This is a single-center, randomized, single-blinded, three-arm phase Ib study of the folate binding protein vaccines E39 and J65. The study target population are patients with breast or ovarian cancer diagnosis who have been treated and are without evidence of disease. Disease-free subjects after standard of care multi-modality therapy will be screened and HLA typed. E39 and J65 are cytotoxic T-lymphocyte-eliciting peptide vaccines that are restricted to HLA-A2+ patients (approximately 50% of the U.S. population).

开始日期2013-09-30

申办/合作机构

San Antonio Military Medical Center

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100 项与 GALE-302 相关的临床结果

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100 项与 GALE-302 相关的专利（医药）

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项与 GALE-302 相关的文献（医药）

2019-08-01·Cancer Medicine3区 · 医学

Final analysis of a phase I/IIa trial of the folate‐binding protein‐derived E39 peptide vaccine to prevent recurrence in ovarian and endometrial cancer patients

3区 · 医学

ArticleOA

作者: Clifton, Guy T. ; Hamilton, Chad A. ; Myers, John W. ; Jackson, Doreen O. ; Herbert, Garth S. ; Vreeland, Timothy J. ; Byrd, Kevin ; Peoples, George E. ; Berry, John S. ; Elkas, John C. ; Hale, Diane F. ; Brown, Tommy A. ; Conrads, Thomas P. ; Darcy, Kathleen M. ; Martin, Jonathan ; Greene, Julia M. ; Maxwel, George L.

AbstractBackgroundE39, an HLA‐A2‐restricted, immunogenic peptide derived from the folate‐binding protein (FBP), is overexpressed in multiple malignancies. We conducted a phase I/IIa trial of the E39 + GM‐CSF vaccine with booster inoculations of either E39 or E39′ (an attenuated version of E39) to prevent recurrences in disease‐free endometrial and ovarian cancer patients(pts). Here, we present the final 24‐month landmark analysis.Patients and methodsHLA‐A2 + patients receiving E39 + GM‐CSF were included in the vaccine group (VG), and HLA‐A2‐ pts (or HLA‐A2 + patients refusing vaccine) were followed as the control group (CG). VG group received 6 monthly inoculations as the primary vaccine series (PVS) and were randomized to receive either E39 or E39′ booster inoculations. Demographic, safety, immunologic, and disease‐free survival (DFS) data were collected and evaluated.ResultsFifty‐one patients were enrolled; 29 in the VG and 22 in the CG. Fourteen patients received <1000 μg and 15 received 1000 μg of E39. There were no clinicopathologic differences between VG and CG or between dose groups. E39 was well tolerated. At the 24 months landmark, DFS was 55.5% (VG) vs 40.0% (CG), P = 0.339. Patients receiving 1000 μg and boosted patients also showed improved DFS (P < 0.03). DFS was improved in the 1000 μg group after treatment of primary disease (90.0% vs CG:42.9%, P = 0.007), but not in recurrent patients. In low‐FBP expressing patients, DFS was 100.0% (1000 μg), 50.0% (<1000 μg), and 25.0% (CG), P = 0.029.ConclusionsThis phase I/IIa trial reveals that E39 + GM‐CSF is safe and may be effective in preventing recurrence in high‐risk ovarian and endometrial cancer when optimally dosed (1000 μg) to FBP low patients being treated for primary disease.

2018-07-01·Clinical Immunology3区 · 医学

Phase Ib trial of folate binding protein (FBP)-derived peptide vaccines, E39 and an attenuated version, E39’: An analysis of safety and immune response

3区 · 医学

Article

作者: Litton, Jennifer K ; Berry, John S ; Hale, Diane F ; Vreeland, Timothy J ; Clifton, Guy T ; Mittendorf, Elizabeth A ; Alatrash, Gheath ; Greene, Julia M ; Philips, Anne V ; Jackson, Doreen O ; Peace, Kaitlin M ; Qiao, Na ; Peoples, George E

In this randomized phase Ib trial, we tested combining the E39 peptide vaccine with a vaccine created from E39', an attenuated version of E39. Patients with breast or ovarian cancer, who were disease-free after standard of care therapy, were enrolled and randomized to one of three arms. Arm EE received six E39 inoculations; arm EE' received three E39 inoculations followed by three E39'; and arm E'E received three E39' inoculations, followed by three E39. Within each arm, the first five patients received 500 μg of peptide and the remainder received 1000 μg. Patients were followed for toxicity, and immune responses were measured. This initial analysis after completion of the primary vaccination series has confirmed the safety of both vaccines. Immune analyses suggest incorporating the attenuated version of the peptide improves immune responses and that sequencing of E39 followed by E39' might produce the optimal immune response.TRIAL REGISTRATIONNCT02019524.

2017-02-28·Oncotarget

Interim analysis of a phase I/IIa trial assessing E39+GM-CSF, a folate binding protein vaccine, to prevent recurrence in ovarian and endometrial cancer patients

Article

作者: Schneble, Erika J. ; Greene, Julia M. ; Darcy, Kathleen M. ; Hamilton, Chad A. ; Hale, Diane F. ; Byrd, Kevin ; Trappey, Alfred F. ; Martin, Jonathan ; Conrads, Thomas P. ; Jackson, Doreen O. ; Berry, John S. ; Peoples, George E. ; Maxwell, George L. ; Travis Clifton, Guy ; Herbert, Garth S. ; Hardin, Mark O. ; Vreeland, Timothy J. ; Elkas, John C.

BACKGROUNDFolate binding protein(FBP) is an immunogenic protein over-expressed in endometrial(EC) and ovarian cancer(OC). We are conducting a phase I/IIa trial of E39 (GALE 301)+GM-CSF, an HLA-A2-restricted, FBP-derived peptide vaccine to prevent recurrences in disease-free EC and OC patients. This interim analysis summarizes toxicity, immunologic responses, and clinical outcomes to date.METHODSHLA-A2+ patients were vaccinated(VG), and HLA-A2- or -A2+ patients were followed as controls(CG). Six monthly intradermal inoculations of E39+250mcg GM-CSF were administered to VG. Demographic, safety, immunologic, and recurrence rate(RR) data were collected and evaluated.RESULTSThis trial enrolled 51 patients; 29 in the VG and 22 in the CG. Fifteen patients received 1000mcg E39, and 14 received <1000mcg. There were no clinicopathologic differences between groups(all p ≥ 0.1). E39 was well-tolerated regardless of dose. DTH increased pre- to post-vaccination (5.7±1.5 mm vs 10.3±3.0 mm, p = 0.06) in the VG, and increased more in the 1000mcg group (3.8±2.0 mm vs 9.5±3.5 mm, p = 0.03). With 12 months median follow-up, the RR was 41% (VG) vs 55% (CG), p = 0.41. Among the 1000mcg patients, the RR was 13.3% vs 55% CG, p = 0.01. Estimated 2-year DFS was 85.7% in the 1000mcg group vs 33.6% in the CG (p = 0.021).CONCLUSIONSThis phase I/IIa trial reveals that E39+GM-CSF is well-tolerated and elicits a strong, dose-dependent in vivo immune response. Early efficacy results are promising in the 1000 mcg dose cohort. This study proves the safety and establishes the dose of E39 for a larger prospective, randomized, controlled trial in HLA-A2+ EC and OC patients to prevent recurrence.

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适应症	最高研发状态	国家/地区	公司	日期
乳腺癌	临床2期	美国	SELLAS Life Sciences Group, Inc.	-
乳腺癌	临床2期	-	Galena Biopharma, Inc.	-
卵巢癌	临床2期	美国	SELLAS Life Sciences Group, Inc.	-
卵巢癌	临床2期	-	Galena Biopharma, Inc.	-

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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


AACR2016	临床1期	卵巢癌	51	E39’	(獵鹽製艱窪襯顧簾獵窪) = 膚廠繭製鬱製繭衊蓋製願壓鑰糧觸鏇蓋憲醖鑰 (廠積選艱廠獵鹹遞齋襯 )	积极	2016-07-15
				E39 + GM-CSF	(獵鹽製艱窪襯顧簾獵窪) = 顧醖餘網壓範顧蓋網觸願壓鑰糧觸鏇蓋憲醖鑰 (廠積選艱廠獵鹹遞齋襯 )