E39'+GM-CSF vaccine(Galena Biopharma)(E39'+GM-CSF vaccine(Galena Biopharma))

概要

基本信息

药物类型

合成肽疫苗、治疗性疫苗

别名

E39'-GM-CSF-vaccine、E39'、FBP-J65

+ [2]

靶点

FOLR1

作用方式

拮抗剂、刺激剂

作用机制

FOLR1拮抗剂(叶酸受体α拮抗剂)、免疫刺激剂、T淋巴细胞刺激剂

治疗领域

肿瘤内分泌与代谢疾病皮肤和肌肉骨骼疾病+ [1]

在研适应症-

非在研适应症

乳腺癌卵巢癌

原研机构

SELLAS Life Sciences Group, Inc.

在研机构-

非在研机构

San Antonio Military Medical Center

权益机构-

最高研发阶段终止临床1期

首次获批日期-

最高研发阶段(中国)-

特殊审评-

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结构/序列

Sequence Code 13858242

关联

1

项与 E39'+GM-CSF vaccine(Galena Biopharma) 相关的临床试验

NCT02019524

/ Completed临床1期IIT

Phase Ib Trial of Two Folate Binding Protein (FBP) Peptide Vaccines (E39 and J65) in Breast and Ovarian Cancer Patients

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

[+1]

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

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100 项与 E39'+GM-CSF vaccine(Galena Biopharma) 相关的转化医学

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100 项与 E39'+GM-CSF vaccine(Galena Biopharma) 相关的专利（医药）

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3

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. ; Hamilton, Chad A. ; Martin, Jonathan ; Hale, Diane F. ; Maxwel, George L. ; Myers, John W. ; Peoples, George E. ; Greene, Julia M. ; Brown, Tommy A. ; 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 ; Philips, Anne V ; Clifton, Guy T ; Peace, Kaitlin M

TRIAL REGISTRATION:

NCT02019524.

2017-01-01·Journal of Cancer3区 · 医学

Evaluation of Attenuated Tumor Antigens and the Implications for Peptide-Based Cancer Vaccine Development

3区 · 医学

ArticleOA

作者: Jackson, D O ; Greene, J M ; Berry, J S ; Clifton, G T ; Herbert, G S ; Vreeland, T J ; Trappey, A F ; Hardin, M O ; Hale, D F ; Peoples, G E

INTRODUCTION:

Peptide vaccines offer anti-tumor efficacy with very low toxicity. However, repeat stimulation with an immunogenic peptide leads to activation induced cell death (AICD), decreasing efficacy. We engineered variants of an immunogenic peptide (E39) and tested their ability to induce a robust, sustainable immune response.

METHODS:

Multiple variants of E39 were created by exchanging 1 or 2 amino acids. We tested the PBMC proliferation, cytokine production and cytolytic activity induced by each variant peptide.

RESULTS:

Repeated stimulation with E39 likely led to in vitro AICD, while stimulation with E39' led to T-cell proliferation with less evidence of AICD, modest cytokine production and high CTL activity.

CONCLUSIONS:

E39' appears to be the optimal variant of E39 for inducing effective long-term immunity.

1

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

100 项与 E39'+GM-CSF vaccine(Galena Biopharma) 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
乳腺癌	临床1期	美国	San Antonio Military Medical Center	2013-09-30
卵巢癌	临床1期	美国	San Antonio Military Medical Center	2013-09-30

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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


P6-10-04 (SABCS2017)	临床1期	乳腺癌 HLA-A2 positive	-	E39 peptide vaccine + GM-CSF	構鹹獵壓積夢淵顧憲鏇(壓膚觸獵襯淵製鹹壓願) = 襯鬱憲夢鑰鹹壓範鹹鏇積顧憲製選膚窪鹹淵積 (蓋簾製積廠膚範構選鑰 ) 更多	积极	2017-02-15
				E39' attenuated peptide vaccine + GM-CSF	構鹹獵壓積夢淵顧憲鏇(壓膚觸獵襯淵製鹹壓願) = 糧鏇壓繭顧遞淵觸膚廠積顧憲製選膚窪鹹淵積 (蓋簾製積廠膚範構選鑰 ) 更多
AACR2016	临床1期	卵巢癌	51	E39’	糧鏇糧糧網獵憲範衊齋(壓鹽襯願窪觸襯夢齋願) = 鏇構遞廠範鹽壓衊蓋蓋製淵鏇衊築醖憲夢蓋衊 (遞衊憲獵齋廠齋廠膚顧 )	积极	2016-07-15
				E39 + GM-CSF	糧鏇糧糧網獵憲範衊齋(壓鹽襯願窪觸襯夢齋願) = 艱壓網衊膚鹹艱淵膚願製淵鏇衊築醖憲夢蓋衊 (遞衊憲獵齋廠齋廠膚顧 )
phase 1 trial of a folate receptor alpha adjuvant cancer vaccine (SITC2013)	临床1期	卵巢癌 \| 子宫内膜癌辅助 HLA-A2-	25	E39 vaccine 100mcg	獵淵鏇顧夢築鑰鑰鹽築(夢廠蓋憲醖蓋願壓襯糧) = 鹽艱構遞製鬱鹹製選鏇製鏇窪鹽網衊選艱鬱鑰 (齋鑰餘構鑰繭夢膚鏇壓 ) 更多	积极	2013-11-07
				E39 vaccine 500mcg	獵淵鏇顧夢築鑰鑰鹽築(夢廠蓋憲醖蓋願壓襯糧) = 鹽醖獵鏇鏇淵遞鬱築齋製鏇窪鹽網衊選艱鬱鑰 (齋鑰餘構鑰繭夢膚鏇壓 ) 更多