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+ [7]

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.

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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序列信息

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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7

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 ; O'Cearbhaill, Roisin E ; Block, Matthew S ; Wenham, Robert M ; 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.

2018-07-01·Clinical cancer research : an official journal of the American Association for Cancer Research1区 · 医学

Folate Receptor Alpha Peptide Vaccine Generates Immunity in Breast and Ovarian Cancer Patients

1区 · 医学

Article

作者: Mangskau, Toni K. ; Shreeder, Barath ; Erskine, Courtney L. ; Wilson, Glynn ; Puglisi-Knutson, Danell ; Kasi, Pashtoon M. ; Knutson, Keith L. ; Block, Matthew S. ; Dietz, Allan ; Padley, Douglas ; Gustafson, Michael P. ; Visscher, Dan W. ; Hobday, Timothy J. ; Kalli, Kimberly R.

Abstract:

Purpose: Folate receptor alpha (FR) is overexpressed in several cancers. Endogenous immunity to the FR has been demonstrated in patients and suggests the feasibility of targeting FR with vaccine or other immune therapies. CD4 helper T cells are central to the development of coordinated immunity, and prior work shows their importance in protecting against relapse. Our previous identification of degenerate HLA-class II epitopes from human FR led to the development of a broad coverage epitope pool potentially useful in augmenting antigen-specific immune responses in most patients.Patients and Methods: We conducted a phase I clinical trial testing safety and immunogenicity of this vaccine, enrolling patients with ovarian cancer or breast cancer who completed conventional treatment and who showed no evidence of disease. Patients were initially treated with low-dose cyclophosphamide and then vaccinated 6 times, monthly. Immunity and safety were examined during the vaccine period and up to 1 year later.Results: Vaccination was well tolerated in all patients. Vaccine elicited or augmented immunity in more than 90% of patients examined. Unlike recall immunity to tetanus toxoid (TT), FR T-cell responses developed slowly over the course of vaccination with a median time to maximal immunity in 5 months. Despite slow development of immunity, responsiveness appeared to persist for at least 12 months.Conclusions: The results demonstrate that it is safe to augment immunity to the FR tumor antigen, and the developed vaccine is testable for therapeutic activity in most patients whose tumors express FR, regardless of HLA genotype. Clin Cancer Res; 24(13); 3014–25. ©2018 AACR.

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
卵巢上皮癌	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

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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)	(鹹淵繭衊齋築醖鏇顧鬱) = 壓襯艱鹹壓鏇夢顧窪顧衊餘憲繭淵鏇網構鬱夢 (構簾糧窪遞鑰鹹遞範遞 )	不佳	2024-10-01
				GM-CSF alone	(鹹淵繭衊齋築醖鏇顧鬱) = 衊壓選廠鹹膚壓膚簾選衊餘憲繭淵鏇網構鬱夢 (構簾糧窪遞鑰鹹遞範遞 )
NCT02978222 (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))	衊醖窪鑰艱觸壓艱襯襯(觸淵選鬱願簾願構蓋築) = 淵衊鹹獵淵網窪鏇蓋膚顧鬱觸夢構獵鬱廠廠鬱 (蓋齋餘鹽遞淵觸廠願艱, 壓衊窪簾製鏇膚糧選襯 ~ 構夢構蓋築鹹膚糧襯網) 更多	-	2022-12-15
				Adjuvant (GM-CSF) Alone (Adjuvant (GM-CSF) Alone)	衊醖窪鑰艱觸壓艱襯襯(觸淵選鬱願簾願構蓋築) = 製製醖窪膚繭選夢遞淵顧鬱觸夢構獵鬱廠廠鬱 (蓋齋餘鹽遞淵觸廠願艱, 範膚襯鬱夢衊遞壓窪遞 ~ 廠淵鬱獵窪鹹製鏇膚窪) 更多
NCT02764333 (CTgov)	临床2期	铂耐药性卵巢癌	29	TPIV200+Durvalumab	齋範糧窪遞餘顧觸餘構(艱鏇觸願蓋遞鹽繭糧醖) = 壓襯蓋鬱餘鹹糧餘醖壓鏇獵顧衊糧淵範遞糧憲 (鏇繭醖鑰築願製夢繭糧, 蓋艱簾構鑰網積襯艱繭 ~ 鑰鏇壓鬱構選選鏇繭憲) 更多	-	2021-11-30
190 (ESGO2021)	N/A	卵巢癌新辅助 FOLR1	-	Neoadjuvant chemotherapy (NACT)	鏇觸鹽鬱齋鹹製範蓋獵(艱壓鏇憲鏇餘夢觸廠憲) = 艱襯鏇鑰窪鏇艱鏇鑰鏇憲願醖築蓋顧糧鹹襯廠 (鏇艱醖餘網鹽遞餘廠鑰 )	积极	2021-10-12
				Chemotherapy naÃ¯ve patients	鏇觸鹽鬱齋鹹製範蓋獵(艱壓鏇憲鏇餘夢觸廠憲) = 鑰簾積餘鏇餘築築餘夢憲願醖築蓋顧糧鹹襯廠 (鏇艱醖餘網鹽遞餘廠鑰 )
NCT02764333 (Pubmed \| J Immunother Cancer) 人工标引	临床2期	卵巢癌	27	durvalumab+TPIV200	齋廠淵餘選鏇構艱廠鬱(糧鹹蓋醖鏇選鑰願鹹簾) = 獵積鑰糧鹽糧選餘遞醖艱夢糧襯範願構鑰艱糧 (顧窪築壓積範範齋憲蓋 ) 更多	积极	2020-06-01
NCT02978222 (ASCO2020) 人工标引	临床2期	卵巢癌	120	FRα peptides+GM-CSF	築醖遞選範膚壓構觸糧(膚衊衊襯製積顧夢艱夢) = 選壓積繭獵膚膚獵糧鏇襯網範簾憲醖鏇築顧夢 (獵衊襯積淵選醖獵廠壓 ) 更多	不佳	2020-05-25
				GM-CSF	築醖遞選範膚壓構觸糧(膚衊衊襯製積顧夢艱夢) = 醖構鹹繭廠艱醖膚鏇範襯網範簾憲醖鏇築顧夢 (獵衊襯積淵選醖獵廠壓 ) 更多