GRI Bio Announces European Patent Office Issued a Decision to Grant Notice for Patent Covering GRI-0803 and Its Library of 500+ Proprietary Compounds
GRI Bio (NASDAQ: GRI) announced that the European Patent Office will issue a patent on January 16, 2025, covering GRI-0803 and its library of 500+ proprietary compounds. The patent, titled 'Oxygenated Amino- or Ammonium-Containing Sulfonic Acid, Phosphonic Acid and Carboxylic Acid Derivatives and Their Medical Use,' includes coverage of GRI-0803, a novel activator of human type 2 NKT cells being developed for autoimmune disorders, particularly systemic lupus erythematosus (SLE).
The company's preclinical studies showed that type 2 NKT activating molecules inhibited both murine and human iNKT cells, with oral administration inhibiting lupus nephritis and improving survival. While GRI Bio is currently focusing on GRI-0621, which is in Phase 2a trials for IPF with interim data expected in Q1 2025, the GRI-0803 program will continue in 2025 pending additional funding.
GRI Bio (NASDAQ: GRI) ha annunciato che l'Ufficio Europeo dei Brevetti rilascerà un brevetto il 16 gennaio 2025, coprendo GRI-0803 e la sua biblioteca di oltre 500 composti proprietari. Il brevetto, intitolato 'Derivati di acidi solfonici, fosfonici e carbossilici contenenti ammine o ammonio ossigenati e il loro uso medico,' include la copertura di GRI-0803, un attivatore innovativo delle cellule NKT di tipo 2 umane in fase di sviluppo per i disordini autoimmuni, in particolare il lupus eritematoso sistemico (LES).
Gli studi preclinici dell'azienda hanno dimostrato che le molecole attivanti le cellule NKT di tipo 2 inibivano sia le cellule iNKT murine che quelle umane, con l'amministrazione orale che inibiva la nefrite lupica e migliorava la sopravvivenza. Sebbene GRI Bio stia attualmente concentrandosi su GRI-0621, che è in fase di sperimentazione 2a per la fibrosi polmonare idiopatica (IPF) con dati preliminari previsti nel Q1 2025, il programma GRI-0803 continuerà nel 2025 in attesa di ulteriori finanziamenti.
GRI Bio (NASDAQ: GRI) anunció que la Oficina Europea de Patentes emitirá una patente el 16 de enero de 2025, cubriendo GRI-0803 y su biblioteca de más de 500 compuestos propietarios. La patente, titulada 'Derivados de ácidos sulfonicos, fosforicos y carboxilicos que contienen amino o amonio oxigenados y su uso médico,' incluye la cobertura de GRI-0803, un nuevo activador de las células NKT tipo 2 humanas que se está desarrollando para trastornos autoinmunes, particularmente el lupus eritematoso sistémico (LES).
Los estudios preclínicos de la empresa mostraron que las moléculas que activan las células NKT tipo 2 inhibieron tanto a las células iNKT murinas como a las humanas, siendo la administración oral efectiva en la inhibición de la nefritis lupica y mejorando la supervivencia. Mientras tanto, GRI Bio se concentra actualmente en GRI-0621, que está en ensayos de Fase 2a para la fibrosis pulmonar idiopática (IPF) con datos preliminares esperados en el primer trimestre de 2025, el programa GRI-0803 continuará en 2025 a la espera de financiamiento adicional.
GRI Bio (NASDAQ: GRI)는 유럽 특허청이 2025년 1월 16일에 GRI-0803과 500개 이상의 독점 화합물 라이브러리를 포함하는 특허를 발급할 것이라고 발표했습니다. 이 특허는 '산소화된 아미노 또는 암모늄 함유 황산, 인산 및 카복실산 유도체 및 그들의 의학적 사용'이라는 제목을 가지고 있으며, 자가면역 질환, 특히 전신 홍반 루푸스(SLE)를 위해 개발 중인 인간 2형 NKT 세포의 새로운 활성화 물질인 GRI-0803을 포함하고 있습니다.
회사의 전임상 연구 결과에 따르면, 2형 NKT 세포를 활성화하는 분자가 마우스 및 인간 iNKT 세포를 모두 억제하였으며, 경구 투여는 루푸스 신염을 억제하고 생존율을 개선하는 것으로 나타났습니다. 현재 GRI Bio는 2025년 1분기에 중간 데이터를 기대하는 IPF에 대한 2a 단계 시험 중인 GRI-0621에 집중하고 있지만, GRI-0803 프로그램은 추가 자금 조달을 위해 2025년에 계속될 예정입니다.
GRI Bio (NASDAQ: GRI) a annoncé que l'Office Européen des Brevets délivrera un brevet le 16 janvier 2025, couvrant GRI-0803 et sa bibliothèque de plus de 500 composés propriétaires. Le brevet, intitulé 'Dérivés d'acides sulfonés, phosphoniques et carboxyliques contenant des amines ou de l'ammonium oxygénés et leur utilisation médicale,' inclut la couverture de GRI-0803, un nouvel activateur des cellules NKT de type 2 humaines en cours de développement pour les maladies auto-immunes, notamment le lupus érythémateux systémique (LES).
Les études précliniques de l'entreprise ont montré que les molécules activant les cellules NKT de type 2 inhibaient à la fois les cellules iNKT murines et humaines, avec une administration orale inhibant la néphrite lupique et améliorant la survie. Alors que GRI Bio se concentre actuellement sur GRI-0621, en phase d'essai 2a pour la fibrose pulmonaire idiopathique (IPF) avec des données intermédiaires attendues au T1 2025, le programme GRI-0803 se poursuivra en 2025 en fonction d'un financement complémentaire.
GRI Bio (NASDAQ: GRI) gab bekannt, dass das Europäische Patentamt am 16. Januar 2025 ein Patent erteilen wird, das GRI-0803 und seine Bibliothek von über 500 proprietären Verbindungen abdeckt. Das Patent mit dem Titel 'Sauerstoffhaltige Amino- oder Ammonium-Sulfonat-, Phosphonsäure- und Carbonsäurederivate und deren medizinische Verwendung' umfasst GRI-0803, einen neuartigen Aktivator menschlicher NKT-Zellen vom Typ 2, der für Autoimmunerkrankungen, insbesondere systemischen Lupus erythematodes (SLE), entwickelt wird.
Die präklinischen Studien des Unternehmens haben gezeigt, dass die aktivierenden Moleküle vom Typ 2 NKT sowohl murine als auch humane iNKT-Zellen hemmen, wobei die orale Verabreichung die Lupusnephritis hemmt und die Überlebensrate verbessert. Während GRI Bio sich derzeit auf GRI-0621 konzentriert, das sich in Phase 2a-Studien für die idiopathische Lungenfibrose (IPF) befindet und erste Daten im Q1 2025 erwartet werden, wird das Programm GRI-0803 im Jahr 2025 fortgesetzt, vorausgesetzt, es stehen zusätzliche Mittel zur Verfügung.
- Secured new European patent protection for GRI-0803 and 500+ compounds
- Preclinical studies showed positive results in lupus nephritis treatment
- Phase 2a trial for GRI-0621 progressing with results expected Q1-Q2 2025
- GRI-0803 program advancement dependent on additional funding
- Resources currently to focus primarily on GRI-0621
Insights
This patent grant in Europe represents a strategic IP milestone for GRI Bio, securing protection for GRI-0803 and their extensive compound library across the European market. The patent's scope covering both composition and medical use strengthens their competitive position in the $150+ billion autoimmune therapeutics market.
The most valuable aspect is the protection of their type 2 NKT cell modulation platform, particularly for treating systemic lupus erythematosus (SLE). The IP coverage extends beyond just GRI-0803 to include their library of 500+ compounds, creating significant barriers to entry and potential licensing opportunities. However, with their current focus on GRI-0621 for IPF, the commercial impact of this patent may not be realized in the near term due to funding constraints.
From a strategic perspective, this patent complements their existing IP portfolio and could make them an attractive acquisition target for larger pharmaceutical companies interested in the autoimmune space. The broad claims covering both mechanism and medical use provide multiple layers of protection through at least 2039.
The preclinical data for GRI-0803 shows promising therapeutic potential through its novel mechanism of type 2 NKT cell activation. The observed inhibition of lupus nephritis and improved survival in preclinical studies suggests a potentially transformative treatment approach for SLE, which affects over 5 million people globally.
However, the company's decision to prioritize resources toward GRI-0621's Phase 2a IPF trial indicates near-term value will likely be driven by that program's upcoming milestones in Q1/Q2 2025. The delay in GRI-0803's development pending additional funding raises questions about the timeline for realizing its potential in autoimmune diseases.
For investors, the key focus should be on the upcoming GRI-0621 interim data in Q1 2025, as positive results could unlock funding for advancing the broader pipeline, including GRI-0803. The patent protection now secured provides valuable optionality for future development or partnership opportunities in the autoimmune space.
– Company committed to building a robust global patent estate across its innovative pipeline of NKT cell modulators
LA JOLLA, CA, Dec. 23, 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 European Patent Office (EPO) has issued a decision to grant notice for patent application number 19,166,502 titled, “Oxygenated Amino- or Ammonium-Containing Sulfonic Acid, Phosphonic Acid and Carboxylic Acid Derivatives and Their Medical Use.” Based on the intention to grant notice, the Company expects the EPO to issue a patent January 16, 2025.
“We have continued to make encouraging progress in our initiative to bolster our global patent estate covering our innovative pipeline of NKT cell modulators and library of over 500 proprietary compounds. We are pleased to add this anticipated European patent to our intellectual property portfolio. We continue to believe in our highly differentiated approach to the prevention and treatment of inflammatory, fibrotic and autoimmune diseases and look forward to further advancing their development to ultimately address areas of significant unmet medical need,” Marc Hertz, PhD, Chief Executive Officer of GRI Bio.
The patent claims include coverage of GRI-0803, the Company’s novel activator of human type 2 NKT cells in development for the treatment of autoimmune disorders, with an initial focus on systemic lupus erythematosus (SLE). Activation of type 2 NKT leads to a dendritic cell-mediated inhibition of iNKT cells. In the Company’s preclinical studies, type 2 NKT activating molecules, GRI-0803 and GRI-0124, were observed to inhibit both murine and human iNKT cells. Oral administration of these type 2 NKT activating molecules was observed to inhibit lupus nephritis and to significantly improve overall survival. The Company is currently focusing its available resources on GRI-0621, but, pending additional funding, the GRI-0803 IND-enabling and Phase1 program will continue in 2025.
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 first quarter of 2025 and topline results are expected in the second 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 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 1 invariant (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, the Company’s beliefs and expectations regarding potential shareholder value and future financial performance, the Company’s beliefs about the timing and outcome of regulatory approvals and potential regulatory approval pathways, the Company’s expected milestones for the first half of 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 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
(908) 824-0775
GRI@jtcir.com
FAQ
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