Delving into the Latest Updates on A-dmDT390-bisFv(National Institutes of Health) with Synapse

Overview

Basic Info

Drug Type

Antibody toxin conjugate

Synonyms

A-dmDT390-anti-CD3 immunotoxin, Anti-CD3 antibody-diphtheria toxin conjugate, Anti-CD3 bivalent antibody-diphtheria toxin conjugate

+ [9]

Target

CD3

Mechanism

CD3 inhibitors(T cell surface glycoprotein CD3 inhibitors)

Therapeutic Areas

NeoplasmsImmune System DiseasesHemic and Lymphatic Diseases+ [1]

Active Indication

Cutaneous T-Cell LymphomaGraft vs Host DiseaseSolid tumor

Inactive Indication

MelanomaMycosis FungoidesSezary Syndrome+ [1]

Originator Organization

National Institutes of Health

Active Organization

Virogen Biotechnology, Inc.

Inactive Organization

Angimmune LLC

University of Louisville

Drug Highest PhasePhase 2

First Approval Date-

RegulationFast Track (US), Orphan Drug (US)

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Structure

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Gene Sequence

Sequence Code 9468850

This study evaluates the effectiveness - as judged by complete response - of a single four-day treatment with the fusion protein A-dmDT390-bisFv(UCHT1) compared to oral Zolinza (Vorinostat), in a randomized 2-arm trial after a maximum of 12 months of treatment. Patient eligibility is stage IB/IIB mycosis fungoides with mSWAT < 50 who have never had lymphoid disease or a prior bone marrow / HSCT transplant.

Start Date01 Jan 2017

Sponsor / Collaborator

Angimmune LLC

[+16]

NCT02990416 / Unknown statusPhase 1/2

Phase I/II Trial of the A-dmDT390-bisFv(UCHT1) Fusion Protein in Combination With Ionizing Radiation and Pembrolizumab for the Treatment of Stage IV Melanoma

This study evaluates the effectiveness of adding a single four-day treatment of the fusion protein A-dmDT390-bisFv(UCHT1) - plus single palliative tumor radiation - with standard of care KEYTRUDA (Pembrolizumab) therapy for the treatment of metastatic melanoma. The results will be measured by comparing the combined therapy to historical data of KEYTRUDA alone.

Start Date01 Jan 2017

Sponsor / Collaborator

Angimmune LLC

NCT01888081 / TerminatedPhase 1/2

Phase I/II Trial of A-dmDT390-bisFv(UCHT1) Fusion Protein in Combination With Ionizing Radiation for the Treatment of Stage IV Melanoma

The purpose of this trial is to study A-dmDT390-bisFv(UCHT1) in combination with ionizing irradiation for the treatment of stage IV melanoma, a disease that is essentially incurable with median overall survival periods that range from 8-16 months.

Start Date01 Feb 2014

Sponsor / Collaborator

Angimmune LLC

[+1]

100 Clinical Results associated with A-dmDT390-bisFv(National Institutes of Health)

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100 Translational Medicine associated with A-dmDT390-bisFv(National Institutes of Health)

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100 Patents (Medical) associated with A-dmDT390-bisFv(National Institutes of Health)

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11

Literatures (Medical) associated with A-dmDT390-bisFv(National Institutes of Health)

01 Oct 2017·Infection

Corynebacterium species nasopharyngeal carriage in asymptomatic individuals aged ≥ 65 years in Germany

Article

Author: Lâm, Thiên-Trí ; Schönberger, Katharina ; Hubert, Kerstin ; Marosevic, Durdica ; Ackermann, Nikolaus ; van der Linden, Mark ; Teutsch, Barbara ; Sing, Andreas ; Beer, Steffi ; Drayß, Maria ; Vogel, Ulrich ; Claus, Heike ; Wienert, Peter ; Thiel, Kathrin ; Berger, Anja

PURPOSEThe prevalence of protective anti-diphtheria toxin antibodies decreases with age. Therefore, the elderly might serve as reservoir for potentially toxigenic Corynebacterium (C.) species (C. diphtheriae, C. ulcerans, and C. pseudotuberculosis). This study aimed to examine the colonization rate of the nasopharynx with corynebacteria of individuals aged 65 years and older.METHODSIn the period from October 2012 to June 2013, nasal and throat swabs were taken from 714 asymptomatic subjects aged 65-106 years (average age 77.2) at three regions in Germany and investigated for Corynebacterium species.RESULTSA total of 402 strains of Corynebacterium species were isolated from 388 out of 714 asymptomatic subjects (carriage rate 54.3%). The carriage rate was significantly higher in study participants living in retirement homes (68.4%) compared to those living autonomously at home (51.1%). Strains were isolated mostly from the nose (99%). Corynebacterium accolens was the most often isolated species (39.8%), followed by C. propinquum (24.1%), C. pseudodiphtheriticum (19.4%), and C. tuberculostearicum (10.2%). No C. diphtheriae, C. ulcerans, and C. pseudotuberculosis strains were isolated. A subsample of 74 subjects was tested serologically for anti-diphtheria antibodies. Protective anti-diphtheria toxin antibodies were found in 29.7% of the subjects; 70.3% showed no protective immunity.CONCLUSIONSThese results suggest that carriage of potentially toxigenic corynebacteria is very rare among people aged 65 and older in Germany. However, the low prevalence of protective anti-diphtheria toxin antibodies might pose a risk for acquiring diphtheria especially for the elderly.

01 Jun 2015·HaematologicaQ1 · MEDICINE

Resimmune, an anti-CD3 recombinant immunotoxin, induces durable remissions in patients with cutaneous T-cell lymphoma

Q1 · MEDICINE

Article

Author: Neville, David M ; Foss, Francine M ; Woo, Jung H ; Ahn, Chul ; Duvic, Madeleine ; Neville, Paul H ; Frankel, Arthur E

Resimmune is a second-generation recombinant immunotoxin composed of the catalytic and translocation domains of diphtheria toxin fused to two single chain antibody fragments reactive with the extracellular domain of CD3ε. We gave intravenous infusions of Resimmune 2.5 - 11.25 μg/kg over 15 minutes to 30 patients (25 with cutaneous T-cell lymphoma, 3 with peripheral T-cell lymphoma, 1 with T-cell large granular lymphocytic leukemia and 1 with T-cell prolymphocytic leukemia) in an inter-patient dose escalation trial. The most common adverse events were fever, chills, hypotension, edema, hypoalbuminemia, hypophosphatemia, and transaminasemia. Among the 25 patients with cutaneous T-cell lymphoma, there were nine responses for a response rate of 36% (95% CI, 18%-57%) including four complete remissions (16%, 95% CI, 5%-36%). The durations of the complete remissions were 72+, 72+, 60+ and 38+ months. There were five partial remissions lasting 3, 3, 3+, 6+ and 14 months. Of 17 patients with a modified skin weighted assessment tool score <50, 17 patients with stage IB/IIB, and 11 patients with both a score <50 and stage IB/IIB, nine (53%), eight (47%), and eight (73%) had responses, respectively. Further studies of Resimmune in patients with low tumor burden, stage IB-IIB cutaneous T-cell lymphoma are warranted. This trial is registered at clinicaltrials.gov as #NCT00611208.

01 Aug 2012·Transplant ImmunologyQ4 · MEDICINE

Effect of pre-existing anti-diphtheria toxin antibodies on T cell depletion levels following diphtheria toxin-based recombinant anti-monkey CD3 immunotoxin treatment

Q4 · MEDICINE

Article

Author: Vimukthi Pathiraja ; Christene A. Huang ; Zhirui Wang ; Ashley Gusha ; Rebecca Crepeau ; Masayuki Tasaki ; David H. Sachs ; Abraham J. Matar ; Raimon Duran-Struuck

Diphtheria toxin (DT)-based anti-CD3 immunotoxins have clinical relevance in numerous applications including autoimmune disease therapies and organ transplantation tolerance protocols. Pre-existing anti-DT antibodies acquired either by vaccination against diphtheria toxin or infections with C. diphtheriae may interfere or inhibit the function of these anti-CD3 immunotoxins. Previously, a full-length anti-rhesus monkey CD3 immunotoxin, FN18-CRM9, was shown to be less effective at depleting circulating T cells in animals with pre-existing anti-DT antibody titers than in animals without antibodies, and subsequent doses were ineffective. In this study, the T cell depletion function of a truncated DT based recombinant anti-monkey CD3 immunotoxin, A-dmDT390-scfbDb (C207), as part of a reduced intensity conditioning regimen prior to hematopoietic cell transplantation, was compared between two groups of monkeys: those with and without pre-existing anti-diphtheria titers. T cell depletion was comparable in both groups of monkeys, and therefore appeared to be unaffected by the presence of moderate levels of pre-existing anti-diphtheria antibodies.

100 Deals associated with A-dmDT390-bisFv(National Institutes of Health)

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External Link

KEGG	Wiki	ATC	Drug Bank
-	A-dmDT390-bisFv(National Institutes of Health)	-	DB16307

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Melanoma	Phase 2	US	Angimmune LLC	01 Feb 2014
Melanoma	Phase 2	US	University of Louisville	01 Feb 2014
Cutaneous T-Cell Lymphoma	Phase 2	US	Virogen Biotechnology, Inc.	-
Graft vs Host Disease	Phase 2	US	Virogen Biotechnology, Inc.	-
Solid tumor	Phase 2	US	Virogen Biotechnology, Inc.	-
Mycosis Fungoides	Phase 1	US	Angimmune LLC	01 Jan 2008
Sezary Syndrome	Phase 1	US	Angimmune LLC	01 Jan 2008
T-Cell Leukemia	Phase 1	US	Angimmune LLC	01 Jan 2008

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT00611208 (Pubmed \| Haematologica) Manual	Not Applicable	Cutaneous T-Cell Lymphoma	30	A-dmDT390-bisFv	(mabhjspnxr) = wfqwenayou gsjpygyvby (evqmzgqkey, 18 - 57) View more	Positive	01 Jun 2015