更新于：2024-05-01

survivin

杆状病毒IAP重复包含蛋白-5

更新于：2024-05-01

基本信息

别名

生存素、API4、Apoptosis inhibitor 4

+ [9]

简介

Multitasking protein that has dual roles in promoting cell proliferation and preventing apoptosis (PubMed:9859993, PubMed:21364656, PubMed:20627126, PubMed:25778398, PubMed:28218735). Component of a chromosome passage protein complex (CPC) which is essential for chromosome alignment and segregation during mitosis and cytokinesis (PubMed:16322459). Acts as an important regulator of the localization of this complex; directs CPC movement to different locations from the inner centromere during prometaphase to midbody during cytokinesis and participates in the organization of the center spindle by associating with polymerized microtubules (PubMed:20826784). Involved in the recruitment of CPC to centromeres during early mitosis via association with histone H3 phosphorylated at 'Thr-3' (H3pT3) during mitosis (PubMed:20929775). The complex with RAN plays a role in mitotic spindle formation by serving as a physical scaffold to help deliver the RAN effector molecule TPX2 to microtubules (PubMed:18591255). May counteract a default induction of apoptosis in G2/M phase (PubMed:9859993). The acetylated form represses STAT3 transactivation of target gene promoters (PubMed:20826784). May play a role in neoplasia (PubMed:10626797). Inhibitor of CASP3 and CASP7 (PubMed:21536684). Essential for the maintenance of mitochondrial integrity and function (PubMed:25778398). Isoform 2 and isoform 3 do not appear to play vital roles in mitosis (PubMed:12773388, PubMed:16291752). Isoform 3 shows a marked reduction in its anti-apoptotic effects when compared with the displayed wild-type isoform (PubMed:10626797).

关联

项与 survivin 相关的药物

SVN53-67/M57-KLH peptide vaccine

靶点

survivin

作用机制

survivin抑制剂

在研机构

Roswell Park Cancer Institute [+3]

原研机构

Roswell Park Cancer Institute

在研适应症

胶质母细胞瘤 [+2]

非在研适应症

自身免疫性疾病 [+1]

最高研发阶段临床2期

首次获批国家/地区-

首次获批日期1800-01-20

Sepantronium Bromide

靶点

survivin

作用机制

survivin抑制剂

在研机构

北京智康博药肿瘤医学研究有限公司 [+1]

原研机构

Astellas Pharma, Inc.

在研适应症

伯基特淋巴瘤 [+3]

非在研适应症

晚期非小细胞肺癌 [+7]

最高研发阶段临床2期

首次获批国家/地区-

首次获批日期1800-01-20

CV-9202

靶点

5T4 x MAGEC1 x MAGEC2 x MUC1 x NY-ESO-1 x survivin

作用机制

5T4抑制剂 [+5]

在研机构

Ludwig Institute for Cancer Research Ltd. [+2]

原研机构

Cancer Research Institute

在研适应症

非小细胞肺癌

非在研适应症-

最高研发阶段临床2期

首次获批国家/地区-

首次获批日期1800-01-20

项与 survivin 相关的临床试验

NCT06206876 / Not yet recruiting临床1期IIT

First-in-Human Phase I Trial of FL118 in Patients With Advanced Pancreatic Ductal Adenocarcinoma

This phase I trial tests the safety, side effects, and best dose of FL118 in treating patients with pancreatic ductal adenocarcinoma that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). FL118 is a small anti-tumor molecule that inhibits the expression of multiple cancer-associated anti-apoptotic proteins. An anti-apoptotic protein is a protein that interferes with or inhibits cell death. In adults, apoptosis is used to rid the body of cells that have been damaged beyond repair. Apoptosis also plays a role in preventing cancer. If apoptosis is for some reason prevented, it can lead to uncontrolled cell production that can subsequently develop into a tumor. FL118 has been shown to inhibit or block the proteins that prevent damaged/mutated (genetically changed) cells from dying, and, by doing so, prevent the growth of cancerous cells and tumor development.

开始日期2024-10-01

申办/合作机构

Roswell Park Cancer Institute

NCT06202066 / Not yet recruiting临床2期IIT

A Phase II Study of Temozolomide and Survivin Long Peptide Vaccine (SurVaxM) in Patients With Progressing Metastatic Neuroendocrine Tumors (NETs)

This phase II trial compares the safety and effect of temozolomide combined with survivin long peptide vaccine (SurVaxM) to temozolomide alone in patients with neuroendocrine tumors (NET) that has spread from where it first started (primary site) to other places in the body (metastatic) and is growing, spreading or getting worse (progressing). Temozolomide is in a class of medications called alkylating agents. It works by damaging the cell's deoxyribonucleic acid and may kill tumor cells and slow down or stop tumor growth. Survivin, a protein, is expressed in 50% of patients that have neuroendocrine tumors and, is associated with poor outcomes. SVN53-67/M57-KLH peptide vaccine (SurVaxM) is a vaccine that has been shown to produce an immune system response against cancer cells that express a survivin and may block the growth of new tumor cells. Giving temozolomide with SurVaxM may kill more tumor cells in patients with progressing metastatic neuroendocrine tumors.

开始日期2024-04-15

申办/合作机构

Roswell Park Cancer Institute

NCT05798897 / Recruiting临床1期

A Phase 1 Study of Patient-Derived Multi-Tumor-Associated Antigen-Specific T Cells (MT-601) Administered to Patients With Relapsed or Refractory Non-Hodgkin Lymphoma (NHL [APOLLO])

This study is a Phase 1multicenter study with a Dose Escalation and Dose Expansion evaluating safety and efficacy of MT-601 administration to patients with Relapsed or Refractory NHL. The dose administered is 200 x 10^6 cells (flat dosing).

开始日期2023-01-02

申办/合作机构

Marker Therapeutics, Inc.

100 项与 survivin 相关的临床结果

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100 项与 survivin 相关的转化医学

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0 项与 survivin 相关的专利（医药）

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10,247

项与 survivin 相关的文献（医药）

2024-02-23·Molecular biology reports

Juglone-ascorbate treatment enhances reactive oxygen species mediated mitochondrial apoptosis in pancreatic cancer.

Article

作者: Dudu Erkoc-Kaya ; Hilal Arikoglu ; Ebru Guclu ; Duygu Dursunoglu ; Esma Menevse

BACKGROUND:

Treatment of Pancreatic Cancer (PC) is challenging due to its aggressiveness and acquired resistance to conventional chemotherapy and radiotherapy. Therefore, the discovery of new therapeutic agents and strategies is essential. Juglone, a naphthoquinone, is a secondary metabolite produced naturally in walnut-type trees having allelopathic features in its native environment. Juglone was shown to prevent cell proliferation and induce ROS-mediated mitochondrial apoptosis. Ascorbate with both antioxidant and oxidant features, shows selective cytotoxicity in cancer cells.

METHODS AND RESULTS:

In this study, we evaluated the anticancer effects of Juglone in combination with ascorbate in PANC-1 and BxPC-3 PC cells. The MTT assay was used to determine the IC₅₀ dose of Juglone with 1 mM NaAscorbate (Jug-NaAsc). Subsequently, the cells were treated with 5, 10, 15 and 20 µM Jug-NaAsc for 24 h. Apoptotic effects were evaluated by analyzing the following genes using qPCR; proapoptotic Bax, antiapoptotic Bcl-2 related to the mitochondrial apoptotic pathway and apoptosis inhibitor Birc5 (Survivin). Immunofluorescence analysis was performed using Annexin V-FITC in PC cells. As an antioxidant enzyme, Trx2 protein levels were determined by a commercial ELISA test kit. Jug-NaAsc treatment decreased the expressions of antiapoptotic genes Bcl-2 and Birc5 while the apoptotic gene Bax expression increased at all doses. Additionally, a dose-dependently increase of apoptosis according to immunofluorescence analysis and the decreases of Trx2 enzyme levels at all treatments in both cell lines supported gene expression results.

CONCLUSION:

Our results suggest that Juglone is a potential anticancer agent especially when combined with ascorbate.

2024-02-22·Oncotarget

Sacituzumab govitecan plus platinum-based chemotherapy mediates significant antitumor effects in triple-negative breast, urinary bladder, and small-cell lung carcinomas.

Article

作者: Thomas M Cardillo ; Maria B Zalath ; Roberto Arrojo ; Robert M Sharkey ; Serengulam V Govindan ; Chien-Hsing Chang ; David M Goldenberg

Sacituzumab govitecan (SG) is an antibody-drug conjugate composed of an anti-Trop-2-directed antibody conjugated with the topoisomerase I inhibitory drug, SN-38, via a proprietary hydrolysable linker. SG has received United States Food and Drug Administration (FDA) approval to treat metastatic triple-negative breast cancer (TNBC), unresectable locally advanced or metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer, and accelerated approval for metastatic urothelial cancer. We investigated the utility of combining SG with platinum-based chemotherapeutics in TNBC, urinary bladder carcinoma (UBC), and small-cell lung carcinoma (SCLC). SG plus carboplatin or cisplatin produced additive growth-inhibitory effects in vitro that trended towards synergy. Immunoblot analysis of cell lysates suggests perturbation of the cell-cycle and a shift towards pro-apoptotic signaling evidenced by an increased Bax to Bcl-2 ratio and down-regulation of two anti-apoptotic proteins, Mcl-1 and survivin. Significant antitumor effects were observed with SG plus carboplatin in mice bearing TNBC or SCLC tumors compared to all controls (P < 0.0062 and P < 0.0017, respectively) and with SG plus cisplatin in UBC and SCLC tumor-bearing animals (P < 0.0362 and P < 0.0001, respectively). These combinations were well tolerated by the animals. Combining SG with platinum-based chemotherapeutics demonstrates the benefit in these indications and warrants further clinical investigation.

2024-02-07·Biomolecules

Terpenoid-Mediated Targeting of STAT3 Signaling in Cancer: An Overview of Preclinical Studies.

Review

作者: Fahad Khan ; Pratibha Pandey ; Meenakshi Verma ; Tarun Kumar Upadhyay

Cancer has become one of the most multifaceted and widespread illnesses affecting human health, causing substantial mortality at an alarming rate. After cardiovascular problems, the condition has a high occurrence rate and ranks second in terms of mortality. The development of new drugs has been facilitated by increased research and a deeper understanding of the mechanisms behind the emergence and advancement of the disease. Numerous preclinical and clinical studies have repeatedly demonstrated the protective effects of natural terpenoids against a range of malignancies. Numerous potential bioactive terpenoids have been investigated in natural sources for their chemopreventive and chemoprotective properties. In practically all body cells, the signaling molecule referred to as signal transducer and activator of transcription 3 (STAT3) is widely expressed. Numerous studies have demonstrated that STAT3 regulates its downstream target genes, including Bcl-2, Bcl-xL, cyclin D1, c-Myc, and survivin, to promote the growth of cells, differentiation, cell cycle progression, angiogenesis, and immune suppression in addition to chemotherapy resistance. Researchers viewed STAT3 as a primary target for cancer therapy because of its crucial involvement in cancer formation. This therapy primarily focuses on directly and indirectly preventing the expression of STAT3 in tumor cells. By explicitly targeting STAT3 in both in vitro and in vivo settings, it has been possible to explain the protective effect of terpenoids against malignant cells. In this study, we provide a complete overview of STAT3 signal transduction processes, the involvement of STAT3 in carcinogenesis, and mechanisms related to STAT3 persistent activation. The article also thoroughly summarizes the inhibition of STAT3 signaling by certain terpenoid phytochemicals, which have demonstrated strong efficacy in several preclinical cancer models.

项与 survivin 相关的新闻（医药）

2024-04-03

·BioSpace

BioVaxys Announces Allowance of DPX Formulation Patent for the United States and Filing of Additional International Patent Applications for Phase 1 DPX SurMAGE

VANCOUVER, B.C., April 3, 2024 /PRNewswire/ -- BioVaxys Technology Corp. (CSE: BIOV) (FRA: 5LB) (OTCQB: BVAXF) ("BioVaxys" or "Company") announced that it has received a Notice of Allowance from the United States Patent and Trademark Office ("USPTO") for a Patent ("Patent") for inducing an antibody immune response from a low dose volume delivery of a B-cell epitope formulated with DPX™. Part of the extensive Intellectual Property portfolio acquired by BioVaxys from the former IMV, Inc, this Patent was recently allowed in Japan and is currently pending in the European Union. DPX™ is a proprietary lipid-based delivery platform with no aqueous component that can be formulated with a range of packaged antigens, proteins, peptides, mRNA, or small molecules. Its unique "no release" mechanism of action allows antigen presenting cells (APCs) to be attracted to the injection site, facilitating a robust and sustained immune response. The smallest dose of a currently approved vaccine is 0.1ml for Sanofi-Pasteur's Fluzone™ Intradermal Quadrivalent vaccine. Low dose volume delivery of DPX™ formulated B-cell epitope is designed to be delivered in single dose as low as 50µL to 90 µL. An epitope is the part of an antigen that the host's immune system recognizes, eliciting the immune response to an invading pathogen. It specifically binds to the corresponding antigen receptor on the immune cell (such as a B-cell). Whereas T-cells protect people from getting infected by destroying cancerous and infected cells, B-cells produce antibodies to fight infection. BioVaxys President and Chief Operating Officer Kenneth Kovan stated "Allowance of this important patent in the United States greatly expands the value of our IP and antigen delivery platform with potential partners. Having the unique ability to deliver B cell epitopes using a low dose DPX™ formulation is an attractive approach for packaging antigens for a range of cancer immunotherapeutics and therapeutic vaccines." BioVaxys also is pleased to announce it has entered the national phase in the United States, Canada, European Union, Japan, and Australia with its patent application for DPX™-survivin/MAGE A9 ("DPX™ SurMAGE"), a DPX™ formulation of the tumor-associated antigens survivin and MAGE A9 as a dual targeted immunotherapy. The survivins and MAGE-A9 are frequently over-expressed in various human cancers including bladder, lung and kidney, and correlate with a resistance to chemotherapy and aggressiveness of tumors, and both are recognized as important targets for cancer vaccines and therapeutics. DPX™ SurMAGE" recently completed a successful Phase I clinical study in Canada with bladder cancer patients conducted at CHU de Québec-Université Laval, and induced a robust peptide-specific T cell response. Kovan further added that "BioVaxys and the Phase 1 clinical study investigators see the potential with further evaluation of DPX™ SurMAGE, and are particularly excited by the proven ability of DPX™ to package multiple different antigens. We will be reconvening with the study team at CHU de Québec-Université Laval to plan further development." About BioVaxys Technology Corp. BioVaxys Technology Corp. ( ), a biopharmaceuticals company registered in British Columbia, Canada, is a clinical-stage biopharmaceutical company dedicated to improving patient lives with novel immunotherapies based on the DPX™ immune-educating technology platform and its HapTenix© 'neoantigen' tumor cell construct platform for treating cancers, infectious disease, antigen desensitization, and other immunological fields. The Company's clinical stage pipeline includes maveropepimut-S which is in Phase II clinical development for advanced Relapsed-Refractory Diffuse Large B Cell Lymphoma (DLBCL) and platinum resistant ovarian cancer, and BVX-0918, a personalized immunotherapeutic vaccine using its proprietary HapTenix© 'neoantigen' tumor cell construct platform which is soon to enter Phase I in Spain for treating refractive late-stage ovarian cancer. The Company is also capitalizing on its tumor immunology know-how and creation of a unique library of T-lymphocytes & other datasets post-vaccination with its personalized immunotherapeutic vaccines to utilize predictive algorithms and other technologies to identify new targetable tumor antigens. BioVaxys common shares are listed on the CSE under the stock symbol "BIOV" and trade on the Frankfurt Bourse (FRA: 5LB) and in the US (OTCQB: BVAXF). For more information, visit and connect with us on X and LinkedIn. ON BEHALF OF THE BOARD Signed "James Passin" James Passin, CEO +1 646 452 7054 Company Codes: Copenhagen:BIOV, OTC-BB:BVAXF, OTC-PINK:BVAXF, OTCQB:BVAXF

免疫疗法临床1期疫苗临床2期

2024-02-23

·药精通Bio

mRNA肿瘤疫苗的研发进度与展望（附2023年度国内企业进展）

IVC2024第四届核酸疫苗与创新型疫苗论坛议程曝光点击图片查看，报名倒计时6天：（扫码立即领取限量免费参会入场券）来源：医麦客作者：香香，RNAScript排版：Vergil随着近年来对肿瘤生物学理解的不断深入，基因组学和蛋白质组学等先进的医疗技术已经成为最新突破和开发新型诊断和治疗方案的关键，特别是肿瘤特异性的靶点或表位，以及多样化的生物标志物的发现，对于mRNA癌症疫苗的开发有重大意义。本文将结合近日华西医院发表在Trends in immunology的综述[1]，对mRNA肿瘤疫苗免疫疗法的近期进展与未来趋势进行浅析。科技成果的转化总是面临重重挑战，但“办法总比困难多”。目前，通过化学修饰增强mRNA的稳定性和翻译，同时减少先天免疫响应已是业内共识；打造新型递送平台不仅可以保护mRNA免于降解并促进细胞摄取和内体逃逸，还具有佐剂活性，可以增强免疫反应而无全身毒性。LNP是目前研究最深入、临床最成熟的载体，辉瑞/BioNTech的BNT162b2和Moderna的mRNA-1273新冠疫苗均采⽤LNP形式。与阳离⼦脂质相⽐，可电离脂质可以根据环境酸碱性改变其状态，便于封装及在体内延长半衰期，并提高翻译效率及稳定性。聚合物基纳⽶颗粒和⽆机纳⽶载体的优势在于其卓越的稳定性，⽽ DC 和 EV 则在免疫调节能⼒和⽣物相容性上更胜一筹。VLP、外泌体、GalNAc、SORT-LNP等新型非病毒载体全面开花，如何扬长避短的取舍。▲不同递送载体的优劣势（图源引用文献1）除了在递送载体的种类上下功夫，对淋巴及肝外组织的靶向研究也是进行的如火如荼。2023年，仅就LNP的特异性靶向方面就有靶向胎盘[2]、骨髓组织[3]、胰腺[4]等多种器官的研究层出不穷。麻省理工Daniel Anderson团队还开发了迄今最高效的向肺部递送mRNA的雾化脂质纳米颗粒（LNP）配方，为肺部疾病的基因治疗带来了更有潜力的递载体。除了常规的化学修饰和靶向递送“两手抓”之外，想要让更多患者受益，免疫逃逸也是亟待解决的问题。纳米载体技术和分析测序技术的发展也给可以增强抗原呈递的个性化mRNA疫苗开发带来了突破性进展。通过对肿瘤生物学及免疫抑制肿瘤微环境（TME）的深入了解，T细胞反应程度的掌握，疫苗与佐剂配方的不断完善以及合适的目标患者的选择等方式，都可以在一定程度上改善现状。此外，得益于下一代测序、增强的计算能力和先进的算法使鉴定高免疫原性新抗原成为可能，为避免在抗原递呈环节给肿瘤可乘之机，研究者们将个性化肿瘤新抗原的治疗性疫苗的开发逐步落实。Moderna和默沙东今年ASO年会公布的针对切除的高危黑色素瘤（III/IV期）患者的肿瘤新抗原疫苗mRNA-4157（V940）与PD-1（K药）联合治疗结果，在总意向治疗（ITT）人群中，mRNA-4157与Keytruda联合的辅助治疗在次要终点无远处转移生存期（DMFS）上显示出统计学显著和临床有意义的改善，与单独使用Keytruda相比，降低肿瘤产生远处转移或死亡的风险达65%（HR=0.347，95% CI：0.145-0.828；单侧P值=0.0063）。▲mRNA 疫苗的分⼦和细胞机制⽰例（图源引用文献1）另外一位mRNA巨头也没闲着，2023年5月，Nature刊载了BioNTech、基因泰克及MSKCC的一项肿瘤新抗原疫苗的小规模临床研究：针对极易复发、5年生存率不到10%且几乎无药可用的胰腺导管癌（PDAC）进行化疗+PD-L1（T药）+肿瘤新抗原疫苗组合治疗，在16例给药患者中，8位患者出现了针对新抗原的T细胞免疫反应，并在整个研究周期内（18个月）都没有出现癌症复发。未出现新抗原免疫反应的患者则大部分都出现了复发，其复发时间的中位数是13.4个月。虽然实验本身没有设置对照组，但从刚好一半对一半的患者表现来看，可以合理推测肿瘤新抗原起到了关键作用。肿瘤新抗原疫苗与免疫检查点抑制剂的联合疗法突出了mRNA疫苗在癌症防治方面的重大潜力，也打开了mRNA疫苗结合免疫检查点抑制剂和其他治疗方案的探索之门。还是以免疫检查点抑制剂为例，疫苗增强抗原特异性T细胞，而检查点阻断抵消了肿瘤微环境中的免疫抑制，二者可能产生协同作用，从而获得比单一药物更好的效果，加上前文所述的在防止癌症复发方面展现的显著效果，与mRNA疫苗的联合治疗方案有望成为抵消TME的免疫抑制环境，减轻免疫治疗耐药性的优选之策。 ▲mRNA疫苗单药及联合疗法临床试验汇总（图源引用文献1）值得期待的mRNA肿瘤疫苗进展一览随着免疫检查点抑制剂和过继细胞疗法等免疫疗法的发展和批准，癌症的治疗方案发生了历史性的变革，作为这次“癌症治疗革命”大潮中的一份子，癌症疫苗在传统的预防性功能基础上，衍生出了专门用于强化患者的免疫系统的治疗性癌症疫苗。同时，得益于精准医疗的前沿进展，个性化癌症疫苗也从设想逐步化为现实，值得期待。有望成为首个上市mRNA肿瘤疫苗研发机构：Moderna & 默沙东项目管线：mRNA-4157（V940），3期适应症：经手术切除高风险黑色素瘤（IIB-IV期）mRNA-4157癌症疫苗是根据每位患者肿瘤独特的DNA序列突变特征通过算法设计而成，包含编码最多34种新抗原的单一合成mRNA分子。凭借2期临床（NCT03897881）FDA和EMA分别授予mRNA-4157与Keytruda组合突破性疗法认定和PRIME资格，作为辅助疗法用以治疗完全切除后的高风险黑色素瘤患者。2023年7月开启了V940-001关键性3期临床。“与市面上最好的免疫检查点阻断疗法相比，我们让一半的患者存活下来，这在癌症治疗领域是个巨大的突破。现有的临床证据已经为有条件批准这款mRNA癌症疫苗（mRNA-4157）奠定基础。”Moderna公司首席执行官 Stephane Bancel 在接受采访时表示：“Moderna针对黑色素瘤的mRNA癌症疫苗可能在两年内上市，这将是抗击这种最严重形式的皮肤癌的里程碑式一步。”有望攻克“癌症之王”研发机构：BioNTech & 基因泰克（罗氏）项目管线：autogene cevumeran（RG6180，BNT122），2期适应症：胰腺导管腺癌（PDAC）Autogene cevumeran是一款基于BioNTech的iNeST癌症疫苗技术平台生成的个体化新抗原疫苗，可以编码数十种新抗原。2023年5月的早期临床结果表明其成功诱导出了靶向胰腺癌癌症新抗原的T细胞活性显示该疗法，显著推迟接受手术切除的胰腺癌患者的复发时间。2023年10月19日，BioNTech宣布已启动Autogene cevumeran的2期临床试验（NCT05968326），用于PDAC患者的辅助治疗。除了PDAC，针对结直肠癌和黑色素瘤的2期临床试验正在进行中。BioNTech联合创始人兼首席医疗官Özlem Türeci博士表示：“最近的1期研究表明，个性化新抗原疫苗接种对于这种具有低突变负荷和免疫抑制微环境肿瘤类型是可行的。自2014年启动的首次临床试验以来，我们一直在评估不同肿瘤的突变，不断探索更多mRNA个性化癌症疫苗的合适靶标。本次2期试验将为我们提供更多数据，帮助Autogene cevumeran在高度未满足的医疗需求环境中更好地为患者提供益处。”国内首个新抗原DC癌症疫苗研发机构：立康生命科技项目管线：LK101，1期适应症：晚期实体瘤LK101是一种个性化的新抗原靶向癌症疫苗，也是一种基于树突状细胞 (DC) 的 mRNA 疫苗，采用专利技术结合 mRNA 和 DC 的优势，根据数10种患者特异性肿瘤突变信息将编码个性化肿瘤抗原靶点的 mRNA 转导到树突状细胞中，从而激活针对癌细胞的特异性免疫反应，有望治疗多种晚期实体瘤。据报道，2018年LK101曾在中国人民解放军总医院（301）进行了针对肝癌术后患者的临床试验，初步数据显示，LK101在所有患者中检测到抗肿瘤新抗原免疫反应的激活，并在术后复发率和生存率方面显示出显着优势，安全性良好。研究人员表示：“后续，LK101的有效性、稳定性将在临床试验中经历严苛考验，同时成本控制、生产工艺等方面也还有很长一段路要走。按照计划，明年将进入临床二期阶段，5到8年后有望实现上市！这意味着，中国的患者有望迎来首款治疗癌症的疫苗！”破解PD-1耐药难题研发机构：OSE Immunotherapeutics项目管线：Tedopi，2期适应症：非小细胞肺癌（NSCLC），PDAC，复发性卵巢癌Tedopi的设计非常有特点：从5个肿瘤相关抗原中筛选出10个最佳新抗原表位（neo-epitope），再进行组合，刺激T淋巴细胞识别和攻击癌细胞。早期研究证明，Tedopi可激发细胞毒性T细胞对癌细胞的特异性反应和相关的辅助型T细胞反应。目前，Tedopi正在进行2期临床试验，旨在治疗PDAC和复发性卵巢癌患者。根据2023年9月发表在Annals of Oncology杂志上的研究结果，对于那些在连续接受化疗和免疫检查点抑制剂治疗至少12周后仍出现病情进展的HLA-A2阳性晚期或转移性NSCLC患者，Tedopi作为单药疗法与化疗相比，不仅可以提高总生存率，而且具有更好的安全性和生活质量。这些结果为那些已经用尽常规治疗方法、没有太多其他选择的患者带来了希望。借力AI新机遇研发机构：Transgene & NEC项目管线：TG4050，1期（2期临床试验即将启动）适应症：卵巢癌，HPV阴性头颈癌TG4050是一款基于MVA病毒载体的治疗性疫苗。NEC公司的AI新抗原预测系统可以识别和选择患者的特异性突变，TG4050可以表达的30多种肿瘤新抗原均由NEC的AI系统选择。目前，该疫苗正在进行治疗卵巢癌和HPV阴性头颈癌的1期临床试验。同时，为了进一步探索TG4050在头颈癌辅助治疗中的潜力，Transgene和NEC公司正筹备开展一项2期临床试验。2023年ASCO年会上展示了TG4050治疗HPV阴性头颈癌患者的1期试验的新数据。数据表明，所有可评估的患者在接受TG4050治疗后都对多种癌症新抗原产生了特异性免疫应答，包含那些在基线时全身免疫状态和肿瘤微环境不利免疫反应产生的患者。同时还报告了两个病例研究：在这些接受TG4050治疗后保持缓解状态的患者中，通过四聚体染色（tetramer staining）评估的结果证实，这些患者的免疫活性T细胞频率大幅增加，进一步证明，TG4050能够诱导抗肿瘤细胞免疫应答。国产mRNA肿瘤疫苗遍地开花mRNA技术领跑全球的Moderna、BioNTech，依靠AI生信技术进行肿瘤新抗原筛选也不过在今年初刚刚起步，而国内多家企业不乏像纽安津生物、新合生物等在新生抗原筛选平台及算法上布局多项专利，并有长期数据积累的优秀企业，早已在新抗原的筛选上走得很远。据不完全统计，我国专注mRNA技术开发的至少有26家，并仍在急剧增加，可以说我国mRNA肿瘤疫苗的研发力量并不逊色全球领先水准。其中，斯微生物自主研发的SWP1001是世界范围内首个获得临床批件的国产自主研发编码新抗原mRNA个性化肿瘤疫苗，也是国内首家进入临床研究公司。2023年4月，艾博生物与广州呼吸健康研究院联合启动自主研发肺癌新抗原mRNA疫苗临床研究项目。2023年6月，艾博生物首款mRNA肿瘤药物ABO2011注射液是一款编码人源IL-12mRNA的新型抗肿瘤药物，通过表达IL-12蛋白，激活免疫细胞以发挥抗肿瘤活性。11月17日，臻知医学与艾博生物共同宣布，其合作的全球首创编码近20种肝癌抗原的mRNA疫苗完成首次人体给药，该疫苗经肌肉注射后可诱导患者自身免疫系统恢复抗肿瘤能力。嘉晨西海的JCXH-211是全球首款表达细胞因子的自复制mRNA癌症治疗药物，标准治疗后进展或对标准治疗不耐受的实体瘤患者（目前仅入组头颈癌和黑色素瘤），目前在中美同步进行临床试验。自复制mRNA癌症疫苗JCXH-212也已进入2期临床试验。2023年1月，启辰生生物治疗原发性脑胶质母细胞瘤的mRNA-DC疫苗—Survivin DC细胞注射液，获得CDE的临床试验批准，成为国内首个获批开展临床试验的mRNA-DC肿瘤治疗性疫苗产品。2024年新年伊始，启辰生生物宣布全球首个靶向Survivin靶点的用于治疗脑胶质母细胞瘤的mRNA-DC肿瘤疫苗，在首都医科大学附属北京天坛医院神经外科病区进行了DC细胞分离机操作培训，标志着该临床试验已经完成各项准备工作，进入到实质开展阶段。威斯津生物鼻咽癌治疗用1类新药EBV-mRNA疫苗于2023年2月启动1期临床。新合生物自主开发的一款全球首创靶点的靶向胃癌公共新抗原的治疗性mRNA肿瘤疫苗，其肿瘤新抗原预测系统的新抗原预测准确率达75%，即将步入临床阶段。2023年8月26日，思路迪医药(3D Medicines Inc.)和上海翊斯生物医药科技有限公司（翊斯生物）宣布达成合作开发协议，共同致力于下一代mRNA肿瘤疫苗。2023年9月，邵逸夫医院与纽安津生物合作启动针对消化道肿瘤的个性化肿瘤新抗原mRNA疫苗IIT临床试验。2023年9月，四川康德赛医疗科技有限公司（以下简称“康德赛”）自主研发用于治疗晚期卵巢癌的个体化树突状细胞（以下简称“DC”）CUD002注射液临床试验的申请获临床试验默示许可。该产品为中国首款基于卵巢癌患者肿瘤新生抗原的mRNA编辑DC肿瘤疫苗。2023年11月6日，仁景生物宣布，公司自主研发的HPV相关肿瘤治疗性mRNA疫苗RG002已于2023年10月27日获得美国食品药品监督管理局（FDA）新药临床试验申请（IND）许可，用于治疗人乳头瘤病毒（HPV）16型和/或18型相关的2级或3级宫颈上皮内瘤变（CIN2/3），成为全球首个批准开展该适应症临床试验的mRNA-LNP治疗性疫苗。公司正同步推进国家药品监督管理局（NMPA）的临床试验申请。2023年11月，瑞宏迪医药宣布，由上海瑞宏迪医药支持，以中国人民解放军总医院肝胆胰外科医学部刘荣主任为主要研究者发起的“新抗原个性化mRNA肿瘤疫苗治疗胰腺癌安全性探索”临床研究(PANC-IIT-HRXG-K-1939；ChiCTR2300077339）顺利完成国内首例胰腺癌患者mRNA肿瘤疫苗（HRXG-K-1939注射液）给药，针对≥2线标准治疗失败或不耐受的晚期胰腺癌患者。2023年11月，远大医药附属公司南京奥罗生物科技有限公司(简称：奥罗生物)的针对人类乳头瘤病毒16型(HPV-16)阳性的晚期不可切除或复发/转移性实体瘤的治疗性肿瘤疫苗ARC01(A002)的新药临床试验申请(IND)获得国家药监局正式受理。可以预见，未来mRNA肿瘤疫苗将在触发有效免疫反应的同时，有效防⽌脱靶毒性，并将通过联合用药等形式在抗癌方面发挥更为多样性的功能。参考资料1.doi:10.1016/j.it.2023.11.0032.https://doi.org/10.1016/j.bioactmat.2023.11.0143.doi:10.1002/advs.2023701414.doi:10.1126/sciadv.ade1444ENDIVC2024第四届核酸疫苗与创新型疫苗论坛招商热线：李欣欣 158 0045 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疫苗信使RNA免疫疗法

2024-02-21

·PRNewswire

BIOVAXYS COMPLETES THE ACQUISITION OF ALL INTELLECTUAL PROPERTY, IMMUNOTHERAPEUTICS PLATFORM TECHNOLOGY, AND CLINICAL STAGE ASSETS OF THE FORMER IMV INC.

VANCOUVER, BC, Feb. 21, 2024 /PRNewswire/ -- BioVaxys Technology Corp. (CSE: BIOV) (FRA: 5LB) (OTCQB: BVAXF) ("BioVaxys" or "Company") is pleased to announce has completed the acquisition of the entire portfolio of discovery, preclinical and clinical development stage assets of former Canadian biotechnology company, IMV Inc., Immunovaccine Technologies Inc., and IMV USA ("IMV"). On February 11th, 2024, the Company executed the definitive Asset Purchase Agreement for the extensive technology portfolio from HIMV, LLC, an acquisition vehicle formed by Horizon Technology Finance Corporation (NASDAQ: HRZN) and IMV's other secured creditors for the purpose of acquiring IMV's intellectual property through a secured party credit bid in the proceedings commenced in Canada by IMV under the Companies' Creditors Arrangement Act, R.S.C. 1985, c. C-36, as amended (the "CCAA"). At the closing, BioVaxys delivered to HIMV a one-time payment of both US$750,000 in cash and 5,034,701 common shares of BioVaxys at a deemed price of CAD$0.067. With the transaction now complete, BioVaxys is working on integrating the acquired assets into the Company. BioVaxys President and Chief Operating Officer Kenneth Kovan stated "We now have massive opportunities in oncology, infectious disease, allergy desensitization, and autoimmune diseases. Adding several clinical-stage programs was critical for us becoming a product-centric company, but there are always inherent risks with clinical programs, and they require significant investment. Maveropepimut-S has incredible potential and is a very important addition to our oncology pipeline." Kovan further stated "Over the upcoming months our plan is to drive more organic growth by pursuing multiple licensing and partnership opportunities with the DPX™ and HapTenix© platforms. We will be identifying target partners where our solutions can address specific needs or gaps, making BioVaxys an attractive 'go-to' partner for targeted immunotherapies." The Company has identified potential for DPX™ in improved mRNA vaccines, multivalent viral vaccines, vaccines for desensitizing immune response for peanut allergies, and immune system diseases. Prior clinical studies by IMV have supported proof of concept and a superior immune response with a DPX™-RSV formulation, DPX™-rHA/DPX-FLU influenza vaccine, DPX™-packaged survivin/MAGE-Ag for advanced metastatic bladder cancer, and certain other infectious diseases. About BioVaxys Technology Corp. BioVaxys Technology Corp. (), a biopharmaceuticals company registered in British Columbia, Canada, is a clinical-stage company dedicated to improving patient lives with novel immunotherapies based on the DPX™ immune-educating technology platform and it's HapTenix© 'neoantigen' tumor cell construct platform, for treating cancers, infectious disease, antigen desensitization, and other immunological fields. The Company's clinical stage pipeline includes maveropepimut-S which is in Phase II clinical development for advanced Relapsed-Refractory Diffuse Large B Cell Lymphoma (DLBCL) and platinum resistant ovarian cancer, and BVX-0918, a personalized immunotherapeutic vaccine using its proprietary HapTenix© 'neoantigen' tumor cell construct platform which is soon to enter Phase I in Spain for treating refractive late-stage ovarian cancer. The Company is also capitalizing on its tumor immunology know-how and creation of a unique library of T-lymphocytes & other datasets post-vaccination with its personalized immunotherapeutic vaccines to utilize predictive algorithms and other technologies to identify new targetable tumor antigens. BioVaxys common shares are listed on the CSE under the stock symbol "BIOV" and trade on the Frankfurt Bourse (FRA: 5LB) and in the US (OTCQB: BVAXF). Contact: James Passin, CEO +1 646 452 7054 Logo - SOURCE BioVaxys Technology Corp.

免疫疗法疫苗临床2期并购引进/卖出