A Phase IIa Open Label, Randomized Clinical Trial to Study the Safety and Efficacy of Vintafolide and the Combination of Vintafolide and Paclitaxel Compared to Paclitaxel in Subjects With Advanced Triple Negative Breast Cancer Using Etarfolatide (EC20) Subject Selection

The purpose of this study is to assess the efficacy and safety of vintafolide alone compared to vintafolide plus paclitaxel and paclitaxel alone in participants with with 100% positive folate receptor (FR) triple negative breast cancer (TNBC).
The primary hypothesis of this study is the vintafolide alone and/or vintafolide + paclitaxel will improve progression free survival (PFS) in participants with FR (100%) TNBC compared to paclitaxel alone.

Start Date01 Apr 2014

Sponsor / Collaborator

Endocyte, Inc.

NCT02049281

/ TerminatedPhase 1

A Phase I Dose Escalation Study Evaluating MK-8109 (Vintafolide) in Japanese Subjects With Advanced Solid Tumor

This study will evaluate thrice weekly dosing with vintafolide to find the maximum tolerable dose. The primary study hypothesis is that administration of vintafolide to participants with advanced solid tumors will have acceptable safety and tolerability.

Start Date01 Feb 2014

Sponsor / Collaborator

Endocyte, Inc.

NCT01688791

/ TerminatedPhase 1

A Phase I Dose Escalation Study Evaluating Vintafolide (MK-8109) Chemotherapy Alone or in Combination in Adult Subjects With Advanced Cancers

This trial will be conducted in three parts. Part A is a dose escalation trial followed by a dose confirmation trial in folate receptor (FR) 100% endometrial cancer participants. The primary hypothesis of this trial is that administration of vintafolide in combination with carboplatin and paclitaxel is safe and tolerable. Part B is a single dose, dose escalation, pharmacokinetic (PK), and QTc interval trial. The primary objectives include determination of the maximum single tolerated dose of vintafolide and to evaluate the effect of this single maximum dose on the QTc interval. Part C is a weekly dose escalation trial of vintafolide followed by a dose confirmation. The primary hypothesis of this part is that weekly vintafolide has acceptable safety and tolerability in participants with advanced cancers.

Start Date01 Dec 2012

Sponsor / Collaborator

Endocyte, Inc.

100 Clinical Results associated with Vintafolide

100 Translational Medicine associated with Vintafolide

100 Patents (Medical) associated with Vintafolide

Literatures (Medical) associated with Vintafolide

01 Mar 2023·International journal of gynecological cancer : official journal of the International Gynecological Cancer Society

Integrating antibody drug conjugates in the management of gynecologic cancers

Review

Author: Mahner, Sven ; Coleman, Robert L ; Lorusso, Domenica ; Moore, Kathleen Nadine ; Chelariu-Raicu, Anca

The clinical development of antibody drug conjugates (ADCs) in ovarian cancer began in 2008 with farletuzumab, a humanized monoclonal antibody, and vintafolide, an antigen drug conjugate, both targeting alpha folate receptor. Over the years, this novel class of drugs expanded to agents with a more sophisticated design and structure, targeting tissue factor (TF) in cervical cancer or human epidermal growth factor receptor 2 (HER2) in endometrial cancer. Despite the impressive number of patients included in clinical trials investigating different ADCs across gynecological cancers, it was only recently that the Food and Drug Administration (FDA) granted accelerated approvals to the first ADCs in gynecologic cancer. In September 2021, the FDA approved tisotumab vedotin (TV) in recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. This was followed in November 2022, by the approval of mirvetuximab soravtansine (MIRV) for adult patients with folate receptor alpha (FRα) positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received one to three prior systemic treatment regimens. Currently, the field of ADCs is rapidly expanding and more than 20 ADC formulations are in clinical trials for the treatment of ovarian, cervical and endometrial tumors. This review summarizes key evidence supporting their use and therapeutic indications, including results from late-stage development trials investigating MIRV in ovarian cancer and TV in cervical cancer. We also outline new concepts in the field of ADCs, including promising targets such as NaPi2 and novel drug delivery platforms such as dolaflexin with a scaffold-linker. Finally, we briefly present challenges in the clinical management of ADC toxicities and the emerging role of ADC combination therapies, including chemotherapy, anti-angiogenic and immunotherapeutic agents.

01 Jan 2018·CANCER CHEMOTHERAPY AND PHARMACOLOGY

Advances in ovarian cancer therapy

Review

Author: Kujawa, Katarzyna A ; Cortez, Alexander J ; Lisowska, Katarzyna M ; Tudrej, Patrycja

Epithelial ovarian cancer is typically diagnosed at an advanced stage. Current state-of-the-art surgery and chemotherapy result in the high incidence of complete remissions; however, the recurrence rate is also high. For most patients, the disease eventually becomes a continuum of symptom-free periods and recurrence episodes. Different targeted treatment approaches and biological drugs, currently under development, bring the promise of turning ovarian cancer into a manageable chronic disease. In this review, we discuss the current standard in the therapy for ovarian cancer, major recent studies on the new variants of conventional therapies, and new therapeutic approaches, recently approved and/or in clinical trials. The latter include anti-angiogenic therapies, polyADP-ribose polymerase (PARP) inhibitors, inhibitors of growth factor signaling, or folate receptor inhibitors, as well as several immunotherapeutic approaches. We also discuss cost-effectiveness of some novel therapies and the issue of better selection of patients for personalized treatment.

01 Nov 2016·International journal of gynecological cancer : official journal of the International Gynecological Cancer SocietyQ3 · MEDICINE

Adverse Event Profile by Folate Receptor Status for Vintafolide and Pegylated Liposomal Doxorubicin in Combination, Versus Pegylated Liposomal Doxorubicin Alone, in Platinum-Resistant Ovarian Cancer

Q3 · MEDICINE

Article

Author: Naumann, R Wendel ; Symanowski, Jim ; Kutarska, Elżbieta ; Rangwala, Reshma A ; Bidzińsk, Mariusz ; Nguyen, Binh ; Herzog, Thomas J

Objective:

This exploratory analysis evaluated the incidence of adverse events (AEs) by folate receptor (FR) status in the randomized, multicenter, open-label PRECEDENT study in women with platinum-resistant ovarian cancer receiving pegylated liposomal doxorubicin (PLD) ± the small-molecule drug conjugate vintafolide.

Methods:

Women 18 years or older with platinum-resistant ovarian cancer were randomized 2:1 to vintafolide (2.5 mg intravenously, 3 times per week, weeks 1 and 3, every 28 days) + PLD (50 mg/m2 intravenously, day 1, every 28 days) or PLD alone (same dose/schedule). The expression of functionally active FR was evaluated by single-photon emission computed tomography with etarfolatide. Patients were categorized according to FR positivity: patients with all target lesions positive for FR expression (FR 100%), patients with 1 or more but not all target lesions positive for FR expression (FR 10%–90%), and patients with all lesions negative for FR expression (FR 0%).

Results:

Data on FR status were available for 94 patients: 38 were FR 100%, 36 were FR 10% to 90%, and 20 were FR 0%. Across all FR subgroups, the duration of treatment was longer, and the number of cycles was higher in combination-therapy arms than PLD-alone arms. Although the frequency of AEs was relatively consistent across subgroups, the FR 100% subgroup had a higher incidence of patients with at least 1 AE for combination therapy versus PLD alone. No surprising safety signals were shown according to FR status. The incidence of grade 3 or 4 treatment-emergent drug-related AEs was generally low across all FR subgroups and treatment arms.

Conclusions:

This exploratory analysis suggests that FR status does not influence the AE profile of vintafolide + PLD combination therapy or PLD alone in patients with platinum-resistant ovarian cancer. Future a priori analyses in larger populations are needed to confirm these findings.

News (Medical) associated with Vintafolide

20 Mar 2026

·www.biospace.com

Kaida BioPharma Announces Executive Leadership Team to Advance KAD-101, Built for the Ovarian Cancer Gap

FORT LAUDERDALE, Fla., March 19, 2026 (GLOBE NEWSWIRE) -- Kaida BioPharma, a biotechnology company developing targeted therapies for women with hard-to-treat gynecologic cancers, today announced its executive leadership team and board. Each member brings decades of experience in biotechnology, clinical development, regulatory strategy, manufacturing, finance, and commercialization to help advance Kaida’s lead product candidate, KAD-101, toward first-in-human clinical evaluation. The company is developing KAD-101 for recurrent ovarian cancer, where treatment options narrow quickly and durable control remains limited. Kaida BioPharma is building KAD-101, a next-generation prolactin receptor antagonist for the ovarian cancer gap, the space where patients are too often left cycling through treatment with too few durable options. In addition to her role as Chairperson of the Board, Kaida founder Dr. Stella Vnook has been named Acting Chief Executive Officer. Dr. Vnook is an accomplished biotechnology founder, executive, and advisor with extensive experience guiding early-stage therapeutics from scientific foundation through capital formation. At Kaida, she leads corporate strategy, development planning, and investor engagement. “The science brought me here, and the women out there still fighting are why I stay. At Kaida, we are building for the ovarian cancer gap, for patients whose options narrow too fast and whose disease still outpaces available therapies,” said Dr. Vnook. “By targeting the survival signals that keep these tumors alive, we believe KAD-101 has the potential to help overcome treatment resistance and create a new path toward more durable control. More options mean more time, and more time means everything.” Craig Pierson , a founder alongside Dr. Vnook, has been appointed Director at Kaida BioPharma. Mr. Pierson is a life sciences investor and company builder with more than 25 years of experience in investment banking and private capital formation. He provides strategic oversight and financing expertise. George E. Peoples, MD, FACS has been appointed fractional Chief Medical Officer. Dr. Peoples is a surgical oncologist with decades of experience in translational oncology and clinical development. He is also the founder of the Cancer Vaccine Development Program, Cancer Insight, and LumaBridge. At Kaida, he helps guide clinical strategy and IND planning. John Langenheim, PhD has been appointed fractional Chief Scientific Officer. Dr. Langenheim is a molecular biologist with more than 20 years of experience in therapeutic protein design and preclinical development. His scientific leadership has been instrumental in advancing KAD-101 toward clinical evaluation. Pamela Swiggard has been appointed Head of Regulatory Affairs. She is a pharmaceutical executive with prior experience at companies including Pfizer and Endo Pharmaceuticals. She brings deep expertise across the product lifecycle, from development through regulatory approval and commercialization. At Kaida, she leads regulatory strategy and FDA engagement in support of IND readiness for KAD-101. Eric Hacherl, PhD has been appointed Head of Manufacturing. Dr. Hacherl is a senior pharmaceutical operations leader with more than 25 years of experience in biologics manufacturing, cGMP compliance, and process development. At Kaida, he is responsible for helping ensure clinical supply readiness for KAD-101. Mark Booth has been appointed Chief Commercial Officer. Mr. Booth is a seasoned pharmaceutical and biotechnology executive with more than 25 years of experience building commercial strategies for oncology and rare disease products. His background includes leadership across launch planning, brand strategy, access, and market development for important oncology products, including EMEND, EMEND IV, Zolinza, vintafolide, KEYTRUDA, and the avutometinib plus defactinib combination for low grade serous ovarian cancer. At Kaida, he is responsible for commercial strategy for KAD-101, including positioning, market development, and long-term access planning. About Kaida BioPharma Kaida BioPharma is a biopharmaceutical company developing targeted therapies for hormone-driven gynecologic cancers. Its lead candidate, KAD-101, is a prolactin receptor antagonist being developed for recurrent ovarian cancer, where treatment options narrow quickly and many patients still face limited durable control. Kaida is focused on building innovative therapies for patients left in the ovarian cancer gap and in other areas of high unmet need. For more information, visit kaida-biopharma.com . Contact: Michelle Kafka michelle@kafka.com 407-603-5716

Executive ChangeVaccine

08 Sep 2015

·www.biospace.com

Endocyte, Inc. Announces Final Overall Survival Results From Phase IIb TARGET Trial In Non-Small Cell Lung Cancer Patients

WEST LAFAYETTE, Ind., Sept. 7, 2015 (GLOBE NEWSWIRE) -- Endocyte, Inc. (Nasdaq:ECYT), today presented the final overall survival (OS) analysis from the Phase 2b TARGET trial evaluating its small molecule drug conjugate (SMDC) vintafolide in combination with docetaxel in patients with FR positive recurrent NSCLC at the World Conference on Lung Cancer in Denver, Colorado. Vintafolide plus docetaxel improved overall survival by 2.7 months in NSCLC regardless of histology (Median OS 11.5 vs. 8.8 months, OS HR=0.86, 95% CI [0.58, 1.26]). In the predefined subset analysis of patients with adenocarcinoma, which expresses higher levels of folate receptor, vintafolide plus docetaxel improved OS by 5.9 months (12.5 vs. 6.6 months, HR=0.72, 95% CI [0.44, 1.16]). OS for vintafolide as single agent was similar to docetaxel (OS 8.4 vs. 8.8 months, HR=1.02, 95% CI [0.70, 1.50]). The study previously reported that the PFS primary endpoint was met, (HR=0.75, 95% CI [0.52, 1.09]) regardless of histology and in the adenocarcinoma subgroup (HR=0.73, 95% CI [0.46, 1.16]). The safety pro the combination arm was consistent with those observed with docetaxel alone and vintafolide alone, though a higher rate of hematologic and peripheral neuropathy adverse events were observed in the combination arm. "The final OS results are consistent with the biology of the folate receptor target, with higher expression levels in the adenocarcinoma subgroup. These data are important in guiding our future studies in NSCLC," said Ron Ellis, president and CEO at Endocyte. "Based on the results to date from the ongoing Phase 1 dose escalation trial of EC1456, we are optimistic that this agent will represent an important improvement in the treatment landscape for NSCLC," said Alison Armour, chief medical officer. EC1456 is a second generation folate-targeted SMDC, which delivers a more potent drug payload at higher doses than vintafolide. About Vintafolide and Etarfolatide Vintafolide is an investigational, proprietary, injectable SMDC consisting of folate (vitamin B9) linked to a potent vinca alkaloid cytotoxic agent, desacetylvinblastine hydrazide (DAVLBH). Vintafolide is designed to selectively target the folate receptor to deliver the anti-cancer agent to the cancerous tissue. Tumors that have high concentrations of the folate receptor are identified by etarfolatide, a non-invasive imaging diagnostic agent. About EC1456 EC1456 is a second generation SMDC consisting of folate (vitamin B9) linked to a potent cytotoxic agent, tubulysin B hydrazide (TubBH). EC1456 includes an advanced spacer/linker to allow for potentially higher dosing in spite of a more potent payload than vintafolide. EC1456 is currently being evaluated in a Phase 1 study in patients with advanced solid tumors (ClinicalTrials.gov Identifier: NCT01999738). About Endocyte Endocyte is a biopharmaceutical company and leader in developing targeted small molecule drug conjugates (SMDCs) and companion imaging agents for personalized therapy in cancer and other serious diseases. Endocyte uses its proprietary technology to create novel SMDCs and companion imaging agents for personalized targeted therapies. The company's SMDCs actively target receptors that are expressed or over-expressed on diseased cells, relative to healthy cells. This targeted approach is designed to enable the treatment of patients with highly potent drugs into these cells. The companion imaging agents are designed to identify patients whose disease expresses the molecular target of the therapy and who therefore may be more likely to benefit from treatment. For more information, visit . Endocyte Forward-Looking Statement Certain of the statements made in this press release are forward looking, such as those relating to the company's future development plans and those relating to possible future clinical trial results. Actual results or developments may differ materially from those projected or implied in these forward-looking statements. Factors that may cause such a difference include risks that early stage clinical data may not be indicative of subsequent clinical data, that trials of earlier stage agents may not be successful or may take longer to complete than anticipated, and that actual cash needs and financial results may differ from the Company's expectations. More information about the risks and uncertainties faced by Endocyte, Inc. is contained in the company's periodic reports filed with the Securities and Exchange Commission. Endocyte, Inc. disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. CONTACT: Stephanie Ascher Stern Investor Relations, Inc. (212) 362-1200 stephanie@sternir.com jobs and post your resume.

Financial StatementDiagnostic ReagentsSmall molecular drug

100 Deals associated with Vintafolide

External Link

KEGG	Wiki	ATC	Drug Bank
D10434	Vintafolide	L01CA06	DB05168

R&D Status

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Ovarian Cancer	NDA/BLA	European Union	Endocyte, Inc.	-
Platinum-Resistant Ovarian Carcinoma	Phase 3	-	Endocyte, Inc.	22 Apr 2011
Advanced Triple-Negative Breast Carcinoma	Phase 2	-	Endocyte, Inc.	01 Apr 2014
Non-small cell lung cancer stage IIIB	Phase 2	-	Endocyte, Inc.	01 Mar 2011
Solid tumor	Phase 2	United States	Endocyte, Inc.	31 Dec 2009
Adenocarcinoma of Lung	Phase 2	-	Endocyte, Inc.	01 Aug 2007
Endometrial Carcinoma	Phase 2	-	Endocyte, Inc.	01 Aug 2007
Ovarian Epithelial Carcinoma	Phase 2	-	Endocyte, Inc.	01 Aug 2007
Non-Small Cell Lung Cancer	Phase 2	-	Merck Sharp & Dohme Corp.	-
Advanced Malignant Solid Neoplasm	Phase 1	-	Endocyte, Inc.	01 Feb 2014

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT00507741 (8109-007 \| EC-FV-02, ASCO2014)	Phase 2	Visible Lesion	44	Etarfolatide	rveslofdpm(bdbmszylzx) = vusteeuhym sqyunsuszr (hptsffeutx ) View more	-	20 May 2014
NCT00507741 (8109-007 \| EC-FV-02, Pubmed \| Ann Oncol)	Phase 2	Ovarian Cancer	49	Vintafolide	qxlludafov(bpkbpweztz) = kggyjzntlj ihxtjkxjmv (nonbdolnhc )	-	01 Apr 2014
				99mTc-etarfolatide	qxlludafov(bpkbpweztz) = alhnbyzhin ihxtjkxjmv (nonbdolnhc )
NCT00722592 (PRECEDENT, Pubmed 1 \| Pubmed 2 \| J Clin Oncol)	Phase 2	Platinum-Resistant Ovarian Carcinoma folate receptor	149	Vintafolide + PLD	rgduucnodk(cmfddbyvtl) = jcambsdmpp tdeqnzzurr (bdyzfvkgrz )	Positive	10 Dec 2013
				PLD alone	rgduucnodk(cmfddbyvtl) = uufztpwjka tdeqnzzurr (bdyzfvkgrz )
NCT01170650 (PROCEED, ASCO2013)	Phase 3	Platinum-Resistant Ovarian Carcinoma	441	Vintafolide + PLD	dsrchgeknh(ftcsqkynwz) = vmqdnfqdoh nrrjphciva (wddxqdxjyc )	-	20 May 2013
				PLD + placebo	dsrchgeknh(ftcsqkynwz) = ncjjiamewb nrrjphciva (wddxqdxjyc )
NCT00722592 (PRECEDENT, ASCO2013)	Phase 2	Platinum-Resistant Ovarian Carcinoma	157	Vintafolide+PLD	qvudwfnjpg(mqmaoscvun) = cturyjqepd smossskbwf (ihzuakrwhv ) View more	-	20 May 2013
				PLD alone	qvudwfnjpg(mqmaoscvun) = uzpzjfqcjk smossskbwf (ihzuakrwhv ) View more
NCT01577654 (TARGET, ASCO2013)	Phase 2	Non-Small Cell Lung Cancer Second line folate-receptor	-	Vintafolide	uwexiajuhz(gzntvrihed) = mfinxwrfzw wcbgknuqxu (vjmfhbierf ) View more	-	20 May 2013
				Vintafolide + Docetaxel	uwexiajuhz(gzntvrihed) = tmxbwacjtn wcbgknuqxu (vjmfhbierf ) View more
Pubmed \| J Clin Oncol	Phase 1	Solid tumor FR-positive tumor xenografts	-	EC145	lehgxllsjm(kqwtrhfzdy) = Constipation was the dose-limiting toxicity with both routes gaopfuyxrl (ebwwxfampu ) View more	-	10 Nov 2012
NCT00507741 (8109-007 \| EC-FV-02, ASCO2010)	Phase 2	Ovarian Cancer	45	EC145 (EC20++)	wswcqqpqug(nfpwyaznur) = mgszmtnqgv wxkixxbftj (gycojvcfzd ) View more	-	20 May 2010
				EC145 (EC20+)	wswcqqpqug(nfpwyaznur) = sxzmfxhjxp wxkixxbftj (gycojvcfzd ) View more
Pubmed \| J Clin Pharmacol	Phase 1	Neoplasms	-	EC145	nxwncedtez(nxzsqmiheh) = Constipation was the most common and clinically relevant toxicity induced by EC145 psvtyjxezb (vlczalxwom ) View more	-	01 Dec 2009

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