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10 Diseases |  |
2 Trials |
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2 Trials |  |
24 News |  |
- adagloxad simolenin (OBI 822) / OBI Pharma, OBI-833 / OBI Pharma
Potential role and prognostic value of Globo-H in lung cancer. () - Apr 24, 2024 - Abstract #ASCO2024ASCO_6657;
In addition, the level of GH is positively correlated with levels of EGFR and EGFR-related signaling proteins in vitro. Expression of GH can induce the expression of EGFR and vice versa in LC cells.
- adagloxad simolenin (OBI 822) / OBI Pharma, OBI-888 / OBI Pharma, OBI-833 / OBI Pharma
Globo H-targeted CAR T cell cancer immunotherapy (Section 23; Poster Board #4) - Mar 14, 2023 - Abstract #AACR2023AACR_6268;
Clinical studies with the Globo H vaccines (OBI-822 and OBI-833) and the humanized anti-Globo H antibody (OBI-888) demonstrating an excellent safety profile. In conclusion, our in vitro and in vivo pharmacology and preliminary toxicology studies support clinical development of Globo H CAR T immunotherapy for patients with cancer.
- ||| adagloxad simolenin (OBI 822) / OBI Pharma
P3 data, Review, Journal: GLORIA: phase III, open-label study of adagloxad simolenin/OBI-821 in patients with high-risk triple-negative breast cancer. (Pubmed Central) - Oct 22, 2022
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.
- | adagloxad simolenin (OBI 822) / OBI Pharma
Journal: 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. (Pubmed Central) - Jun 29, 2022
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.
- adagloxad simolenin (OBI 822) / OBI Pharma
A phase 3, randomized, open-label study of the anti-Globo H vaccine adagloxad simolenin/obi-821 in the adjuvant treatment of high-risk, early-stage, Globo H-positive triple-negative breast cancer. (Available On Demand; 380a) - Apr 28, 2022 - Abstract #ASCO2022ASCO_3308;
P3
An estimated 668 subjects will be enrolled, treated for up to 2 years, and followed until occurrence of 187 events (invasive disease recurrence or death) or 3 years from last subject randomized. Survival follow-up is for 5 years from randomization of last subject.
- adagloxad simolenin (OBI-822/821) / OBI Pharma
Globo H: A Globo series glycosphingolipid target antigen in breast cancer (Hall 1) - Oct 26, 2021 - Abstract #SABCS2021SABCS_1310;
Adagloxad simolenin (AS/OBI-822) is a Globo H conjugate vaccine that when administered in combination with the adjuvant OBI-821 results in anti‒Globo H IgM and IgG humoral immune responses...To enter the GLORIA study, patients must have a centrally confirmed Globo H IHC H-score of ≥15, and it is anticipated that approximately 40% of patients screened will have this level of expression. The GLORIA study is presently enrolling patients in 7 countries, with another 9 countries anticipated to begin recruiting in 2021.
- || adagloxad simolenin (OBI-822/821) / OBI Pharma
Clinical, P2 data, Journal: Globo H-KLH vaccine adagloxad simolenin (OBI-822)/OBI-821 in patients with metastatic breast cancer: phase II randomized, placebo-controlled study. (Pubmed Central) - Sep 22, 2021
P2
However, humoral immune response to Globo H correlated with improved PFS in AS/OBI-821 recipients, leading the way to further marker-driven studies. Treatment was well tolerated.NCT01516307.
- | adagloxad simolenin (OBI 822) / OBI Pharma
Enrollment change, Trial termination, Combination therapy: Adagloxad Simolenin/OBI-821 in Combination With TACE Therapy in HCC Patients With GALNT14-rs9679162-non-TT Genotype (clinicaltrials.gov) - May 6, 2021
P2, N=5, Terminated, Sponsor: Chang Gung Memorial Hospital
Treatment was well tolerated.NCT01516307. N=51 --> 5 | Recruiting --> Terminated; The biopsies in the first 5 screened patients were all negative for Globo-H, of which positive is required to include the patients.
- ||| adagloxad simolenin (OBI 822) / OBI Pharma
Trial completion date: Study of Adagloxad Simolenin (OBI-822)/OBI-821 in the Adjuvant Treatment of Patients With Globo H Positive TNBC (clinicaltrials.gov) - Aug 8, 2020
P3, N=668, Recruiting, Sponsor: OBI Pharma, Inc
N=51 --> 5 | Recruiting --> Terminated; The biopsies in the first 5 screened patients were all negative for Globo-H, of which positive is required to include the patients. Trial completion date: Nov 2025 --> Dec 2027
- ||||| adagloxad simolenin (OBI-822/821) / OBI Pharma
Clinical: New #JITC article: Globo H-KLH vaccine adagloxad simolenin (OBI-822)/OBI-821 in patients with metastatic breast cancer: phase II randomized, placebo-controlled study @hoperugo https://t.co/SHzeFhN9OA (Twitter) - Jul 23, 2020
- adagloxad simolenin (OBI-822/821) / OBI Pharma
[VIRTUAL] Phase III, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of adagloxad simolenin (OBI-822) and OBI-821 treatment in patients with early-stage triple-negative breast cancer (TNBC) at high risk for recurrence. (Poster Board 91) - Apr 29, 2020 - Abstract #ASCO2020ASCO_1716;
Survival follow-up is for 5 years from randomization of last subject. Research Funding: OBI Pharma Inc.
- | adagloxad simolenin (OBI 822) / OBI Pharma
Enrollment open, Combination therapy: Adagloxad Simolenin/OBI-821 in Combination With TACE Therapy in HCC Patients With GALNT14-rs9679162-non-TT Genotype (clinicaltrials.gov) - Dec 3, 2019
P2, N=51, Recruiting, Sponsor: Chang Gung Memorial Hospital
Research Funding: OBI Pharma Inc. Not yet recruiting --> Recruiting
- adagloxad simolenin (OBI-822/821) / OBI Pharma
Phase 3, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of adagloxad simolenin (OBI-822) and OBI-821 treatment in patients with early-stage triple-negative breast cancer (TNBC) at high risk for recurrence (Hall 1 - Poster Session 1) - Sep 25, 2019 - Abstract #SABCS2019SABCS_911;
Patients will be treated for up to 2 years and followed until occurrence of 187 events (invasive disease recurrence or death) or 3 years from last patient randomized. Survival follow-up is for 5 years from randomization of last patient.
- | adagloxad simolenin (OBI 822) / OBI Pharma
Trial completion, Metastases: Trial of Active Immunotherapy With Globo H-KLH (OPT-822) in Metastatic Breast Cancer Subjects (clinicaltrials.gov) - Sep 16, 2019
P2, N=349, Completed, Sponsor: OBI Pharma, Inc
Survival follow-up is for 5 years from randomization of last patient. Active, not recruiting --> Completed
- | adagloxad simolenin (OBI 822) / OBI Pharma
Trial initiation date, Combination therapy: Adagloxad Simolenin/OBI-821 in Combination With TACE Therapy in HCC Patients With GALNT14-rs9679162-non-TT Genotype (clinicaltrials.gov) - Jan 31, 2019
P2, N=51, Not yet recruiting, Sponsor: Chang Gung Memorial Hospital
Active, not recruiting --> Completed Initiation date: Sep 2018 --> Mar 2019
- |||||||||| adagloxad simolenin (OBI 822) / OBI Pharma
New P3 trial: Study of Adagloxad Simolenin (OBI-822)/OBI-821 in the Adjuvant Treatment of Patients With Globo H Positive TNBC (clinicaltrials.gov) - Jan 17, 2019
P3, N=668, Not yet recruiting, Sponsor: OBI Pharma, Inc
- |||||| adagloxad simolenin (OBI 822) / OBI Pharma
Enrollment open: Study of Adagloxad Simolenin (OBI-822)/OBI-821 in the Adjuvant Treatment of Patients With Globo H Positive TNBC (clinicaltrials.gov) - Dec 11, 2018
P3, N=668, Recruiting, Sponsor: OBI Pharma, Inc
Initiation date: Sep 2018 --> Mar 2019 Not yet recruiting --> Recruiting
- | adagloxad simolenin (OBI 822) / OBI Pharma
Trial completion date, Trial primary completion date: Study of Adagloxad Simolenin (OBI-822)/OBI-821 in the Adjuvant Treatment of Patients With Globo H Positive TNBC (clinicaltrials.gov) - Sep 21, 2018
P3, N=668, Not yet recruiting, Sponsor: OBI Pharma, Inc
Not yet recruiting --> Recruiting Trial completion date: Aug 2025 --> Nov 2025 | Trial primary completion date: Aug 2025 --> Nov 2025
- | adagloxad simolenin (OBI 822) / OBI Pharma
New P2 trial, Combination therapy: Adagloxad Simolenin/OBI-821 in Combination With TACE Therapy in HCC Patients With GALNT14-rs9679162-non-TT Genotype (clinicaltrials.gov) - Aug 1, 2018
P2, N=51, Not yet recruiting, Sponsor: Chang Gung Memorial Hospital
- || adagloxad simolenin (OBI 822) / OBI Pharma
Trial primary completion date, Metastases: Trial of Active Immunotherapy With Globo H-KLH (OPT-822) in Metastatic Breast Cancer Subjects (clinicaltrials.gov) - Feb 11, 2017
P2, N=349, Active, not recruiting, Sponsor: OBI Pharma, Inc
Trial completion date: Aug 2025 --> Nov 2025 | Trial primary completion date: Aug 2025 --> Nov 2025 Trial primary completion date: Dec 2016 --> Aug 2016
- || adagloxad simolenin (OBI 822) / OBI Pharma
Trial primary completion date, Metastases: Trial of Active Immunotherapy With Globo H-KLH (OPT-822) in Metastatic Breast Cancer Subjects (clinicaltrials.gov) - Sep 15, 2016
P2, N=349, Active, not recruiting, Sponsor: OBI Pharma, Inc
Trial primary completion date: Dec 2016 --> Aug 2016 Trial primary completion date: Mar 2016 --> Dec 2016
- || adagloxad simolenin (OBI 822) / OBI Pharma
Trial primary completion date, Metastases: Trial of Active Immunotherapy With Globo H-KLH (OPT-822) in Metastatic Breast Cancer Subjects (clinicaltrials.gov) - Jan 17, 2016
P2, N=349, Active, not recruiting, Sponsor: OBI Pharma, Inc
Trial primary completion date: Mar 2016 --> Dec 2016 Trial primary completion date: Aug 2016 --> Mar 2016
- ||| adagloxad simolenin (OBI 822) / OBI Pharma
Enrollment closed, Trial primary completion date, Metastases: Trial of Active Immunotherapy With Globo H-KLH (OPT-822) in Metastatic Breast Cancer Subjects (clinicaltrials.gov) - Aug 15, 2014
P2, N=342, Active, not recruiting, Sponsor: OBI Pharma, Inc
Trial primary completion date: Aug 2016 --> Mar 2016 Recruiting --> Active, not recruiting | Trial primary completion date: Dec 2013 --> Aug 2016
- ||||| adagloxad simolenin (OBI 822) / OBI Pharma
New P2 trial: Trial of Active Immunotherapy With Globo H-KLH (OPT-822/821) in Women Who Have Non-Progressive Ovarian Cancer (clinicaltrials.gov) - May 5, 2014
P2, N=110, Recruiting, Sponsor: Mackay Memorial Hospital
- ||||| adagloxad simolenin (OBI 822) / OBI Pharma
New P2 trial, Metastases: Trial of Active Immunotherapy With Globo H-KLH (OPT-822) in Metastatic Breast Cancer Subjects (clinicaltrials.gov) - Jan 22, 2012
P2, N=342, Recruiting, Sponsor: OBI Pharma, Inc