Delving into the Latest Updates on Tucotuzumab celmoleukin with Synapse

Overview

Basic Info

Drug Type

Antibody

Synonyms

KS-interleukin-2, Tucotuzumab celmoleukin (USAN/INN)

+ [2]

Target

EpCAM x IL-2R

Mechanism

EpCAM inhibitors(Epithelial cell adhesion molecule inhibitors), IL-2R agonists(Interleukin-2 receptor agonists)

Therapeutic Areas

NeoplasmsEndocrinology and Metabolic DiseaseRespiratory Diseases+ [2]

Active Indication-

Inactive Indication

Bladder CancerColorectal CancerKidney Neoplasms+ [6]

Originator Organization

EMD Lexigen Research Center Corp.

Active Organization-

Inactive Organization

EMD Serono, Inc.EMD Lexigen Research Center Corp.Merck KGaA

+ [1]

Drug Highest PhaseDiscontinuedPhase 2

First Approval Date-

Regulation-

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Gene Sequence

Sequence Code 1191632848H

Source: *****

Sequence Code 88455L

Source: *****

An open-label, randomised, phase II study in subjects with extensive disease, small cell lung cancer (ED-SCLC) after an initial response (complete response or partial response) to platinum-based therapy to determine the effect of EMD 273066 following low-dose cyclophosphamide on disease progression and survival versus best supportive care alone.

Start Date26 Mar 2008

Sponsor / Collaborator

Merck KGaA

NCT00408967 / WithdrawnPhase 2

An Open-label Phase II Study of Two Dose Levels of EMD 273066 Administered With Low-dose Cyclophosphamide Following Objective Response to Second-line Chemotherapy in Women With Recurrent Ovarian Carcinoma

The purpose of this study is to determine if either of two doses of EMD 273066 when given with a low dose of cyclophosphamide will result in a second time to progression that is as long or longer than the first time to progression

Start Date31 Dec 2006

Sponsor / Collaborator

EMD Serono, Inc.

NCT00132522 / CompletedPhase 1

A Study to Find the Highest Dose of Biological Study Drug (EMD 273066) That Can Be Given Safely to Patients With Recurrent EpCAM Positive Ovarian, Prostate, Colorectal or Non-Small Cell Lung Cancers When First Given a Low Dose of Cyclophosphamide

This study is looking at the safety and tolerability of the experimental biological drug EMD 273066 when given with low dose cyclophosphamide to patients with recurring EpCAM positive ovarian, prostate, colorectal or non-small cell lung cancers. EMD 273066 is an experimental biological drug that may increase the immune response to certain cancers. Patients will be enrolled in groups of 3, with each successive group receiving a higher dose if the prior group adequately tolerates the study medication.

Start Date01 May 2005

Sponsor / Collaborator

EMD Serono, Inc.

100 Clinical Results associated with Tucotuzumab celmoleukin

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100 Translational Medicine associated with Tucotuzumab celmoleukin

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100 Patents (Medical) associated with Tucotuzumab celmoleukin

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14

Literatures (Medical) associated with Tucotuzumab celmoleukin

01 Nov 2022·Bioorganic Chemistry

Discovery of N-arylcinnamamides as novel erythroblast enucleation inducers

Article

Author: Zhao, Baobing ; Li, Yanxia ; Lu, Zhiyuan ; Lu, Chunhua ; Shen, Yuemao ; Xu, Guangsen

Derivation of mature red blood cells (RBCs) from stem cells in vitro is a promising solution to the current shortage of blood supply, in which terminal enucleation is the rate-limiting step. Here we discovered two cinnamamides B8 and B16 showed potential activities of enhancing the enucleation of erythroblasts through the screening of "in-house" compound library. Subsequently, twenty-four N-arylcinnamamides were rationally designed and synthesized on the basis of the structure of B8 and B16, in which N-(9H-carbazol-2-yl)cinnamamide (KS-2) significantly elevated the percentage of reticulocytes in the cultured mouse fetal liver cells in vitro (relative enucleation = 2.43). The underlying mechanism of KS-2 in promoting mouse erythroid enucleation is accelerating the process of cell cycle exit via p53 activation in late stage erythrocytes. These results strongly suggest that compound KS-2 is worthy of further study as a potential erythrocyte enucleation inducer.

01 Nov 2015·Anti-Cancer DrugsQ4 · MEDICINE

Cyclophosphamide and tucotuzumab (huKS-IL2) following first-line chemotherapy in responding patients with extensive-disease small-cell lung cancer

Q4 · MEDICINE

Article

Author: Krzakowski, Maciej J. ; Komarnitsky, Philip B. ; Serwatowski, Piotr ; Ramlau, Rodryg ; Kramer, Daniel ; Milanowski, Janusz ; Gladkov, Oleg ; Tomeczko, Janusz

The humanized KS-interleukin-2, tucotuzumab (huKS-IL2; EMD 273066), is an EpCAM-specific immunocytokine with reported immunologic activity in combination with cyclophosphamide. This Phase 2, randomized, open-label study compared tucotuzumab/cyclophosphamide, administered as maintenance, with best supportive care (BSC) in patients with extensive-disease small-cell lung cancer (ED-SCLC) who responded to first-line platinum-based chemotherapy with/without prophylactic cranial irradiation (PCI). Patients received cyclophosphamide (300 mg/m, Day 1 of every 3-week cycle), followed by tucotuzumab (1.5 mg/m, Days 2-4) until disease progression. The primary endpoint was 6-month progression-free survival (PFS); the secondary objectives included overall survival (OS), treatment response, and safety. The 6-month PFS rate was lower in the tucotuzumab/cyclophosphamide group (n=64) than in the BSC group (n=44): 6.4 versus 12.2% [hazard ratio (HR): 0.98; 80% confidence interval (CI): 0.74-1.31]. HRs for PFS, time to progression, and OS indicated a similar risk of disease progression and death in both groups and best overall responses were generally comparable. For patients with previous PCI (n=26), there was a nonsignificant trend toward prolonged median PFS (1.7 vs. 1.5 months; HR: 0.60; 80% CI: 0.33-1.11) and OS (21.5 vs. 14.3 months; HR: 0.58; 80% CI: 0.31-1.05) in the tucotuzumab/cyclophosphamide group. Adverse events were more frequent with tucotuzumab/cyclophosphamide (92.2%) than with BSC (47.7%). Tucotuzumab/cyclophosphamide was well tolerated in ED-SCLC patients, but did not show PFS or OS benefits compared with BSC. The observed trend toward prolonged PFS and OS in the subgroup of patients receiving previous PCI may support further confirmation in a larger population.

01 Dec 2013·BMC CancerQ2 · MEDICINE

A phase 1b study of humanized KS-interleukin-2 (huKS-IL2) immunocytokine with cyclophosphamide in patients with EpCAM-positive advanced solid tumors

Q2 · MEDICINE

ArticleOA

Author: Jean Henslee-Downey ; Lionel D Lewis ; Sarah Stewart ; Nancy L Lewis ; Daniel Kramer ; Josephine Harter ; Roger Stupp ; Roland Neugebauer ; Mildred Felder ; Joseph P Connor ; Philip B Komarnitsky ; Maria R Mattiacci ; Mihaela C Cristea

BACKGROUNDHumanized KS-interleukin-2 (huKS-IL2), an immunocytokine with specificity for epithelial cell adhesion molecule (EpCAM), has demonstrated favorable tolerability and immunologic activity as a single agent.METHODSPhase 1b study in patients with EpCAM-positive advanced solid tumors to determine the maximum tolerated dose (MTD) and safety profile of huKS-IL2 in combination with low-dose cyclophosphamide. Treatment consisted of cyclophosphamide (300 mg/m2 on day 1), and escalating doses of huKS-IL2 (0.5-4.0 mg/m2 IV continuous infusion over 4 hours) on days 2, 3, and 4 of each 21-day cycle. Safety, pharmacokinetic profile, immunogenicity, anti-tumor and biologic activity were evaluated.RESULTSTwenty-seven patients were treated for up to 6 cycles; 26 were evaluable for response. The MTD of huKS-IL2 in combination with 300 mg/m2 cyclophosphamide was 3.0 mg/m2. At higher doses, myelosuppression was dose-limiting. Transient lymphopenia was the most common grade 3/4 adverse event (AE). Other significant AEs included hypotension, hypophosphatemia, and increase in serum creatinine. All patients recovered from these AEs. The huKS-IL2 exposure was dose-dependent, but not dose-proportional, accumulation was negligible, and elimination half-life and systemic clearance were independent of dose and time. Most patients had a transient immune response to huKS-IL2. Immunologic activity was observed at all doses. Ten patients (38%) had stable disease as best response, lasting for ≥ 4 cycles in 3 patients.CONCLUSIONThe combination of huKS-IL2 with low-dose cyclophosphamide was well tolerated. Although no objective responses were observed, the combination showed evidence of immunologic activity and 3 patients showed stable disease for ≥ 4 cycles.

100 Deals associated with Tucotuzumab celmoleukin

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External Link

KEGG	Wiki	ATC	Drug Bank
D09027	Tucotuzumab celmoleukin	-	DB15402

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Recurrent ovarian cancer	Phase 2	-	EMD Serono, Inc.	31 Dec 2006
Non-Small Cell Lung Cancer	Phase 2	US	EMD Serono, Inc.	01 May 2005
Bladder Cancer	Phase 2	US	EMD Serono, Inc.	01 Dec 2000
Kidney Neoplasms	Phase 2	US	EMD Serono, Inc.	01 Dec 2000
Refractory Cancer	Phase 2	US	EMD Serono, Inc.	01 Dec 2000
Ovarian Cancer	Phase 2	US	EMD Lexigen Research Center Corp.	-
Ovarian Cancer	Phase 2	US	EMD Lexigen Research Center Corp.	-
Small Cell Lung Cancer	Phase 2	US	Merck KGaA	-
Small Cell Lung Cancer	Phase 2	-	EMD Lexigen Research Center Corp.	-
Small Cell Lung Cancer	Phase 2	-	Merck Serono SA	-

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT00132522 (Pubmed \| BMC Cancer)	Phase 1	EpCAM positive Solid Tumors	45	huKS-IL2	(louulurien) = The combination of huKS-IL2 with low-dose cyclophosphamide was well tolerated. Although no objective responses were observed, the combination showed evidence of immunologic activity and 3 patients showed stable disease for ≥ 4 cycles gbcttbcqft (ajpqwfzwyn ) View more	-	15 Jan 2013
ASCO2012	Phase 2	Extensive stage Small Cell Lung Cancer	108	huKS-IL2/CTXhuKS-IL2/CTX	trrygeufbi(rqvpogawkg) = odzhytdojm surbekdywk (jntruaaxbi ) View more	-	20 May 2012
ASCO2011	Phase 1	EpCAM positive Solid Tumors	27	EMD 273066 (huKS-IL2) + cyclophosphamide	(vzxtnymtzf) = ztznkpcqzc fejktaalky (mskkynefbz ) View more	-	20 May 2011