Workshop, poster and oral presentation of data given as part of the 8th Annual Antifibrotic Drug Development (AFDD) Summit
Data demonstrate that NKT cells are activated in airways in IPF patients and inhibition of iNKT cell activity with GRI-0621 ameliorates pulmonary fibrosis in a preclinical model
Ongoing Phase 2 study with GRI-0621 in IPF patients to examine iNKT activity along with key biomarkers; Topline data readout expected in Q2 2025
LA JOLLA, CA, Nov. 21, 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 the presentation of positive preclinical data demonstrating its lead program GRI-0621 reduces important inflammatory and fibrotic drivers in Idiopathic Pulmonary Fibrosis (IPF).
The data were presented as part of an invited talk titled, "A New Approach to Inflammatory Diseases," delivered by Marc Hertz PhD, Chief Executive Officer of GRI Bio, at the 8th Annual Antifibrotic Drug Development (AFDD) Summit, held November 19-21, 2024, in Boston, MA.
"We were pleased to participate at this prestigious event and engage with thought leaders in the field and present our novel approach for the treatment of inflammatory diseases. There remains a significant unmet need for therapeutic solutions that halt disease progression of fibrotic diseases such as IPF. Based on the growing body of positive data demonstrated by our lead program GRI-0621, we believe we have a validated and derisked clinical approach to address that need," commented Marc Hertz, PhD, Chief Executive Officer of GRI Bio. "We believe GRI-0621 has the potential to provide meaningful benefit to IPF patients and we look forward to advancing it development and realizing its full value."
Key Highlights
- Enhanced iNKT activity correlates with progression of fibrosis in MASH patients and key proinflammatory genes in BAL from IPF patients
- iNKT cells are activated and accumulate in liver and lung in experimental fibrosis models
- iNKT promote Type 1, Type 2 and Type 3 immune pathways involved in fibrosis
- iNKT-deficient mice have reduced inflammatory damage and fibrosis
- Daily oral administration of GRI-0621 in experimental animals
- Inhibits key pro-inflammatory cytokines and inflammation
- Decreases accumulation of neutrophils and activation of pro-fibrotic fibroblasts
- Inhibits key fibrogenic cytokines including TGF-β
Additionally, the Company presented a poster titled, "Involvement of Type 1 Invariant Natural Killer T Cells in Driving Lung Fibrosis," outlining flow cytometry and quantitative PCR analysis in bronchoalveolar lavage (BAL) fluid from IPF patients and healthy controls to characterize NKT cells. A bleomycin (3.0 IU/Kg via the intratracheal route) model was used with or without daily administration of nintedanib or a small molecule selective inhibitor of iNKT activity, GRI-0621, during the fibrotic phase to study the role of iNKT cells in pulmonary fibrosis in a treatment protocol.
Results highlighted in the poster demonstrated that IPF patients had increased expression of pro-fibrotic molecules in BAL, including Collagen 1-α1, osteopontin and TGF-β. There was an increase in IFN-γ producing CD45+CD3+CD56+ NKT cells in IPF patients compared to controls. In a second cohort, we confirmed the iNKT phenotype using an anti-Vα24-Jα18 TCR antibody. In the bleomycin model, GRI-0621 inhibition of iNKT cells improved a majority of inflammatory, fibrotic, and pathological features, including a reduction in lung injury, myofibroblast activity, collagen deposition, and fibrosis.
GRI Bio's lead program, GRI-0621, is a small molecule RAR-βɣ dual agonist that inhibits the activity of human iNKT cells. In preliminary trials to date and previous trials with the oral formulation, GRI-0621 has been shown to improve fibrosis in multiple disease models and improve liver function tests and other markers of inflammation and injury in patients.
The Company is currently advancing the development of 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
第8回アンチファイブローシス剤開発(AFDD)サミットの一環として与えられたデータのワークショップ、ポスター、口頭プレゼンテーション
データによると、IPF患者の気道においてNKt細胞が活性化され、GRI-0621によるiNKt細胞活性の阻害が、前臨床モデルにおいて肺線維症を改善することが示されています
IPF患者におけるGRI-0621の第2相研究が進行中で、iNKt活性と主要なバイオマーカーを調査する予定です。トップラインデータの読み出しは2025年第2四半期を予定しています
2024年11月21日、カリフォルニア州ラホヤ（米国太平洋沿岸）-- バイオテクノロジー企業であるGRI Bio, Inc.（NASDAQ：GRI）（以下「GRI Bio」または「同社」）は、炎症性、線維化性、および自己免疫疾患の治療のために革新的なNatural Killer t（「NKT」）細胞調節因子パイプラインを進めるバイオテクノロジー企業である同社が、特発性肺線維症（IPF）において主要な炎症性および線維化性ドライバーを減少させるリードプログラムであるGRI-0621がポジティブな前臨床データを示すプレゼンテーションを本日行ったことを発表しました
データは、2024年11月19日から21日にボストン、マサチューセッツで開催された第8回抗線維化薬剤開発（AFDD）サミットで、GRI Bioの最高経営責任者であるMarc Hertz博士が行った「炎症性疾患への新しいアプローチ」と題された招待講演の一環として発表されました。
"この格式高いイベントに参加し、この分野の有識者と交流し、炎症性疾患の治療のための新しいアプローチを発表できたことを嬉しく思います。 IPFなどの線維症状性疾患の疾患進行を停止する治療ソリューションには、まだ大きな未解決のニーズがあります。主力プログラムであるGRI-0621によって示された前向きなデータの成長する一連の肯定的なデータに基づき、我々はそのニーズを満たすための検証されたリスクヘッジされた臨床アプローチを持っていると確信しています。"と、GRI Bioの最高経営責任者であるMarc Hertz博士はコメントしました。 "GRI-0621がIPF患者に有益な効果を提供できる可能性があると考えており、その開発を進め、その真の価値を実現することを楽しみにしています。"
主なポイント
- エンハンストiNKt活性は、MASH患者における線維症の進行とIPF患者からのBAL中の主要な前炎症遺伝子と関連しています
- iNKt細胞は、実験的線維化モデルで肝臓と肺で活性化され、蓄積します
- iNKtは、線維症に関与するタイプ1、タイプ2、およびタイプ3の免疫経路を促進します。
- iNKt欠損マウスは、炎症性損傷と線維症が軽減されます。
- 実験動物に対するGRI-0621の経口投与は日常的に行われます。
- 主要なプロ炎性サイトカインと炎症を抑制します。
- 好中球の蓄積および線維芽細胞のプロ線維性活性化を減少させます。
- TGF-βを含む主要な線維原性サイトカインを抑制します。
さらに、会社は「Involvement of Type 1 Invariant Natural Killer t Cells in Driving Lung Fibrosis」と題されたポスターを発表し、肺線維症におけるiNKt細胞の役割を研究するため、IPF患者と健康な対照群から気管肺洗浄（BAL）液中での流式細胞解析および定量的PCR解析を概説しました。線維化段階中にニンテダニブまたはiNKt活性の選択的小分子阻害剤であるGRI-0621の日常的な投与の有無で、ブレオマイシン（3.0 IU/Kg経気管内ルート経由）モデルを用いて、iNKt細胞の役割を研究しました。
ポスターで示された結果によれば、IPF患者はBAL中で線維形成促進分子の発現が増加しており、その中にはコラーゲン1-α1、オステオポンチン、TGF-βが含まれます。IPF患者では、コントロール群と比較して、IFN-γ産生CD45+CD3+CD56+ NKt細胞が増加しています。第2コホートでは、抗Vα24-Jα18 TCR抗体を用いて、iNKt表現型を確認しました。ブレオマイシンモデルでは、iNKt細胞のGRI-0621阻害が、肺損傷、ミオフィブロブラスト活性、コラーゲン沈着、線維症を含む多くの炎症、線維症、および病理学的特徴の改善につながった。
GRI BioのリードプログラムであるGRI-0621は、ヒトiNKt細胞の活性を抑制する小さな分子RAR-βɣデュアルアゴニストです。迄今の予備試験と経口製剤を使用した過去の試験で、GRI-0621は複数の疾患モデルで線維症を改善し、肝機能検査や患者の炎症や損傷の他のマーカーを改善することが示されています。
当社は、IPFの治療のために第2a相、無作為化、二重盲検、多施設、プラセボ対照、並行設計、2本腕研究の開発を現在進行中です。第2a相バイオマーカー研究からの中間データは2025年第1四半期に予想され、トップライン結果は2025年第2四半期に予想されています。第2a相研究の詳細については、こちらをご覧ください。 clinicaltrials.gov およびリファレンス識別子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.
前向きな言明
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.
投資家コンタクト:
JTCチーム、LLC
Jenene Thomas
(908) 824-0775
GRI@jtcir.com
