Folate receptor alpha vaccine(Mayo Clinic)(Folate receptor alpha vaccine(Mayo Clinic)) - 药物靶点：FOLR1_在研适应症：卵巢子宫内膜样癌，输卵管透明细胞腺癌，高级别输卵管浆液性腺癌_专利_临床

概要

基本信息

药物类型

治疗性疫苗、树突状细胞疫苗

别名

Folate receptor alpha-loaded dendritic cell vaccine、FR alpha peptide vaccine、FRa peptide vaccine

+ [6]

靶点

FOLR1

作用方式

调节剂

作用机制

FOLR1调节剂(叶酸受体α调节剂)

治疗领域

肿瘤消化系统疾病内分泌与代谢疾病+ [2]

在研适应症

卵巢子宫内膜样癌输卵管透明细胞腺癌高级别输卵管浆液性腺癌+ [6]

非在研适应症

3型乳腺癌复发性乳腺癌铂耐药性卵巢癌+ [4]

原研机构

Mayo Clinic

在研机构

Mayo Clinic

非在研机构

Marker Therapeutics, Inc.

权益机构-

最高研发阶段临床2期

首次获批日期-

最高研发阶段(中国)-

特殊审评-

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结构/序列

Sequence Code 1646436

Sequence Code 9957632

Sequence Code 9957659

Sequence Code 9957680

Sequence Code 9957689

关联

5

项与 Folate receptor alpha vaccine(Mayo Clinic) 相关的临床试验

NCT06639074

/ Recruiting临床2期IIT

Folate Receptor Alpha Dendritic Cells (FRαDCs) or Placebo for Patients with Advanced Stage Ovarian Cancer: a Phase II Double-Blind Randomized Clinical Trial (FAROUT)

This phase II trial compares the effect of folate receptor alpha dendritic cells (FRαDCs) to placebo in treating patients with stage III or IV ovarian, fallopian tube or primary peritoneal cancer. FRαDCs, a dendritic cell vaccine, is made from a person's white blood cells. The white blood cells are treated in the laboratory to make dendritic cells (a type of immune cell) mixed with folate receptor alpha (FRalpha), a protein found in high levels on ovarian tumor cells. FRαDCs work by boosting the immune system to recognize and destroy the tumor cells by targeting the FRalpha protein on the tumor cell. Placebo is an inactive substance that looks the same as, and is given the same way as, the active drug or treatment being tested. The effects of the active drug are compared to the effects of the placebo. Giving FRαDCs may work better in preventing or delaying recurrence compared to placebo in patients with stage III or IV ovarian, fallopian tube, or primary peritoneal cancer.

开始日期2024-11-08

申办/合作机构

Mayo Clinic

NCT02978222

/ Terminated临床2期

A Randomized Multicenter Phase II Trial to Evaluate the Safety, Efficacy and Immunogenicity of Vaccination With Folate Receptor Alpha Peptides With GM-CSF Versus GM-CSF Alone in Patients With Platinum Sensitive Ovarian Cancer and a Response or Stable Disease to Platinum Therapy

This is a double-blind, randomized, parallel groups Phase II trial. Patients with platinum-sensitive advanced ovarian cancer, defined as a lack of progression by RECIST v1.1 criteria following completion of standard-of-care chemotherapy, including a minimum of 4 cycles of a platinum-containing regimen. Patients will be randomized to either the vaccine regimen with GM-CSF adjuvant or GM-CSF adjuvant alone as a control group. Treatment will be administered as a consolidation therapy within one year of the last administration of platinum, targeting the first remission.

开始日期2017-07-20

申办/合作机构

Marker Therapeutics, Inc.

NCT02764333

/ Completed临床2期IIT

A Phase II Trial of TPIV200/huFR-1 (A Multi-Epitope Anti-Folate Receptor Vaccine) Plus Anti-PD-L1 MEDI4736 (Durvalumab) in Patients With Platinum Resistant Ovarian Cancer

This is a Phase 2 clinical trial, which tests two investigational drugs: TPIV200/huFR-1 (also called TPIV200), which is a vaccine consisting of proteins from the folate receptor alpha mixed with GM-CSF, and durvalumab (MEDI4736) , which is an antibody drug that help un-block parts of the immune system. The aim of this study is to find out whether these drugs, when given together are safe, and whether they are effective in treating cancer.

开始日期2016-05-06

申办/合作机构

Memorial Sloan Kettering Cancer Center

[+2]

100 项与 Folate receptor alpha vaccine(Mayo Clinic) 相关的临床结果

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100 项与 Folate receptor alpha vaccine(Mayo Clinic) 相关的转化医学

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100 项与 Folate receptor alpha vaccine(Mayo Clinic) 相关的专利（医药）

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2

项与 Folate receptor alpha vaccine(Mayo Clinic) 相关的文献（医药）

2024-10-01·GYNECOLOGIC ONCOLOGY

Vaccination with folate receptor-alpha peptides in patients with ovarian cancer following response to platinum-based therapy: A randomized, multicenter clinical trial

Article

作者: Potts, James ; Knutson, Keith L ; Kenney, Richard T ; Wenham, Robert M ; O'Cearbhaill, Roisin E ; Block, Matthew S ; Garrett, Gerald ; Hamilton, Erika ; Gupta, Aditi ; Konner, Jason A

OBJECTIVE:

Folate receptor alpha (FRα) is overexpressed on >90% of high-grade epithelial ovarian cancers (EOC). Targeting FRα with antibody-drug conjugates has proven utility in the platinum-resistant setting. It is also a potential therapeutic target for immuno-oncologic agents, such as peptide vaccines that work primarily via adaptive and humoral immunity. We tested the hypothesis that FRα peptide immunization could improve outcomes in patients with EOC following response to platinum-based therapy.

METHODS:

We conducted a randomized, double-blind, multicenter, phase II study to evaluate the safety and efficacy of TPIV200 (a multi-epitope FRα peptide vaccine admixed with GM-CSF) versus GM-CSF alone in 120 women who did not have disease progression after at least 4 cycles of first-line platinum-based therapy. Patients were vaccinated intradermally once every 4 weeks up to 6 times, followed by a boosting period of 6 vaccinations at 12-week intervals. Primary endpoints included safety, tolerability, and progression free survival (PFS).

RESULTS:

At study termination with a median follow-up of 15.2 months (range 1.2-28.4 months), 68 of 119 intention-to-treat patients had disease progression (55% in TPIV200 + GM-CSF arm and 59% in GM-CSF alone arm). The median PFS was 11.1 months (95% CI 8.3-16.6 months) with no significant difference between the treatment groups (10.9 months with TPIV200 + GM-CSF versus 11.1 months with GM-CSF, HR, 0.85; upper 90% CI 1.17]. No patient experienced a ≥ grade 3 drug-related adverse event.

CONCLUSION:

TPIV200 was well tolerated but was not associated with improved PFS. Additional studies are required to uncover potential synergies using multiepitope vaccines targeting FRα. Trial Registration NLM/NCBI Registry, NCT02978222, https://clinicaltrials.gov/search?term=NCT02978222.

2020-06-01·Journal for immunotherapy of cancer2区 · 医学

Safety, immunogenicity, and clinical efficacy of durvalumab in combination with folate receptor alpha vaccine TPIV200 in patients with advanced ovarian cancer: a phase II trial

2区 · 医学

ArticleOA

作者: Torrisi, Jean M ; Zamarin, Dmitriy ; Holland, Aliya ; Erskine, Courtney L ; O'Cearbhaill, Roisin E ; Aghajanian, Carol ; Li, Yanyun ; Mcdonnell, Autumn S ; Konner, Jason A ; Knutson, Keith L ; Hollmann, Travis J ; Grisham, Rachel N ; Chesebrough, Lewis F ; Gallagher, Jacqueline M ; Block, Mathew S ; Walderich, Sven ; Merghoub, Taha ; Iasonos, Alexia E ; Zhou, Qin

Background:

Immune checkpoint inhibitors (ICIs) to date have demonstrated limited activity in advanced ovarian cancer (OC). Folate receptor alpha (FRα) is overexpressed in the majority of OCs and presents an attractive target for a combination immunotherapy to potentially overcome resistance to ICI in OCs. The current study sought to examine clinical and immunologic responses to TPIV200, a multiepitope FRα vaccine administered with programmed death ligand 1 (PD-L1) inhibitor durvalumab in patients with advanced platinum-resistant OC.

Methods:

Following Simon two-stage phase II trial design, 27 patients were enrolled. Treatment was administered in 28-day cycles (intradermal TPIV200 and granulocyte-macrophage colony-stimulating factor (GM-CSF) for 6 cycles and intravenous durvalumab for 12 cycles). Primary endpoints included overall response rate and progression-free survival at 24 weeks. Translational parameters focused on tumor microenvironment, PD-L1 and FRα expression, and peripheral vaccine-specific immune responses.

Results:

Treatment was well tolerated, with related grade 3 toxicity rate of 18.5%. Increased T cell responses to the majority of peptides were observed in all patients at 6 weeks (p<0.0001). There was one unconfirmed partial response (3.7%) and nine patients had stable disease (33.3%). Clinical benefit was not associated with baseline FRα or PD-L1 expression. One patient with prolonged clinical benefit demonstrated loss of FRα expression and upregulation of PD-L1 in a progressing lesion. Despite the low overall response rate, the median overall survival was 21 months (13.5–∞), with evidence of benefit from postimmunotherapy regimens.

Conclusions:

Combination of TPIV200 and durvalumab was safe and elicited robust FRα-specific T cell responses in all patients. Unexpectedly durable survival in this heavily pretreated population highlights the need to investigate the impact of FRα vaccination on the OC biology post-treatment.

1

项与 Folate receptor alpha vaccine(Mayo Clinic) 相关的新闻（医药）

2018-08-29

·BioSpace

TapImmune to Participate at Two Upcoming September 2018 Industry Conferences

JACKSONVILLE, Fla., Aug. 29, 2018 /PRNewswire/ -- TapImmune Inc.(NASDAQ: TPIV), a clinical-stage immuno-oncology company, today announced that its President and CEO, Peter L. Hoang, will participate at two upcoming industry conferences. Mr. Hoang will present and participate in a panel discussion at the Hanson Wade CAR-TCR Summit, to be held September 4-7, 2018, in Boston, Massachusetts, and present at BioCentury's 25th Annual NewsMakers in the Biotech Industry to be held September 7, 2018, in New York City. CAR-TCR Summit Details: Date: Wednesday, September 5, 2018 Location: Cityview Room; Seaport Hotel and World Trade Center, Boston, MA Time: 2:25pm (ET): Company Presentation 5:15pm (ET): Panel - How to Make CAR/TCR Therapies Work Beyond the CD19/ALL Paradigm BioCentury Newsmakers Presentation Details: Date: Friday, September 7, 2018 Location: Millennium Broadway Hotel & Conference Center, New York City, NY Time: 2:30pm (ET): Presentation - Room 302/303 3:00pm (ET): Breakout Session - Room 301 Webcast: Available at About TapImmune Inc. TapImmune Inc. is a leader in the development of novel immunotherapies for cancer, with multiple Phase 2 and Phase 1b/2 clinical studies currently ongoing for the treatment of ovarian and breast cancer. The Company's peptide or nucleic acid-based immunotherapeutic products comprise multiple naturally processed epitopes (NPEs) that are designed to comprehensively stimulate a patient's killer T cells and helper T cells, and to restore or further augment antigen presentation using proprietary nucleic acid-based expression systems. This unique approach can produce off-the-shelf T cell vaccine candidates that elicit a broad-based T cell response and can be used without respect to HLA type. The Company's technologies may be used as stand-alone medications or in combination with other treatment modalities. TapImmune has announced a proposed merger with Marker Therapeutics, Inc., a privately-held clinical stage developer of a transformative, non-genetically engineered, multi-antigen T cell therapy platform, which will add a significant portfolio of clinical-stage cell therapies to create a leading immuno-oncology pipeline. For additional information, please visit: To receive future press releases via email, please visit: Follow us on Twitter @Tapimmune_Inc, or follow us on Facebook. For answers to frequently asked questions, please visit our FAQs page: Forward-Looking Statement Disclaimer This release contains forward-looking information within the meaning of the Private Securities Litigation Reform Act of 1995. Statements in this news release concerning the Company's expectations, plans, business outlook or future performance, and any other statements concerning assumptions made or expectations as to any future events, conditions, performance or other matters, are "forward-looking statements". Forward-looking statements are by their nature subject to risks, uncertainties and other factors which could cause actual results to differ materially from those stored in such statements. Such risks, uncertainties and factors include, but are not limited to the results of the Phase 2 clinical trials, the ability to obtain regulatory approval of TPIV200, the Company's ability to raise future financing for continued development and the ability to successfully commercialize TPIV200 as well as the risks and uncertainties set forth in the Company's most recent Form 10-K, 10-Q and other SEC filings which are available through EDGAR at The Company assumes no obligation to update the forward-looking statements. View original content with multimedia: SOURCE TapImmune Inc. Company Codes: NASDAQ-SMALL:TPIV

细胞疗法疫苗并购

100 项与 Folate receptor alpha vaccine(Mayo Clinic) 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
卵巢子宫内膜样癌	临床2期	美国	Mayo Clinic	2024-11-08
输卵管透明细胞腺癌	临床2期	美国	Mayo Clinic	2024-11-08
高级别输卵管浆液性腺癌	临床2期	美国	Mayo Clinic	2024-11-08
卵巢高级别浆液性腺癌	临床2期	美国	Mayo Clinic	2024-11-08
卵巢腺癌	临床2期	美国	Mayo Clinic	2024-11-08
卵巢癌肉瘤	临床2期	美国	Mayo Clinic	2024-11-08
原发性腹膜透明细胞癌	临床2期	美国	Mayo Clinic	2024-11-08
原发性腹膜子宫内膜样腺癌	临床2期	美国	Mayo Clinic	2024-11-08
原发性腹膜高级别浆液性腺癌	临床2期	美国	Mayo Clinic	2024-11-08
铂敏感性卵巢癌	临床2期	美国	Marker Therapeutics, Inc.	2017-07-20

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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


NCT02978222 (Pubmed) 人工标引	临床2期	卵巢癌	120	TPIV200receptor-alpha peptides (TPIV200 + GM-CSF)	憲艱艱構製願衊衊獵廠(顧夢醖簾鬱廠鏇選鬱鏇) = 淵繭廠淵願築繭鑰鏇壓蓋繭選觸鹹願遞範鹹糧 (蓋範構範壓夢獵範艱願 )	不佳	2024-10-01
				GM-CSF alone	憲艱艱構製願衊衊獵廠(顧夢醖簾鬱廠鏇選鬱鏇) = 遞觸顧壓糧願觸遞觸願蓋繭選觸鹹願遞範鹹糧 (蓋範構範壓夢獵範艱願 )
NCT02978222 (NCT02978222 \| ###DELETE, CTgov)	临床2期	铂敏感性卵巢癌	120	FRα peptide plus Adjuvant (GM-CSF) (FRα Peptide Plus Adjuvant (GM-CSF))	觸鏇壓壓憲製願淵夢餘(鏇糧壓齋蓋構遞範鑰獵) = 壓淵構網築艱艱顧構鬱繭壓襯艱壓餘繭餘願餘 (膚製網積餘範鑰鹹夢醖, 顧蓋顧簾顧膚鏇獵製壓 ~ 積願選淵選鹽製襯顧繭) 更多	-	2022-12-15
				Adjuvant (GM-CSF) Alone (Adjuvant (GM-CSF) Alone)	觸鏇壓壓憲製願淵夢餘(鏇糧壓齋蓋構遞範鑰獵) = 鹹範襯鬱艱齋繭鹹蓋蓋繭壓襯艱壓餘繭餘願餘 (膚製網積餘範鑰鹹夢醖, 膚繭淵鹽遞襯襯遞鹽襯 ~ 夢憲膚鑰餘顧衊顧艱蓋) 更多
NCT02764333 (CTgov)	临床2期	铂耐药性卵巢癌	29	TPIV200+Durvalumab	顧範鬱膚衊膚襯蓋簾憲 = 窪獵簾襯鹽壓襯鑰範願遞遞繭築醖醖醖鹽蓋廠 (齋製鹽廠願衊鑰繭簾壓, 範齋遞齋糧鏇鏇顧鑰範 ~ 鏇鹽餘積窪鏇糧蓋壓繭) 更多	-	2021-11-30
190 (ESGO2021)	N/A	卵巢癌新辅助 FOLR1	-	Neoadjuvant chemotherapy (NACT)	糧願網願鹹艱願鏇襯糧(選簾鹽積膚願襯觸廠膚) = 構觸衊衊鏇簾餘積淵鏇構範顧憲膚鹽廠醖構鑰 (選構醖蓋膚醖觸餘構襯 )	积极	2021-10-12
				Chemotherapy naÃ¯ve patients	糧願網願鹹艱願鏇襯糧(選簾鹽積膚願襯觸廠膚) = 憲鏇構衊繭膚鏇窪顧積構範顧憲膚鹽廠醖構鑰 (選構醖蓋膚醖觸餘構襯 )
NCT02764333 (Pubmed \| J Immunother Cancer) 人工标引	临床2期	卵巢癌	27	durvalumab+TPIV200	餘衊選膚顧觸窪艱衊鏇(鹽選夢製糧鹹顧醖糧獵) = 顧選鏇築構衊簾構願餘淵淵餘選蓋繭範廠醖積 (遞艱衊遞簾願膚築鑰顧 ) 更多	积极	2020-06-01
NCT02978222 (ASCO 12020 \| ASCO 22020) 人工标引	临床2期	卵巢癌	120	FRα peptides+GM-CSF	構顧夢廠選鬱鏇構淵憲(選構築觸繭蓋艱膚淵醖) = 衊顧鹹積鹽醖鬱願艱廠鏇膚窪鏇蓋網壓獵糧壓 (製顧淵觸獵夢壓淵艱鹹 ) 更多	不佳	2020-05-25
				GM-CSF	構顧夢廠選鬱鏇構淵憲(選構築觸繭蓋艱膚淵醖) = 淵鹹築觸積網構鏇窪廠鏇膚窪鏇蓋網壓獵糧壓 (製顧淵觸獵夢壓淵艱鹹 ) 更多