Opaganib

Oct. 19, 2026 -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that its partner, the University of Oklahoma (OU), has received $2.9 million in funding from the National Cancer Institute (NCI) to study, in clinical trials, whether RedHill's opaganib[1], given after CAR (chimeric antigen receptor) T-cell therapy, may help immune cells fight cancer more effectively. The five-year, $2.9 million grant from the NCI is planned to fund two phases of clinical trials. A Phase 1b trial plans to enroll up to 18 patients to evaluate the safety of the treatment combination of CAR T-cell therapy and opaganib and determine the appropriate dosage of opaganib. A subsequent Phase 2 trial plans to enroll up to 21 additional patients to seek preliminary evidence of effectiveness. CAR T-cell therapy takes a patient's immune cells, genetically modifies them so they can recognize and attack cancer cells, and then returns them to the patient. In a first for Oklahoma, the CAR T cells will be manufactured on the OU campus rather than being sent to a commercial manufacturer, potentially saving both time and money. "We need to find a novel, more effective treatment option for patients with ultra-high-risk multiple myeloma as they continue to have poor outcomes despite current treatments,"said grant awardee,Yubin Kang, M.D., OU Health hematologist-oncologist, division chief of Hematology, Bone Marrow Transplant and Cellular Therapy at OU Health Stephenson Cancer Center, and a professor at the OU College of Medicine. "With 10 years of preclinical studies on CAR T-cell therapy and opaganib, we believe the findings suggest that opaganib may help the modified immune cells remain active and continue attacking myeloma for longer. Opaganib works by blocking a protein called sphingosine kinase-2 (SPHK2), which appears to act as a kind of brake on the immune system's cancer-fighting T cells. When SPHK2 was absent or blocked in mice, T cells multiplied more effectively and became better at killing myeloma cells. When combining opaganib with CAR T-cell therapy in vivo in mice, the results were encouraging, with tumor growth controlled for a longer period of time[2]. I am excited to see whether combining CAR T-cell therapy with opaganib can produce longer-lasting responses and improve outcomes for these high-risk patients." Dr. Mark Levitt, RedHill's Chief Scientific Officer said: "Opaganib has shown promise in preclinical studies as a potential combination therapy in a number of oncology and other indications. Prior preclinical and clinical work has shown that through a reduction of cancer cell survival proteins like c-Myc and Mcl-1[3], opaganib can potentially play a role in the treatment of multiple myeloma. We congratulate Dr. Kang and OU on this grant, which has the potential to be an important step to determine through clinical trials, whether these preclinical findings can turn into reality." For patients with ultra-high-risk multiple myeloma, cancer often returns despite treatment, including bone marrow transplantation. CAR T-cell therapy is already an option for some patients whose cancer has returned. The clinical trials will be conducted in partnership with RedHill, which is expected to provide opaganib, and Lentigen Technology, Inc., a Miltenyi Biotec, which developed the CAR construct. Miltenyi Biotec is enabling clinical translation by producing GMP-grade lentiviral vector for CAR T manufacturing on the CliniMACs Prodigy. Research reported in this press release is supported by the National Cancer Institute of the National Institutes of Health under award No. R01CA293516-01A1. Opaganib is a proprietary first-in-class investigational, orally administered sphingosine kinase-2 (SPHK2) selective inhibitor drug. Potentially broad-acting, it is in development for multiple oncology, viral, inflammatory, metabolic (diabetes and obesity) and additional indications. Opaganib's suggested mechanism of action, published in the journal Drug Design, Development and Therapy, is host-directed and potentially broad-acting and is expected to maintain its effect against emerging viral variants. Opaganib is thought to work through the inhibition of multiple pathways, the induction of autophagy and apoptosis, and disruption of viral replication, through simultaneous inhibition of three sphingolipid-metabolizing enzymes in human cells (SPHK2, DES1 and GCS). Opaganib has received Orphan Drug designation from the FDA for the treatment of neuroblastoma and cholangiocarcinoma. A Bayer-supported placebo-controlled randomized Phase 2 study is ongoing to evaluate the efficacy of opaganib in combination with Bayer's darolutamide in men with metastatic castrate-resistant prostate cancer (mCRPC), testing the potentially enhancing effect of opaganib in patients with a poor prognosis[4]. Opaganib also has a Phase 1 chemoradiotherapy study protocol ready for FDA-IND submission. Opaganib has demonstrated its safety and tolerability profile in more than 470 participants in multiple clinical studies and expanded access use, including a large global Phase 2/3 study in hospitalized patients with moderate to severe COVID-19, published in Microorganisms2. Founded in 1890, the University of Oklahoma is a public research university with campuses in Norman, Oklahoma City and Tulsa. As the state's flagship university, OU serves the educational, cultural, economic and healthcare needs of the state, region and nation. In Oklahoma City, the Harold Hamm Health Campus is one of the nation's few academic health centers with seven health profession colleges located on the same campus. The Harold Hamm Health Campus serves approximately 4,000 students in more than 70 undergraduate and graduate degree programs spanning Oklahoma City and Tulsa and is the leading research institution in Oklahoma. RedHill Biopharma Ltd. (Nasdaq: RDHL) is a U.S. specialty biopharmaceutical company primarily focused on the development and commercialization of proprietary drugs for gastrointestinal diseases, infectious diseases and oncology. RedHill promotes the FDA-approved gastrointestinal therapies Rebyota®, for the prevention of recurrent C. diff infection (rCDI), and the bowel preparation treatment, Clenpiq®. RedHill's key clinical late-stage development programs include: (i)opaganib (ABC294640), a first-in-class, orally administered sphingosine kinase-2 (SPHK2) selective inhibitor with anti-inflammatory, antiviral, metabolic and anticancer activity, targeting multiple indications with a track record of U.S. government and academic collaborations intended for medical countermeasure development including for Ebola virus disease, radiation exposure indications such as GI-Acute Radiation Syndrome (GI-ARS), a Phase 2/3 program for hospitalized COVID-19, and an ongoing Phase 2 study in prostate cancer in combination with darolutamide; (ii) RHB-102 (Bekinda), with a Phase 2-ready proof-of-concept study for GLP-1/GIP receptor agonist-associated GI intolerance, positive results from a first U.S. Phase 3 study for acute gastroenteritis and gastritis, positive results from a U.S. Phase 2 study for IBS-D and potential UK submission for chemotherapy and radiotherapy induced nausea and vomiting. RHB-102 is partnered with Hyloris Pharmaceuticals (EBR: HYL) for worldwide development and commercialization outside North America; (iii) RHB-204, a next-generation optimized formulation of RHB-104, with a Phase 2-ready study for Crohn's disease (based on RHB-104's positive U.S. Phase 3 Crohn's disease study results); and (iv) RHB-107 (upamostat), an oral broad-acting, host-directed, serine protease inhibitor with potential for pandemic preparedness, including COVID-19 and influenza and also targeting multiple cancer and inflammatory gastrointestinal diseases. [1] Opaganib is an investigational new drug, not available for commercial distribution. [2] Yubin Kang, Xiaobei Wang, Jian Wu, Shaima Jabbar, Chongming Jiang, Xiliing Shen, Besim Ogretmen. Inhibition of Sphingosine Kinase 2 Enhances Immunotherapy in Mouse Model of Multiple Myeloma. (Oral presentation). 2023 ASH annual meeting, Dec 7-12, 2023, San Diego. https://ashpublications.org/blood/article/142/Supplement%201/876/502773/Inhibition-of-Sphingosine-Kinase-2-Enhances [3] Abstract 7879: Opaganib in combination with oxaliplatin and doxorubicin as a novel salvage therapy for relapsed/refractory high-risk neuroblastoma. Jeremy Hengst, Mohammad Haque, Muhammad Younis, Thussenthan Walter Angelo, Anna Bourne, Katherine McClain, Meenakshi Shukla, Jonathan Lerch, Tarlan Arjmandi, Eric Cochran, Lynn Maines, Charles D. Smith, Vladimir S. Spiegelman, Jacqueline M. Kraveka, Giselle L. Saulnier Sholler. Cancer Res (2026) 86 (7_Supplement): 7879. https://doi.org/10.1158/1538-7445.AM2026-7879 [4] https://www.redhillbio.com/news/news-details/2025/RedHill-Announces-Initiation-of-Phase-2-Study-of-Opaganib-and-Darolutamide-in-Advanced-Prostate-Cancer/default.aspx The content above comes from the network. if any infringement, please contact us to modify.

TEL AVIV, Israel and RALEIGH,N.C. 以色列特拉维夫和北卡罗来纳州罗利, ，Oct. 19, 2026 2026年10月19日/PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: /美通社/ -- RedHill Biopharma Ltd.（纳斯达克：RDHL RDHL) ('RedHill' or the 'Company'), a specialty biopharmaceutical company, today announced that its partner, the University of Oklahoma (OU), has received $2.9 million in funding from the National Cancer Institute (NCI) to study, in clinical trials, whether RedHill's opaganib[1], given after CAR (chimeric antigen receptor) T-cell therapy, may help immune cells fight cancer more effectively.. 专业生物制药公司RedHill（以下简称“RedHill”或“公司”）今日宣布，其合作伙伴俄克拉荷马大学（OU）已获得美国国家癌症研究所（NCI）提供的290万美元资金，用于开展临床试验，研究在CAR（嵌合抗原受体）T细胞疗法之后使用RedHill的opaganib[1]是否有助于免疫细胞更有效地对抗癌症。The five-year, $2.9 million grant from the NCI is planned to fund two phases of clinical trials. A Phase 1b trial plans to enroll up to 18 patients to evaluate the safety of the treatment combination of CAR T-cell therapy and opaganib and determine the appropriate dosage of opaganib. A subsequent Phase 2 trial plans to enroll up to 21 additional patients to seek preliminary evidence of effectiveness.. 美国国家癌症研究所（NCI）提供的为期五年、金额为290万美元的资助，计划用于支持两个阶段的临床试验。一项1b期临床试验计划招募最多18名患者，以评估CAR T细胞疗法与opaganib联合治疗的安全性，并确定opaganib的合适剂量。随后的2期临床试验计划再招募最多21名患者，以寻求初步的有效性证据。CAR T-cell therapy takes a patient's immune cells, genetically modifies them so they can recognize and attack cancer cells, and then returns them to the patient. In a first for Oklahoma, the CAR T cells will be manufactured on the OU campus rather than being sent to a commercial manufacturer, potentially saving both time and money.. CAR T细胞疗法提取患者的免疫细胞，通过基因改造使其能够识别并攻击癌细胞，然后将这些细胞回输到患者体内。在俄克拉荷马州，此举尚属首次：CAR T细胞将在俄克拉荷马大学校园内制备，而非送往商业制造商处，这有望节省时间和费用。'We need to find a novel, more effective treatment option for patients with ultra-high-risk multiple myeloma as they continue to have poor outcomes despite current treatments,' “我们需要为超高危多发性骨髓瘤患者寻找一种新颖且更有效的治疗方案，因为尽管接受当前治疗，他们的预后仍然不佳。”said grant awardee, 该资助获得者表示，Yubin Kang, M.D., OU Health hematologist-oncologist, division chief of Hematology, Bone Marrow Transplant and Cellular Therapy at OU Health Stephenson Cancer Center, and a professor at the OU College of Medicine 康玉斌（Yubin Kang）医学博士，OU Health 血液肿瘤科医生，OU Health 斯蒂芬森癌症中心血液学、骨髓移植和细胞治疗部门主任，俄克拉荷马大学医学院教授. 'With 10 years of preclinical studies on CAR T-cell therapy and opaganib, we believe the findings suggest that opaganib may help the modified immune cells remain active and continue attacking myeloma for longer. Opaganib works by blocking a protein called sphingosine kinase-2 (SPHK2), which appears to act as a kind of brake on the immune system's cancer-fighting T cells. “基于对CAR-T细胞疗法和奥帕加尼布（opaganib）长达10年的临床前研究，我们认为这些发现表明，奥帕加尼布可能有助于修饰后的免疫细胞保持活性，并更持久地持续攻击骨髓瘤细胞。奥帕加尼布通过阻断一种名为鞘氨醇激酶-2（SPHK2）的蛋白质发挥作用，该蛋白似乎对免疫系统抗癌T细胞的功能起到某种抑制作用。”When SPHK2 was absent or blocked in mice, T cells multiplied more effectively and became better at killing myeloma cells. When combining opaganib with CAR T-cell therapy . 当小鼠体内缺乏或阻断SPHK2时，T细胞更有效地增殖，并增强了杀伤骨髓瘤细胞的能力。将奥帕加尼布与CAR T细胞疗法联合使用时。in vivo 体内in mice, the results were encouraging, with tumor growth controlled for a longer period of time[2]. I am excited to see whether combining CAR T-cell therapy with opaganib can produce longer-lasting responses and improve outcomes for these high-risk patients.' 在小鼠实验中，结果令人鼓舞，肿瘤生长在更长时间内得到了控制[2]。我期待看到CAR T细胞疗法与奥帕加尼布联合使用是否能产生更持久的缓解反应，并改善这些高危患者的预后。Dr. Mark Levitt, RedHill's Chief Scientific Officer said RedHill 首席科学官 Mark Levitt 博士表示: 'Opaganib has shown promise in preclinical studies as a potential combination therapy in a number of oncology and other indications. Prior preclinical and clinical work has shown that through a reduction of cancer cell survival proteins like c-Myc and Mcl-1[3], opaganib can potentially play a role in the treatment of multiple myeloma. 奥帕加尼布在临床前研究中显示出作为多种肿瘤学及其他适应症潜在联合疗法的希望。先前的临床前和临床研究显示，通过降低c-Myc和Mcl-1等癌细胞存活蛋白的水平[3]，奥帕加尼布可能在多发性骨髓瘤的治疗中发挥作用。We congratulate Dr. Kang and OU on this grant, which has the potential to be an important step to determine through clinical trials, whether these preclinical findings can turn into reality.'. 我们祝贺康博士和俄克拉荷马大学获得此项资助，该资助有望成为通过临床试验确定这些临床前发现能否转化为现实的重要一步。For patients with ultra-high-risk multiple myeloma, cancer often returns despite treatment, including bone marrow transplantation. CAR T-cell therapy is already an option for some patients whose cancer has returned. 对于超高危多发性骨髓瘤患者，尽管接受了包括骨髓移植在内的治疗，癌症仍常常复发。CAR T细胞疗法已是部分复发患者的可选治疗方案。The clinical trials will be conducted in partnership with RedHill, which is expected to provide opaganib, and Lentigen Technology, Inc., a Miltenyi Biotec, which developed the CAR construct. Miltenyi Biotec is enabling clinical translation by producing GMP-grade lentiviral vector for CAR T manufacturing on the CliniMACs Prodigy.. 临床试验将与RedHill公司（预计提供opaganib）以及Miltenyi Biotec旗下的Lentigen Technology, Inc.（开发了CAR结构）合作开展。Miltenyi Biotec通过在CliniMACS Prodigy系统上生产用于CAR-T制造的GMP级慢病毒载体，推动临床转化。About the project 关于项目Research reported in this press release is supported by the National Cancer Institute of the National Institutes of Health under award No. R01CA293516-01A1. 本新闻稿中报告的研究得到了美国国立卫生研究院下属国家癌症研究所的支持，资助编号为 R01CA293516-01A1。About Opaganib (ABC294640) 关于奥帕加尼布（ABC294640）Opaganib is a proprietary first-in-class investigational, orally administered sphingosine kinase-2 (SPHK2) selective inhibitor drug. Potentially broad-acting, it is in development for multiple oncology, viral, inflammatory, metabolic (diabetes and obesity) and additional indications. Opaganib 是一种专有的、首创类的在研口服选择性鞘氨醇激酶-2（SPHK2）抑制剂药物。该药具有潜在的广谱作用，目前正针对多种肿瘤学、病毒性、炎症性、代谢性（糖尿病和肥胖症）以及其他适应症进行开发。Opaganib's suggested mechanism of action, 奥帕加尼布的推荐作用机制，published 已发布in the journal Drug Design, Development and Therapy, is host-directed and potentially broad-acting and is expected to maintain its effect against emerging viral variants. Opaganib is thought to work through the inhibition of multiple pathways, the induction of autophagy and apoptosis, and disruption of viral replication, through simultaneous inhibition of three sphingolipid-metabolizing enzymes in human cells (SPHK2, DES1 and GCS).. 发表在《药物设计、开发与治疗》期刊上的研究表明，该疗法以宿主为靶点，可能具有广谱活性，并有望对新兴的病毒变异株保持疗效。据认为，Opaganib 通过同时抑制人体细胞中的三种鞘脂代谢酶（SPHK2、DES1 和 GCS），从而抑制多条信号通路、诱导自噬和凋亡，并破坏病毒复制。Opaganib has received Orphan Drug designation from the FDA for the treatment of neuroblastoma and cholangiocarcinoma. A Bayer-supported placebo-controlled randomized Phase 2 study is ongoing to evaluate the efficacy of opaganib in combination with Bayer's darolutamide in men with metastatic castrate-resistant prostate cancer (mCRPC), testing the potentially enhancing effect of opaganib in patients with a poor prognosis. 奥帕加尼布已获得美国食品药品监督管理局（FDA）授予的孤儿药资格，用于治疗神经母细胞瘤和胆管癌。目前，一项由拜耳支持的安慰剂对照随机二期临床试验正在进行中，旨在评估奥帕加尼布与拜耳的达罗他胺联合用药在治疗转移性去势抵抗性前列腺癌（mCRPC）男性患者中的疗效，并检验奥帕加尼布对预后不良患者的潜在增强作用。[4] [4]. Opaganib also has a Phase 1 chemoradiotherapy study protocol ready for FDA-IND submission. 奥帕加尼布还有一项1期放化疗研究的方案已准备就绪，可向美国食品药品监督管理局提交新药临床试验申请（IND）。Opaganib has demonstrated its safety and tolerability profile in more than 470 participants in multiple clinical studies and expanded access use, including a large global Phase 2/3 study in hospitalized patients with moderate to severe COVID-19, published in 奥帕加尼布在多项临床研究及扩大使用项目中，已在超过470名参与者中展现出其安全性和耐受性特征，其中包括一项针对住院的中重度COVID-19患者的大型全球性2/3期研究，该研究发表于Microorganisms 微生物2 2. 。About the University of Oklahoma 关于俄克拉荷马大学Founded in 1890, the University of Oklahoma is a public research university with campuses in Norman, Oklahoma City and Tulsa. As the state's flagship university, OU serves the educational, cultural, economic and healthcare needs of the state, region and nation. In Oklahoma City, the Harold Hamm Health Campus is one of the nation's few academic health centers with seven health profession colleges located on the same campus. 俄克拉荷马大学成立于1890年，是一所公立研究型大学，在诺曼、俄克拉荷马城和塔尔萨设有校区。作为该州的旗舰大学，俄克拉荷马大学服务于本州、本地区及全国在教育、文化、经济和医疗保健方面的需求。在俄克拉荷马城，哈罗德·哈姆健康校区是全国少数几个在同一校区内设有七所健康职业学院的学术健康中心之一。The Harold Hamm Health Campus serves approximately 4,000 students in more than 70 undergraduate and graduate degree programs spanning Oklahoma City and Tulsa and is the leading research institution in Oklahoma. For more information about the Harold Hamm Health Campus, visit. 哈罗德·哈姆健康校区为约4,000名学生提供服务，开设70多个本科和研究生学位课程，覆盖俄克拉荷马城和塔尔萨地区，是俄克拉荷马州领先的研究机构。欲了解有关哈罗德·哈姆健康校区的更多信息，请访问。www.ouhsc.edu www.ouhsc.edu. 。About RedHill Biopharma 关于 RedHill BiopharmaRedHillBiopharma Ltd. (Nasdaq: RedHill Biopharma有限公司（纳斯达克：RDHL RDHL) is a U.S. specialty biopharmaceutical company primarily focused onthe development and commercialization of proprietary drugs for gastrointestinal diseases, infectious diseases and oncology.RedHill promotes the FDA-approved gastrointestinal therapies ）是一家美国专业生物制药公司，主要专注于胃肠道疾病、传染病和肿瘤学领域专有药物的开发与商业化。RedHill 推广经美国食品药品监督管理局（FDA）批准的胃肠道疗法Rebyota Rebyota® ®, for the prevention of recurrent ，用于预防复发性C. diff 艰难梭菌infection (rCDI), and the bowel preparation treatment, 感染（rCDI）以及肠道准备治疗，Clenpiq Clenpiq® 注册商标符号. RedHill'skey clinical late-stage development programs include: (i) . RedHill 的关键临床后期开发项目包括：(i)opaganib (ABC294640) 奥帕加尼布 (ABC294640), a first-in-class, orally administeredsphingosinekinase-2 (SPHK2) selective inhibitor with anti-inflammatory, antiviral, metabolic and anticancer activity, targeting multiple indications witha track record of U.S. government and academic collaborations intended for medical countermeasure development including for Ebola virus disease, radiation exposure indications such as GI-Acute Radiation Syndrome (GI-ARS), a Phase 2/3 program for hospitalized COVID-19, and an ongoing Phase 2 study in prostate cancer in combination with darolutamide; (ii). ，一种首类口服选择性鞘氨醇激酶-2（SPHK2）抑制剂，具有抗炎、抗病毒、代谢调节和抗癌活性，针对多种适应症，并拥有与美国政府及学术界合作的记录，旨在开发包括埃博拉病毒病、辐射暴露相关适应症（如胃肠道急性放射综合征，GI-ARS）、针对住院COVID-19患者的2/3期临床试验项目，以及正在进行的与达罗鲁胺联合治疗前列腺癌的2期研究在内的医疗对策；(ii) 。RHB-102 (Bekinda) RHB-102（Bekinda）, with a Phase 2-ready proof-of-concept study for ，并开展了一项具备二期临床条件的概念验证研究GLP-1 胰高血糖素样肽-1/GIP receptor agonist-associated GI intolerance, positive results from a first U.S. Phase 3 study for acute gastroenteritis and gastritis, positive results from a U.S. Phase 2 study forIBS-D and potential UK submission for chemotherapy and radiotherapy induced nausea and vomiting. RHB-102 is partnered with Hyloris Pharmaceuticals (EBR: HYL) for worldwide development and commercialization outside North America; (iii). 与GIP受体激动剂相关的胃肠道不耐受、在美国进行的首项针对急性胃肠炎和胃炎的III期临床试验取得阳性结果、在美国进行的针对腹泻型肠易激综合征（IBS-D）的II期临床试验取得阳性结果，以及潜在地在英国提交针对化疗和放疗引起的恶心和呕吐的上市申请。RHB-102已与Hyloris Pharmaceuticals（EBR: HYL）合作，在北美以外的全球范围内进行开发和商业化；(iii) 。RHB-204 RHB-204, a next-generation optimized formulation of RHB-104, with aPhase 2-ready study for Crohn's disease (based on RHB-104's positive U.S. Phase 3 Crohn's disease study results); and (iv) ，RHB-104 的下一代优化配方，拥有一项针对克罗恩病的、已具备开展二期临床试验条件的研究（基于 RHB-104 在美国克罗恩病三期临床试验中的阳性结果）；以及 (iv)RHB-107 RHB-107( （upamostat 乌帕莫司他), an oral broad-acting, host-directed,serine protease inhibitor with potential for pandemic preparedness, including COVID-19 and influenza and also targeting multiple cancer and inflammatory gastrointestinal diseases. ），一种口服广谱、宿主导向的丝氨酸蛋白酶抑制剂，具有应对大流行病的潜力，包括针对COVID-19和流感，同时也靶向多种癌症和炎症性胃肠道疾病。Visit 访问www.redhillbio.com www.redhillbio.com/ /X.com/RedHillBio X.com/RedHillBiofor more information about the Company 有关公司的更多信息Forward-Looking Statements 前瞻性陈述This press release contains 'forward-looking statements' within the meaning of the Private Securities Litigation Reform Act of 1995 and may discuss investment opportunities, stock analysis, financial performance, investor relations, and market trends. Such statements may be preceded by the words 'intends,' 'may,' 'will,' 'plans,' 'expects,' 'anticipates,' 'projects,' 'predicts,' 'estimates,' 'aims,' 'believes,' 'hopes,' 'potential' or similar words, and include, among others, statements regarding the NCI grant awarded to OU; the anticipated use of grant funding for the planned Phase 1b and Phase 2 trials; planned enrollment, timing and design of those trials and the potential benefits, if any, of opaganib in combination with CAR T-cell therapy. 本新闻稿包含1995年《私人证券诉讼改革法案》所定义的“前瞻性陈述”，并可能涉及投资机会、股票分析、财务表现、投资者关系以及市场趋势。此类陈述之前通常会出现“打算”、“可能”、“将”、“计划”、“预期”、“预计”、“规划”、“预测”、“估计”、“旨在”、“相信”、“希望”、“潜在”等词语或类似表述，其中包括但不限于以下陈述：授予俄克拉荷马大学（OU）的美国国家癌症研究所（NCI）资助；拟将该资助资金用于计划的1b期和2期临床试验；这些试验的预定入组、时间安排和设计；以及奥帕加尼布（opaganib）与CAR T细胞疗法联合使用（如有）的潜在益处。Forward-looking statements are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company's control and cannot be predicted or quantified, and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. 前瞻性陈述基于某些假设，并受各种已知和未知的风险及不确定性的影响，其中许多因素超出公司的控制范围，无法预测或量化，因此，实际结果可能与这些前瞻性陈述所明示或暗示的结果存在重大差异。Such risks and uncertainties include, without limitation: the risk that the NCI funding may be reduced, delayed or terminated, or may be affected by broader uncertainty regarding government funding; the risks arising with trials conducted by a third party not controlled by RedHill; the risk that the trials may be delayed or may not demonstrate safety or efficacy; the risk that the acquisition of commercialization rights for Rebyota® and Clenpiq does not result in the planned commercial growth; the risk that opaganib is not accepted into Ebola virus disease control programs, or if accepted, that it does not demonstrate efficacy; the risk that development of RHB-204 for Crohn's disease may not be c. 此类风险和不确定性包括但不限于：NCI资金可能被削减、延迟或终止，或可能受到政府资金更广泛不确定性的影响；由RedHill无法控制的第三方开展的试验所带来的风险；试验可能延迟或可能无法证明安全性或有效性的风险；收购Rebyota®和Clenpiq商业化权利未能实现计划中的商业增长的风险；opaganib未被纳入埃博拉病毒病控制项目，或即使被纳入也未能证明有效性的风险；RHB-204用于克罗恩病的开发可能无法c的风险。GLP-1 胰高血糖素样肽-1/GIP-related nausea, vomiting and diarrhea; the risk regarding the Company's ability to regain and maintain compliance with Nasdaq's listing requirements, including the minimum bid price requirement; the risk that the addition of new revenue generating products or out-licensing transactions will not occur; the risk that the Company will not receive future milestone payments under its existing agreements or that they will be less than anticipated; the risk of current uncertainty regarding U.S. /与GIP相关的恶心、呕吐和腹泻；公司能否恢复并维持符合纳斯达克上市要求（包括最低出价要求）的相关风险；新增创收产品或对外许可交易可能无法实现的风险；公司可能无法根据其现有协议收到未来里程碑付款，或收到的款项低于预期的风险；当前围绕美国的不确定性风险government research and development funding and that the U.S. government is under no obligation to continue to support development of our products and can cease such support at any time; the risk that acceptance onto the RNCP Product Development Pipeline or other governmental and non-governmental development programs will not guarantee ongoing development or that any such development will not be completed or successful; the risk that the FDA does not agree with the Company's proposed development plans for its programs; the risk that the Company's development programs and studies may not be successful and, even if successful, such studies and results may not be sufficient for regulatory applications, including emergency use or marketing applications, and that additional studies may be required; the risk that the Company will not successfully commercialize its products; as well as risks and uncertainties associated with (i) the initiation, timing, progress and results of the Company's research, manufacturing, pre-clinical studies, clinical trials, and other therapeutic candidate development efforts, and the timing of the commercial launch of its commercial products and ones it may acquire or develop in the future; (ii) the Company's ability to advance its therapeutic candidates into . 政府研发资金，且美国政府没有义务继续支持我们产品的开发，并可以随时终止此类支持；进入RNCP产品开发管道或其他政府和非政府开发项目并不保证持续开发，或任何此类开发可能无法完成或取得成功；FDA不同意公司为其项目提出的开发计划的风险；公司的开发项目和研究可能不会成功，即使成功，这些研究和结果也可能不足以满足监管申请（包括紧急使用或上市申请）的要求，且可能需要进行额外的研究；公司无法成功将其产品商业化的风险；以及与以下方面相关的风险和不确定性：(i) 公司研究、生产、临床前研究、临床试验及其他治疗候选产品开发工作的启动、时间安排、进展和结果，以及其现有产品或未来可能收购或开发的产品的商业发布时间安排；(ii) 公司推进其治疗候选产品进入的能力。Company contact: 公司联系人：Adi Frish 阿迪·弗里什Chief Corporate & Business Development Officer 首席企业与业务发展官RedHill Biopharma 红山生物制药[emailprotected] [email protected]Category: R&D 类别：研发[1] Opaganib is an investigational new drug, not available for commercial distribution. [1] Opaganib 是一种研究性新药，尚未用于商业销售。[2] Yubin Kang, Xiaobei Wang, Jian Wu, Shaima Jabbar, Chongming Jiang, Xiliing Shen, Besim Ogretmen. Inhibition of Sphingosine Kinase 2 Enhances Immunotherapy in Mouse Model of Multiple Myeloma. (Oral presentation). 2023 ASH annual meeting, Dec 7-12, 2023, San Diego. [2] Yubin Kang, Xiaobei Wang, Jian Wu, Shaima Jabbar, Chongming Jiang, Xiliing Shen, Besim Ogretmen. 抑制鞘氨醇激酶2增强多发性骨髓瘤小鼠模型的免疫治疗效果。（口头报告）。2023年美国血液学会（ASH）年会，2023年12月7日至12日，圣地亚哥。https://ashpublications.org/blood/article/142/Supplement%201/876/502773/Inhibition-of-Sphingosine-Kinase-2-Enhances https://ashpublications.org/blood/article/142/Supplement%201/876/502773/抑制鞘氨醇激酶-2可增强[3] [3]Abstract 7879:Opaganibin combination with oxaliplatin and doxorubicin as a novel salvage therapy for relapsed/refractory high-risk neuroblastoma 摘要 7879：Opaganib 联合奥沙利铂和多柔比星作为复发/难治性高危神经母细胞瘤的新型挽救疗法. 。Jeremy Hengst 杰里米·亨斯特, ，Mohammad Haque 穆罕默德·哈克, ，Muhammad Younis 穆罕默德·尤尼斯, ，Thussenthan Walter Angelo 图森坦·沃尔特·安杰洛, ，Anna Bourne 安娜·伯恩, ，Katherine McClain 凯瑟琳·麦克莱恩, ，Meenakshi Shukla 米纳克希·舒克拉, ，Jonathan Lerch 乔纳森·莱尔赫, ，Tarlan Arjmandi 塔兰·阿尔詹迪, ，Eric Cochran 埃里克·科克伦, ，Lynn Maines 林恩·梅恩斯, ，Charles D. Smith 查尔斯·D·史密斯, ，Vladimir S. Spiegelman 弗拉基米尔·S·斯皮格尔曼, ，Jacqueline M. Kraveka 杰奎琳·M·克拉韦卡, ，Giselle L. Saulnier Sholler 吉赛尔·L·索尔尼尔·肖勒. 。Cancer Res 癌症研究(2026) 86 (7_Supplement): 7879. (2026) 86 (7_增刊): 7879.https://doi.org/10.1158/1538-7445.AM2026-7879 https://doi.org/10.1158/1538-7445.AM2026-7879[4] [4]https://www.redhillbio.com/news/news-details/2025/RedHill-Announces-Initiation-of-Phase-2-Study-of-Opaganib-and-Darolutamide-in-Advanced-Prostate-Cancer/default.aspx https://www.redhillbio.com/news/news-details/2025/RedHill-Announces-Initiation-of-Phase-2-Study-of-Opaganib-and-Darolutamide-in-Advanced-Prostate-Cancer/default.aspxSOURCE RedHill Biopharma Ltd. 来源：RedHill Biopharma Ltd.21 二十一% %more press release views with 更多新闻稿浏览量，通过Request a Demo 申请演示