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.

Start Date08 Nov 2024

Sponsor / Collaborator

Mayo Clinic

NCT02978222

/ TerminatedPhase 2

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.

Start Date20 Jul 2017

Sponsor / Collaborator

Marker Therapeutics, Inc.

NCT02764333

/ CompletedPhase 2IIT

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.

Start Date06 May 2016

Sponsor / Collaborator

Memorial Sloan Kettering Cancer Center

[+2]

100 Clinical Results associated with Folate receptor alpha vaccine(Mayo Clinic)

100 Translational Medicine associated with Folate receptor alpha vaccine(Mayo Clinic)

100 Patents (Medical) associated with Folate receptor alpha vaccine(Mayo Clinic)

Literatures (Medical) associated with Folate receptor alpha vaccine(Mayo Clinic)

01 Oct 2024·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

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

OBJECTIVEFolate 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.METHODSWe 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).RESULTSAt 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.CONCLUSIONTPIV200 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.

01 Jun 2020·Journal for ImmunoTherapy of CancerQ2 · MEDICINE

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

Q2 · MEDICINE

ArticleOA

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

BackgroundImmune 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.MethodsFollowing 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.ResultsTreatment 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.ConclusionsCombination 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.

01 Jul 2018·Clinical Cancer ResearchQ1 · MEDICINE

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

Q1 · MEDICINE

Article

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

AbstractPurpose: 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.

News (Medical) associated with Folate receptor alpha vaccine(Mayo Clinic)

29 Aug 2018

·www.biospace.com

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

Cell TherapyVaccineAcquisition

100 Deals associated with Folate receptor alpha vaccine(Mayo Clinic)

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Endometrioid carcinoma ovary	Phase 2	US	Mayo Clinic	08 Nov 2024
Fallopian Tube Clear Cell Adenocarcinoma	Phase 2	US	Mayo Clinic	08 Nov 2024
Fallopian Tube High Grade Serous Adenocarcinoma	Phase 2	US	Mayo Clinic	08 Nov 2024
high grade serous adenocarcinoma of ovary	Phase 2	US	Mayo Clinic	08 Nov 2024
Ovarian Carcinosarcoma	Phase 2	US	Mayo Clinic	08 Nov 2024
Primary clear cell peritoneal carcinoma	Phase 2	US	Mayo Clinic	08 Nov 2024
Primary Peritoneal Endometrioid Adenocarcinoma	Phase 2	US	Mayo Clinic	08 Nov 2024
Platinum-Sensitive Ovarian Carcinoma	Phase 1	US	Marker Therapeutics, Inc.	20 Jul 2017
Platinum-Resistant Ovarian Carcinoma	Phase 1	US	Marker Therapeutics, Inc.	06 May 2016
Triple Negative Breast Cancer	Phase 1	US	Marker Therapeutics, Inc.	01 Apr 2016

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02978222 (Pubmed) Manual	Phase 2	Ovarian Cancer	120	TPIV200receptor-alpha peptides (TPIV200 + GM-CSF)	(syfjmjkxxe) = izupvhstxb wqgirfusrt (ygpbzrvaym )	Negative	01 Oct 2024
NCT02978222 (Pubmed) Manual	Phase 2	Ovarian Cancer	120	GM-CSF alone	(syfjmjkxxe) = izvdhiorxt wqgirfusrt (ygpbzrvaym )	Negative	01 Oct 2024
NCT02978222 (NCT02978222 \| ###DELETE, CTgov)	Phase 2	Platinum-Sensitive Ovarian Carcinoma	120	FRα peptide plus Adjuvant (GM-CSF) (FRα Peptide Plus Adjuvant (GM-CSF))	(ortkxmpboa) = pbndnitrix sidtwmbwdd (idzrujystk, ujfqggzycc - kjgxokzosf) View more	-	15 Dec 2022
NCT02978222 (NCT02978222 \| ###DELETE, CTgov)	Phase 2	Platinum-Sensitive Ovarian Carcinoma	120	Adjuvant (GM-CSF) Alone (Adjuvant (GM-CSF) Alone)	(ortkxmpboa) = pijcxwjprw sidtwmbwdd (idzrujystk, emvirauhyx - uzhzpjkvcc) View more	-	15 Dec 2022
NCT02764333 (CTgov)	Phase 2	Platinum-Resistant Ovarian Carcinoma	29	TPIV200+Durvalumab	jitxamoeks(iyjwfjezar) = wtmpfnayya wfmjarxysv (uaucktnbbv, fvfcidjfbr - dbzgfofwjq) View more	-	30 Nov 2021
NCT02764333 (Pubmed \| J Immunother Cancer) Manual	Phase 2	Ovarian Cancer	27	durvalumab+TPIV200	(rykujjnlja) = sykefacktd ptpylzwxgh (gnbcxmzlmt ) View more	Positive	01 Jun 2020

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