GRI Bio Announces Korea Patent Granted for Proprietary Natural Killer T (NKT) Cell Modulators
GRI Bio has been granted Patent No. 10-2665487 by the Korean Intellectual Property Office for its Natural Killer T (NKT) cell modulators.
The patent covers compositions and methods for modulating type 2 and/or type 1 invariant NKT (iNKT) cells to treat inflammatory, fibrotic, and autoimmune conditions through the administration of a Retinoic Acid Receptor (RAR) agonist.
CEO Marc Hertz emphasized the importance of this patent in expanding their intellectual property portfolio and advancing their clinical programs.
GRI Bio's lead program, GRI-0621, is currently in a Phase 2a trial for Idiopathic Pulmonary Fibrosis (IPF), with interim data expected in Q3 2024 and topline results in Q4 2024.
- GRI Bio secured a patent in Korea for its NKT cell modulators.
- The patent encompasses treatments for inflammatory, fibrotic, and autoimmune conditions.
- GRI Bio's lead program, GRI-0621, is progressing in a Phase 2a trial.
- None.
Insights
The grant of a patent in South Korea for GRI Bio's Natural Killer T (NKT) cell modulators is a noteworthy milestone. This patent enhances the company's intellectual property portfolio, which is critical in the competitive biotechnology landscape. The protection provided by patents is essential for biotechs to secure market exclusivity, thereby allowing them to recoup R&D investments.
South Korea is a strategic choice due to its growing pharmaceutical market and robust intellectual property enforcement. This move could also pave the way for future partnerships or licensing deals in the region, potentially creating new revenue streams. However, investors need to be cautious about overestimating the immediate financial impact, as clinical success and market adoption remain significant hurdles.
Moreover, the announcement emphasizes the ongoing clinical trials, particularly the Phase 2a study for GRI-0621. Positive interim data in Q3 2024 could act as a catalyst for the stock, while negative results could have the opposite effect. Hence, investors should closely follow these forthcoming updates.
The granted patent covers compositions and methods for modulating invariant NKT (iNKT) cells using a Retinoic Acid Receptor (RAR) agonist. This innovative approach could address unmet needs in treating inflammatory, fibrotic and autoimmune conditions. The specificity of targeting iNKT cells is promising because these cells play a significant role in regulating immune responses. By modulating these cells, GRI Bio aims to offer new therapeutic options beyond current treatments, which often have limited efficacy and significant side effects.
It is important to understand that while patents are important, clinical efficacy and safety data ultimately determine a drug's success. The ongoing Phase 2a trial for GRI-0621 in Idiopathic Pulmonary Fibrosis (IPF) is particularly intriguing. IPF is a severe condition with limited treatment options and a successful outcome could significantly boost the company's valuation. Investors should be aware of the trial design - a randomized, double-blind, placebo-controlled study - which is the gold standard for clinical research, indicating a rigorous assessment of the drug's potential.
Company is strategically building a global patent estate in key territories for a growing pipeline targeting potentially high-value indications in need of innovation
LA JOLLA, CA, June 27, 2024 (GLOBE NEWSWIRE) -- 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 that the Korean Intellectual Property Office (KIPO) has granted Patent No. 10-2665487 titled, "Prevention and Treatment of Inflammatory Conditions."
The granted patent covers claims including compositions and methods for modulating type 2 and/or type 1 invariant NKT (iNKT) cells in the prevention and treatment of inflammatory conditions. More specifically, the patent covers the prevention and treatment of inflammatory, fibrotic and autoimmune conditions through the administration of a Retinoic Acid Receptor (RAR) agonist that inhibits iNKT cells in a subject.
“We wholeheartedly believe in our highly differentiated approach to the prevention and treatment of inflammatory, fibrotic and autoimmune diseases. We are pleased to now have this Korea patent granted and added to our intellectual property portfolio covering our innovative pipeline of NKT cell modulators. Our primary focus is on advancing our clinical development programs and look forward to announcing interim data from our lead program GRI-0621 for our Phase 2a biomarker study in the third quarter of this year,” Marc Hertz, PhD, Chief Executive Officer of GRI Bio.
GRI Bio is currently advancing its lead program GRI-0621, a small molecule RAR-βɣ dual agonist candidate that inhibits the activity of human iNKT cells, in a Phase 2a, randomized, double-blind, multi-center, placebo-controlled, parallel-design, 2-arm study for the treatment of Idiopathic Pulmonary Fibrosis (IPF). IPF is a rare chronic progressive pulmonary disease with abnormal scarring of the lung blocking the movement of oxygen into the bloodstream. Topline results from this study are expected in the fourth quarter of 2024.
For more information about the Company’s innovative pipeline of NKT cell regulators for the treatment of inflammatory, fibrotic and autoimmune diseases, visit gribio.com.
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 Natural Killer T (“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 and availability of resulting data, 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 and the Company’s beliefs about the timing and outcome of regulatory approvals and potential regulatory approval pathways. 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 and to comply with applicable listing requirements; (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 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 March 28, 2024 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, LLC
Jenene Thomas
(833) 475-8247
GRI@jtcir.com
FAQ
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