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Ocean Biomedical (NASDAQ: OCEA) Will Target Pulmonary Fibrosis Discoveries as Novel Treatments of Hermansky-Pudlak Syndrome

Ocean Biomedical (NASDAQ: OCEA) Will Target Pulmonary Fibrosis Discoveries as Novel Treatments of Hermansky-Pudlak Syndrome

海洋生物醫學(納斯達克股票代碼:OCEA)將把肺纖維化的發現作爲赫爾曼斯基-普德拉克綜合徵的新療法
GlobeNewswire ·  2023/04/06 08:05

On Hermansky-Pudlak Syndrome (HPS) Awareness Day, Ocean Biomedical announces
a commitment to developing viable treatment options for HPS-1 and HPS-4

開啓 赫爾曼斯基-普德拉克 綜合症 (HPS) 宣傳日,海洋生物醫學 宣佈
一個 承諾 發展 可行的治療選擇s 適用於 HPS-1 和 HPS-4

Providence, RI, April 06, 2023 (GLOBE NEWSWIRE) -- Ocean Biomedical, Inc. (NASDAQ: OCEA) announced today a strong commitment to targeting its pulmonary fibrosis treatment candidate, "OCF-203," as a novel therapeutic for fatal pulmonary fibrotic conditions caused by Hermansky-Pudlak Syndrome (HPS). Discoveries in recent years by Ocean Biomedical's Scientific Co-founder, Dr. Jack A. Elias, and his colleagues at Brown University, have revealed a new target and a new pathway for treating pulmonary tissue damage in Idiopathic Pulmonary Fibrosis (IPF). Experiments have also been performed with genetically modified "pale-ear" mice, which have the same mutations that are seen in patients with Hermansky-Pudlak Syndrome (HPS). These experiments demonstrated that the same small molecule may be effective in treating pulmonary fibrosis conditions in patients with HPS, especially the most deadly forms of that disease, HPS-1 and HPS-4.

羅得島州普羅維登斯,2023 年 4 月 6 日(GLOBE NEWSWIRE)— 海洋生物醫學公司(納斯達克股票代碼:OCEA)今天宣佈,堅定承諾將其肺纖維化候選治療藥物 “OCF-203” 作爲治療赫爾曼斯基-普德拉克綜合徵(HPS)引起的致命肺纖維化疾病的新療法。海洋生物醫學的科學聯合創始人傑克·埃利亞斯博士及其在布朗大學的同事近年來的發現揭示了治療特發性肺纖維化(IPF)肺組織損傷的新靶點和新途徑。還對轉基因 “淡耳” 小鼠進行了實驗,它們的突變與Hermansky-Pudlak綜合徵(HPS)患者身上的突變相同。這些實驗表明,同樣的小分子可能有效治療 HPS 患者的肺纖維化疾病,尤其是該疾病中最致命的形式,即 HPS-1 和 HPS-4。

Ocean Biomedical's novel approach to treating pulmonary fibrosis – a condition with no disease modifying agents currently available – is focused on inhibiting Chitinase 1 (Chit1) with patented "OCF-203." Chit1 is also a critical biomarker in Scleroderma-associated interstitial lung disease (SSc-ILD) and plays a role in bleomycin- and IL-13-induced pulmonary fibrosis. In four pulmonary fibrosis animal models, Ocean Biomedical's OCF-203 has shown an 85% – 90% reduction in collagen accumulation. The results of this antifibrotic (termed molecule X: SMX) in the bleomycin model can be seen in the diagram above. Results also showed efficacy in the pale-ear mouse model of HPS, including impressive reductions in fibrosis. As a result, efforts are now moving towards IND-enabling studies.

Ocean Biomedical治療肺纖維化的新方法側重於通過專利 “OCF-203” 抑制幾丁質酶1(Chit1)。Chit1 也是硬皮病相關性間質性肺病 (SSC-ILD) 的關鍵生物標誌物,在博來黴素和白介素-13 引起的肺纖維化中起作用。在四個肺纖維化動物模型中,海洋生物醫學的 OCF-203 顯示了 85% — 膠原蛋白積累減少 90%博來黴素模型中這種抗纖維化(稱爲分子 X:SMX)的結果可以在上圖中看到。 R結果 也顯示出療效淡耳鼠標 模型 的 HPS,包括纖維化的顯著減少 結果,現在正在努力 向 Ind-enabl 邁進ing 學習

Ocean Biomedical's anti-fibrosis platform seeks to address major unmet needs for IPF and HPS, and has shown potential for expanded application into fibrotic diseases in other organs, such as scleroderma, alcoholic liver disease, NASH, and kidney failure (see below). This unique approach has been developed by a research team led by Dr. Jack A. Elias, who is the former Dean of Medicine and Biology at Brown University, and former Chair of Medicine and Chief of Pulmonology and Critical Care Medicine at Yale University and Yale-New Haven Hospital.

Ocean Biomedical的抗纖維化平臺旨在解決IPF和HPS尚未得到滿足的主要需求,並顯示出將應用範圍擴大到其他器官的纖維化疾病的潛力,例如硬皮病、酒精性肝病、NASH和腎衰竭(見下文)。這種獨特的方法是由傑克·埃利亞斯博士領導的研究小組開發的,傑克·埃利亞斯博士是布朗大學前醫學和生物學系主任,耶魯大學和耶魯-紐黑文醫院前醫學系主任兼肺病學和重症監護醫學主任。

IPF is a devastating lung condition that currently affects about 100,000 people per year in the United States, and about 15 per 100,000 people worldwide, with a much higher prevalence in males over 50 years old. The median survival rate ranges from 2 – 5 years. Current standard-of-care therapeutics have limited efficacy and significant side effects such that patients choose to forgo drug therapy. There are no therapies currently available that can reverse loss of lung function.

IPF是一種毀滅性的肺部疾病,目前在美國每年影響約10萬人,全球每10萬人中約有15人受到影響,50歲以上的男性的患病率要高得多。中位存活率介於 2 — 5 年之間。目前的標準護理療法療效有限,副作用明顯,因此患者選擇放棄藥物治療。目前沒有可以逆轉肺功能喪失的療法。

Hermansky-Pudlak Syndrome (HPS) is a rare genetic condition that affects about 1 in 750,000 people worldwide, and about 1 in 1800 people in northwest Puerto Rico. In HPS-1 and HPS-4 patients pulmonary fibrosis occurs early in life (30s and 40s) and symptoms are often severe. Patients who have the HPS-1 or HPS-4 variants of the disease often develop terminal lung fibrosis with no therapeutic treatment currently approved.

赫爾曼斯基-普德拉克綜合症(HPS)是一種罕見的遺傳病,全球約每75萬人中就有1人受到影響,在波多黎各西北部,大約每1800人中就有1人受到影響。在 HPS-1 和 HPS-4 患者中,肺纖維化發生在生命早期(30 多歲和 40 多歲),症狀通常很嚴重。患有該疾病 HPS-1 或 HPS-4 變異的患者通常會發展爲晚期肺纖維化,目前尚未批准任何治療方法。

IPF and HPS are both considered "rare diseases" under the Orphan Drug Act, which qualifies them for potential orphan drug designation, and Ocean is moving towards IND filings for OCF-203 with both patient populations in mind.

根據《孤兒藥法》,IPF 和 HPS 都被視爲 “罕見疾病”,這使他們有資格獲得潛在的孤兒藥稱號,而且 Ocean 正在考慮這兩個患者羣體的前提下,向 OCF-203 申請 IND。

"My life's work has been focused on caring for patients with pulmonary conditions and it is difficult to see the limited treatment options that are available for many of these diseases. We are working to change that, and we're really excited about the broad therapeutic potential for this unique treatment pathway," commented Dr. Elias.

“我一生的工作重點是照顧肺部疾病患者,很難看出其中許多疾病的治療選擇有限。我們正在努力改變這種狀況,我們對這種獨特的治療途徑具有廣泛的治療潛力感到非常興奮,” 埃利亞斯博士評論道。

"This company was founded by physician-researchers to find solutions for large, unmet medical needs and we are pleased with the possibility of extending the anti-fibrosis platform into a broad range of hard-to-treat conditions," said Dr. Chirinjeev Kathuria, Ocean's co-founder and Executive Chairman.

Ocean的聯合創始人兼執行董事長Chirinjev Kathuria博士說:“這家公司由醫生和研究人員創立,旨在爲大量未得到滿足的醫療需求尋找解決方案,我們對將抗纖維化平臺擴展到各種難以治療的疾病的可能性感到滿意。”

Suren Ajjarapu, a director of Ocean, commented, "This company is pushing to translate discovery research into the clinic for a range of conditions that will provide global health solutions, and pulmonary fibrosis has potential to have positive returns for patients and our shareholders."

Ocean董事蘇倫·阿賈拉普評論說:“這家公司正在努力將發現研究轉化爲針對一系列疾病的臨牀研究,這將提供全球健康解決方案,肺纖維化有可能爲患者和我們的股東帶來積極的回報。”

"We are pleased to see the strong results being generated in our anti-fibrosis platform, and we are proud to be moving them forward, especially for patients with conditions like HPS that do not currently have effective treatment options," said Elizabeth Ng, CEO of Ocean Biomedical.

Ocean Biomedical首席執行官Elizabeth Ng表示:“我們很高興看到我們的抗纖維化平臺取得了強勁的結果,我們很自豪能夠推動這些成果,特別是對於像HPS這樣目前沒有有效治療選擇的患者。”

About Ocean Biomedical

關於海洋生物醫學

Ocean Biomedical, Inc. ("Ocean Biomedical" or the "Company") is a Providence, Rhode Island-based biopharma company with an innovative business model that accelerates the development and commercialization of scientifically compelling assets from research universities and medical centers. Ocean Biomedical deploys the funding and expertise to move new therapeutic candidates efficiently from the laboratory to the clinic, to the world. Ocean Biomedical is currently developing five promising discoveries that have the potential to achieve life-changing outcomes in lung cancer, brain cancer, pulmonary fibrosis, and the prevention and treatment of malaria. The Ocean Biomedical team is working on solving some of the world's toughest problems, for the people who need it most.

Ocean Biomedical, Inc.(“海洋生物醫學” 或 “公司”)是一家總部位於羅德島普羅維登斯的生物製藥公司,其創新的商業模式可加速研究型大學和醫學中心具有科學吸引力的資產的開發和商業化。Ocean Biomedical利用資金和專業知識,將新的候選治療藥物有效地從實驗室轉移到診所,再到世界。海洋生物醫學目前正在開發五項有前途的發現,這些發現有可能在肺癌、腦癌、肺纖維化以及瘧疾的預防和治療方面取得改變生活的結果。海洋生物醫學團隊正在努力爲最需要的人們解決一些世界上最棘手的問題。

To learn more, visit .

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Forward-Looking Statements

前瞻性陳述

The information included herein and in any oral statements made in connection herewith include "forward-looking statements" within the meaning of the "safe harbor" provisions of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the use of words such as "estimate," "plan," "project," "forecast," "intend," "will," "expect," "anticipate," "believe," "seek," "target," or other similar expressions that predict or indicate future events or trends or that are not statements of historical matters, although not all forward-looking statements contain such identifying words. These forward-looking statements include but are not limited to: the expected timing and success of investigational new drug ("IND") filings for our initial product candidates; statements regarding the expected timing of our IND-enabling studies; the frequency and timing of filing additional INDs; expectations regarding the availability and addition of future assets to our pipeline; the advantages of any of our pipeline assets and platforms; the potential benefits of our product candidates; potential commercial opportunities; the timing of key milestones for our programs; the future financial condition, results of operations, business strategy and plans, and objectives of management for future strategy and operations; and statements about industry trends and other companies in the industry. These forward-looking statements are based on various assumptions, whether or not identified herein, and on the current expectations of the Company's management, and they are not predictions of actual performance. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as, and must not be relied on by any investor as, a guarantee, an assurance, a prediction, or a definitive statement of fact or probability. Actual events and circumstances are difficult or impossible to predict and will differ from assumptions.

此處包含的信息以及與此相關的任何口頭陳述中包含的信息包括1995年《美國私人證券訴訟改革法》“安全港” 條款所指的 “前瞻性陳述”。前瞻性陳述可以通過使用 “估計”、“計劃”、“項目”、“預測”、“打算”、“將”、“期望”、“預期”、“相信”、“尋求”、“目標” 等詞語或其他預測或表明未來事件或趨勢或不是歷史問題陳述的類似表達來識別,儘管並非所有前瞻性陳述都包含此類識別詞。這些前瞻性陳述包括但不限於:我們初始候選產品在研新藥(“IND”)申請的預期時機和成功率;關於我們支持IND的研究的預期時間的陳述;提交額外IND的頻率和時間;對我們未來產品供應和增加資產的預期;我們的任何在研資產和平臺的優勢;我們的候選產品的潛在收益;潛在的商業機會;關鍵時機我們的里程碑項目;未來的財務狀況、經營業績、業務戰略和計劃以及未來戰略和運營的管理目標;以及關於行業趨勢和該行業其他公司的陳述。這些前瞻性陳述基於各種假設,無論此處是否確定,也基於公司管理層當前的預期,它們不是對實際業績的預測。這些前瞻性陳述僅用於說明目的,無意作爲擔保、保證、預測或對事實或概率的明確陳述,也不得被任何投資者作爲擔保、保證、預測或最終陳述。實際事件和情況很難或無法預測,並且會與假設有所不同。

Any discoveries announced by the Company are based solely on laboratory and animal studies. Ocean Biomedical has not conducted any studies that show similar efficacy or safety in humans. There can be no assurances that any treatment tested by the Company will prove safe or effective in humans, and any clinical benefit of any such treatment is subject to clinical trials and ultimate approval of its use in patients by the FDA. Such approval, if granted, could be years away.

公司宣佈的任何發現僅基於實驗室和動物研究。海洋生物醫學尚未進行任何顯示對人類具有類似療效或安全性的研究。無法保證該公司測試的任何療法都會被證明對人體安全或有效,任何此類治療的任何臨牀益處都必須經過臨牀試驗,並最終獲得美國食品藥品管理局對患者的批准。如果獲得批准,可能需要數年的時間。

Forward-looking statements are predictions, projections, and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to risks and uncertainties. These forward-looking statements are not guarantees of future performance, conditions, or results, and involve a number of known and unknown risks, uncertainties, assumptions, and other important factors, many of which are outside the control of the Company that could cause actual results or outcomes to differ materially from those discussed in the forward-looking statements. Important factors, among others, that may affect actual results or outcomes include but are not limited to: recently transitioning to operating as a NASDAQ-listed public company with a limited operating history; our ability to successfully complete our pre-clinical trials and for those trials to produce positive results; our ability to timely file and obtain approval of INDs from the FDA in the future; the timing of the initiation, progress and potential results of our planned pre-clinical studies and clinical trials and our research programs; our ability to access additional product candidates from research universities and medical centers; the timing or likelihood of regulatory filings and approvals; the commercializing of our product candidates, if approved; our product development and marketing strategy; our ability and the potential to successfully manufacture and supply our product candidates for clinical trials and for commercial use, if approved; future strategic arrangements and/or collaborations and partnerships, and the potential benefits of such arrangements; our assessment that the early observations from our pre-clinical studies are encouraging; the potential for IND-enabling studies and future clinical trial results to differ from initial results or from our pre-clinical studies; regulatory developments in the United States and other countries; difficulties in managing our growth; our estimates regarding expenses, future revenue, capital requirements and needs for financing and our ability to obtain capital; the sufficiency of our existing and anticipated capital to fund our planned operating expenses; our ability to retain the continued service of our key personnel and to identify, hire and retain additional qualified professionals; the implementation of our business model and strategic plans for our business and product candidates; the scope of protection we are able to establish and maintain for intellectual property rights, product candidates and our pipeline; our ability to contract with third-party suppliers and manufacturers and their ability to perform adequately; the pricing, coverage and reimbursement of our product candidates, if approved; developments relating to our competitors and our industry, including competing product candidates and therapies; changes in the markets in which the Company competes, including with respect to its competitive landscape, technology evolution, or regulatory changes; changes in domestic and global general economic and market conditions; risks related to the ongoing COVID-19 pandemic and response, including supply chain disruptions; the risk that the Company may fail to keep pace with rapid technological developments to provide new and innovative products and services or make substantial investments in unsuccessful new products and services; the outcome of any legal proceedings that may be instituted against the Company; the risk of product liability or regulatory lawsuits or proceedings relating to the Company's business; the risk of cyber security or foreign exchange losses; the risk that the Company is unable to secure or protect its intellectual property; the risk that the Company may not be able to develop and maintain effective internal controls; the ability to develop, license, or acquire new therapeutics; the risk that the Company will need to raise additional capital to execute its business plan, which may not be available on acceptable terms or at all; and those factors discussed in the Company's filings with the SEC.

前瞻性陳述是基於當前預期和假設的關於未來事件的預測、預測和其他陳述,因此受風險和不確定性的影響。這些前瞻性陳述不能保證未來的業績、狀況或業績,涉及許多已知和未知的風險、不確定性、假設和其他重要因素,其中許多因素不在公司的控制範圍內,可能導致實際結果或結果與前瞻性陳述中討論的結果或結果存在重大差異。可能影響實際結果或結果的重要因素包括但不限於:最近過渡到在納斯達克上市的上市公司運營,運營歷史有限;我們成功完成臨牀前試驗並使這些試驗產生積極結果的能力;我們能夠及時向FDA申請並獲得INDA的批准;我們計劃中的臨牀前研究和臨牀試驗的啓動時間、進展和潛在結果以及我們的研究項目;我們的能力接觸來自研究型大學和醫學中心的其他候選產品;監管申請和批准的時間或可能性;我們的候選產品如果獲得批准,其商業化情況;我們的產品開發和營銷策略;如果獲得批准,我們成功製造和供應用於臨牀試驗和商業用途的候選產品的能力和潛力;未來的戰略安排和/或合作與夥伴關係,以及此類安排的潛在好處;我們的評估是,早期觀察結果來自我們的臨牀前研究令人鼓舞;支持IND的研究和未來的臨牀試驗結果可能與初步結果或我們的臨牀前研究有所不同;美國和其他國家的監管進展;管理增長方面的困難;我們對支出、未來收入、資本要求和融資需求的估計以及獲得資本的能力;我們現有和預期資本是否足以爲我們的計劃運營支出提供資金;我們保留關鍵運營持續服務的能力人員以及識別、僱用和留住其他合格專業人員;爲我們的業務和產品候選人實施我們的商業模式和戰略計劃;我們能夠爲知識產權、候選產品和渠道建立和維持的保護範圍;我們與第三方供應商和製造商簽訂合同的能力及其表現良好的能力;候選產品的定價、覆蓋範圍和報銷(如果獲得批准);與競爭對手和行業相關的發展,包括競爭的候選產品和療法;公司競爭市場的變化,包括競爭格局、技術演變或監管變化;國內和全球總體經濟和市場狀況的變化;與持續的 COVID-19 疫情和應對措施相關的風險,包括供應鏈中斷;公司可能跟不上快速技術發展的步伐,無法提供新的創新產品和服務,或者對不成功的新產品和服務進行大量投資產品和服務;可能對公司提起的任何法律訴訟的結果;與公司業務有關的產品責任或監管訴訟或訴訟的風險;網絡安全或外匯損失的風險;公司無法保護或保護其知識產權的風險;公司可能無法制定和維持有效的內部控制的風險;開發、許可或收購新療法的能力;公司的風險需要籌集額外資金來執行其商業計劃,該計劃可能無法以可接受的條件出臺或根本無法出臺;以及公司向美國證券交易委員會提交的文件中討論的那些因素。

The foregoing list of factors is not exhaustive. You should carefully consider the foregoing factors and the other risks and uncertainties that are described in the Company's Annual Report on Form 10-K for the year ended December 31, 2022, and which are described in the "Risk Factors" section of the Company's definitive proxy statement filed by the Company on January 12, 2023, and other documents to be filed by the Company from time to time with the SEC and which are and will be available at www.sec.gov. These filings identify and address other important risks and uncertainties that could cause actual events and results to differ materially from those contained in the forward-looking statements. Forward-looking statements speak only as of the date they are made. Readers are cautioned not to put undue reliance on forward-looking statements. These forward-looking statements should not be relied upon as representing the Company's assessments as of any date subsequent to the date of this filing. Accordingly, undue reliance should not be placed upon the forward-looking statements.

上述因素清單並不詳盡。您應仔細考慮上述因素以及公司不時向美國證券交易委員會提交的10-K表年度報告中描述的其他風險和不確定性,這些因素在公司於2023年1月12日提交的公司最終委託書的 “風險因素” 部分以及公司不時向美國證券交易委員會提交的其他文件中進行了描述,這些文件現在和將在www.sec.gov上公佈。這些文件確定並解決了其他重要的風險和不確定性,這些風險和不確定性可能導致實際事件和結果與前瞻性陳述中包含的事件和結果存在重大差異。前瞻性陳述僅代表其發表之日。提醒讀者不要過分依賴前瞻性陳述。自提交本文件之日起,不得將這些前瞻性陳述作爲公司評估的依據。因此,不應過分依賴前瞻性陳述。

Ocean Biomedical Investor Relations
OCEANIR@westwicke.com

海洋生物醫學投資者關係
OCEANIR@westwicke.com

Ocean Biomedical Media Relations
OCEANPR@westwicke.com

海洋生物醫學媒體關係
OCEANPR@westwicke.com

Kevin Kertscher
Communications Director

凱文·克切爾
傳播總監


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