Delving into the Latest Updates on Abituzumab with Synapse

Overview

Basic Info

Drug Type

Monoclonal antibody

Synonyms

Anti-CD51 antigen mAb, Anti-integrin alphaV mAb

+ [3]

Target

CD51

Action

antagonists

Mechanism

CD51 antagonists(Integrin alpha-V antagonists), ADCC(Antibody-dependent cell-mediated cytotoxicity (ADCC) effects)

Therapeutic Areas

NeoplasmsDigestive System DisordersRespiratory Diseases+ [5]

Active Indication-

Inactive Indication

Advanced Malignant Solid NeoplasmBone DiseasesBone metastases+ [10]

Originator Organization

Merck Serono SA

Active Organization-

Inactive Organization

Merck KGaA

EMD Serono, Inc.

SFJ Pharmaceuticals, Inc.

License Organization

Merck KGaA

SFJ Pharmaceuticals, Inc.

Drug Highest PhaseDiscontinuedPhase 2

First Approval Date-

Regulation-

Login to view timeline

Structure/Sequence

Sequence Code 9976294H

Source: *****

Sequence Code 15623086L

Source: *****

AMELION: A Randomized, Double Blinded, Phase 2, Efficacy and Safety Study of Abituzumab (EMD 525797) in Combination With Cetuximab and FOLFIRI Versus Placebo in Combination With Cetuximab and FOLFIRI in First-line RAS Wild-type, Left-sided, Metastatic Colorectal Cancer Patients With High ανβ6 Integrin Expression.

The purpose of this study is to evaluate the safety and efficacy of the experimental drug abituzumab (EMD525797) in combination with cetuximab and FOLFIRI in RAS wild-type, left-sided, metastatic colorectal cancer patients with high ανβ6 integrin expression.

Start Date01 Apr 2019

Sponsor / Collaborator

SFJ Pharmaceuticals X, LTD.

[+3]

NCT02745145

/ TerminatedPhase 2

A Phase II, Randomized, Double-blind, Placebo Controlled, Parallel-group, Multicenter Trial to Evaluate the Efficacy and Safety of Abituzumab in Subjects With Systemic Sclerosis-associated Interstitial Lung Disease (SSc-ILD)

The purpose of this trial was to compare two doses of abituzumab with placebo and determine whether abituzumab was more effective, safer, would be better tolerated and could provoke better immune response than placebo in the treatment of participants with SSc-ILD who already receive constant doses of mycophenolate.

Start Date31 May 2016

Sponsor / Collaborator

EMD Serono Research & Development Institute, Inc.

[+1]

NCT01360840

/ CompletedPhase 2

A Randomized, Double-blind, Placebo-controlled, Multicenter Phase II Trial Investigating Two Doses of EMD 525797 in Subjects With Asymptomatic or Mildly Symptomatic Metastatic Castrate-resistant Prostate Cancer (mCRPC)

The primary objective of the trial is to evaluate the clinical anti-tumor activity of EMD 525797 administered as 1-hour intravenous infusion every 3 weeks in terms of progression free survival (PFS) time in subjects with asymptomatic or mildly symptomatic metastatic castrate-resistant prostate cancer (mCRPC).

Start Date01 Apr 2011

Sponsor / Collaborator

EMD Serono, Inc.

100 Clinical Results associated with Abituzumab

Login to view more data

100 Translational Medicine associated with Abituzumab

Login to view more data

100 Patents (Medical) associated with Abituzumab

Login to view more data

13

Literatures (Medical) associated with Abituzumab

20 Jun 2023·Analytical chemistry

Integration of NMR Spectroscopy in an Analytical Workflow to Evaluate the Effects of Oxidative Stress on Abituzumab: Beyond the Fingerprint of mAbs.

Article

Author: Fischer, Christian ; Trovato, Andrea ; Ravera, Enrico ; Baroni, Fabio ; Fragai, Marco ; Angiuoni, Gabriella ; Cerofolini, Linda ; Palinsky, Wolf ; Sacco, Francesca

The assessment of the higher-order structure (HOS) by NMR is a powerful methodology to characterize the structural features of biologics. Forced oxidative stress studies are used to investigate the stability profile, to develop pharmaceutical formulations and analytical methods. Here, the effects of forced oxidative stress by H₂O₂ on the monoclonal antibody Abituzumab have been characterized by a multianalytical approach combining NMR spectroscopy, mass spectrometry, differential scanning calorimetry, surface plasmon resonance, computational tools, and bioassays. This integrated strategy has provided qualitative and semiquantitative characterization of the samples and information at residue level of the effects that oxidation has on the HOS of Abituzumab, correlating them to the loss of the biological activity.

01 Aug 2021·The Journal of RheumatologyQ2 · MEDICINE

STRATUS: A Phase II Study of Abituzumab in Patients With Systemic Sclerosis–associated Interstitial Lung Disease

Q2 · MEDICINE

Article

Author: Wells, Athol U ; Fleuranceau-Morel, Patricia ; Denton, Christopher P ; Tashkin, Donald P ; Khanna, Dinesh ; Vazquez-Mateo, Cristina ; Seibold, James R ; Damian, Doris ; Wax, Stephen

ObjectiveTo investigate the effects of abituzumab in systemic sclerosis–associated interstitial lung disease (SSc-ILD).MethodsSTRATUS was a phase II, double-blind, parallel-group, multicenter trial (ClinicalTrials.gov: NCT02745145). Adults (≤ 75 yrs) with SSc-ILD on stable mycophenolate were randomized (2:2:1) to receive intravenous abituzumab 1500 mg, abituzumab 500 mg, or placebo every 4 weeks for 104 weeks. The primary endpoint was the annual rate of change in absolute forced vital capacity.ResultsSTRATUS was terminated prematurely due to slow enrollment (n = 75 screened, n = 24 randomized), precluding robust analysis of efficacy. Abituzumab was well tolerated; no new safety signals were detected.ConclusionFurther investigation of abituzumab for treatment of SSc-ILD is required.

27 Jun 2019·Anti-Cancer Agents in Medicinal Chemistry

Integrins as A New Target for Cancer Treatment

Review

Author: Mackiewicz, Jacek ; Łasiñska, Izabela

:Despite the great progress in the development of targeted therapies for different types of cancer utilizing monoclonal antibodies (e.g., cetuximab for colorectal cancer and head and neck cancer therapy), kinase inhibitors (e.g., sorafenib for kidney cancer and gastrointestinal stromal tumours therapy), and immunomodulatory treatments (e.g., nivolumab and pembrolizumab for melanoma therapy and lung cancer therapy), there is still a need to search for new, more effective treatments.:Integrins are responsible for intercellular adhesion and interaction with the cellular matrix. The function of integrins is related to the transduction of intracellular signals associated with adhesion, migration, cell proliferation, differentiation, and apoptosis. Molecules targeting integrins that lead to cancer cell death have been developed. The most advanced molecules studied in clinical trials are abituzumab, intetumumab and cilengitide. There are different groups of anti-integrin drugs: monoclonal antibodies (e.g., abituzumab) and other such as cilengitide, E7820 and MK-0429. These drugs have been evaluated in various cancer types. However, they have shown modest efficacy, and none of them have yet been approved for cancer treatment. Studies have shown that patient selection using biomarkers might improve the efficacy of anti-integrin cancer treatment. Many preclinical models have demonstrated promising results using integrin visualization for cancer detection and treatment efficacy monitoring; however, these strategies require further evaluation in humans.

100 Deals associated with Abituzumab

Login to view more data

External Link

KEGG	Wiki	ATC	Drug Bank
-	Abituzumab	-	DB12775

R&D Status

10 top R&D records.

Login

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Metastatic Colorectal Carcinoma	Phase 2	Germany	Merck KGaA	01 Oct 2009
Metastatic Colorectal Carcinoma	Phase 2	Russia	Merck KGaA	01 Oct 2009
Metastatic Colorectal Carcinoma	Phase 2	Israel	Merck KGaA	01 Oct 2009
Metastatic Colorectal Carcinoma	Phase 2	Spain	Merck KGaA	01 Oct 2009
Metastatic Colorectal Carcinoma	Phase 2	Spain	Merck KGaA	01 Oct 2009
Metastatic Colorectal Carcinoma	Phase 2	Israel	Merck KGaA	01 Oct 2009
Metastatic Colorectal Carcinoma	Phase 2	Russia	Merck KGaA	01 Oct 2009
Metastatic Colorectal Carcinoma	Phase 2	United Kingdom	Merck KGaA	01 Oct 2009
Metastatic Colorectal Carcinoma	Phase 2	United Kingdom	Merck KGaA	01 Oct 2009
Metastatic Colorectal Carcinoma	Phase 2	Germany	Merck KGaA	01 Oct 2009

Login to view more data

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02745145 (CTgov)	Phase 2	Interstitial lung disease due to systemic disease	24	Placebo (Placebo)	qngyxzyavo(fnqfyyndhd) = krktlkcuzk agfsgixmvy (gwgfdcdiaj, jhglglnghb - zjkxcscrjk) View more	-	18 Jun 2019
				Abituzumab 500 mg (Abituzumab 500 mg)	fmgvrgnxnm(wekvaljipt) = vpcjnwwiyu ejvumazsnf (rkpbyxmzlm, xguuijjxts - ukloxsgaly) View more
NCT01008475 (Poseidon, ESMO2018)	Phase 1/2	Metastatic Colorectal Carcinoma	232	Abituzumab 1000mg + irinotecan+cetuximab	(tmzxenhrne) = ubcozfhxck idhjdvnuff (tsjuonyjcg ) View more	Positive	21 Oct 2018
				Irinotecan+cetuximab	(tmzxenhrne) = temapjhrhj idhjdvnuff (tsjuonyjcg ) View more
NCT00958477 (CTgov)	Phase 1	Castration-Resistant Prostatic Cancer \| Bone Diseases \| Bone metastases	26	EMD 525797 (EMD 525797 250 mg)	ntrupfihzg(issnabfcdc) = evnujokmyo jhqpogrvpp (yifqijgicz, wdbynfsyrx - opljzrfwli) View more	-	02 Aug 2017
				EMD 525797 (EMD 525797 500 mg)	ntrupfihzg(issnabfcdc) = sctoznicxx jhqpogrvpp (yifqijgicz, rdnauawczg - pxdocrbhgc) View more
NCT01327313 (CTgov)	Phase 1	Neurosyphilis \| Advanced Malignant Solid Neoplasm	27	EMD525797 (EMD525797 500 mg)	obfhqtutai(siwkrsbwtg) = pxqtczogrc zezvjglxyi (urbkkyyjgc, jkbsbhjfyz - lyadzbmrik) View more	-	13 May 2016
				EMD525797 (EMD525797 1000 mg)	obfhqtutai(siwkrsbwtg) = ficnpflbpg zezvjglxyi (urbkkyyjgc, fhbreggaxz - axahufquuz) View more
NCT01008475 (POSEIDON, CTgov)	Phase 1/2	KRAS Wild-type Colorectal Cancer \| Metastatic Colorectal Carcinoma	232	Cetuximab+EMD 525797 500 mg+Irinotecan	npapyqiyaf(cvnulvjwaf) = hwszlmmplj rykziylntp (yxouaorqct, pvpjvppcjj - kxtpmcvkjg) View more	-	30 Mar 2016
NCT00848510 (CTgov)	Phase 1	Liver metastases \| Ovarian Cancer \| Colorectal Cancer	41	Abituzumab (Abituzumab 250 mg)	lspoktllxn(htrjvsctxb) = zdpumcroxi wlxvwjysab (uijzhagnlw, rhfjlbkrop - hapmuhrquf) View more	-	14 Dec 2015
				Abituzumab (Abituzumab 500 mg)	lspoktllxn(htrjvsctxb) = vplntltuac wlxvwjysab (uijzhagnlw, ifwjecljzi - opbisjgtfi) View more
NCT01360840 (PERSEUS, CTgov)	Phase 2	Metastatic castration-resistant prostate cancer \| Metastatic Prostate Carcinoma	180	Standard of Care (SoC)+EMD 525797 (EMD 525797 750 mg + SoC)	fanvkibrmi(fqtkpdqrhu) = lbxgekmlut zjalioumaz (coidtwjwlm, bkkdzcoyyu - rwwccadpsh) View more	-	14 Dec 2015
				Standard of Care (SoC)+EMD 525797 (EMD 525797 1500 mg + SoC)	fanvkibrmi(fqtkpdqrhu) = pztldjwjcc zjalioumaz (coidtwjwlm, dvvljgmhla - wubjhstrer) View more
NCT01008475 (POSEIDON, Pubmed)	Phase 1/2	KRAS Wild-type Colorectal Cancer	232	Abituzumab 500mg	(dfewzidgch) = A trend toward improved OS was observed lsogeoksrd (vglwiuaekh )	Negative	01 Jan 2015
				Abituzumab 1000mg
NCT01008475 (POSEIDON, ESMO_GI2014)	Phase 1/2	KRAS Wild-type Colorectal Cancer Second line KRAS wild-type	216	Abituzumab 500 mg	(zdfpavlnzf) = bertzratdl lqthglktuu (uuiieapnrc ) View more	Negative	25 Jun 2014
				Abituzumab 1000 mg	(zdfpavlnzf) = moiimbhtvx lqthglktuu (uuiieapnrc ) View more
NCT01360840 (PERSEUS, ASCO2014)	Phase 2	Metastatic castration-resistant prostate cancer	180	Placebo	(biedqoxhhf) = cotljlmioc cxmwezobiy (whszvuhenb, 2.8 - 4.8)	-	20 May 2014
				Abituzumab 750 mg	(biedqoxhhf) = xydtaytkip cxmwezobiy (whszvuhenb, 2.8 - 5.6)

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

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.

Regulation

Understand key drug designations in just a few clicks with Synapse.

login

or

view full example data

Understand key drug designations in just a few clicks with Synapse.

Abituzumab

Overview

Basic Info

Structure/Sequence

Related

External Link

R&D Status

Clinical Result

Translational Medicine

Deal

Core Patent

Clinical Trial

Approval

Biosimilar

Regulation