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

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.

Drug Highest PhaseDiscontinuedPhase 2

First Approval Date-

Regulation-

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Gene 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

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100 Translational Medicine associated with Abituzumab

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100 Patents (Medical) associated with Abituzumab

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35

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·Clinical & Experimental MetastasisQ3 · MEDICINE

CXCL2-CXCR2 axis mediates αV integrin-dependent peritoneal metastasis of colon cancer cells

Q3 · MEDICINE

Article

Author: Lepsenyi, Mattias ; Al-Haidari, Amr A ; Syk, Ingvar ; Thorlacius, Henrik ; Algaber, Anwar ; Rahman, Milladur ; Algethami, Nader

AbstractPeritoneal metastasis is an insidious aspect of colorectal cancer. The aim of the present study was to define mechanisms regulating colon cancer cell adhesion and spread to peritoneal wounds after abdominal surgery. Mice was laparotomized and injected intraperitoneally with CT-26 colon carcinoma cells and metastatic noduli in the peritoneal cavity was quantified after treatment with a CXCR2 antagonist or integrin-αV-antibody. CT-26 cells expressed cell surface chemokine receptors CXCR2, CXCR3, CXCR4 and CXCR5. Stimulation with the CXCR2 ligand, CXCL2, dose-dependently increased proliferation and migration of CT-26 cells in vitro. The CXCR2 antagonist, SB225002, dose-dependently decreased CXCL2-induced proliferation and migration of colon cancer cells in vitro. Intraperitoneal administration of CT-26 colon cancer cells resulted in wide-spread growth of metastatic nodules at the peritoneal surface of laparotomized animals. Laparotomy increased gene expression of CXCL2 at the incisional line. Pretreatment with CXCR2 antagonist reduced metastatic nodules by 70%. Moreover, stimulation with CXCL2 increased CT-26 cell adhesion to extracellular matrix (ECM) proteins in a CXCR2-dependent manner. CT-26 cells expressed the αV, β1 and β3 integrin subunits and immunoneutralization of αV abolished CXCL2-triggered adhesion of CT-26 to vitronectin, fibronectin and fibrinogen. Finally, inhibition of the αV integrin significantly attenuated the number of carcinomatosis nodules by 69% in laparotomized mice. These results were validated by use of the human colon cancer cell line HT-29 in vitro. Our data show that colon cancer cell adhesion and growth on peritoneal wound sites is mediated by a CXCL2-CXCR2 signaling axis and αV integrin-dependent adhesion to ECM proteins.

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.

100 Deals associated with Abituzumab

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External Link

KEGG	Wiki	ATC	Drug Bank
-	Abituzumab	-	DB12775

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
KRAS Wild-type Colorectal Cancer	Phase 2	IL	Merck KGaA	01 Oct 2009
KRAS Wild-type Colorectal Cancer	Phase 2	CY	Merck KGaA	01 Oct 2009
KRAS Wild-type Colorectal Cancer	Phase 2	CZ	Merck KGaA	01 Oct 2009
KRAS Wild-type Colorectal Cancer	Phase 2	ES	Merck KGaA	01 Oct 2009
KRAS Wild-type Colorectal Cancer	Phase 2	RU	Merck KGaA	01 Oct 2009
KRAS Wild-type Colorectal Cancer	Phase 2	PL	Merck KGaA	01 Oct 2009
KRAS Wild-type Colorectal Cancer	Phase 2	BG	Merck KGaA	01 Oct 2009
KRAS Wild-type Colorectal Cancer	Phase 2	GB	Merck KGaA	01 Oct 2009
KRAS Wild-type Colorectal Cancer	Phase 2	GR	Merck KGaA	01 Oct 2009
KRAS Wild-type Colorectal Cancer	Phase 2	DE	Merck KGaA	01 Oct 2009

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02745145 (CTgov)	Phase 2	Interstitial lung disease due to systemic disease	24	Placebo (Placebo)	pgtdhhopol(ygxlhkvbec) = pspighhsae cazonctpgd (bcebjwvxbt, vczojlvgie - ypsbjsiizh) View more	-	18 Jun 2019
				Abituzumab 500 mg (Abituzumab 500 mg)	ahoybrwxmb(dakcmquzwa) = vdrznhghhg urhwiewhxq (yqgpougxuc, fjqzjjokia - xjzpgaztyx) View more
NCT01008475 (Poseidon, ESMO2018)	Phase 1/2	Metastatic Colorectal Carcinoma	232	Abituzumab 1000mg + irinotecan+cetuximab	(skkgqgaxpv) = rgnqtoqhgo tfdflkkxxg (wrdrccunfs ) View more	Positive	21 Oct 2018
				Irinotecan+cetuximab	(skkgqgaxpv) = ofjuboentc tfdflkkxxg (wrdrccunfs ) View more
NCT00958477 (CTgov)	Phase 1	Castration-Resistant Prostatic Cancer \| Bone Diseases \| Bone metastases	26	EMD 525797 (EMD 525797 250 mg)	krtxraacsu(vonnoeeczc) = tfxylifcqa ixlfmasagx (izmrjhxsir, lkrxajqfwh - afglydfqzf) View more	-	02 Aug 2017
				EMD 525797 (EMD 525797 500 mg)	krtxraacsu(vonnoeeczc) = uhsnaydlat ixlfmasagx (izmrjhxsir, gsnjfagzca - flekhfwlkk) View more
NCT01327313 (CTgov)	Phase 1	Neurosyphilis \| Advanced Malignant Solid Neoplasm	27	EMD525797 (EMD525797 500 mg)	ynmrssumyy(qepijybwxl) = qewbxytnxr taelmegfzc (gskdppnhao, rlwhnzvzbk - wghswxrmfp) View more	-	13 May 2016
				EMD525797 (EMD525797 1000 mg)	ynmrssumyy(qepijybwxl) = zncjhqfeyq taelmegfzc (gskdppnhao, pjkgwwjbah - dcipuijvwo) View more
NCT01008475 (POSEIDON, CTgov)	Phase 1/2	KRAS Wild-type Colorectal Cancer \| Metastatic Colorectal Carcinoma	232	Cetuximab+EMD 525797 500 mg+Irinotecan	ztdsjlyckf(gspiegqiuo) = xrjftikagx jutxjlolyq (xfbqmbffft, uhggdrfgub - wmxgkmwgjt) View more	-	30 Mar 2016
NCT00848510 (CTgov)	Phase 1	Liver metastases \| Ovarian Cancer \| Colorectal Cancer	41	Abituzumab (Abituzumab 250 mg)	qsmkuedxnj(qxmjxmwdcd) = wmjwboyvln qriomknfyt (hdifqxtnpo, pyohpfktmi - suynepflqd) View more	-	14 Dec 2015
				Abituzumab (Abituzumab 500 mg)	qsmkuedxnj(qxmjxmwdcd) = orpckvbcae qriomknfyt (hdifqxtnpo, hoopgjulwe - joqtifvuhv) 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)	kupgzxjybv(qekdevldgl) = knlawvpwmo gavshfppis (odyxwaldbl, nojztplxow - swnxracuhu) View more	-	14 Dec 2015
				Standard of Care (SoC)+EMD 525797 (EMD 525797 1500 mg + SoC)	kupgzxjybv(qekdevldgl) = hjmuqetdql gavshfppis (odyxwaldbl, raakzpyfxm - zkdskoewwd) View more
NCT01008475 (POSEIDON, Pubmed \| Ann Oncol)	Phase 1/2	KRAS Wild-type Colorectal Cancer	232	Abituzumab 500 mg	(smviboncmp) = A trend toward improved OS was observed iqvextghmm (zlsbditjvk )	Negative	01 Jan 2015
				Abituzumab 1000 mg
NCT01008475 (POSEIDON, Pubmed)	Phase 1/2	KRAS Wild-type Colorectal Cancer	232	Abituzumab 500mg	(kfgggdzueb) = A trend toward improved OS was observed gzaqwnlwbx (qgbqzbuuwi )	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	(gbwfgtoyvq) = cpugscfayj rjrvoodrtq (tgxxalpfyb ) View more	Negative	25 Jun 2014
				Abituzumab 1000 mg	(gbwfgtoyvq) = rxbvemlyme rjrvoodrtq (tgxxalpfyb ) View more