR112013033309B1
GRI-0803
- U.S. Patent No. 11,453,642
GRI-0124
- China Patent No. CN107206086B
- Hong Kong Patent No. HK1243961
GRI-0729
- U.S. Patent No. 11,564,895
The Company remains committed to bolstering its
IP protection across its innovative pipeline of NKT cell
modulators.
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, individual
patents, patent portfolio and strategy, the ability of the Company
to achieve the milestones presented and the timing of such
milestones, the ability of the Company to utilize any particular
regulatory approval strategy, any implication that the results or
preliminary results of earlier or prior clinical trials or
preclinical studies will be representative or indicative of future
clinical trials or preclinical studies 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, including
any newly issued patents; 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 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 limitations, and you are cautioned not to
give undue weight to such estimates.
Investor Contact:JTC Team,
LLCJenene Thomas(833) 475-8247GRI@jtcir.com
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