Phase II Trial of a Bivalent Vaccine With the Immunological Adjuvant OPT-821 (QS-21), in Combination With Randomization of Oral ?-glucan, for High-Risk Neuroblastoma

The purpose of this study is to test which treatment schedule of ?-glucan with bivalent vaccine is more effective for participants with high-risk neuroblastoma that is in complete remission.

开始日期2023-09-21

申办/合作机构

Memorial Sloan Kettering Cancer Center

KCT0005816

/ Recruiting临床3期

The GLORIA Study: A Phase 3, Randomized, Open-Label Study of theAnti-Globo H Vaccine Adagloxad Simolenin (OBI822)/OBI-821 in the AdjuvantTreatment of Patients with HighRisk, Early-Stage Globo H-Positive TripleNegative Breast Cancer

开始日期2021-05-31

申办/合作机构-

NCT03562637

/ Active, not recruiting临床3期

The GLORIA Study: A Phase 3, Randomized, Open-Label Study of the Anti-Globo H Vaccine Adagloxad Simolenin (OBI-822)/OBI-821 in the Adjuvant Treatment of Patients With High Risk, Early Stage Globo H-Positive Triple Negative Breast Cancer

The GLORIA study is a Phase III, randomized, open-label study to prospectively evaluate the efficacy and safety of adagloxad simolenin (OBI 822)/OBI-821 in the adjuvant treatment of patients with high risk, early stage Globo-H Positive TNBC.

开始日期2018-12-05

申办/合作机构

台湾浩鼎生技股份有限公司

100 项与 Adagloxad simolenin 相关的临床结果

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100 项与 Adagloxad simolenin 相关的转化医学

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100 项与 Adagloxad simolenin 相关的专利（医药）

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项与 Adagloxad simolenin 相关的文献（医药）

2023-11-09·British journal of cancer

Heat-shock protein 90α protects NME1 against degradation and suppresses metastasis of breast cancer

Article

作者: Wang, Xun ; Zhao, Guomeng ; Wang, Xindong ; Yin, Yongmei ; Mao, Jinlei ; Fu, Ziyi ; Li, Jinyao ; Zhang, Yanchao ; Guo, Changying ; Yu, Liting ; Meng, Yao

BACKGROUND:

NME1 has been exploited as a potential translational target for decades. Substantial efforts have been made to upregulate the expression of NME1 and restore its anti-metastasis function in metastatic cancer.

METHODS:

Cycloheximide (CHX) chase assay was used to measure the steady-state protein stability of NME1 and HSP90α. The NME1-associating proteins were identified by immunoprecipitation combined with mass spectrometric analysis. Gene knockdown and overexpression were employed to examine the impact of HSP90AA1 on intracellular NME1 degradation. The motility and invasiveness of breast cancer cells were examined in vitro using wound healing and transwell invasion assays. The orthotopic spontaneous metastasis and intra-venous experimental metastasis assays were used to test the formation of metastasis in vivo, respectively.

RESULTS:

HSP90α interacts with NME1 and increases NME1 lifetime by impeding its ubiquitin-proteasome-mediated degradation. HSP90α overexpression significantly inhibits the metastatic potential of breast cancer cells in vitro and in vivo. A novel cell-permeable peptide, OPT22 successfully mimics the HSP90α function and prolongs the life span of endogenous NME1, resulting in reduced metastasis of breast cancer.

CONCLUSION:

These results not only reveal a new mechanism of NME1 degradation but also pave the way for the development of new and effective approaches to metastatic cancer therapy.

2022-11-01·Future oncology (London, England)

GLORIA: phase III, Open-Label Study of Adagloxad Simolenin/OBI-821 in Patients with High-Risk Triple-Negative Breast Cancer

Review

作者: Rugo, Hope S ; Huang, Chiun-Sheng ; Rapoport, Bernardo L ; Cabrera, Paula ; Cortes, Javier ; Pieńkowski, Tadeusz ; Xu, Binghe ; Kim, Sung-Bae ; Schwab, Richard ; Melisko, Michelle ; Nanda, Rita ; Barrios, Carlos H

Triple-negative breast cancer (TNBC) has the highest rate of distant metastasis and poorest overall survival among breast cancer subtypes. In a phase II study, adagloxad simolenin (AdaSim), a synthetic Globo H conjugate vaccine administered with adjuvant OBI-821, was shown to induce IgM and IgG anti-Globo H humoral responses in patients with metastatic breast cancer overexpressing the glycosphingolipid Globo H. GLORIA is an ongoing phase III, randomized, open-label clinical trial to evaluate the safety and efficacy of AdaSim and the quality of life (QoL) of patients receiving AdaSim plus standard of care (SOC) versus SOC alone in high-risk, early-stage TNBC. The primary end point is invasive progression-free survival; secondary end points include overall survival, QoL, breast cancer-free interval, distant disease-free survival, safety, and tolerability.

2022-06-01·Journal for immunotherapy of cancer

The clinical relevance of humoral immune responses to Globo H-KLH vaccine adagloxad simolenin (OBI-822)/OBI-821 and expression of Globo H in metastatic breast cancer

Article

作者: Chen, Shin-Cheh ; Campbell, Michael J ; Huang, Chiun-Sheng ; Chen, I-Ju ; Ueng, Shir-Hwa ; Yu, Alice L ; Chen, Mu-Yi ; Lin, Chun-Yen ; Rugo, Hope S ; Hung, Jung-Tung ; Lin, Yung-Chang

An international randomized phase II trial of Globo H (GH) vaccine, adagloxad simolenin/OBI-821 in 349 patients with metastatic breast cancer showed longer progression-free survival (PFS) in vaccinated patients who developed anti-Globo H (anti-GH) IgG than those who did not and the placebo group. The impacts of anti-GH IgM and GH expression on peak anti-GH IgG and clinical outcome were further evaluated. The titers of anti-GH IgG and IgM were determined by ELISA. GH expression in tumor was examined by immunohistochemical staining. Immunophenotyping was conducted by flow cytometry. Adagloxad simolenin elicited anti-GH IgM which peaked at titers ≥1:80 between weeks 5 and 13. The mean anti-GH IgG titer peaked at week 41 and decreased thereafter on the completion of vaccination. One log increase in peak IgM was associated with 10.6% decrease in the HR of disease progression (HR: 0.894, 95% CI: 0.833 to 0.960, p=0.0019). Patients with anti-GH IgM ≥1:320 within first 4 weeks after vaccination had significantly higher maximum anti-GH IgM (p<0.0001) and IgG titers (p<0.0001) than those with <1:320. Moreover, the median PFS appears to be longer for patients with anti-GH IgM ≥1:320 within first 4 weeks than those with anti-GH IgM titer <1:320 (11.1 vs 7.3 months, p=0.164), but not statistically significant. Among patients with H score ≥80 for GH expression by immunohistochemistry, the vaccination group (n=42) seemed to have better PFS than the placebo group (n=23) (HR=0.59; 95% CI: 0.32 to 1.10, p=0.10), but the difference did not reach statistical significance. In addition, peak levels of anti-GH IgM were higher in patients who had lower percentage of activated regulatory T cells (Treg cells; CD4+CD45RA-Foxp3high) at baseline than those who had higher activated Treg cells (p=0.042). This study demonstrates that adagloxad simolenin induced both IgG and IgM antibodies against GH. Anti-GH IgM ≥1:320 within first 4 weeks or low activated Treg cells at baseline may help to select patients who are likely to produce a higher level of GH-specific IgM and IgG in the future.

项与 Adagloxad simolenin 相关的新闻（医药）

2025-01-01

·GlobeNewswire-Health Care

OBI Pharma Enters Collaboration with GlyTech to Expand GlycOBI® Enabling Technologies Outreach in Japan and to Advance Glycan Production

Dec. 23, 2024 -- OBI Pharma, Inc. (OBI), a clinical-stage global oncology company specialized in the development of novel cancer therapies such as antibody-drug conjugates (ADC) and active immunotherapies (4174. TWO), and GlyTech, Inc. (GlyTech), a Japan manufacturer that focuses on glycan production and chemical glycosylation technologies, have entered into a Marketing Agreement and a Material Transfer Agreement. Under the terms of the Marketing Agreement, OBI grants GlyTech rights to market and promote OBI’s GlycOBI® ADC enabling technologies, powered by EndoSymeOBI®, to potential pharma and biotech partners in Japan. GlyTech will also be a key supplier of glycans in Japan. Under the terms of the Material Transfer Agreement, OBI will transfer some of its cutting-edge materials to GlyTech for research in advancing the efficient production of glycans for ADCs. Heidi Wang, Ph.D., OBI Pharma’s Chief Executive Officer, noted, “GlyTech has been one of our trusted suppliers for high quality glycans. We are excited to collaborate with GlyTech to broaden the reach of OBI’s novel GlycOBI® ADC enabling technologies with potential pharma and biotech partners in Japan. We also look forward to the collaborative research with GlyTech, which is part of our plan to ensure high quality, scalable glycan manufacturing and supply for ADCs.” Hiroaki Asai, President & CEO of GlyTech, added, “OBI Pharma's innovative GlycOBI® ADC technologies are testaments to their command of enzyme-based precision synthetic organic chemistry. GlyTech, Inc. is pleased to support the contribution of GlycOBI® ADC technologies to the world as a supplier of highly pure human glycans, a key material for this technology. We greatly look forward to OBI Pharma's continuing progress in new drug development.” OBI Pharma, Inc., is a clinical stage global oncology company that is headquartered in Taiwan and established in 2002. Its mission is to develop novel cancer therapeutic agents for patients with high unmet medical needs. Using the company’s proprietary ADC enabling technologies, including but not limited to GlycOBI®, powered by EndoSymeOBI®, OBI has created its novel ADC pipeline, including OBI-992, OBI-902 and OBI-904, targeting TROP2 and Nectin-4, respectively. Additionally, the company’s novel first-in-class immuno-oncology portfolio targeting Globo H includes: two Globo H active immunotherapy vaccines, adagloxad simolenin (formerly OBI-822) and OBI-833. OBI’s pipeline also includes the first-in-class AKR1C3-targeted small-molecule prodrug OBI-3424, which selectively releases a potent DNA-alkylating antitumor agent in the presence of the aldo-keto reductase 1C3 (AKR1C3) enzyme that is highly expressed in tumors. Additional information can be found at www.obipharma.com. GlycOBI® and EndoSymeOBI® are registered trademarks of OBI Pharma, Inc. GlyTech, Inc. is headquartered in Kyoto, Japan and was established in 2012 as the only bio-venture company in the world capable of the commercial production of human-type glycans. Its current mission is to contribute to efforts enabling people to live healthier lives by supporting the development of advanced products and technologies that take advantage of glycans, proteins, nucleotides and other naturally occurring biochemicals. GlyTech’s technology platforms include the glycan-based enhancement of drugs of various modalities, brain drug delivery technology, and peptide binder discovery services. GlyTech’s own pipeline contains several assets that utilize glycans, and the company is conducting investigator-initiated clinical trials (P2a) for a glycosylated somatostatin with acromegaly as the target indication. The content above comes from the network. if any infringement, please contact us to modify.

引进/卖出免疫疗法疫苗抗体药物偶联物

2024-06-13

·PipelineReview

OBI Pharma Announces Phase 1/2 Study Initiation for OBI-992, a TROP2-Targeted Antibody-Drug Conjugate (ADC) for Cancer Therapy

Clinical trial to evaluate the safety and efficacy of OBI-992 in advanced solid tumors. TAIPEI, Taiwan I June 12, 2024 I OBI Pharma, a clinical-stage oncology company (4174.TWO), today announced the initiation of a Phase 1/2 clinical trial of OBI-992, an antibody-drug conjugate (ADC) targeting TROP2 (Trophoblast cell-surface antigen 2), an antigen overexpressed in multiple tumor types. OBI plans to enroll patients with advanced solid tumors, including non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), gastric cancer (GC), and other potential cancers. The objective of the trial is to verify the safety, pharmacokinetics, and preliminary efficacy profile of OBI-992 in these patient populations. OBI Pharma’s Chief Medical Officer, M. Wayne Saville, M.D., noted, “Based on our preclinical data, OBI-992 has several important advantages over other TROP2 ADCs in development; including high serum stability, excellent bystander effect, potential ability to overcome drug resistance, and outstanding activity in animal and organoid models of cancer 1 , 2 , 3 . We look forward to investigating this potential best-in-class TROP2 ADC in the clinic. Leia Tsimberidou MD, of MD Anderson Cancer Center in Houston, TX. USA is the lead investigator for the study.” Heidi Wang, Ph.D., OBI Pharma’s Chief Executive Officer, added, “We are excited to initiate this first in human study of OBI-992. This is an important company milestone and highlights our commitment to building and strengthening the novel OBI Pharma oncology pipeline. We thank the patients and the investigators for their efforts and dedication.” About OBI-992 OBI-992 is a TROP2-targeted antibody-drug conjugate (ADC) that carries a potent topoisomerase I inhibitor payload (exatecan) proven to kill tumor cells. TROP2 is highly expressed in a variety of solid tumors such as lung, breast, ovarian, gastric, and other cancers, rendering it an ideal target for cancer therapy. OBI-992 uses a unique hydrophilic, enzyme-cleavable linker that is stable in circulation but releases the cytotoxic payload inside tumor cells. In preclinical animal models, OBI-992 demonstrated remarkable antitumor activity, improved pharmacokinetic characteristics, and a favorable safety profile relative to comparator ADCs. The TROP2 targeting antibody was in-licensed from Biosion, Inc. www.Biosion.com , in December 2021. OBI Pharma owns ex-China commercial rights for OBI-992. About OBI Pharma OBI Pharma, Inc., is a clinical stage oncology company that is headquartered in Taiwan and established in 2002. Its mission is to develop novel cancer therapeutic agents for patients with high unmet medical needs. The company’s novel first-in-class immuno-oncology portfolio targeting Globo H includes: two Globo H active immunotherapy vaccines, adagloxad simolenin (formerly OBI-822) and OBI-833. Using the company’s unique ADC platforms, including GlycOBI™, OBI created its novel ADC pipeline which includes OBI-992, OBI-902 and OBI-904, targeting TROP2 and Nectin-4, respectively. OBI’s pipeline also includes the first-in-class AKR1C3-targeted small-molecule prodrug OBI-3424, which selectively releases a potent DNA-alkylating antitumor agent in the presence of the aldo-keto reductase 1C3 (AKR1C3) enzyme. Additional information can be found at www.obipharma.com . GlycOBI™ is a trademark of OBI Pharma, Inc. 1 , 2 , 3 : AACR Annual Meeting 2024 Abstracts online. OBI Pharma, Inc. Taipei, Taiwan. https://www.obipharma.com/zh-hant/news-zh-hant/poster-presentations-at-the-aacr-2024-annual-meeting-for-obi-992-and-glycobi-adc-platform/ SOURCE: OBI Pharma

免疫疗法AACR会议抗体药物偶联物疫苗临床申请

2024-06-12

·BioSpace

OBI Pharma Announces Phase 1/2 Study Initiation for OBI-992, a TROP2-Targeted Antibody-Drug Conjugate (ADC) for Cancer TherapyClinical trial to evaluate the safety and efficacy of OBI-992 in advanced solid tumors.

TAIPEI, Taiwan, June 12, 2024 (GLOBE NEWSWIRE) -- OBI Pharma, a clinical-stage oncology company (4174.TWO), today announced the initiation of a Phase 1/2 clinical trial of OBI-992, an antibody-drug conjugate (ADC) targeting TROP2 (Trophoblast cell-surface antigen 2), an antigen overexpressed in multiple tumor types. OBI plans to enroll patients with advanced solid tumors, including non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), gastric cancer (GC), and other potential cancers. The objective of the trial is to verify the safety, pharmacokinetics, and preliminary efficacy pro OBI-992 in these patient populations. OBI Pharma's Chief Medical Officer, M. Wayne Saville, M.D., noted, “Based on our preclinical data, OBI-992 has several important advantages over other TROP2 ADCs in development; including high serum stability, excellent bystander effect, potential ability to overcome drug resistance, and outstanding activity in animal and organoid models of cancer 1, 2,3. We look forward to investigating this potential best-in-class TROP2 ADC in the clinic. Leia Tsimberidou MD, of MD Anderson Cancer Center in Houston, TX. USA is the lead investigator for the study.” Heidi Wang, Ph.D., OBI Pharma’s Chief Executive Officer, added, “We are excited to initiate this first in human study of OBI-992. This is an important company milestone and highlights our commitment to building and strengthening the novel OBI Pharma oncology pipeline. We thank the patients and the investigators for their efforts and dedication.” About OBI-992 OBI-992 is a TROP2-targeted antibody-drug conjugate (ADC) that carries a potent topoisomerase I inhibitor payload (exatecan) proven to kill tumor cells. TROP2 is highly expressed in a variety of solid tumors such as lung, breast, ovarian, gastric, and other cancers, rendering it an ideal target for cancer therapy. OBI-992 uses a unique hydrophilic, enzyme-cleavable linker that is stable in circulation but releases the cytotoxic payload inside tumor cells. In preclinical animal models, OBI-992 demonstrated remarkable antitumor activity, improved pharmacokinetic characteristics, and a favorable safety pro to comparator ADCs. The TROP2 targeting antibody was in-licensed from Biosion, Inc. , in December 2021. OBI Pharma owns ex-China commercial rights for OBI-992. About OBI Pharma OBI Pharma, Inc., is a clinical stage oncology company that is headquartered in Taiwan and established in 2002. Its mission is to develop novel cancer therapeutic agents for patients with high unmet medical needs. The company’s novel first-in-class immuno-oncology portfolio targeting Globo H includes: two Globo H active immunotherapy vaccines, adagloxad simolenin (formerly OBI-822) and OBI-833. Using the company’s unique ADC platforms, including GlycOBI™, OBI created its novel ADC pipeline which includes OBI-992, OBI-902 and OBI-904, targeting TROP2 and Nectin-4, respectively. OBI’s pipeline also includes the first-in-class AKR1C3-targeted small-molecule prodrug OBI-3424, which selectively releases a potent DNA-alkylating antitumor agent in the presence of the aldo-keto reductase 1C3 (AKR1C3) enzyme. Additional information can be found at . GlycOBI™ is a trademark of OBI Pharma, Inc. 1, 2,3: AACR Annual Meeting 2024 Abstracts online. OBI Pharma, Inc. Taipei, Taiwan. Forward-Looking Statements Statements included in this press release that are not a description of historical facts are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include, but are not limited to, statements about future clinical trials, results and the timing of such trials and results. Such risk factors are identified and discussed from time to time in OBI Pharma’s reports and presentations, including OBI Pharma’s filings with the Taiwan Securities and Futures Bureau. COMPANY CONTACT: Kevin Poulos Chief Business Officer OBI Pharma, Inc. 1.619.537.7698 Ext. 102 kpoulos@obipharmausa.com 115011台北市南港区忠孝东路七段508号6楼 6F., No. 508, Sec 7, Zhongxiao E. R., Nangang Dist., Taipei 115011, Taiwan R.O.C. OBI PHARMA台灣浩鼎

免疫疗法AACR会议

100 项与 Adagloxad simolenin 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D11205	-	-	DB16082

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
转移性乳腺癌	临床3期	中国台湾	台湾浩鼎生技股份有限公司	2022-08-12
转移性乳腺癌	临床3期	中国台湾	MSD Czech Republic sro	2022-08-12
三阴性乳腺癌	临床3期	美国	台湾浩鼎生技股份有限公司	2018-12-05
三阴性乳腺癌	临床3期	中国	台湾浩鼎生技股份有限公司	2018-12-05
三阴性乳腺癌	临床3期	澳大利亚	台湾浩鼎生技股份有限公司	2018-12-05
三阴性乳腺癌	临床3期	巴西	台湾浩鼎生技股份有限公司	2018-12-05
三阴性乳腺癌	临床3期	中国香港	台湾浩鼎生技股份有限公司	2018-12-05
三阴性乳腺癌	临床3期	墨西哥	台湾浩鼎生技股份有限公司	2018-12-05
三阴性乳腺癌	临床3期	秘鲁	台湾浩鼎生技股份有限公司	2018-12-05
三阴性乳腺癌	临床3期	波兰	台湾浩鼎生技股份有限公司	2018-12-05

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临床结果

适应症

分期

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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


NCT01516307 (Pubmed \| J Immunother Cancer)	临床2期	转移性乳腺癌	349	Adagloxad simolenin (AS/OBI-821)	願遞鹹願壓網窪簾淵餘(餘製窪窪鏇齋鑰淵簾淵) = 願構鏇齋鏇鏇衊齋範鏇願選顧夢鹹淵鬱夢構選 (糧淵蓋鬱蓋鏇憲顧選獵, 6.5 ~ 10.9)	不佳	2020-07-01
NCT01516307 (Pubmed \| J Immunother Cancer)	临床2期	转移性乳腺癌	349	Placebo	願遞鹹願壓網窪簾淵餘(餘製窪窪鏇齋鑰淵簾淵) = 齋鏇窪醖餘遞餘蓋鹹選願選顧夢鹹淵鬱夢構選 (糧淵蓋鬱蓋鏇憲顧選獵, 7.3 ~ 11.3)	不佳	2020-07-01
NCT03562637 (P163, SITC2018)	临床2期	转移性乳腺癌 GH expression	349	Adagloxad simolenin (OBI-822/821)	衊醖襯廠夢醖膚網憲繭(齋餘艱艱範鏇範獵淵壓) = 鹹齋觸壓憲鬱簾艱鑰選蓋夢淵範顧蓋窪簾窪鏇 (獵壓範艱製憲鏇網繭範 )	积极	2018-11-06