The goal of this phase 1 study is to assess the safety, and tolerability of FP002 to determine the dose recommended for dose expansion in subjects with advanced solid tumor.

开始日期2023-08-02

申办/合作机构

广东菲鹏制药股份有限公司

CTR20231847 / Suspended临床1期

评估FP002在晚期恶性肿瘤受试者中的安全性、有效性、药代动力学、药效学特征的1期临床研究

评估FP002治疗的安全性和耐受性，并确定用于治疗晚期实体瘤的剂量扩展推荐剂量。

开始日期2023-07-21

申办/合作机构

广东菲鹏制药股份有限公司

100 项与 FP-002 (Fapon Biotech) 相关的临床结果

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100 项与 FP-002 (Fapon Biotech) 相关的转化医学

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100 项与 FP-002 (Fapon Biotech) 相关的专利（医药）

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项与 FP-002 (Fapon Biotech) 相关的文献（医药）

2023-08-01·Bioorganic chemistry

Influence of amino acid size at the P3 position of N-Cbz-tripeptide Michael acceptors targeting falcipain-2 and rhodesain for the treatment of malaria and human african trypanosomiasis

Article

作者: Zappala, Maria ; Ettari, Roberta ; Bogacz, Marta ; Previti, Santo ; Legac, Jenny ; Rosenthal, Philip J. ; Schirmeister, Tanja ; Zimmer, Collin ; Di Chio, Carla

In recent decades, several structure-activity relationship (SAR) studies provided potent inhibitors of the cysteine proteases falcipain-2 (FP-2) and rhodesain (RD) from Plasmodium falciparum and Trypanosoma brucei rhodesiense, respectively. Whilst the roles of the warhead and residues targeting the P1 and P2 pockets of the proteases were extensively investigated, the roles of the amino acids occupying the S3 pocket were not widely assessed. Herein we report the synthesis and biological evaluation of a set of novel Michael acceptors bearing amino acids of increasing size at the P3 site (1a-g/2a-g, SPR20-SPR33) against FP-2, RD, P. falciparum, and T. brucei. Overall, the Michael acceptors bearing small amino acids at the P3 site exhibited the most potent inhibitory properties towards FP-2. In contrast, analogues with bulky residues at the P3 position were very potent rhodesain inhibitors. In cell based assays, single-digit micromolar EC₅₀ values against the two protozoa were observed. These findings can be a starting point for the development of peptide-based FP-2 and RD inhibitors.

2023-02-01·Poultry science

Metagenomics analysis of the morphological aspects and bacterial composition of broiler feces

Article

作者: Tizioto, Polyana C ; Alvarenga, Bauer O ; Rodrigues, Denise R ; Paiva, Jacqueline B ; Souza, Andrei I S ; Ferreira, Antonio J Piantino

In this descriptive study, we used metagenomics to analyze the relationship between the morphological aspects of chicken feces and its respective bacterial compositions. The microbiota composition was determined by sequencing the V4 region of the 16S rRNA genes collected from fresh broiler feces at 19 d old. In total, 48 samples were collected and divided into 8 groups of 6 samples each. The morphological changes studied were feed passage (FP) and reddish mucus (RM). Each was classified into 3 levels of intensity: 1 (slight), 2 (moderate), or 3 (intense). Thus, the 8 groups studied were feed passage (FP-1; FP-2; FP-3), reddish mucus (RM-1; RM-2; RM-3), normal ileal feces (NIF), and cecal discharge (CD). The alpha diversity (Shannon's index) revealed that the CD group showed greater diversity, and was significantly different from FP-2, FP-3, and RM-1. The beta diversity showed that the CD group samples were more homogeneous than the ileal feces groups. The relative abundance analysis revealed that Firmicutes and Proteobacteria were the most abundant phyla in the ileal feces groups. In CD, Firmicutes and Bacteroidetes were the most abundant. The relative abundance at the genus level revealed 136 different bacterial genera. In the ileal feces groups, the two most abundant genera were Lactobacillus and Escherichia/Shigella, except in the FP-1 and RM-2 groups, which had the opposite order. Unlike the others, the CD group had a higher abundance of Bacteroides and Faecalibacterium. When comparing the NIF group with the others, significant changes were found in the fecal microbiota, with nine genera for the FP groups, 19 for the RM groups, and 61 when compared to CD. The results of the present study suggest that evaluation of fecal morphology is a fundamental task that makes it possible to act quickly and assertively, as the morphological aspects of the feces may be related to the composition and structure of fecal microbiota.

2022-09-01·Journal of molecular recognition : JMR4区 · 生物学

Computational design of immunogenic peptide constructs comprising multiple human leukocyte antigen restricted dengue virus envelope epitopes

4区 · 生物学

Article

作者: Jain, Sahil ; Kaushal, Neha ; Baranwal, Manoj

Abstract:

Dengue virus (DENV) is endemic in 100 countries with the ability to impact nearly 50% of world population. DENV envelope (E) protein is responsible for viral attachment to host cells and has been target of various countermeasure development efforts. The current study focuses on a consensus computational approach to identify cross‐reactive, immunogenic DENV‐2 E peptides displaying promiscuity with a wide array of human leukocyte antigen (HLA) molecules. Four conserved peptides (FP‐1, FP‐2, FP‐3 and FP‐4) containing multiple CD8+ and CD4+ T cell epitopes were identified by employment of various immunoinformatics tools. FP‐1, FP‐2, FP‐3 and FP‐4 were estimated to bind with 227, 1787, 1008 and 834 HLA alleles, respectively. Root mean square deviation (RMSD) values obtained by molecular docking (CABS‐Dock) with 20 HLA alleles (10 each of HLA classes I and II) resulted into comparable RMSD values of identified epitopes with native peptides, which represents the natural presentation of epitopes to HLA molecules. These peptides were also found to be part of previous experimentally validated immunogenic peptides. Further, a dengue immunogenic peptide construct was generated by linking the four peptides, an adjuvant and a 6× histidine tag. The construct showed strong binding and stability with Toll‐like receptor. Collectively, these results provide strong evidence in the support of the immunogenic potential of the dengue immunogenic peptide construct.

项与 FP-002 (Fapon Biotech) 相关的新闻（医药）

2023-07-24

·PRNewswire

Fapon to Showcase Innovative Diagnostic and Biopharma Solutions at 2023 AACC Expo

ANAHEIM, Calif., July 24, 2023 /PRNewswire/ -- Fapon, a leading life science company, will showcase its latest innovations in in-vitro diagnostic and biopharma solutions at the 2023 American Association of Clinical Chemistry (AACC) Scientific Meeting and Clinical Lab Expo from July 25 to 27. At the exhibition, Fapon will unveil its latest chemiluminescence immunoassay (CLIA) system, the Shine i8000/9000, an ultra-high throughput and fully automatic analyzer that delivers preliminary results within 10 minutes, with a testing speed of 900 tests per hour. The high throughput per footprint of 377 tests/hour/m2 makes it an ideal solution for laboratories looking to increase their testing capacity and efficiency. The launch of the Shine i8000/9000 marks the company's comprehensive layout in the high, medium, and low-throughput platforms for chemiluminescence instruments. Leveraging on the fundamentals of IVD technology, Fapon consistently integrates its one-stop solution on CLIA raw materials, reagents and open instruments services to further innovate clinical diagnostic solutions for its IVD partners. Rooted in IVD raw materials for 22 years, Fapon will showcase its comprehensive core IVD raw materials solutions for immunoassay and PCR & LAMP. During the exhibition, the Company will feature its high-quality respiratory raw materials, which are designed to accelerate the development of rapid tests for SARS-CoV-2Influenza A/B and RSV antigen-based multi-analyte tests. The materials offer authoritative panels validation, excellent sensitivity, as well as affordable and high-quality supply. Additionally, the Company will introduce its qPCR lyophilized master mix, which boasts equally high activity before and after lyophilization, strong stability, fast solubilized cakes/beads, and customized solutions and lyophilization service. Fapon will also exhibit its innovative solution on drug discovery and development. Fapon Biopharma, a subsidiary of Fapon, has developed a fully-integrated platform that includes programs from discovery to clinical research stages for novel biological products. Its antibody platform is pioneered in the development and manufacture of innovative antibodies and fusion proteins. Fapon has an expertise in antibody discovery, bispecific antibodies, antibody-cytokine fusion proteins, and PROTiNB. The development of FP002, a stronger anti-tumor efficacy and higher reliability anti-CD47 drug, demonstrates Fapon's holistic capabilities from early discovery, CMC, preclinical studies to clinical registration. The cell therapy platform focuses on the universal and next-generation CAR-T cell therapies for solid tumors, and their flagship product FC001 is an autologous CAR-T cell targeting CD19. Finally, as the world's leading circular RNA technology platform, Fapon will continue to address the key technical bottleneck of circRNA industrialization and demonstrate its competitive edge in the industry through rich cooperative models. During the expo, Fapon will also present an interactive lecture titled "Bioanalytical Performance of Novel Protein-free Blockers & Heterophilic Antibody Interference Blockers for the IVD Industry & Clinical Diagnostics," which will provide insights into the latest advancements in IVD blockers. "We are thrilled to be showcasing our latest solutions and offerings at the 2023 AACC Expo," said Jielun ZHU, CFO & CIO of Fapon. "Fapon is committed in becoming a global leading provider of fundamental technological solutions for diagnosis and biotherapy. We aim to establish a global open ecosystem with our partners to develop cutting-edge diagnostic and biopharma solutions that can address diverse needs in healthcare." Visit booth No. 3712 to learn more about Fapon's offerings. About FAPON Fapon is a global leading life sciences company dedicated to providing integrated solutions and services for diagnostics, biopharma and biotherapy. Integrating a one-stop solution on raw materials, reagents and innovative open instrument platforms, the Company has grown into a leading supplier in in-vitro diagnostics. Fapon boasts advanced innovations in therapeutics technologies and AI algorithm platforms with data insights that contribute to a better and healthier world. Supported by its strong global R&D, manufacturing, sales and service network, Fapon's products have established presence in 68 countries and regions, serving more than 2,500 business partners worldwide. Follow us on LinkedIn (Fapon) or visit our website . SOURCE Fapon

2023-06-03

·医药观澜

安进、辉瑞、正大天晴、迈威生物等公司1类新药获批临床

▎药明康德内容团队编辑根据中国国家药监局药品审评中心（CDE）官网数据，近期又有多款1类新药获批临床，其中多款新药为首次获得临床试验默示许可。通过梳理发现，这些新药包括了抗IL-11单抗、周剂型GLP-1/GCG受体双激动剂、P2X3受体抑制剂、抗EpCAM-CD3抗体、CGRP受体拮抗剂、CD200R激动型单抗等等。本文中我们将挑选部分1类新药作介绍，仅供读者参阅（排名不分先后）。截图来源：123RF迈威生物：9MW3811注射液作用机制：抗IL-11单抗适应症：特发性肺纤维化、晚期恶性肿瘤根据迈威生物新闻稿，9MW3811是其研发的靶向人白介素-11（IL-11）的人源化单克隆抗体。临床前研究数据表明，该药可高亲和力结合IL-11，有效阻断IL-11信号通路的活化，特异性调节肿瘤细胞与T细胞、巨噬细胞以及肿瘤相关成纤维细胞的相互作用，从而达到治疗纤维化和肿瘤的效果。该药本次获批针对晚期恶性肿瘤和特发性肺纤维化开展临床试验。据悉，9MW3811在多种实体瘤模型中观察到与抗PD-1抗体的联合抗肿瘤治疗效果；在纤维化疾病的临床前研究中，9MW3811可以显著降低纤维化模型小鼠的肺纤维化面积、减少肺胶原含量、改善肺功能，有望用于治疗特异性肺纤维化等疾病。派格生物：PB-718注射液作用机制：GLP-1/GCG受体双激动剂适应症：超重或肥胖根据派格生物公开资料介绍，PB-718是一款周剂型GLP-1/GCG受体双激动剂，可同时激活GLP-1受体及GCG受体，形成最大化协同效应，产生改善体重等作用。针对小鼠、灵长类肥胖模型的临床前药效实验显示，PB-718重复给药可显著降低体重摄食量、增加能量消耗、改善血脂、改善肝脏病理评分；同时该产品具备半衰期较长的优势，可开发为长效周制剂，这有望在未来大大减少患者的给药频次，提高治疗依从性。该药本次获批临床的适应症为超重或肥胖。映恩生物：注射用DB-1310作用机制：靶向HER3的ADC适应症：晚期/转移性实体瘤根据映恩生物公开资料，DB-1310是该公司基于其DITAC技术平台开发的靶向HER3的抗体偶联药物（ADC）。HER3作为HER家族成员之一，在多种实体肿瘤中均有表达。然而HER3由于结合力低、内在激酶活性极低等问题导致其成药难度较大。DB-1310由新型人源化抗HER3单克隆抗体通过马来酰亚胺可裂解linker，与专有的DNA拓扑异构酶I抑制剂共价连接。该药本次获批临床的适应症为晚期/转移性实体瘤。映恩生物已经在2023年美国癌症研究协会年会（AACR）上公布了DB-1310的最新临床前研究结果。研究显示，DB-1310表现出较好的肿瘤抑制效果和安全性，并且在与EGFR小分子抑制剂联合治疗中表现出较好的协调治疗效果。截图来源：123RF海正药业：HS336片作用机制：SHP2小分子抑制剂适应症：晚期实体瘤根据海正药业公告，HS336是一种SHP2小分子抑制剂。SHP2是一个关键的信号节点和调节因子，通过RAS通路促进癌细胞存活和生长，在癌细胞对靶向治疗产生耐药性的方式中发挥关键作用。据悉，HS336可将SHP2锁定在自抑制构象，阻止蛋白酪氨酸磷酸酶（PTP）催化中心与底物的接触，从而发挥相应的抗肿瘤作用。该药拟开发用于治疗晚期实体瘤，如食管鳞状细胞癌、头颈部鳞状细胞癌、非小细胞肺癌、结直肠癌等。维坦医药：WT-1108片作用机制：P2X3受体抑制剂适应症：难治性或不明原因的慢性咳嗽根据维坦医药公开资料，WT-1108为该公司研发的具有全新骨架结构、全新作用机制、高选择性的P2X3受体抑制剂，本次获批临床的适应症为难治性或不明原因的慢性咳嗽。P2X3受体是位于呼吸道内衬的感觉神经纤维（主要是C纤维）上发现的受体类型之一。细胞外ATP与呼吸道C纤维上P2X3受体的结合可以被感知为潜在损伤的信号，从而产生动作电位，这可能会引发咳嗽。因此，阻断细胞外ATP与P2X3受体的结合有望减少感觉C纤维的激活，从而缓解咳嗽。嘉因生物：EXG102-031眼用注射液作用机制：靶向VEGF/ANG2基因疗法适应症：湿性年龄相关性黄斑变性（wAMD）根据嘉因生物新闻稿介绍，EXG102-031眼内注射是一种基于rAAV的基因疗法，表达一种治疗性融合蛋白，能够结合/中和所有已知的血管内皮生长因子（VEGF）和血管生成素-2（ANG2）亚型。与现有的需要反复注射的抗体药物不同，该产品只需要一针注射，就可在体内长期表达并有望有效治疗视网膜中异常血管形成和血液渗漏，从而用于治疗湿性年龄相关性黄斑变性（wAMD）。该药获批1期临床试验，将评估其在wAMD患者中的安全性和耐受性，同时也会评估其对患者的视力改善程度。截图来源：123RF菲鹏制药：FP002注射液作用机制：抗CD47单抗适应症：晚期恶性肿瘤公开资料显示，FP002为菲鹏制药研发的一款抗CD47蛋白的人源化IgG4单克隆抗体。该抗体在保持与肿瘤细胞表面CD47强结合的前提下，基本不结合人红细胞表面的CD47，不引起血液凝集，并在多种临床前肿瘤模型中展现出较好的药效。基于现有数据，FP002在整体上具备更好的抗肿瘤药效和更显著的安全性优势。该药获批临床的适应症为晚期恶性肿瘤。天劢源和：重组抗EpCAM-CD3抗体注射液作用机制：抗EpCAM-CD3抗体适应症：EpCAM表达阳性的晚期实体瘤天劢源和申报的重组抗EpCAM-CD3抗体注射液获批临床，拟开发用于EpCAM表达阳性的晚期实体瘤。公开资料显示，上皮细胞粘附分子（EpCAM）是上皮恶性肿瘤细胞表面最常见的特异性抗原之一。抗EpCAM-CD3抗体通过靶向EpCAM抗原及CD3抗原，可将T细胞招募至肿瘤细胞处，并激活T细胞对肿瘤细胞进行免疫杀伤，从而抑制肿瘤细胞生长。Inventiva公司/正大天晴：lanifibranor片作用机制：PPAR激动剂适应症：NASHInventiva公司申请的1类新药lanifibranor片（拉尼兰诺）获批临床，拟开发用于治疗伴有肝纤维化的非肝硬化非酒精性脂肪性肝炎（NASH）的成人患者。公开资料显示，lanifibranor是一种口服PPAR激动剂，可同时激活PPARα、PPARδ和PPARγ，这些受体在调控脂质代谢、炎症反应和纤维化过程中发挥重要作用。正大天晴此前通过一项超5000万美元的合作，获得了该药在大中华区的开发、生产和商业化权利。辉瑞：zavegepant鼻喷雾剂作用机制：CGRP受体拮抗剂适应症：成人偏头痛的急性期治疗辉瑞（Pfizer）申请的zavegepant鼻喷雾剂获批临床，拟开发用于成人偏头痛的急性期治疗（有或无先兆）。公开资料显示，这是辉瑞约116亿美元收购Biohaven公司获得的一款CGRP受体拮抗剂鼻内喷剂。它通过可逆性地阻断CGRP受体，从而抑制CGRP神经肽的生物活性，可以实现缓解与预防偏头痛发作。该药已在美国获批用于急性治疗偏头痛成人患者，可在15分钟内快速起效。安进/百济神州：tarlatamab作用机制：靶向DLL3和CD3的双抗适应症：小细胞肺癌安进（Amgen）申报的1类新药tarlatamab获批临床，拟用于接受含铂一线化疗后的复发性小细胞肺癌受试者。公开资料显示，tarlatamab是百济神州与安进合作研发的管线之一，为一款靶向DLL3和CD3的双特异性T细胞衔接蛋白（BiTE），可以将T细胞募集到小细胞肺癌细胞附近，激活T细胞杀伤肿瘤细胞。百济神州拥有该药的中国商业化权益。礼来：LY3454738注射液作用机制：CD200R激动型单抗适应症：特应性皮炎礼来（Eli Lilly and Company）申报的1类新药LY3454738注射液获批临床，针对适应症为特应性皮炎。根据礼来公司公开资料，LY3454738是该公司在研的免疫检查点受体蛋白激动剂，为一种靶向激活CD200R的单克隆抗体。CD200R在先天和适应性免疫细胞表面表达，激活这一受体可以降低细胞因子的释放和减少细胞增生。赛诺菲：注射用SAR443579作用机制：靶向CD123的NK细胞接合剂适应症：复发/难治性恶性血液病赛诺菲（Sanofi）申报的1类新药注射用SAR443579获批临床，拟开发用于治疗12岁及以上复发/难治性恶性血液病。公开资料显示，这是赛诺菲合作研发的一款单克隆抗体，也是一款基于NKp46/CD16的NK细胞接合剂，靶向肿瘤抗原CD123。它可通过激活受体NKp46和CD16来激活NK细胞，同时结合癌细胞上的肿瘤抗原，进而诱导NK细胞完全活化和肿瘤细胞裂解。除了上述产品，还有其他1类新药获批临床试验。限于篇幅，本文不再一一介绍。希望这些在研疗法后续进展顺利，早日惠及患者。参考资料：[1]中国国家药监局药品审评中心（CDE）官网.Retrieved Jun 2，2023, From https://www.cde.org.cn/main/xxgk/listpage/4b5255eb0a84820cef4ca3e8b6bbe20c[2]各公司官网及公开资料本文来自药明康德内容团队，欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载授权请在「医药观澜」微信公众号留言联系我们。其他合作需求，请联系wuxi_media@wuxiapptec.com。免责声明：药明康德内容团队专注介绍全球生物医药健康研究进展。本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。

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适应症	最高研发状态	国家/地区	公司	日期
晚期恶性实体瘤	临床1期	中国	广东菲鹏制药股份有限公司	2023-08-02
晚期癌症	临床1期	中国	广东菲鹏制药股份有限公司	2023-07-21
肿瘤	临床1期	美国	菲鹏生物股份有限公司	2023-02-22