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 E39'+GM-CSF vaccine(Galena Biopharma) 相关的临床结果

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项与 E39'+GM-CSF vaccine(Galena Biopharma) 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. ; Vreeland, Timothy J. ; Berry, John S. ; Martin, Jonathan ; Hamilton, Chad A. ; Hale, Diane F. ; Maxwel, George L. ; Myers, John W. ; Brown, Tommy A. ; Peoples, George E. ; Greene, Julia M. ; Jackson, Doreen O. ; Herbert, Garth S. ; Elkas, John C. ; Conrads, Thomas P. ; Darcy, Kathleen M. ; Byrd, Kevin

Abstract:

Background:

E39, 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 methods:

HLA‐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.

Results:

Fifty‐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.

Conclusions:

This 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 immunology (Orlando, Fla.)3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: Jackson, Doreen O ; Greene, Julia M ; Qiao, Na ; Hale, Diane F ; Peoples, George E ; Mittendorf, Elizabeth A ; Berry, John S ; Vreeland, Timothy J ; Alatrash, Gheath ; Litton, Jennifer K ; Clifton, Guy T ; Philips, Anne V ; Peace, Kaitlin M

TRIAL REGISTRATION:

NCT02019524.

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

BACKGROUND:

Folate 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.

METHODS:

HLA-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.

RESULTS:

This 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).

CONCLUSIONS:

This 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.

项与 E39'+GM-CSF vaccine(Galena Biopharma) 相关的新闻（医药）

2017-03-10

·BioSpace

Bay Area’s Galena Biopharma Exploring Strategic Alternatives Just One Month After CEO Steps Down

March 10, 2017 By Mark Terry , BioSpace.com Breaking News Staff San Ramon, Calif.-based Galena Biopharma announced that it had hired Canaccord Genuity to help it develop a plan to sell the company or its assets. This comes about five weeks after its chief executive officer, Mark Schwartz , stepped down over a civil and criminal investigation into the company’s marketing of Abstral (fentanyl). The company was under investigation by the U.S. Department of Justice, looking into several employees, as well as two high-prescribing physicians, over a rebate deal between the company and the two doctors. Schwartz took over the job in 2014. At that time, the company was headquartered in Lake Oswego, Ore. Its then-CEO Mark Ahn resigned after Galena was, according to Xconomy ,“accused of tricking potential investors by allegedly paying a publicity firm to inflate its stock. Galena settled a lawsuit for $20 million in 2015 (most of it was paid by insurance).” The company indicates that it is reviewing options, including “a sale of the company, a business combination, a merger or reverse merger with another party, continuing to advance the clinical programs as a stand-alone entity, and a license or other disposition of corporate assets of the Company.” The company’s assets include GALE-401, currently in a Phase III-ready program for essential thrombocythemia, and an immune-oncology franchise for prevention of recurrence in breast and ovarian cancer, that includes NeuVax (nelipepimut-S), which has three Phase II clinical trials, a Phase IIb trial that expects to complete enrollment in the second quarter, and GALE-301 and GALE-302, which completed early-stage trials in ovarian cancer. The Phase III trial of NeuVax didn’t go well. The drug didn’t perform as well as placebo, which caused independent data monitors to recommend halting the trial, which was then officially closed on August 10, 2016. “Although the Phase III PRESENT trial of the HER2 vaccine was terminated early, after unblinding the data, it appears that the trial failed due to a design flaw in the study and not due to lack of activity of the vaccine (data to be published soon),” wrote George Peoples to Xconomy . Peoples is the San Antonio-based scientist who developed NeuVax. Galena, which was then known as RXi Pharmaceuticals and headquartered in Worcester, Mass., acquired the Arizona biotech company, Apthera , in 2011 that held the license for NeuVax. Apthera had licensed NeuVax from the MD Anderson Cancer Center in Houston and the Henry Jackson Foundation in 2006. Not surprisingly, Galena has tanked recently. Shares are currently trading for $0.59. Shares traded at $45.40 on June 22, 2016, before they plunged to $7 on June 29, 2016. The stock has a one-year high of $49.80 and a one-year low of $0.21. Its 50-day moving average is $1.09 and its 200-day moving average is $1.21. On February 6, FBR analyst Vernon Bernardino downgraded the stock to “Hold,” with a price target of $4. On February 2, Jason McCarthy , an analyst with Maxim , downgraded the stock to “Hold.”

临床2期并购临床3期疫苗高管变更

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研发状态

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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1期	美国	The University of Texas MD Anderson Cancer Center	2013-09-30
卵巢癌	临床1期	美国	The University of Texas MD Anderson Cancer Center	2013-09-30

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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


SITC2013	临床1期	卵巢癌 \| 子宫内膜癌辅助 HLA-A2-	25	E39 vaccine 100mcg	積鹽簾鏇襯糧蓋醖齋廠(蓋顧簾夢艱範獵廠艱鏇) = 糧鑰鬱鏇齋齋壓製簾顧顧衊廠積糧繭遞願蓋觸 (鹹網觸鬱繭蓋顧繭夢選 ) 更多	积极	2013-11-07
				E39 vaccine 500mcg	積鹽簾鏇襯糧蓋醖齋廠(蓋顧簾夢艱範獵廠艱鏇) = 襯衊膚選糧遞網齋窪糧顧衊廠積糧繭遞願蓋觸 (鹹網觸鬱繭蓋顧繭夢選 ) 更多