GRI Bio Bolsters Intellectual Property Portfolio with Granting of Two Global Patents for Europe and Japan
GRI Bio (NASDAQ: GRI) has strengthened its intellectual property portfolio with two significant patent grants in Europe and Japan. The European patent covers GRI-0803, a novel activator of type 2 diverse NKT cells being developed for autoimmune disorders, particularly systemic lupus erythematosus. The Japanese patent focuses on methods for modulating dNKT and iNKT cells in treating inflammatory conditions through Retinoic Acid Receptor agonists.
The company's lead program, GRI-0621, is currently in a Phase 2a clinical trial for idiopathic pulmonary fibrosis (IPF). Interim data is expected in Q2 2025, with topline results anticipated in Q3 2025. The study is designed as a randomized, double-blind, multi-center, placebo-controlled trial.
GRI Bio (NASDAQ: GRI) ha rafforzato il suo portafoglio di proprietà intellettuale con due importanti concessioni di brevetto in Europa e Giappone. Il brevetto europeo copre GRI-0803, un attivatore innovativo delle cellule NKT di tipo 2, sviluppato per i disturbi autoimmuni, in particolare il lupus eritematoso sistemico. Il brevetto giapponese si concentra su metodi per modulare le cellule dNKT e iNKT nel trattamento delle condizioni infiammatorie attraverso agonisti del recettore dell'acido retinoico.
Il programma principale dell'azienda, GRI-0621, è attualmente in fase di sperimentazione clinica di Fase 2a per la fibrosi polmonare idiopatica (IPF). I dati provvisori sono attesi nel secondo trimestre del 2025, con i risultati principali previsti per il terzo trimestre del 2025. Lo studio è progettato come uno studio randomizzato, in doppio cieco, multicentrico e controllato con placebo.
GRI Bio (NASDAQ: GRI) ha fortalecido su cartera de propiedad intelectual con dos importantes concesiones de patentes en Europa y Japón. La patente europea cubre GRI-0803, un nuevo activador de células NKT diversas tipo 2, que se está desarrollando para trastornos autoinmunes, especialmente el lupus eritematoso sistémico. La patente japonesa se centra en métodos para modular las células dNKT e iNKT en el tratamiento de condiciones inflamatorias a través de agonistas del receptor de ácido retinoico.
El programa principal de la empresa, GRI-0621, se encuentra actualmente en un ensayo clínico de Fase 2a para la fibrosis pulmonar idiopática (IPF). Se esperan datos interinos en el segundo trimestre de 2025, con resultados finales anticipados para el tercer trimestre de 2025. El estudio está diseñado como un ensayo aleatorizado, doble ciego, multicéntrico y controlado con placebo.
GRI Bio (NASDAQ: GRI)는 유럽과 일본에서 두 가지 중요한 특허를 확보하여 지식 재산 포트폴리오를 강화했습니다. 유럽 특허는 자가면역 질환, 특히 전신성 홍반성 루푸스 치료를 위해 개발 중인 GRI-0803이라는 새로운 유형 2 NKT 세포 활성제를 포함합니다. 일본 특허는 레티노산 수용체 작용제를 통해 염증 상태 치료를 위한 dNKT 및 iNKT 세포 조절 방법에 중점을 두고 있습니다.
회사의 주요 프로그램인 GRI-0621은 현재 특발성 폐섬유증(IPF)에 대한 2a 단계의 임상 시험 중입니다. 중간 데이터는 2025년 2분기에 예상되며, 주요 결과는 2025년 3분기에 발표될 것으로 예상됩니다. 이 연구는 무작위 이중 맹검 다기관 위약 대조 시험으로 설계되었습니다.
GRI Bio (NASDAQ: GRI) a renforcé son portefeuille de propriété intellectuelle avec deux importantes concessions de brevet en Europe et au Japon. Le brevet européen couvre GRI-0803, un nouvel activateur de cellules NKT de type 2, développé pour les troubles auto-immuns, en particulier le lupus érythémateux systémique. Le brevet japonais se concentre sur des méthodes de modulation des cellules dNKT et iNKT dans le traitement des conditions inflammatoires par le biais d'agonistes des récepteurs de l'acide rétinoïque.
Le programme phare de l'entreprise, GRI-0621, est actuellement en essai clinique de Phase 2a pour la fibrose pulmonaire idiopathique (IPF). Des données intermédiaires sont attendues au deuxième trimestre 2025, avec des résultats principaux anticipés au troisième trimestre 2025. L'étude est conçue comme un essai randomisé, en double aveugle, multicentrique et contrôlé par placebo.
GRI Bio (NASDAQ: GRI) hat sein Portfolio an geistigem Eigentum mit zwei bedeutenden Patenterteilungen in Europa und Japan gestärkt. Das europäische Patent umfasst GRI-0803, einen neuartigen Aktivator von NKT-Zellen des Typs 2, der für Autoimmunerkrankungen, insbesondere systemischen Lupus erythematodes, entwickelt wird. Das japanische Patent konzentriert sich auf Methoden zur Modulation von dNKT- und iNKT-Zellen zur Behandlung von entzündlichen Erkrankungen durch Agonisten des Retinsäure-Rezeptors.
Das Hauptprogramm des Unternehmens, GRI-0621, befindet sich derzeit in einer Phase-2a-Studie zur idiopathischen Lungenfibrose (IPF). Vorläufige Daten werden im 2. Quartal 2025 erwartet, während die endgültigen Ergebnisse im 3. Quartal 2025 prognostiziert werden. Die Studie ist als randomisierte, doppelblinde, multizentrische, placebo-kontrollierte Studie konzipiert.
- Secured two strategic patents in major markets (Europe and Japan)
- Phase 2a clinical trial for lead program GRI-0621 actively progressing
- Owns library of over 500 proprietary compounds
- No immediate revenue generation from patents
- Clinical trial results pending - success not guaranteed
Insights
The granting of these two patents in major global markets significantly strengthens GRI Bio's intellectual property position for its NKT cell modulator platform. In the competitive biotech landscape, securing patent protection in Europe and Japan represents crucial defensive assets that protect GRI's commercial opportunities in key pharmaceutical markets.
The European patent specifically covering GRI-0803 for systemic lupus erythematosus (SLE) is particularly valuable given the significant unmet need in autoimmune disorders. SLE affects approximately 5 million people globally with effective treatment options, representing a substantial market opportunity.
The Japanese patent's broader claims covering methods of modulating dNKT/iNKT cells provides versatile protection across multiple potential therapeutic applications. This patent architecture intelligently builds a wall around GRI's therapeutic approach rather than just specific compounds.
GRI's reference to their library of over 500 proprietary compounds indicates substantial R&D investment already committed. The IP protection now secured enhances the potential ROI on this research investment.
With interim Phase 2a data for their lead program GRI-0621 in IPF expected in Q2 2025, these patent announcements strategically reinforce the company's longer-term commercial protection in advance of potentially value-inflecting clinical results.
GRI Bio's patent approvals cover a scientifically distinctive approach targeting the interplay between different NKT cell subtypes. Their mechanism focusing on dendritic cell-mediated inhibition of type 1 invariant NKT cells represents an innovative pathway intervention with applications across multiple immune-mediated disorders.
The European patent specifically protects GRI-0803, which activates diverse NKT (dNKT) cells – a mechanism that differs significantly from conventional immunomodulatory approaches. This modality could potentially offer advantages over current SLE treatments that broadly suppress immune function.
The Japanese patent covering Retinoic Acid Receptor (RAR) agonists for inhibiting iNKT cells demonstrates a complementary approach within their platform. The ability to both activate dNKT and inhibit iNKT cells through different mechanisms provides multiple therapeutic angles to address immune dysregulation.
Their lead compound GRI-0621 for IPF targets a disease with substantial mortality and treatment options. Current IPF therapies like nintedanib and pirfenidone only slow progression without addressing underlying immunological mechanisms.
The company's parallel development of multiple NKT modulators indicates a comprehensive understanding of this immunological pathway. If validated in clinical trials, this approach could represent a paradigm shift in treating fibrotic and autoimmune conditions that have proven challenging with conventional therapeutic approaches.
Company committed to building a robust global patent estate across its innovative pipeline of NKT cell modulators for the treatment of inflammatory, fibrotic and autoimmune diseases
LA JOLLA, CA, March 31, 2025 (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 the granting of two global patents.
The granted patents include:
- Europe patent application No. 19,166,502 titled, “Oxygenated Amino- or Ammonium-Containing Sulfonic Acid, Phosphonic Acid and Carboxylic Acid Derivatives and Their Medical Use.” The patent claims include coverage of GRI-0803, the Company’s novel activator of human type 2 diverse NKT (dNKT) cells in development for the treatment of autoimmune disorders, with an initial focus on systemic lupus erythematosus (SLE). Activation of dNKT leads to a dendritic cell-mediated inhibition of type 1 invariant NKT (iNKT) cells.
- Japan application No. 2023-000750 titled, “Prevention and Treatment of Inflammatory Conditions.” This patent covers claims including compositions and methods for modulating dNKT and/or 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.
“These granted patents represent another achievement in our initiative to bolster our global patent estate. We remain committed to expanding our intellectual property portfolio and strengthening our innovative pipeline of NKT cell modulators and library of over 500 proprietary compounds,” commented Marc Hertz, PhD, Chief Executive Officer of GRI Bio. “We believe our in highly differentiated approach to the prevention and treatment of inflammatory, fibrotic and autoimmune diseases represents a compelling opportunity to address unmet medical needs for patients.”
The Company is currently advancing the development of its lead program, GRI-0621, in a Phase 2a, randomized, double-blind, multi-center, placebo-controlled, parallel-design, 2-arm study for the treatment of IPF. Interim data from the Phase 2a biomarker study is expected in the second quarter of 2025 and topline results are expected in the third quarter of 2025. For more information about the Phase 2a study, please visit clinicaltrials.gov and reference identifier NCT06331624.
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 diverse NKT (“dNKT”) 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, the Company’s beliefs and expectations regarding potential shareholder value and future financial performance, the Company’s beliefs and estimates about its cash and available resources and its ability to fund its planned operations through any particular date, the Company’s beliefs about the timing and outcome of regulatory approvals and potential regulatory approval pathways, the Company’s expected milestones in 2025, and the Company’s beliefs and expectations regarding the sufficiency of its existing cash and cash equivalents to fund its planned operations, its ability to raise additional funds, which may not be available to the Company on acceptable terms, or at all, and capital expenditure requirements. 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 The Nasdaq Capital Market 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 14, 2025 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
(908) 824-0775
GRI@jtcir.com
FAQ
What patents did GRI Bio recently receive for their NKT cell modulators?
When will GRI Bio release Phase 2a results for GRI-0621 in IPF treatment?
What is the primary focus of GRI Bio's GRI-0803 drug candidate?
What is the design of GRI Bio's Phase 2a trial for IPF treatment?
