Combinatorial Therapy With a Therapeutic Conserved Element DNA Vaccine, MVA Vaccine Boost, TLR9 Agonist and Broadly Neutralizing Antibodies: a Proof-of-concept Study Aimed at Inducing an HIV Remission

Combination approaches will almost certainly be required to generate durable control of HIV in the absence of antiretroviral therapy (a "remission"). In this study, 20 individuals will receive a combination regimen administered during ART and then undergo an analytic treatment interruption (ATI).

开始日期2020-08-01

申办/合作机构

The University of California, San Francisco

[+7]

NCT02116205 / Completed临床2期IIT

A Phase 2a Double-Blind, Dose-optimizing Study to Evaluate the Immunogenicity of Hantaan/Puumala Virus DNA Vaccine Administered to Healthy Adult Volunteers by Electroporation for Prevention of Hemorrhagic Fever With Renal Syndrome

The purpose of this study is to compare the immune responses of two different doses (1.0 mg and 2.0 mg) and two different dosing schedules (two doses or three doses) of a mixed Hantaan virus (HTNV) and Puumala virus (PUUV) DNA vaccine in healthy participants. To maintain a blind, participants in the two-dose group will receive one dose of normal saline placebo. All of the groups will also receive a booster dose 6 months after first vaccination. The results will help to determine which dose and vaccination schedule will be best to move forward in the vaccine development process.

开始日期2014-07-09

申办/合作机构

U S Army Medical Research & Development Command

[+4]

NCT02099994 / Completed临床1/2期IIT

A Phase I/IIa Clinical Trial of HIV-1 Vaccines pSG2.HIVconsv DNA, MVA.HIVconsv and Ad35-GRIN in Combined Regimens in Healthy HIV-1/2-negative Adults in Nairobi.

The study is part of a long-term aim to develop an effective HIV-1 vaccine and will evaluate safety and immunogenicity of vaccines focusing T cell responses on the conserved region of the HIV-1 proteome. The vaccines used are pSG2.HIVconsv DNA (D), MVA.HIVconsv (M) and Ad35-GRIN (A), delivered in regimens AM, DDDAM and DeDeDeAM, where e indicates electroporation.

开始日期2014-03-01

申办/合作机构

University of Oxford

[+4]

100 项与 Ichor Medical Systems, Inc. 相关的临床结果

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0 项与 Ichor Medical Systems, Inc. 相关的专利（医药）

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项与 Ichor Medical Systems, Inc. 相关的文献（医药）

2018-06-03·Journal of immunology research3区 · 医学

A Multiagent Alphavirus DNA Vaccine Delivered by Intramuscular Electroporation Elicits Robust and Durable Virus-Specific Immune Responses in Mice and Rabbits and Completely Protects Mice against Lethal Venezuelan, Western, and Eastern Equine Encephalitis Virus Aerosol Challenges

3区 · 医学

ArticleOA

作者: Hannaman, Drew ; Livingston, Brian D. ; Richards, Michelle J. ; Schmaljohn, Connie S. ; Dupuy, Lesley C.

There remains a need for vaccines that can safely and effectively protect against the biological threat agents Venezuelan (VEEV), western (WEEV), and eastern (EEEV) equine encephalitis virus. Previously, we demonstrated that a VEEV DNA vaccine that was optimized for increased antigen expression and delivered by intramuscular (IM) electroporation (EP) elicited robust and durable virus-specific antibody responses in multiple animal species and provided complete protection against VEEV aerosol challenge in mice and nonhuman primates. Here, we performed a comparative evaluation of the immunogenicity and protective efficacy of individual optimized VEEV, WEEV, and EEEV DNA vaccines with that of a 1 : 1 : 1 mixture of these vaccines, which we have termed the 3-EEV DNA vaccine, when delivered by IM EP. The individual DNA vaccines and the 3-EEV DNA vaccine elicited robust and durable virus-specific antibody responses in mice and rabbits and completely protected mice from homologous VEEV, WEEV, and EEEV aerosol challenges. Taken together, the results from these studies demonstrate that the individual VEEV, WEEV, and EEEV DNA vaccines and the 3-EEV DNA vaccine delivered by IM EP provide an effective means of eliciting protection against lethal encephalitic alphavirus infections in a murine model and represent viable next-generation vaccine candidates that warrant further development.

2017-12-01·Vaccine3区 · 医学

Comparative functional potency of DNA vaccines encoding Plasmodium falciparum transmission blocking target antigens Pfs48/45 and Pfs25 administered alone or in combination by in vivo electroporation in rhesus macaques

3区 · 医学

Article

作者: Gerloff, Dietlind ; Philipp, Mario ; Bansal, Geetha P ; Ellefsen, Barry ; Kumar, Nirbhay ; Grasperge, Brooke ; Datta, Dibyadyuti ; Hannaman, Drew ; Martin, Dale S

Antibodies recognizing conformational epitopes in Pfs48/45, an antigen expressed on the surface of Plasmodium falciparum gametes and zygotes, have firmly established Pfs48/45 as a promising transmission blocking vaccine (TBV) candidate. However, it has been difficult to reproducibly express Pfs48/45 in a variety of recombinant expression systems. The goal of our studies was to evaluate functional immunogenicity of Pfs48/45 using DNA vaccine format in rhesus macaques. An additional goal was to ensure that when used in combination with another malarial antigen, specific immunity to both antigens was not compromised. For testing combination vaccines, we employed Pfs25 DNA plasmids that have previously undergone evaluations in rodents and nonhuman primates. Pfs25 is expressed on the surface of parasites after fertilization and is also a lead TBV candidate. DNA plasmids based on codon-optimized sequences of Pfs48/45 and Pfs25 were administered by in vivo electroporation, followed by a final recombinant protein boost. Our studies demonstrate that Pfs48/45 encoded by DNA plasmids is capable of inducing potent transmission blocking antibody responses, and such transmission blocking immune potency of Pfs48/45 was not compromised when tested in combination with Pfs25, These findings provide the evidence in favor of further studies on Pfs48/45 and Pfs25, either alone or in combination with other known malaria vaccine candidates for developing effective vaccines capable of interrupting malaria transmission.

2017-11-01·Clinical and vaccine immunology : CVI

DNA Priming Increases Frequency of T-Cell Responses to a Vesicular Stomatitis Virus HIV Vaccine with Specific Enhancement of CD8 ⁺ T-Cell Responses by Interleukin-12 Plasmid DNA

Article

作者: Hannaman, Drew ; Allen, Mary ; Eldridge, John H. ; Li, Shuying S. ; Elizaga, Marnie ; McElrath, M. Juliana ; De Rosa, Stephen C. ; Gilbert, Peter B. ; Frank, Ian ; Egan, Michael A. ; Cohen, Kristen W. ; Tomaras, Georgia D. ; Frahm, Nicole ; Hay, Christine M. ; Clarke, David K. ; Ota-Setlik, Ayuko ; Kochar, Nidhi K. ; Sobieszczyk, Magdalena E. ; Xu, Rong ; Wilson, Gregory J. ; Finak, Greg ; Gottardo, Raphael ; Tieu, Hong-Van ; Morris, Daryl ; Corey, Lawrence

ABSTRACT:

The HIV Vaccine Trials Network (HVTN) 087 vaccine trial assessed the effect of increasing doses of pIL-12 (interleukin-12 delivered as plasmid DNA) adjuvant on the immunogenicity of an HIV-1 multiantigen (MAG) DNA vaccine delivered by electroporation and boosted with a vaccine comprising an attenuated vesicular stomatitis virus expressing HIV-1 Gag (VSV-Gag). We randomized 100 healthy adults to receive placebo or 3 mg HIV-MAG DNA vaccine (ProfectusVax HIV-1 gag / pol or ProfectusVax nef / tat / vif , env ) coadministered with pIL-12 at 0, 250, 1,000, or 1,500 μg intramuscularly by electroporation at 0, 1, and 3 months followed by intramuscular inoculation with 3.4 × 10 7 PFU VSV-Gag vaccine at 6 months. Immune responses were assessed after the prime and boost and 6 months after the last vaccination. High-dose pIL-12 increased the magnitude of CD8 + T-cell responses postboost compared to no pIL-12 ( P = 0.02), while CD4 + T-cell responses after the prime were higher in the absence of pIL-12 than with low- and medium-dose pIL-12 ( P ≤ 0.05). The VSV boost increased Gag-specific CD4 + and CD8 + T-cell responses in all groups ( P < 0.001 for CD4 + T cells), inducing a median of four Gag epitopes in responders. Six to 9 months after the boost, responses decreased in magnitude, but CD8 + T-cell response rates were maintained. The addition of a DNA prime dramatically improved responses to the VSV vaccine tested previously in the HVTN 090 trial, leading to broad epitope targeting and maintained CD8 + T-cell response rates at early memory. The addition of high-dose pIL-12 given with a DNA prime by electroporation and boosted with VSV-Gag increased the CD8 + T-cell responses but decreased the CD4 + responses. This approach may be advantageous in reshaping the T-cell responses to a variety of chronic infections or tumors. (This study has been registered at ClinicalTrials.gov under registration no. NCT01578889.)

项与 Ichor Medical Systems, Inc. 相关的新闻（医药）

2024-01-31

·FierceBiotech

CRO Ichor Life Sciences launches clinical trial services unit

As part of the rollout, Ichor announced that Lisa Sonneborn was named president of the new trial services unit. Ichor Life Sciences, a CRO based in upstate New York, has launched a clinical trial services unit to serve clients in preclinical studies through late-stage trials and regulatory approval. Dubbed Ichor Clinical, the new branch offers clients in the preclinical arena protein, pharmacology, discovery and consulting services, the company said in a January 14 press release. As part of the rollout, Ichor announced that Lisa Sonneborn was named president of the new trial services unit. Sonneborn was founder and chief executive of Clarity Clinical Research, which was acquired by the site management giant Velocity in 2021. Ichor Life Sciences, which rebranded itself from Ichor Therapeutics in 2021, is not connected to San Diego-based biotech Ichor Medical Systems.

并购高管变更临床研究

2023-08-12

·药时代

截至2023年7月，全球乙肝新药进展汇总

编者按：近几个月Hepatitis B Foundation网站乙肝新药表单未见更新，为帮助大家更准确地获取全球乙肝新药最前沿信息，查询了各大药企官网更新的产品管线信息和相关网络资料中的乙肝新药报道做了系统地整理，并汇总了慢乙肝新药与新药联合、新药与现有药物联合治疗的临床研究进展。本期表单更新有：新增处于临床前研究阶段的进入抑制剂PRX-202。Janssen公司停止衣壳抑制剂JNJ 64530440、治疗性疫苗JNJ 64300535和PD-L1抑制剂JNJ 63723283的进一步开发。新药联合治疗的探索明显加速，包括新药与新药联合、新药与现有药物的联合。许多新药单药在I期或II期研究中未达到主要疗效目标，企业便积极开始了不同联合治疗方案的探索。这也将是未来乙肝全面临床治愈的必要策略。新药相关联合用药临床研究汇总部分新药进展01PRX-202韩国Prazer Therapeutics自主研发了一款靶向NTCP的小分子进入抑制剂PRX-202，目前处于IND阶段。02JNJ 64530440、JNJ 64300535、JNJ 63723283根据Janssen公司官网的最新研发管线信息显示，用于慢乙肝治疗的在研新药JNJ3989、JNJ 64300545、JNJ 64530440、JNJ 64300535和JNJ 63723283均从研发管线中剔除，其中合作开发药物JNJ3989的合作企业Arrowhead Pharma以及JNJ 64300545的合作企业Ichor Medical Systems暂未公布这两款药物未来的开发计划。据ClinicalTrials.gov网站信息，相关药物的联合治疗研究还在进行当中。故当前已停止JNJ 64530440、JNJ 64300535和JNJ 63723283的进一步开发。封面图来源：123rfK药或成“最短寿”药王？凯风创投王立铭：first-in-class或为伪命题，中国创新药面临时代主题切换PHDI 2023 倒计时1个月丨30+业内大咖云集制药产业数智化峰会最后的「退货」，EQRx把翰森的阿美替尼也放弃了...点击这里，与药时代一起快乐学习！

临床1期疫苗临床申请临床2期

2023-06-22

·PRNewswire

Global Cancer Vaccine Partnering Terms and Agreements Analysis Report/Directory 2023: Access Over 350 Cancer Vaccine Deals - Disclosed Headlines, Upfronts, Milestones and Royalties

DUBLIN, June 22, 2023 /PRNewswire/ -- The "Global Cancer Vaccine Partnering Terms and Agreements 2010-2023" report has been added to ResearchAndMarkets.com's offering. The Global Cancer Vaccine Partnering Terms and Agreements 2010-2023 report provides comprehensive access to available deals and contract documents for over 350 cancer vaccine deals. Trends in cancer vaccine partnering deals Disclosed headlines, upfronts, milestones and royalties by stage of development Cancer vaccine partnering contract documents Top cancer vaccine deals by value This report provides details of the latest cancer vaccine agreements announced in the life sciences since 2010. The report takes the reader through a comprehensive review cancer vaccine deal trends, key players, top deal values, as well as deal financials, allowing the understanding of how, why and under what terms, companies are entering cancer vaccine partnering deals. The report presents financial deal term values for cancer vaccine deals, listing by headline value, upfront payments, milestone payments and royalties, enabling readers to analyse and benchmark the financial value of deals. The middle section of the report explores the leading dealmakers in the cancer vaccine partnering field; both the leading deal values and most active cancer vaccine dealmaker companies are reported allowing the reader to see who is succeeding in this dynamic dealmaking market. One of the key highlights of the report is that over 350 online deal records of actual cancer vaccine deals, as disclosed by the deal parties, are included towards the end of the report in a directory format - by company A-Z, stage of development, deal type, therapy focus, and technology type - that is easy to reference. Each deal record in the report links via Weblink to an online version of the deal. In addition, where available, records include contract documents as submitted to the Securities Exchange Commission by companies and their partners. Whilst many companies will be seeking details of the payment clauses, the devil is in the detail in terms of how payments are triggered - contract documents provide this insight where press releases and databases do not. The initial chapters of this report provide an orientation of cancer vaccine dealmaking. Chapter 1 provides an introduction to the report, whilst chapter 2 provides an overview of the trends in cancer vaccine dealmaking since 2010, including details of headline, upfront, milestone and royalty terms. Chapter 3 provides a review of the leading cancer vaccine deals since 2010. Deals are listed by headline value. Where the deal has an agreement contract published at the SEC a link provides online access to the contract. Chapter 4 provides a comprehensive listing of the top 25 most active companies in cancer vaccine dealmaking with a brief summary followed by a comprehensive listing of cancer vaccine deals announced by that company, as well as contract documents, where available. Chapter 5 provides a comprehensive and detailed review of cancer vaccine partnering deals signed and announced since Jan 2010, where a contract document is available in the public domain. Each deal title links via Weblink to an online version of the deal record and contract document, providing easy access to each contract document on demand. Chapter 6 provides a comprehensive and detailed review of cancer vaccine partnering deals signed and announced since Jan 2010. The chapter is organized by specific cancer vaccine technology type. Each deal title links via Weblink to an online version of the deal record and where available, the contract document, providing easy access to each deal on demand. A comprehensive series of appendices is provided organized by cancer vaccine partnering company A-Z, stage of development, deal type, and therapy focus. Each deal title links via Weblink to an online version of the deal record and where available, the contract document, providing easy access to each deal on demand. The report also includes numerous tables and figures that illustrate the trends and activities in cancer vaccine partnering and dealmaking since 2010. In conclusion, this report provides everything a prospective dealmaker needs to know about partnering in the research, development and commercialization of cancer vaccine technologies and products. Key benefits In-depth understanding of cancer vaccine deal trends since 2010 Access to headline, upfront, milestone and royalty data Detailed access to actual cancer vaccine contracts entered into by leading biopharma companies Identify most active cancer vaccine dealmakers since 2010 Insight into terms included in a cancer vaccine partnering agreement, with real world examples Understand the key deal terms companies have agreed in previous deals Undertake due diligence to assess suitability of your proposed deal terms for partner companies In Global Cancer Vaccine Partnering Terms and Agreements 2010-2023, the available deals are listed by: Company A-Z Headline value Stage of development at signing Deal component type Specific therapy target Technology type Analyzing actual contract agreements allows assessment of the following: What are the precise rights granted or optioned? What is actually granted by the agreement to the partner company? What exclusivity is granted? What is the payment structure for the deal? How are sale sand payments audited? What is the deal term? How are the key terms of the agreement defined? How are IPRs handled and owned? Who is responsible for commercialization? Who is responsible for development, supply, and manufacture? How is confidentiality and publication managed? How are disputes to be resolved? Under what conditions can the deal be terminated? What happens when there is a change of ownership? What sublicensing and subcontracting provisions have been agreed? Which boilerplate clauses does the company insist upon? Which boilerplate clauses appear to differ from partner to partner or deal type to deal type? Which jurisdiction does the company insist upon for agreement law? Companies Mentioned 2A 3D Medicines A*STAR Bioprocessing Technology Institute Aura Biosciences Averion AV Therapeutics Beth Israel Deaconess Medical Center BGI CureLab Oncology CureVac Cyplasin Biomedical CYTLIMIC Daiichi Sankyo Dainippon Sumitomo Pharma Dalton Pharma Services Exiqon ExpreS2ion Biotechnologies Federal Ministry of Education and Research (BMBF) Flaskworks Georgia Health Sciences University GeoVax German Cancer Research Center Hookipa Pharma Human Vaccines Project iBio Icahn School of Medicine at Mount Sinai Ichor Medical Systems Leukaemia & Lymphoma Research LG Life Sciences Ligand Pharmaceuticals Massachusetts Life Sciences Center Mayo Clinic National Research Council Canada National Surgical Adjuvant Breast and Bowel Project OncoQR OncoSec Medical Oncotherapy Science PsiOxus Therapeutics Pulmotec PX Biosolutions Qiagen Radboud University Nijmegen Medical Centre Selecta Biosciences Selexis Sellas Clinicals Holding Seres Therapeutics Telormedix Teva Pharmaceutical Industries VGX International Vinnova ViroMed Vivalis VLP Therapeutics VLST Corporation Y-mAbs Therapeutics Yale University Yamaguchi University For more information about this report visit About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends. Contact: Research and Markets Laura Wood, Senior Manager [email protected] For E.S.T Office Hours Call +1-917-300-0470 For U.S./CAN Toll Free Call +1-800-526-8630 For GMT Office Hours Call +353-1-416-8900 U.S. Fax: 646-607-1907 Fax (outside U.S.): +353-1-481-1716 Logo: SOURCE Research and Markets

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药物(靶点)	适应症	全球最高研发状态

JNJ-64300535	乙型肝炎更多	临床1期
pNGVL-4a-CRT/E7 DNA vaccine(Ichor Medical Systems, Inc.) ( HPV E7 )	头颈部肿瘤更多	终止
Ad35-GRIN/ENV ( Envelope (E) protein x GAG )	HIV感染更多	无进展
HIV-MAG pDNA vaccine(Auro Vaccines)	HIV感染更多	无进展
pWRG/HTN-M(co)/pWRG/PUUV-M(United States Army Medical Research and Materiel Command) ( 汉坦病毒M蛋白 )	肾综合征出血热更多	无进展