A Phase 2 Study of Pembrolizumab in Combination With Plinabulin and Docetaxel in Previously Treated Patients With Metastatic Non-Small Cell Lung Cancer and Progressive Disease (PD) After Immunotherapy (Anti-PD-1/PD-L1 Inhibitor) Alone or in Combination With Platinum-doublet Chemotherapy (KeyPemls-004)

A Phase 2 Study of Pembrolizumab in Combination with Plinabulin and Docetaxel in previously treated Patients with Metastatic Non-Small Cell Lung Cancer and progressive disease (PD) after immunotherapy (Anti-PD-1/PD-L1 inhibitor) alone or in combination with Platinum-doublet Chemotherapy.

开始日期2023-02-01

申办/合作机构

北京协和医院

[+2]

NCT05130827 / Active, not recruiting临床2期IIT

Pilot Trial of Plinabulin and Pegfilgrastim to Reduce the Duration of Absolute Neutropenia After Autologous Hematopoietic Cell Transplantation for Patients With Multiple Myeloma

This study will see how long it takes for white blood cell counts to return to normal in people with multiple myeloma (MM) who receive plinabulin and pegfilgrastim after undergoing an autologous hematopoietic stem cell transplant (AHCT).

开始日期2021-12-21

申办/合作机构

Memorial Sloan Kettering Cancer Center

[+1]

NCT03294577 / Active, not recruiting临床3期

A Phase 3, Randomized Study to Evaluate Plinabulin Versus Pegfilgrastim in the Prevention of Severe Neutropenia in Breast Cancer Patients Receiving Myelosuppressive Chemotherapy With Docetaxel, Doxorubicin, and Cyclophosphamide (TAC) (Protective 2)

The primary purpose of this study is to compare the percentage of patients with Duration of Severe Neutropenia (DSN) =0 in patients treated with:
Docetaxel, doxorubicin, and cyclophosphamide (TAC) + pegfilgrastim versus Docetaxel, doxorubicin, and cyclophosphamide (TAC) + combination plinabulin/pegfilgrastim
Severe neutropenia is an absolute neutrophil count (ANC) <0.5 × 10^9/L.
Docetaxel, doxorubicin, and cyclophosphamide (TAC) will be used as the chemotherapy in this study.

开始日期2019-10-23

申办/合作机构

BeyondSpring Pharmaceuticals, Inc.

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项与 BeyondSpring, Inc. 相关的文献（医药）

2024-03-04·Cancer Research

Abstract A009: Plinabulin, a novel tubulin targeting agent, collapses the tumor microtube network in primary and recurrent patient derived glioblastoma cell lines to inhibit neurosphere invasion and survival

作者: Reinard, Kevin ; Schroeder, Jason L. ; Huang, Lan ; Becker, Kathryn M. ; Tonra, James R. ; Pettee, Krista M. ; Eisenmann, Kathryn M. ; Mohanlol, Ramon ; Lloyd, Kenneth

AbstractGlioblastoma multiforme (GBM) is the most common adult primary brain malignancy. Aggressive, diffuse invasion is regulated by a dynamic cytoskeleton and significantly contributes to poor survival. Intraparenchymal tumor cell dissemination prevents complete surgical resection and compromises essential brain functions. Invasive cells are inherently less sensitive to traditional cytotoxic therapies. Recent investigation into targeted therapies has failed to address invasion/cytoskeleton based GBM therapy resistance. Furthermore, established GBM cell line modeling in 2 or 3 dimensions (3D) does not capture the genetic diversity or clinical relevance of patient derived primary (1') GBM cell lines, which may uncover/predict differential responses in tumors to novel therapies. Cytoskeleton remodeling and cell invasion in patient-derived primary GBM cells generates unique structures called tumor microtubes (TMs) not seen in established, cultured GBM cell lines. TMs are ultralong, pro-invasive, tubulin-enriched protrusions that promote chemo- and radioresistance in GBM patient derived primary cells. Using our extensive GBM cell line biobank derived from 1' and/or therapy resistant recurrent (2') tumors, we investigated the effects of a novel drug targeting the microtubule cytoskeleton. Plinabulin is a tubulin targeting agent that crosses the blood brain barrier and demonstrated anticancer efficacy in Phase III trial patients with non-small cell lung carcinoma. Plinabulin also has antiproliferative properties in 2D GBM cells. Here, we evaluate the efficacy of plinabulin treatment upon 3D neurosphere viability and invasion in 5 GBM 1' and 2' recurrent patient derived cell lines. Within 24h of matrigel embedding, 3D GBM patient neurospheres generate robust pro-invasive TMs. Plinabulin treatment (10-30 nM) at embedding followed by drug washout after 24h eliminated existing TMs and inhibited single cell invasion (80% relative to controls) in both 1' and 2' GBM patient neurospheres. Cell survival was significantly reduced in plinabulin treated neurospheres (30 nM). Plinabulin efficacy was evaluated in a clinically relevant therapeutic ITR model: GBM patient neurospheres invaded (I) for 48h to establish TM networks; were treated (T) with 1-50 nM plinabulin for 24h prior to drug washout; and recovered (R) for 96h. In 1', 2', or matched 1' and 2' cell line pairs from the same patient, 10-40 nM plinabulin sustained invasion inhibition (>90%) through 96h post washout and completely blocked TM extension relative to controls, consistent with established clinical concentrations of plinabulin. This study reveals plinabulin as a potent GBM therapeutic targeting pro-invasion TM networks and survival in 1' and therapy resistant 2' GBM patient cell lines.Citation Format: Kathryn M. Eisenmann, Kenneth Lloyd, Krista M. Pettee, Kathryn M. Becker, Jason L. Schroeder, Kevin Reinard, James R. Tonra, Ramon Mohanlol, Lan Huang. Plinabulin, a novel tubulin targeting agent, collapses the tumor microtube network in primary and recurrent patient derived glioblastoma cell lines to inhibit neurosphere invasion and survival [abstract]. In: Proceedings of the AACR Special Conference on Brain Cancer; 2023 Oct 19-22; Minneapolis, Minnesota. Philadelphia (PA): AACR; Cancer Res 2024;84(5 Suppl_1):Abstract nr A009.

2023-09-01·Journal of the National Comprehensive Cancer Network : JNCCN

Real-World Impact of Prophylactic Growth Factor Use on Timing of Febrile Neutropenia and Infection After High-Risk Chemotherapy.

Article

作者: Wells, Jasmine ; Jarvis, John ; Kuderer, Nicole M ; Cummings Joyner, Alice Kate ; Nunag, Dominic ; Mohanlal, Ramon ; Huang, Lan ; Lyman, Gary H ; Blayney, Douglas W

BACKGROUNDProphylactic growth-factor therapy with granulocyte colony-stimulating factor (G-CSF) reduces the risk of febrile neutropenia (FN) in patients with breast cancer initiating myelosuppressive chemotherapy. However, little is known about the protective benefit early in the chemotherapy cycle.METHODSTo assess the relationship between G-CSF prophylaxis and incidence of FN/infection in week 1 versus beyond week 1 of the first chemotherapy cycle, a retrospective study was conducted using Medicare claims from 2005 through 2020 among patients with breast cancer initiating high-risk chemotherapy. Two cohorts were compared based on G-CSF prophylaxis within 3 days following chemotherapy initiation. The primary outcome was FN or infection, defined as hospitalization with neutropenia, fever, or infection diagnosis. Secondary outcomes were a stricter definition of FN and infection-related hospitalization. Unadjusted and regression-adjusted proportions of patients experiencing each outcome during week 1 versus beyond week 1 of the first chemotherapy cycle were compared.RESULTSOf 78,810 patients meeting all inclusion criteria (>98% female; mean age, 69 years), 79% initiated TC (docetaxel/cyclophosphamide), 14% TCH (docetaxel/carboplatin/trastuzumab), and 7% TAC (docetaxel/doxorubicin/cyclophosphamide). Among patients receiving G-CSF (74%), incidence of first-cycle FN/infection was lower compared with patients not receiving G-CSF (overall, 6% vs 13%; TAC, 12% vs 19%; TC, 6% vs 12%; TCH, 5% vs 15%). However, patients who received G-CSF were generally more likely to experience FN/infection in week 1 (adjusted odds ratio [aOR], 1.24 for all; 1.73 for TAC; 1.35 for TC; and 0.76 for TCH). Results were similar for strictly defined FN (overall aOR, 1.29 for week 1 and 0.12 for beyond week 1) and infection-related hospitalization (overall aOR, 1.33 for week 1 and 0.27 for beyond week 1).CONCLUSIONSOverall, the rates of chemotherapy-related FN and infection in week 1 of the first chemotherapy cycle are similar for patients receiving and not receiving G-CSF, suggesting continued risk in week 1 despite prophylactic G-CSF.

2023-06-01·Journal of Clinical Oncology

Prevention of chemotherapy-induced neutropenia (CIN) with plinabulin (Plin) vs placebo (Plac) in patients (pts) with non-small cell lung cancer (NSCLC) treated with docetaxel (Doc): A pooled analysis from 3 randomized trials.

作者: Blayney, Douglas W. ; Huang, Lan ; Mohanlal, Ramon W. ; Duprez, Stephen ; Hurley, Jasmine ; Legaspi, Gabrielle

e21163 Background: CIN can lead to increased patient/healthcare burden, resource utilization, hospitalizations, and poorer quality of life (QoL). G-CSF has a high incidence of bone pain and mild thrombopenia and is given the day after chemo. Plin, a novel non-G-CSF small molecule, protects the bone marrow stem cell, has minimal bone pain, and protects platelet precursors. Plin is given on the same day as chemo and has NSCLC anticancer efficacy (ESMO 2021, Feinstein). The CIN effects of Doc plus Plin vs Doc with Plac were pooled from 3 NSCLC clinical trials. Methods: Data from randomized trials, phase (Ph) 3 trial 103 (NCT02504489), Ph2/3 trial 105 ( NCT03102606 ), and Ph2 trial 101 (NCT00630110) were pooled. Pts were randomized to either Doc (75mg/m2) plus Plin (20mg/m2 or its pharmacokinetic equivalent) (n = 146) or Doc plus Plac (n = 296). Doc was administered on day 1 of each 21-day cycle x 4 cycles, and Plin or Plac was administered ~30 minutes after Doc. Neutrophil counts were taken at predose and day (D) 8 of each cycle in studies 101 & 103, and on predose, D1, 2, 6, 7, 8, 9, 10, 15, and 21 in study 105. Pts given G-CSF in D1-D3 were excluded. Duration of severe neutropenia (DSN) was calculated by methods previously reported (ASH 2022, Blayney). All Grade (Gr) and Gr4 neutropenia (N) rates, Absolute N count (ANC), febrile N (FN) rate, and ANC on D8 (‘nadir’) were obtained. QoL scores were obtained in studies 103 and 105 by EORTC QLQ-C30. Patient-reported adverse events (AEs) were collected. Results: Pt demographics were comparable. Plin was statistically and clinically significantly superior to Plac for All Gr and Gr4 N frequencies, Day 8 ANC (‘nadir’), and DSN (all had p < 0.0001). Febrile Neutropenia (FN) and infection rates were numerically lower (see table). Fewer pts were treated with antibiotics among pts treated with Plin. Platelet count was unaffected with Plin; grade (gr) 3/4 thrombocytopenia was < 1% with either Plin or Plac. The total frequency of treatment-emergent AEs for Plin vs Plac were 71% vs 80%. QoL scores were similar for Plin and Plac. Conclusions: In 3 independent randomized studies (101, 103, and 105), Plin demonstrated a superior benefit for CIN and showed clinical benefit for infection rate versus Plac. Additionally, Plin has the added benefits of pt convenience (same-day dosing and no additional visits or wearable device), a favorable safety and tolerability profile, anticancer efficacy, and QoL maintenance, which represents a distinct advantage over G-CSF. Clinical trial information: NCT02504489 ; NCT03102606 ; NCT00630110 . [Table: see text]

163

项与 BeyondSpring, Inc. 相关的新闻（医药）

2024-10-30

·医药魔方Pro

Biogen豪掷14.5亿美元，MNC围猎分子胶

10月29日，Biogen和Neomorph宣布达成合作，开发用于治疗阿尔茨海默病、罕见神经疾病和免疫疾病的分子胶降解剂。根据协议条款，Biogen和Neomorph将合作确定、验证和优化几个高优先级靶点的小分子分子胶降解剂，Biogen将推进临床候选药物的进一步开发和潜在商业化。Neomorph将获得预付款，并有资格里程碑付款，总金额高达14.5亿美元。 Neomorph成立于2020年，由Deerfield Management Company提供风险投资支持。公司通过发现和开发针对“不可成药”靶点的创新药来解决人类健康中的关键问题。Neomorph团队由蛋白质降解和分子胶领域的行业领先专家组成，与Dana Farber癌症研究所的蛋白质降解中心保持着重要的紧密联系。 2020年12月，Neomorph宣布获得1.09亿美元的A轮融资，以推进专有的靶向蛋白质降解平台和特定项目开发。目前，公司尚未披露产品进入临床阶段。 2024年2月，Neomorph宣布与诺和诺德签订合作和许可协议，用于发现、开发和商业化多个分子胶降解剂，潜在交易总价值高达14.6亿美元。 2024年以来，制药巨头充分展露了布局分子胶降解剂的热情： 2月，BMS与VantAI合作，借助生成式AI技术加速分子胶的发现； 2月，诺和诺德与Neomorph合作，发现用于心脏代谢和罕见疾病的新型分子胶降解剂； 5月，武田与达歌生物合作，发现和开发用于肿瘤学、神经科学和炎症领域多个靶点的新型分子胶降解剂； 8月，卫材与SEED Therapeutics合作，发现、开发及商业化用于多个未公开神经退行性疾病及肿瘤靶点的新型分子胶降解剂。 10月，辉瑞与TRIANA Biomedicines达成合作，为包括肿瘤学在内的多种疾病领域的多个靶点发现新型分子胶降解剂； 10月，诺华与Monte Rosa Therapeutics合作，推动靶向VAV1的分子胶降解剂的研发。（推荐阅读：分子胶火爆！罗氏、BMS、诺和诺德、武田、卫材，都来了）此前，有资深业内人士表示，随着分子胶理性发现的突破以及不断有积极研发进展披露，全球越来越多的MNC及Biotech相信分子胶具有开启小分子药物研发下一个黄金时代的巨大潜能。可以预见，未来2-3年将是分子胶赛道的一个爆发期。如今，越来越多的MNC齐聚分子胶赛道也势必会加速分子胶药物在临床上取得突破。参考资料： https://www.globenewswire.com/news-release/2024/10/29/2971307/0/en/Biogen-and-Neomorph-Announce-Multi-Target-Research-Collaboration-to-Discover-and-Develop-Molecular-Glue-Degraders-for-Alzheimer-s-Rare-and-Immunological-Diseases.html 推荐阅读超15亿美元！辉瑞“加码”分子胶超前布局AI赛道！AI制药明星公司“押中”三大诺奖领域 Copyright © 2024 PHARMCUBE. All Rights Reserved. 欢迎转发分享及合理引用，引用时请在显要位置标明文章来源；如需转载，请给微信公众号后台留言或发送消息，并注明公众号名称及ID。免责申明：本微信文章中的信息仅供一般参考之用，不可直接作为决策内容，医药魔方不对任何主体因使用本文内容而导致的任何损失承担责任。

细胞疗法引进/卖出

2024-10-25

·PMLiVE

Pfizer and Triana enter molecular glue degrader partnership worth over $1.5bn

Pfizer and Triana Biomedicines have entered into a strategic collaboration and licensing agreement worth over $1.5bn to discover molecular glue degraders (MGDs) for cancer and other severe diseases. MGDs are a new class of drugs that can be directed at targets that have previously been considered ‘undruggable’ by other approaches. The partnership will leverage Triana’s molecular glue and E3-ligase pairing platform to identify new MGDs against multiple targets across various disease areas, including oncology. Triana will lead the discovery and identification of potential development candidates, while Pfizer will have the option for an exclusive license to pursue further preclinical and clinical development. In exchange, Triana will receive an upfront payment of $49m from Pfizer and will be eligible for potential future milestone payments exceeding $1.5bn, as well as tiered royalties. Jeff Settleman, chief scientific officer of Pfizer Oncology, said: “We look forward to working together to advance scientific innovation for patients living with cancer.” Triana’s president and chief executive officer, Patrick Trojer, added that the company is “thrilled to partner with Pfizer to create potentially transformative medicines for disease targets with critical unmet needs”. Drugmakers have been increasingly focused on MGDs, which eliminate disease-causing proteins by promoting their interaction with the cell’s ubiquitin-proteasome system. In August, Eisai partnered with SEED Therapeutics to develop MGDs for multiple undisclosed neurodegeneration and oncology targets. The alliance, worth up to $1.5bn, will see SEED lead preclinical discovery activities for the selected targets, including E3 ligase selection and identification of appropriate MGDs. Eisai will then have exclusive rights to develop and commercialise any resulting compounds. Takeda entered the MGD field in May with its $1.2bn partnership with Degron Therapeutics for targets in oncology, neuroscience and inflammation, while Novo Nordisk entered into a $1.46bn collaboration and licensing agreement with Neomorph in February to develop MGDs for cardiometabolic and rare diseases. Other recent MGD-centred deals include Roche’s agreement with Monte Rosa Therapeutics and Merck & Co’s – known as MSD outside the US and Canada – multi-year collaboration with Proxygen.

引进/卖出蛋白降解靶向嵌合体

2024-10-16

·医药魔方Pro

超15亿美元！辉瑞“加码”分子胶

10月15日，TRIANA Biomedicines宣布与辉瑞达成战略合作和许可协议，为包括肿瘤学在内的多种疾病领域的多个靶点发现新型分子胶降解剂。根据合作协议条款，TRIANA将获得4900万美元的预付款，并有资格获得超过15亿美元的潜在里程碑付款。 TRIANA将利用其靶点优先和邻近优先（proximity-first）的分子胶发现平台，针对多个靶点发现分子胶降解剂。TRIANA负责潜在候选药物的发现工作。辉瑞拥有排他性选择权，可以获得独家许可并进一步推进临床前和临床开发。 TRIANA总部位于美国马萨诸塞州，2019年由RA Capital Management和Atlas Venture创立，并于当年完成种子轮融资。2022年4月，TRIANA完成1.1亿美元A轮融资，值得一提的是，当时辉瑞也作为跟投方参与了TRIANA的A轮融资。 TRIANA专注于构建领先的分子胶发现平台，以靶向难成药的疾病靶点。TRIANA目前专注于诱导/增强癌症靶点的降解。TRIANA的治疗方法有可能从根本上改变小分子药物发现的范式，并为许多患者带来显著的治疗益处。分子胶作用机制（来源：TRIANA官网） TRIANA总裁兼首席执行官Patrick Trojer博士表示：“很高兴能与辉瑞合作，利用我们的分子胶和E3连接酶配体平台，为具有关键未满足需求的疾病靶点创造潜在的变革性药物。TRIANA正朝着实现其以产品为中心的战略迈进，这项合作协议标志着公司发展过程中的一个重要里程碑。” 2024年以来，制药巨头充分展露了布局分子胶降解剂的热情： 2月，BMS与VantAI合作，借助生成式AI技术加速分子胶的发现； 2月，诺和诺德与Neomorph合作，发现用于心脏代谢和罕见疾病的新型分子胶降解剂； 5月，武田与达歌生物合作，发现和开发用于肿瘤学、神经科学和炎症领域多个靶点的新型分子胶降解剂； 8月，卫材与SEED Therapeutics合作，发现、开发及商业化用于多个未公开神经退行性疾病及肿瘤靶点的新型分子胶降解剂。（推荐阅读：分子胶火爆！罗氏、BMS、诺和诺德、武田、卫材，都来了）此前，有资深业内人士表示，随着分子胶理性发现的突破以及不断有积极研发进展披露，全球越来越多的MNC及Biotech相信分子胶具有开启小分子药物研发下一个黄金时代的巨大潜能。可以预见，未来2-3年将是分子胶赛道的一个爆发期。如今，越来越多的MNC齐聚分子胶赛道也势必会加速分子胶药物在临床上取得突破。参考资料： https://trianabio.com/press-release-10152024 Copyright © 2024 PHARMCUBE. All Rights Reserved. 欢迎转发分享及合理引用，引用时请在显要位置标明文章来源；如需转载，请给微信公众号后台留言或发送消息，并注明公众号名称及ID。免责申明：本微信文章中的信息仅供一般参考之用，不可直接作为决策内容，医药魔方不对任何主体因使用本文内容而导致的任何损失承担责任。

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