Delving into the Latest Updates on Abagovomab with Synapse

Overview

Basic Info

Drug Type

Monoclonal antibody

Synonyms

Anti-idiotype ovarian cancer vaccine, Monoclonal Anti-idiotype Antibody ACA125

+ [4]

Target

MUC16

Action

inhibitors

Mechanism

MUC16 inhibitors(Mucin-16 inhibitors)

Therapeutic Areas

NeoplasmsDigestive System DisordersEndocrinology and Metabolic Disease+ [1]

Active Indication-

Inactive Indication

Ovarian Epithelial CarcinomaPancreatic Cancer

Originator Organization

Cellcontrol Biomedical Laboratories AG

Active Organization-

Inactive Organization

A. Menarini Industrie Farmaceutiche Riunite SrlCellcontrol Biomedical Laboratories AG

License Organization-

Drug Highest PhaseDiscontinuedPhase 3

First Approval Date-

RegulationOrphan Drug (United States)

Login to view timeline

Structure/Sequence

Sequence Code 13006883H

Source: *****

Sequence Code 13007347L

Source: *****

INTRODUCTIONDespite encouraging phase I and II study results, vaccination of ovarian cancer patients with abagovomab - an anti-idiotypic mAb that mimics the ovarian cancer CA125 protein - failed to demonstrate efficacy in the phase III trial named MIMOSA (NCT00418574). We postulated that in this trial patients with a more robust immune system did respond to abagovomab but went undetected among a larger number of non-responders. We also postulated that assessment of the immune system status ahead of abagovomab administration might predict patients' propensity to respond to abagovomab.MATERIALS AND METHODSThe immune system status was assessed as percentage and absolute count of CD8⁺ T cells producing IFN-γ after stimulation with Staphylococcal Enterotoxin B (SEB) in 80 patients on abagovomab and 31 patients on placebo from the MIMOSA trial ahead of treatment. Optimal cutoffs of the two variables were calculated by the web application "Cutoff Finder" as the points with most significant (log-rank test) splits based on relapse-free survival (RFS). The Kaplan-Meier curves and log-rank test served to estimate and compare RFS in patients with percentage and absolute count of IFN-γ producing CD8⁺ T cells around the cutoffs.RESULTSPatients on abagovomab with IFN-γ producing CD8⁺T cell percentage above the cutoff had a better RFS (p=0.042) than those with IFN-γ producing CD8⁺T cell percentage below the cutoff. Patients on abagovomab with IFN-γ producing CD8⁺T cell absolute count above the cutoff had a better RFS (p=0.019) than those with IFN-γ producing CD8⁺T cell absolute counts below the cutoff. Consistently, the RFS of patients on abagovomab with IFN-γ producing CD8⁺T cell percentage and absolute counts values below the respective cutoffs was identical to that of patients on placebo. Neither the percentage nor the absolute count of IFN-γ producing CD8⁺T cells correlated with RFS in patients on placebo.CONCLUSIONSA robust immune system is essential to obtain a clinical response in OC patients undergoing abagovomab immunotherapy whereas a robust immune system does not confer per se a survival advantage. Further work will clarify whether the results shown here apply only in the present setting or extend to other types of cancer and/or immunotherapeutic agents.

01 Aug 2016·European journal of gynaecological oncologyQ4 · MEDICINE

The antibody-based CA125-targeted maintenance therapy for the epithelial ovarian cancer: a meta-analysis.

Q4 · MEDICINE

Review

Author: F Fang ; L Mei ; H Wang ; Q Hou

OBJECTIVESTo assess the effect and toxicity of CA125-targeted antibody used as maintenance therapy for advanced epithelial ovarian cancer (EOC).MATERIALS AND METHODSTwo reviewers searched PubMed, Medline, Embase, VIP databases, and the references of selected articles for randomized controlled trials comparing maintenance CA125-targeted antibody treatment with placebo/observation. One-, two-, three-, and five-year overall survival (OS) and progression free survival (PFS) were collected. Incidence and severity of adverse events were extracted. Meta-analysis of combined risk ratio (RR) for OS , PFS, and toxicity were conducted.RESULTSFour trials including 1,259 women were identified. Meta-analysis showed the combined RR was 1.02 (95% CI, 0.85-1.22) for three-year OS and 0.98 (95% CI, 0.70-1.39) for the three-year PFS. This review found that abagovomab and oregovomab caused toxicity no more than placebo.CONCLUSIONSCA125-targeted antibody used as maintenance therapy alone is not more effective than placebo but they were safe as maintenance therapy.

15 Nov 2015·Cancer ResearchQ1 · MEDICINE

Understanding the Unique Attributes of MUC16 (CA125): Potential Implications in Targeted Therapy

Q1 · MEDICINE

Review

Author: Das, Srustidhar ; Batra, Surinder K.

AbstractCA125, the most widely used ovarian cancer biomarker, was first identified approximately 35 years ago in an antibody screen against ovarian cancer antigen. Two decades later, it was cloned and characterized to be a transmembrane mucin, MUC16. Since then, several studies have investigated its expression, functional, and mechanistic involvement in multiple cancer types. Antibody-based therapeutic approaches primarily using antibodies against the tandem repeat domains of MUC16 (e.g., oregovomab and abagovomab) have been the modus operandi for MUC16-targeted therapy, but have met with very limited success. In addition, efforts have been also made to disrupt the functional cooperation of MUC16 and its interacting partners; for example, use of a novel immunoadhesin HN125 to interfere MUC16 binding to mesothelin. Since the identification of CA125 to be MUC16, it is hypothesized to undergo proteolytic cleavage, a process that is considered to be critical in determining the kinetics of MUC16 shedding as well as generation of a cell-associated carboxyl-terminal fragment with potential oncogenic functions. In addition to our experimental demonstration of MUC16 cleavage, recent studies have demonstrated the functional importance of carboxyl terminal fragments of MUC16 in multiple tumor types. Here, we provide how our understanding of the basic biologic processes involving MUC16 influences our approach toward MUC16-targeted therapy. Cancer Res; 75(22); 4669–74. ©2015 AACR.

100 Deals associated with Abagovomab

Login to view more data

External Link

KEGG	Wiki	ATC	Drug Bank
-	Abagovomab	-	DB16077

R&D Status

10 top R&D records.

Login

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Ovarian Epithelial Carcinoma	Phase 3	Germany	A. Menarini Industrie Farmaceutiche Riunite Srl	01 Dec 2006
Ovarian Epithelial Carcinoma	Phase 3	Czechia	A. Menarini Industrie Farmaceutiche Riunite Srl	01 Dec 2006
Ovarian Epithelial Carcinoma	Phase 3	Hungary	A. Menarini Industrie Farmaceutiche Riunite Srl	01 Dec 2006
Ovarian Epithelial Carcinoma	Phase 3	Italy	A. Menarini Industrie Farmaceutiche Riunite Srl	01 Dec 2006
Ovarian Epithelial Carcinoma	Phase 3	Spain	A. Menarini Industrie Farmaceutiche Riunite Srl	01 Dec 2006
Ovarian Epithelial Carcinoma	Phase 3	Belgium	A. Menarini Industrie Farmaceutiche Riunite Srl	01 Dec 2006
Ovarian Epithelial Carcinoma	Phase 3	United States	A. Menarini Industrie Farmaceutiche Riunite Srl	01 Dec 2006
Ovarian Epithelial Carcinoma	Phase 3	Poland	A. Menarini Industrie Farmaceutiche Riunite Srl	01 Dec 2006
Pancreatic Cancer	Phase 3	-	Cellcontrol Biomedical Laboratories AG	-
Pancreatic Cancer	Phase 3	-	A. Menarini Industrie Farmaceutiche Riunite Srl	-

Login to view more data

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT00418574 (MIMOSA, ASCO2013)	Phase 3	Ovarian Cancer Maintenance	888	Abagovomab	(dhivprsava) = vnjfckbbra shyksrpacw (hofkdvrsdt )	-	20 May 2013
				Placebo	(dhivprsava) = grweobxzjg shyksrpacw (hofkdvrsdt )
NCT00418574 (MIMOSA, CTgov)	Phase 2/3	Ovarian Epithelial Carcinoma	888	Abagovomab (Abagovomab)	bvwgmmisbj(annjgkvlqb) = txpjzptjyv tayobvysyy (vxdrfmzrly, zgoxvrasen - pepmbfnglt) View more	-	18 Nov 2011
				Placebo (Placebo)	bvwgmmisbj(annjgkvlqb) = pbboluyxyy tayobvysyy (vxdrfmzrly, gcnqoanjxh - dqyaakgzng) View more
NCT00418574 (MIMOSA, ASCO2011)	Phase 2/3	Ovarian Cancer Maintenance	888	Abagovomab	(ljksscmaqt) = agglmqarxu aflajifmvd (lcpgzutntj, 10.612 - 13.602)	Negative	20 Jun 2011
				Placebo	(ljksscmaqt) = ziyxsbarnn aflajifmvd (lcpgzutntj, 10.612 - 16.000)
NCT00418574 (MIMOSA, ASCO2010)	Phase 3	Ovarian Epithelial Carcinoma Maintenance	888	Abagovomab 2 mg	snrvvzfyoz(fosqpmcpmo) = pixqcvplpb rgeuyblilx (jmyqzhqzhg )	-	20 May 2010
				Placebo	snrvvzfyoz(fosqpmcpmo) = ovodsqvaty rgeuyblilx (jmyqzhqzhg )

Login to view more data

Translational Medicine

Boost your research with our translational medicine data.

login

or

view full example data

Boost your research with our translational medicine data.

Deal

Boost your decision using our deal data.

login

or

view full example data

Boost your decision using our deal data.

Core Patent

Boost your research with our Core Patent data.

login

or

view full example data

Boost your research with our Core Patent data.

Clinical Trial

Identify the latest clinical trials across global registries.

login

or

view full example data

Identify the latest clinical trials across global registries.

Approval

Accelerate your research with the latest regulatory approval information.

login

or

view full example data

Accelerate your research with the latest regulatory approval information.

Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

login

or

view full example data