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BeyondSpring研发日重点介绍癌症新的Plinabulin开发战略和SEED治疗的最新进展

BeyondSpring R&D Day Highlights New Plinabulin Development Strategy for Cancer and Updates for SEED Therapeutics

BioSpace 等信源发布 2024-05-16 20:25

可切换为仅中文


FLORHAM PARK, N.J., May 16, 2024 (GLOBE NEWSWIRE) -- BeyondSpring Inc. (NASDAQ: BYSI) (“BeyondSpring” or the “Company”), a clinical-stage global biopharmaceutical company focused on developing innovative cancer therapies, today announced that it hosted a virtual Research and Development (R&D) Day to discuss its lead asset Plinabulin, a dendritic cell (DC) maturation agent, in drug combinations to potentially address the current unmet medical needs in cancer indications where patients failed prior PD-1/PD-L1 inhibitors, as well as updates for SEED Therapeutics which focuses on target protein degradation (TPD) platform for innovative molecular glue drug discovery on May 15, 2024..

新泽西州弗洛勒姆公园,2024年5月16日(环球通讯社)--BeyondSpring Inc.(NASDAQ:BYSI)(“BeyondSpring”或“公司”),一家专注于开发创新癌症疗法的临床阶段全球生物制药公司,今天宣布,它于2024年5月15日举办了一个虚拟研发日,讨论其主要资产Plinabulin(一种树突状细胞(DC)成熟剂)的药物组合,以潜在地解决目前未满足的癌症适应症的医疗需求,其中患者在PD-1/PD-L1抑制剂之前失败,以及种子疗法的更新,该疗法侧重于靶蛋白降解(TPD)平台,用于创新分子胶药物的发现。(笑声)。。

The R&D Day was led by Key Opinion Leaders (KOLs) Trevor M. Feinstein, M.D. (Piedmont Cancer Institute), Alberto Chiappori, M.D. (Moffitt Cancer Center), and Steven Lin, M.D., Ph.D. (MD Anderson Cancer Center), as well as BeyondSpring and SEED Therapeutics management.

研发日由关键意见领袖(KOL)TrevorM.Feinstein医学博士(皮埃蒙特癌症研究所)、AlbertoChiappori医学博士(莫菲特癌症中心)、StevenLin医学博士(MD安德森癌症中心)以及BeyondSpring和SEED Therapeutics management领导。

Invited KOLs shared their latest insights on plinabulin’s durable anti-cancer benefit, mechanism-of-action (MOA), and its unique potential as an I/O combination agent with chemotherapy or radiation, in patients that have progressed on PD-1/PD-L1 therapy. Over time, plinabulin may have the potential to move into earlier lines of treatment in combination with I/O:.

受邀的KOLs分享了他们对plinabulin的持久抗癌益处,作用机制(MOA)及其作为化疗或放疗I/O联合药物的独特潜力的最新见解,这些患者在PD-1/PD-L1治疗方面取得了进展。随着时间的推移,plinabulin可能有可能与I/O结合进入早期治疗领域:。

As a unique tubulin binder, plinabulin drives dendritic cell (DC) maturation/T-cell activation by effectively liberating the immune defense protein GEF-H1 from microtubules.

作为一种独特的微管蛋白粘合剂,plinabulin通过有效地从微管中释放免疫防御蛋白GEF-H1来驱动树突状细胞(DC)成熟/T细胞活化。

Plinabulin alone or in combination has been well-tolerated in >700 cancer patients in two positive phase 3 studies.

在两项阳性3期研究中,超过700名癌症患者单独或联合使用Plinabulin的耐受性良好。

In a phase 3 study with EGFR wild-type 2L/3L NSCLC, the combination of plinabulin and docetaxel significantly extended OS in all subgroup analyses and doubled 2-year and 3-year OS rates compared to docetaxel alone.

在EGFR野生型2L/3L NSCLC的3期研究中,与单独使用多西紫杉醇相比,plinabulin和多西紫杉醇的组合显着延长了所有亚组分析中的OS,并使2年和3年OS率翻了一番。

In an MD Anderson phase 1 study, in combination with radiotherapy and a PD-1 inhibitor, plinabulin demonstrated its DC maturation MOA in responding patients (PR+SD) in multiple cancers that had progressed during PD-1/PD-L1 inhibitor therapy with >50% disease control rate (PR+SD). The most responding cancers include NSCLC, HNSCC and Hodgkin’s lymphoma..

在MD Anderson 1期研究中,结合放疗和PD-1抑制剂,plinabulin在PD-1/PD-L1抑制剂治疗期间进展的多种癌症的反应患者(PR+SD)中证明了其DC成熟MOA疾病控制率>50%(PR+SD)。反应最快的癌症包括NSCLC,HNSCC和霍奇金淋巴瘤。。

PD-1/PD-L1 inhibitors have been approved in approximately 20 cancer indications with >$40 billion annual sales, and yet around 60% of patients eventually fail, leaving them with limited treatment options.

PD-1/PD-L1抑制剂已被批准用于大约20种癌症适应症,年销售额超过400亿美元,但约60%的患者最终失败,使他们的治疗选择有限。

Plinabulin’s potent DC maturation effect, in combination with PD-1/PD-L1 and radiation or chemotherapy, may address unmet medical needs across numerous patient settings following progression from PD-1/PD-L1 inhibitor therapy.

Plinabulin的有效DC成熟作用,结合PD-1/PD-L1和放疗或化疗,可以解决PD-1/PD-L1抑制剂治疗进展后许多患者环境中未满足的医疗需求。

Plinabulin has the potential to fill a substantial gap in cancer treatment for precisely the same patient settings that have been found elusive to other mechanisms or combinations.

Plinabulin有可能填补癌症治疗中的巨大空白,因为对于其他机制或组合来说,这些患者的情况是难以捉摸的。

“Additionally, significant headway is being made through various Investigator-Initiated Trial (IIT) studies of plinabulin at leading institutions in the U.S. and China. Preliminary results are expected to be reported in 2H 2024, that are expected to reinforce our unique MOA and lead to a transformative year for BeyondSpring.

“此外,通过在美国和中国领先机构对plinabulin进行的各种研究者发起的试验(IIT)研究,正在取得重大进展。初步结果预计将于2024年下半年报告,预计将加强我们独特的MOA,并为BeyondSpring带来变革之年。

If interim clinical data from our ongoing studies further validates our unique MOA, then we will look for opportunities to extend and accelerate plinabulin’s outreach through third-party partnerships,” said Dr. Lan Huang, Co-Founder, Chairman and CEO of BeyondSpring..

如果我们正在进行的研究的中期临床数据进一步验证了我们独特的MOA,那么我们将寻找机会通过第三方合作伙伴关系扩展和加速plinabulin的推广,”BeyondSpring联合创始人、董事长兼首席执行官黄兰博士说。。

Following the plinabulin presentations, Dr. Lan Huang discussed how BeyondSpring’s majority-owned subsidiary, SEED Therapeutics, uses its proprietary TPD platforms to develop “molecular glues” for undruggable targets. Different from PROTAC platforms, molecular glues have the potential advantage of targeting un-ligandable proteins, including proteins without ligandable pocket, and unfolded protein, such as Tau.

在plinabulin的演讲之后,黄兰博士讨论了BeyondSpring的控股子公司SEED Therapeutics如何使用其专有的TPD平台开发用于不可药用靶标的“分子胶”。与PROTAC平台不同,分子胶具有靶向不可连接蛋白质(包括没有可连接口袋的蛋白质)和未折叠蛋白质(例如Tau)的潜在优势。

The SEED TPD platform referred to as RITE3, has translated the scientific breakthroughs and insights of its co-founders, including a Nobel Laureate and two Howard Hughes Medical Institute investigators, into a diversified and fast-evolving drug development pipeline:.

被称为RITE3的种子TPD平台已将其联合创始人(包括一名诺贝尔奖获得者和两名霍华德·休斯医学研究所研究人员)的科学突破和见解转化为多样化和快速发展的药物开发管道:。

Differentiated from other molecular glue companies, which are mainly “E3 centric”, SEED’s RITE3 platform is “target centric” and uses novel E3 ligases for protein targets. With detectable weak basal interaction between selected E3 and protein target, the binder hit rates from its high throughput screening is higher..

与其他主要以“E3为中心”的分子胶公司不同,SEED的RITE3平台以“目标为中心”,并使用新型E3连接酶作为蛋白质靶标。由于选定的E3和蛋白质靶标之间可检测到微弱的基础相互作用,因此其高通量筛选的粘合剂命中率更高。。

6 internal pipeline assets and 2 partnered assets, in oncology, neurodegeneration, immunology, and virology used 5 novel E3 ligases.

肿瘤学,神经退行性疾病,免疫学和病毒学中的6个内部管道资产和2个合作资产使用了5种新型E3连接酶。

SEED expects to file an IND in early 2025 for its IND Candidate oral RBM39 degrader, for the treatment of rationally selected cancer indications.

SEED预计在2025年初为其IND候选口服RBM39降解剂提交IND,用于治疗合理选择的癌症适应症。

SEED R&D has a focus on the development of orally delivered molecular glues for CNS indications, with a lead internal program against Tau.

SEED研发的重点是开发用于中枢神经系统适应症的口服分子胶,并针对Tau进行了领先的内部计划。

Eli Lilly is a current investor and R&D collaborator with upfront and milestone payments up to $780 million, plus tiered royalties. SEED has achieved 3 milestones with Lilly R&D collaboration.

礼来是目前的投资者和研发合作者,预付款和里程碑付款高达7.8亿美元,外加分层版税。SEED与礼来研发合作实现了3个里程碑。

“I'm delighted to announce SEED's substantial progress in advancing internal initiatives, including an oncology asset advancing towards first human dose in the first half of 2025, Tau degraders for neurodegeneration advancing towards lead molecule status towards the end of 2024. In addition, we have a synergistic collaboration with Eli Lilly, which achieved multiple milestone payments.

“我很高兴宣布SEED在推进内部举措方面取得了实质性进展,包括在2025年上半年实现第一次人体剂量的肿瘤学资产,在2024年底实现神经退行性变的Tau降解物向铅分子状态迈进。此外,我们与礼来公司进行了协同合作,实现了多个里程碑式的付款。

In the recent “Nature Biotechnology” review article on molecular glues, it was truly a privilege for SEED Therapeutics to be recognized alongside other prominent companies employing groundbreaking TPD molecular glue strategies. Leveraging our unique and proprietary RITE3 platform that focuses on predicting, detecting, and utilizing a pre-existing weak interaction between an E3 ligase and the target disease-causing protein, SEED consistently garners growing interest for additional partnerships and investment,” said Dr.

在最近关于分子胶的“自然生物技术”评论文章中,种子疗法与其他采用开创性TPD分子胶策略的知名公司一起获得认可确实是一种特权。利用我们独特且专有的RITE3平台,该平台专注于预测,检测和利用E3连接酶与目标致病蛋白之间预先存在的弱相互作用,SEED一直吸引着越来越多的合作伙伴和投资兴趣,”Dr。

James Tonra, President and CSO of SEED Therapeutics..

James Tonra,SEED Therapeutics总裁兼CSO。。

An archived replay of the webinar will be available on BeyondSpring’s website www.beyondspringpharma.com under “Events and Presentations” in the Investors section.

在线研讨会的存档重播将在BeyondSpring的网站www.beyondspringpharma.com的投资者部分的“活动和演示”下提供。

Trevor M. Feinstein, M.D.

Trevor M.Feinstein,医学博士。

Dr. Feinstein is board certified in medical oncology and hematology. He joined Piedmont Cancer Institute in 2011 and is the Director of Research at Piedmont Fayette Hospital. Dr. Feinstein is actively involved in clinical trials focused on improved therapies for various cancers. He is a member of Georgia CORE’s research committee along with Georgia Society for Clinical Oncology Clinical Practice Committee.

范斯坦博士拥有医学肿瘤学和血液学的董事会认证。他于2011年加入皮埃蒙特癌症研究所,是皮埃蒙特法耶特医院的研究主任。范斯坦博士积极参与旨在改善各种癌症治疗方法的临床试验。他是佐治亚州核心研究委员会和佐治亚州临床肿瘤学会临床实践委员会的成员。

He also chairs the Lung Disease Group for the entire OneOncology network. He is a co-investigator on several peer-reviewed research projects and has authored numerous publications and abstracts in Hematology and Oncology. Dr. Feinstein graduated from the University of Illinois medical school and completed his residence and fellowships at the University of Pittsburgh..

他还担任整个OneOncology网络肺部疾病小组的主席。他是几个同行评审研究项目的联合研究员,并在血液学和肿瘤学领域撰写了许多出版物和摘要。范斯坦博士毕业于伊利诺伊大学医学院,并在匹兹堡大学完成了住所和奖学金。。

Alberto Chiappori, M.D.

Alberto Chiappori,医学博士。

Dr. Chiappori is board certified in medical oncology. He serves as senior member of oncology and medicine for the Thoracic Oncology Program at the H. Lee Moffitt Cancer Center and Research Institute in Tampa and Florida. Dr. Chiappori is an active member of the American Society of Clinical Oncology, the European Society of Medical Oncology, the American Association for Cancer Research, and the International Association for the Study of Lung Cancer (IASLC).

Chiappori博士拥有医学肿瘤学委员会认证。他是坦帕和佛罗里达州H.Lee Moffitt癌症中心和研究所胸肿瘤项目肿瘤学和医学高级成员。Chiappori博士是美国临床肿瘤学会、欧洲医学肿瘤学会、美国癌症研究协会和国际肺癌研究协会(IASLC)的活跃成员。

Dr. Chiappori received his M.D. from the Universidad Peruana Cayetano Heredia in Lima, Peru, completed his residency at Southern Illinois University School of Medicine in Springfield, Illinois, and finished his fellowship and senior fellowship in medical oncology-hematology at Vanderbilt University School of Medicine in Nashville, Tennessee..

Chiappori博士在秘鲁利马的秘鲁卡耶塔诺·埃雷迪亚大学获得了医学博士学位,在伊利诺伊州斯普林菲尔德的南伊利诺伊大学医学院完成了住院治疗,并在田纳西州纳什维尔的范德比尔特大学医学院完成了医学肿瘤学血液学奖学金和高级奖学金。。

Steven Lin, M.D., Ph.D.

Steven Lin,医学博士,博士。

Dr. Lin is a Professor and Physician-Scientist at MD Anderson Cancer Center, with joint appointments in the Departments of Radiation Oncology and Experimental Radiation Oncology. Dr. Lin’s practice focuses on thoracic malignancies, and he oversees several clinical trials including the use of proton beam therapy for esophageal cancer and in the combination of immunotherapy with radiotherapy in lung and esophageal cancers.

林博士是MD安德森癌症中心的教授和医生兼科学家,在放射肿瘤学和实验放射肿瘤学系联合任职。林博士的实践侧重于胸部恶性肿瘤,他监督了多项临床试验,包括质子束疗法治疗食管癌以及免疫疗法与放疗联合治疗肺癌和食管癌。

Dr. Lin runs a translational research team that evaluates biomarkers for treatment response and disease outcomes after cancer therapy. Dr. Lin acquired his M.D. and Ph.D. in the Medical Scientist Training Program at the University of California Irvine Medical School. He went on for residency training in Radiation Oncology at The Johns Hopkins Hospital..

林博士管理着一个转化研究团队,负责评估癌症治疗后治疗反应和疾病结果的生物标志物。林博士在加州大学欧文医学院的医学科学家培训计划中获得了医学博士和博士学位。他继续在约翰·霍普金斯医院接受放射肿瘤学住院医师培训。。

About BeyondSpring

关于BeyondSpring

BeyondSpring is a global clinical-stage biopharmaceutical company focused on developing innovative therapies to improve clinical outcomes for patients with high unmet medical needs. The Company is advancing its first-in-class lead asset, Plinabulin, as a direct anti-cancer agent in various cancer indications and to prevent chemotherapy-induced neutropenia.

BeyondSpring是一家全球临床阶段的生物制药公司,专注于开发创新疗法,以改善未满足医疗需求的患者的临床结果。该公司正在推进其一流的领先资产Plinabulin,作为各种癌症适应症的直接抗癌剂,并预防化疗引起的中性粒细胞减少症。

BeyondSpring’s pipeline also includes three preclinical immuno-oncology assets. Additionally, BeyondSpring’s subsidiary, SEED Therapeutics, leverages a proprietary TPD drug discovery platform and has an initial R&D collaboration with Eli Lilly. Learn more by visitinghttps://beyondspringpharma.com..

BeyondSpring的管道还包括三个临床前免疫肿瘤学资产。此外,BeyondSpring的子公司SEED Therapeutics利用专有的TPD药物发现平台,并与礼来公司进行了初步的研发合作。通过visi了解更多信息tinghttps://beyondspringpharma.com..

About SEED Therapeutics

关于种子疗法

SEED Therapeutics is an innovative biotech company focusing on harnessing and engineering “molecular glues” and targeted protein degradation (TPD) to attack previously undruggable targets. Backed by a comprehensive intellectual property portfolio, SEED Therapeutics' mission is to positively impact human health by creating novel protein degradation therapeutics to treat various severe diseases that currently have limited treatment options for patients and their families.

SEED Therapeutics是一家创新的生物技术公司,专注于利用和工程化“分子胶”和靶向蛋白质降解(TPD)来攻击以前无法治疗的目标。在全面的知识产权组合的支持下,SEED Therapeutics的使命是通过创建新型蛋白质降解疗法来治疗目前对患者及其家属的治疗选择有限的各种严重疾病,从而对人类健康产生积极影响。

Through ongoing collaborations with world-leading academic experts in the field, SEED Therapeutics is developing a growing pipeline of novel drug candidates on a path to potential clinical and commercial success. SEED has an initial R&D collaboration and investment from Eli Lilly and Company. Learn more by visiting https://seedtherapeutics.com/..

通过与该领域世界领先学术专家的持续合作,SEED Therapeutics正在开发越来越多的新型候选药物,以实现潜在的临床和商业成功。SEED与礼来公司进行了初步的研发合作和投资。通过访问了解更多信息https://seedtherapeutics.com/..

Cautionary Note Regarding Forward-Looking Statements

关于前瞻性声明的警示说明

This press release includes forward-looking statements that are not historical facts. Words such as “will,” “expect,” “anticipate,” “plan,” “believe,” “design,” “may,” “future,” “estimate,” “predict,” “objective,” “goal,” or variations thereof and variations of such words and similar expressions are intended to identify such forward-looking statements.

本新闻稿包括非历史事实的前瞻性声明。诸如“将”、“期望”、“预期”、“计划”、“相信”、“设计”、“可能”、“未来”、“估计”、“预测”、“目标”、“目标”等词语或其变体以及此类词语和类似表达的变体旨在识别此类前瞻性陈述。

Forward-looking statements are based on BeyondSpring’s current knowledge and its present beliefs and expectations regarding possible future events and are subject to risks, uncertainties, and assumptions. Actual results and the timing of events could differ materially from those anticipated in these forward-looking statements as a result of several factors including, but not limited to, our ability to continue as a going concern, difficulties raising the anticipated amount needed to finance the Company’s future operations on terms acceptable to the Company, if at all, unexpected results of clinical trials, delays or denial in regulatory approval process, results that do not meet the Company’s expectations regarding the potential safety, the ultimate efficacy or clinical utility of the Company’s product candidates, increased competition in the market, the Company’s ability to meet Nasdaq's continued listing requirements, and other risks described in BeyondSpring’s most recent Form 20-F on file with the U.S.

前瞻性陈述基于BeyondSpring目前的知识及其对未来可能发生的事件的信念和期望,并受到风险、不确定性和假设的影响。由于以下几个因素,实际结果和事件发生的时间可能与这些前瞻性声明中的预期有很大不同,包括但不限于我们持续经营的能力,难以按照公司可接受的条款提高公司未来运营所需的预期金额,如果有的话,临床试验的意外结果,监管审批流程的延迟或拒绝,结果不符合公司对潜在安全性的预期,公司候选产品的最终功效或临床效用,市场竞争加剧,公司满足纳斯达克继续上市要求的能力,以及BeyondSpring提交给美国证券交易管理局的最新表格20-F中描述的其他风险美国。

Securities and Exchange Commission. All forward-looking statements made herein speak only as of the date of this release and BeyondSpring undertakes no obligation to update publicly such forward-looking statements to reflect subsequent events or circumstances, except as otherwise required by law..

证券交易委员会。本文件中的所有前瞻性声明仅在本发布之日起生效,BeyondSpring不承担公开更新此类前瞻性声明以反映后续事件或情况的义务,除非法律另有要求。。

Investor Contact:

投资者联系人:

IR@beyondspringpharma.com

IR@beyondspringpharma.com

Media Contact:

媒体联系人:

PR@beyondspringpharma.com

PR@beyondspringpharma.com