P10s-PADRE vaccine(University of Arkansas)(P10s-PADRE vaccine(University of Arkansas)) - 在研适应症：三阴性乳腺癌_专利_临床

概要

基本信息

药物类型

治疗性疫苗

别名

Mimotope P10s-PADRE/MONTANIDE ISA 51 VG vaccine(University of Arkansas)、P10s-PADRE/ MONTANIDE ISA 51 VG(University of Arkansas)

靶点-

作用方式

刺激剂

作用机制

免疫刺激剂

治疗领域

肿瘤皮肤和肌肉骨骼疾病

在研适应症

三阴性乳腺癌

非在研适应症

晚期肺腺癌转移性乳腺癌转移性肺癌+ [1]

原研机构

The University of Arkansas

在研机构

The University of Arkansas

非在研机构-

最高研发阶段临床1/2期

首次获批日期-

最高研发阶段(中国)-

特殊审评-

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关联

4

项与 P10s-PADRE vaccine(University of Arkansas) 相关的临床试验

NCT03003195

/ Withdrawn临床2期IIT

A Combined Phase I/II Study of a Carbohydrate Mimotope-Based Vaccine with MONTANIDE™ ISA 51 VG STERILE for Metastatic Cancer

The purpose of this study is to evaluate the clinical efficacy of an investigational agent, P10s-PADRE, a peptide mimotope-based vaccine in subjects with metastatic cancer.

开始日期2021-03-01

申办/合作机构

The University of Arkansas

NCT02938442

/ Completed临床1/2期IIT

A Combined Phase i/II Efficacy Study of a Carbohydrate Mimotope-based Vaccine With MONTANIDE™ ISA 51 VG STERILE Combined With Neoadjuvant Chemotherapy in Triple Negative Breast Cancer

The purpose of this study is to evaluate a new investigational cancer vaccine, P10s-PADRE in combination with standard neoadjuvant chemotherapy and surgery in patients with clinical stage I, II or III triple negative breast cancer (TNBC). This study will compare the vaccine plus standard neoadjuvant chemotherapy and surgery to standard neoadjuvant chemotherapy and surgery alone.

开始日期2019-01-25

申办/合作机构

The University of Arkansas

NCT02264236

/ Withdrawn临床1/2期IIT

"Vaccination of Advanced-Stage Lung Cancer Patients" A Phase I/II Study of a Carbohydrate Mimotope Based Vaccine With MONTANIDETM ISA 51 VG ST Adjuvant

The overarching purpose of this study is to evaluate the clinical efficacy of an investigational agent, P10s-PADRE, a peptide mimotope-based vaccine, in combination with standard-of-care (SoC) treatment in subjects with advanced-stage (i.e., metastatic) Lung Cancer. Vaccine will consist of P10s-PADRE admixed with an adjuvant, MONTANIDETM ISA 51 VG. Up to one hundred fifty (150) subjects with advanced-stage Lung Cancer of any histologic type will be enrolled for this vaccine trial.
This single-arm, multi-site trial is designed to evaluate the therapeutic benefits of the vaccine in subjects with advanced-stage lung cancer. The primary objectives of the study are: (1) to monitor the safety and tolerability of the vaccine when it is administered in combination with SoC therapy; and (2) to determine whether immunization with vaccine can successfully elicit a robust immune response in subjects with advanced-stage lung cancer.

开始日期2015-10-01

申办/合作机构

The University of Arkansas

100 项与 P10s-PADRE vaccine(University of Arkansas) 相关的临床结果

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100 项与 P10s-PADRE vaccine(University of Arkansas) 相关的转化医学

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100 项与 P10s-PADRE vaccine(University of Arkansas) 相关的专利（医药）

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4

项与 P10s-PADRE vaccine(University of Arkansas) 相关的文献（医药）

2021-10-26·Oncotarget

P10s-PADRE vaccine combined with neoadjuvant chemotherapy in ER-positive breast cancer patients induces humoral and cellular immune responses

Article

作者: Jousheghany, Fariba ; Beck, J. Thaddeus ; Siegel, Eric R. ; Rogers, Lora J. ; Post, Ginell R. ; Kieber-Emmons, Thomas ; Makhoul, Issam ; Ibrahim, Saddam Mohammed ; Pina-Oviedo, Sergio ; Abu-Rmaileh, Muhammad ; Lee, John J. ; Monzavi-Karbassi, Behjatolah

Breast cancer patients diagnosed with HR+/HER2- tumors face a persistent risk of distant recurrence long after completion of their treatment. Strategies to induce anti-tumor immune responses could complement standard-of-care therapies for these patients. The current study was performed to examine the feasibility, safety and immunogenicity of adding P10s-PADRE to standard-of-care chemotherapy in HR+/HER2- early-stage breast cancer patients. Twenty-five subjects were treated in a single-arm Phase Ib clinical trial. Five different immunization schedules were considered to evaluate the feasibility of eliciting an immune response. The primary immunogenicity endpoint was antibody titer. The expression of several activation markers on natural killer (NK) cells and serum concentrations of Th1/Th2 cytokines were also examined. The percentage of tumor-infiltrating lymphocytes (TILs) was determined. Antibody response was superior in schedule C where 3 weekly immunizations preceded the first dose of chemotherapy. A significant change in CD16, NKp46 and CD94 expression levels on NK cells and a rise in serum content of IFN-γ was observed after treatment. Schedule C showed an increase in TILs in residual lesions. The combination therapy is safe and immunogenic with treatment schedule C being immunologically promising. Randomized trials focused on long-term survival outcomes are needed to evaluate clinical benefits.

2017-11-17·Oncotarget

Targeting tumor-associated carbohydrate antigens: a phase I study of a carbohydrate mimetic-peptide vaccine in stage IV breast cancer subjects

Article

作者: Kieber-Emmons, Thomas ; Monzavi-Karbassi, Behjatolah ; Jousheghany, Fariba ; Makhoul, Issam ; Siegel, Eric R. ; Hutchins, Laura F. ; Emanuel, Peter D. ; Pennisi, Angela ; Pashov, Anastas D. ; Guo, Xueyan

Tumor-associated carbohydrate antigens (TACAs) support cell survival that could be interrupted by anti-TACA antibodies. Among TACAs that mediate cell survival signals are the neolactoseries antigen Lewis Y (LeY) and the ganglioside GD2. To induce sustained immunity against both LeY and GD2, we developed a carbohydrate mimicking peptide (CMP) as a surrogate pan-immunogen that mimics both. This CMP, referred to as P10s, is the N-terminal half of a peptide vaccine named P10s-PADRE, the C-terminal half of which (PADRE) is a Pan-T-cell epitope. A Phase I dose-escalation trial of P10s-PADRE plus adjuvant MONTANIDE™ ISA 51 VG was conducted in subjects with metastatic breast cancer to test 300 and 500 μg/injection in two cohorts of 3 subjects each. Doses of the P10s-PADRE vaccine were administered to research participants subcutaneously on weeks 1, 2, 3, 7 and 19. Antibody responses to P10s, GD2, and LeY were measured by ELISA. The P10s-PADRE vaccine induced antibodies specifically reactive with P10s, LeY and GD2 in all 6 subjects. Serum antibodies displayed Caspase-3-dependent apoptotic functionality against LeY or GD2 expressing breast cancer cell lines. Immunization with the P10s-PADRE vaccine was well-tolerated and induced functional antibodies, and the data suggest potential clinical benefit.

2015-01-01·Human Vaccines & Immunotherapeutics3区 · 医学

Moving a Carbohydrate Mimetic Peptide into the clinic

3区 · 医学

Article

作者: Peter D Emanuel ; Fariba Jousheghany ; Laura Hutchins ; Angela Pennisi ; Eric Siegel ; Thomas Kieber-Emmons ; Behjatolah Monzavi-Karbassi ; Issam Makhoul

Tumor-Associated Carbohydrate Antigens (TACAs) are broad-spectrum targets for immunotherapy. Immunization with Carbohydrate Mimetic Peptides (CMPs) is a strategy to induce broad-spectrum TACA-reactive antibodies hypothesized to interfere with cellular pathways involved in tumor cell survival. A Phase I study was conducted with a first-in-man CMP referred to as P10s, conjugated to the Pan T cell carrier PADRE, along with MONTANIDE(™) ISA 51 VG as adjuvant over a course of 5 immunizations. While designed as a safety and tolerability study, the potential for therapeutic impact was observed in a subject with metastatic lesions as evaluated before and after vaccine treatment. The subject received Vinorelbine and Trastuzumab (VT) for two months prior to study eligibility. PET scans showed partial response in the lungs and complete resolution of a previously enlarged subpectoral lymph node. Immunization with P10s vaccine resulted in responses to P10s, with serum and plasma antibodies reactive with and cytotoxic to human breast cancer cells in vitro, including the Trastuzumab-resistant HCC1954 cell line. However, the patient developed cystic masses in the brain parenchyma with no apparent evidence of metastases. The subject was switched to Docetaxel, Pertuzumab and Trastuzumab a year later, and her last PET scan showed a complete response in the lungs and lymph nodes. Incubation of cancer cells with a combination of vaccine-induced serum and docetaxel suggests that the induced antibodies sensitize tumor cells for more efficient killing upon administration of docetaxel. The data suggest that P10s-PADRE induces anti-tumor antibody response that in combination with chemotherapy can affect metastatic lesions in breast cancer patients.

100 项与 P10s-PADRE vaccine(University of Arkansas) 相关的药物交易

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研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
肿瘤转移	临床2期	-	The University of Arkansas	2021-03-01
实体瘤	临床2期	-	The University of Arkansas	2021-03-01
三阴性乳腺癌	临床2期	美国	The University of Arkansas	2019-01-25
晚期肺腺癌	临床2期	美国	The University of Arkansas	2015-10-01
转移性肺癌	临床2期	美国	The University of Arkansas	2015-10-01
转移性乳腺癌	药物发现	美国	The University of Arkansas	2011-07-01

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT02938442 (CTgov)	临床1/2期	三阴性乳腺癌	16	MONTANIDE™ ISA 51 VG+P10s-PADRE+cyclophosphamide+doxorubicin+Paclitaxel	範廠廠鑰夢窪憲糧築獵(壓蓋網鏇構鑰繭遞簾遞) = 遞窪襯鹹膚艱鏇艱鹽鑰簾鏇襯鏇網糧觸襯獵齋 (遞鑰鏇艱鹹襯積鑰淵顧, 鏇夢膚糧選積齋壓築鬱 ~ 廠廠獵鹽膚繭鏇憲繭襯) 更多	-	2024-07-05
NCT01390064 (CTgov)	临床1期	转移性乳腺癌	6	Mimotope P10s-PADRE/MONTANIDE ISA 51 VG (Initial Cohort)	廠廠艱顧積選獵衊鬱蓋(糧齋壓糧鏇願鹽夢鹹夢) = 夢鏇繭襯齋膚獵製簾淵簾選壓窪鏇願獵糧壓繭 (鹹觸積願壓網衊鹽鬱廠, 窪築觸築網廠鹹積艱網 ~ 願顧齋繭蓋鑰鏇遞鏇範) 更多	-	2019-06-03
NCT01390064 (CTgov)	临床1期	转移性乳腺癌	6	Mimotope P10s-PADRE/MONTANIDE ISA 51 VG (Escalation Cohort)	廠廠艱顧積選獵衊鬱蓋(糧齋壓糧鏇願鹽夢鹹夢) = 衊範積艱淵鹹鹹繭廠選簾選壓窪鏇願獵糧壓繭 (鹹觸積願壓網衊鹽鬱廠, 遞艱範網遞襯獵構蓋製 ~ 蓋鬱構衊鬱廠獵選鑰夢) 更多	-	2019-06-03