This study in healthy volunteers will provide a basis for evaluation of TRL345 as a first in human study, specifically, important safety, tolerability, and pharmacokinetic data, and provide serum samples for ex vivo studies of concentration-dependent antiviral activity to support the dose selection for as well as design and conduct of a clinical study in transplant patients.

开始日期2023-09-14

申办/合作机构

Trellis Bioscience, Inc.

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100 项与 TRL-345 相关的临床结果

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100 项与 TRL-345 相关的转化医学

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100 项与 TRL-345 相关的专利（医药）

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项与 TRL-345 相关的文献（医药）

2015-03-01·Antimicrobial Agents and Chemotherapy2区 · 医学

A High-Affinity Native Human Antibody Neutralizes Human Cytomegalovirus Infection of Diverse Cell Types

2区 · 医学

Article

作者: Fang-Hoover, June ; McVoy, Michael A. ; Petitt, Matthew ; Liu, Keyi ; Stephenson, Robert ; DeChene, Neal ; Ellsworth, Stote L. ; Adler, Stuart P. ; Pereira, Lenore ; Tsuge, Mitsuru ; Kauvar, Lawrence M. ; Park, Minha ; Cui, Xiaohong ; Tabata, Takako ; Tenorio, Edgar

ABSTRACT Human cytomegalovirus (HCMV) is the most common infection causing poor outcomes among transplant recipients. Maternal infection and transplacental transmission are major causes of permanent birth defects. Although no active vaccines to prevent HCMV infection have been approved, passive immunization with HCMV-specific immunoglobulin has shown promise in the treatment of both transplant and congenital indications. Antibodies targeting the viral glycoprotein B (gB) surface protein are known to neutralize HCMV infectivity, with high-affinity binding being a desirable trait, both to compete with low-affinity antibodies that promote the transmission of virus across the placenta and to displace nonneutralizing antibodies binding nearby epitopes. Using a miniaturized screening technology to characterize secreted IgG from single human B lymphocytes, 30 antibodies directed against gB were previously cloned. The most potent clone, TRL345, is described here. Its measured affinity was 1 pM for the highly conserved site I of the AD-2 epitope of gB. Strain-independent neutralization was confirmed for 15 primary HCMV clinical isolates. TRL345 prevented HCMV infection of placental fibroblasts, smooth muscle cells, endothelial cells, and epithelial cells, and it inhibited postinfection HCMV spread in epithelial cells. The potential utility for preventing congenital transmission is supported by the blockage of HCMV infection of placental cell types central to virus transmission to the fetus, including differentiating cytotrophoblasts, trophoblast progenitor cells, and placental fibroblasts. Further, TRL345 was effective at controlling an ex vivo infection of human placental anchoring villi. TRL345 has been utilized on a commercial scale and is a candidate for clinical evaluation.

Viruses3区 · 医学

HCMV Infection of Human Trophoblast Progenitor Cells of the Placenta Is Neutralized by a Human Monoclonal Antibody to Glycoprotein B and Not by Antibodies to the Pentamer Complex

3区 · 医学

ArticleOA

作者: Pereira, Lenore ; Zydek, Martin ; Fang-Hoover, June ; Kauvar, Lawrence M ; Petitt, Matthew ; Tabata, Takako ; Adler, Barbara

Human cytomegalovirus (HCMV) is the major viral cause of congenital infection and birth defects. Primary maternal infection often results in virus transmission, and symptomatic babies can have permanent neurological deficiencies and deafness. Congenital infection can also lead to intrauterine growth restriction, a defect in placental transport. HCMV replicates in primary cytotrophoblasts (CTBs), the specialized cells of the placenta, and inhibits differentiation/invasion. Human trophoblast progenitor cells (TBPCs) give rise to the mature cell types of the chorionic villi, CTBs and multi-nucleated syncytiotrophoblasts (STBs). Here we report that TBPCs are fully permissive for pathogenic and attenuated HCMV strains. Studies with a mutant virus lacking a functional pentamer complex (gH/gL/pUL128-131A) showed that virion entry into TBPCs is independent of the pentamer. In addition, infection is blocked by a potent human neutralizing monoclonal antibody (mAb), TRL345, reactive with glycoprotein B (gB), but not mAbs to the pentamer proteins pUL130/pUL131A. Functional studies revealed that neutralization of infection preserved the capacity of TBPCs to differentiate and assemble into trophospheres composed of CTBs and STBs in vitro. Our results indicate that mAbs to gB protect trophoblast progenitors of the placenta and could be included in antibody treatments developed to suppress congenital infection and prevent disease.

项与 TRL-345 相关的新闻（医药）

2015-08-18

·BioPortfolio

Trellis Bioscience, Inc. - Product Pipeline Review - 2015

Recently added to the BioPortfolio report store, Trellis Bioscience, Inc. - Product Pipeline Review - 2015 is a new report from Global Markets Direct published on 2015-07-14. This 28-page report is available in PDF from $1500. Trellis Bioscience, Inc. - Product Pipeline Review - 2015 Summary Global Markets Direct’s, ‘Trellis Bioscience, Inc. - Product Pipeline Review - 2015’, provides an overview of the Trellis Bioscience, Inc.’s pharmaceutical research and development focus. This report provides comprehensive information on the current therapeutic developmental pipeline of Trellis Bioscience, Inc.’s, complete with comparative analysis at various stages, therapeutics assessment by drug target, mechanism of action (MoA), route of administration (RoA) and molecule type. It also reviews latest updates, and featured news and press releases, along with special features on late-stage and discontinued projects. Global Markets Direct’s report features investigational drugs from across globe covering over 20 therapy areas and nearly 3,000 indications. The report is built using data and information sourced from Global Markets Direct’s proprietary databases, Company/University websites, SEC filings, investor presentations and featured press releases from company/university sites and industry-specific third party sources, put together by Global Markets Direct’s team. Drug profiles/records featured in the report undergoes periodic updation following a stringent set of processes that ensures that all the profiles are updated with the latest set of information. Additionally, processes including live news & deals tracking, browser based alert-box and clinical trials registries tracking ensure that the most recent developments are captured on a real time basis. The report enhances decision making capabilities and help to create effective counter strategies to gain competitive advantage. It strengthens R&D pipelines by identifying new targets and MOAs to produce first-in-class and best-in-class products. Note*: Certain sections in the report may be removed or altered based on the availability and relevance of data for the indicated disease. Scope - The report provides brief overview of Trellis Bioscience, Inc. including business description, key information and facts, and its locations and subsidiaries - The report reviews current pipeline of Trellis Bioscience, Inc.’s human therapeutic division and enlists all their major and minor projects - The report features product description and descriptive mechanism of action for key pipeline products along with the product’s developmental history and major milestones - Special feature on out-licensed and partnered product portfolio - The report summarizes all the dormant and discontinued pipeline projects - Latest company statement - Latest news and deals relating to the Trellis Bioscience, Inc.’s pipeline products Reasons to buy - Evaluate Trellis Bioscience, Inc.’s strategic position with total access to detailed information on its product pipeline - Assess the growth potential of Trellis Bioscience, Inc. in its therapy areas of focus - Identify new drug targets and therapeutic classes in the Trellis Bioscience, Inc.’s R&D portfolio and develop key strategic initiatives to reinforce pipeline in those areas - Exploit in-licensing opportunities by identifying windows of opportunity to fill portfolio gaps - Develop strategic initiatives by understanding the focus areas of Trellis Bioscience, Inc. and exploit collaboration and partnership opportunities - Identify emerging… Table of Contents Table of Contents 2 List of Tables 4 List of Figures 4 Trellis Bioscience, Inc. Snapshot 5 Trellis Bioscience, Inc. Overview 5 Key Information 5 Key Facts 5 Trellis Bioscience, Inc. - Research and Development Overview 6 Key Therapeutic Areas 6 Trellis Bioscience, Inc. - Pipeline Review 8 Pipeline Products by Stage of Development 8 Pipeline Products - Monotherapy 9 Pipeline Products - Partnered Products 10 Partnered Products/Combination Treatment Modalities 11 Pipeline Products - Out-Licensed Products 12 Out-Licensed Products/Combination Treatment Modalities 13 Trellis Bioscience, Inc. - Pipeline Products Glance 14 Trellis Bioscience, Inc. - Early Stage Pipeline Products 14 Preclinical Products/Combination Treatment Modalities 14 Discovery Products/Combination Treatment Modalities 15 Trellis Bioscience, Inc. - Drug Profiles 16 Monoclonal Antibody To Antagonize HER-3 for Cancer 16 Product Description 16 Mechanism of Action 16 R&D Progress 16 TRL-345 17 Product Description 17 Mechanism of Action 17 R&D Progress 17 Monoclonal Antibodies for Group A Streptococcus Infections 18 Product Description 18 Mechanism of Action 18 R&D Progress 18 Monoclonal Antibodies for Rabies 19 Product Description 19 Mechanism of Action 19 R&D Progress 19 Monoclonal Antibody 1 for Bacterial Infections 20 Product Description 20 Mechanism of Action 20 R&D Progress 20 Monoclonal Antibody 2 for Bacterial Infections 21 Product Description 21 Mechanism of Action 21 R&D Progress 21 Trellis Bioscience, Inc. - Pipeline Analysis 22 Trellis Bioscience, Inc. - Pipeline Products by Target 22 Trellis Bioscience, Inc. - Pipeline Products by Molecule Type 23 Trellis Bioscience, Inc. - Pipeline Products by Mechanism of Action 24 Trellis Bioscience, Inc. - Recent Pipeline Updates 25 Trellis Bioscience, Inc. - Locations And Subsidiaries 26 Head Office 26 Appendix 27 Methodology 27 Coverage 27 Secondary Research 27 Primary Research 27 Expert Panel Validation 27 Contact Us 27 Disclaimer 28 For more information open Trellis Bioscience, Inc. - Product Pipeline Review - 2015. SKU: GMDHC07298CDB

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