Delving into the Latest Updates on Recombinant MAGE-3.1 antigen(NCI) with Synapse

Overview

Basic Info

Drug Type

Shared antigen vaccine, Therapeutic vaccine

Synonyms-

Target

MAGEA1

Mechanism

MAGEA1 inhibitors(Melanoma-associated antigen 1 inhibitors)

Therapeutic Areas

NeoplasmsEye DiseasesSkin and Musculoskeletal Diseases+ [1]

Active Indication-

Inactive Indication

Extranodal ExtensionMelanoma recurrentMelanoma, Cutaneous Malignant+ [3]

Originator Organization

National Cancer Institute

Active Organization-

Inactive Organization

National Cancer Institute

Drug Highest PhaseDiscontinuedPhase 2

First Approval Date-

Regulation-

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This randomized phase II trial is studying how well giving vaccine therapy together with or without recombinant interleukin-12 followed by daclizumab works in treating patients with melanoma that has spread to other places in the body. Vaccines made from peptides or antigens may help the body build an effective immune response to kill tumor cells. Recombinant interleukin-12 may kill tumor cells by stopping blood flow to the tumor and by stimulating white blood cells to kill melanoma cells. Monoclonal antibodies, such as daclizumab, may decrease the number of regulatory T cells (T cells that suppress the activation of the immmune system) and may lead to a better immune response against melanoma. It is not yet known whether vaccine therapy is more effective with interleukin-12 and daclizumab in treating melanoma.

Start Date01 Feb 2011

Sponsor / Collaborator

National Cancer Institute

NCT00085189 / CompletedPhase 2IIT

A PHASE II TRIAL OF A VACCINE COMBINING MULTIPLE CLASS I PEPTIDES WITH MONTANIDE ISA 51 OR ISA 51 VG AND CpG ADJUVANT 7909 FOR PATIENTS WITH RESECTED STAGES IIC/III AND IV MELANOMA

This pilot phase II trial studies how well giving vaccine therapy works in treating patients with stage IIC-IV melanoma. Vaccines made from melanoma peptides or antigens may help the body build an effective immune response to kill tumor cells

Start Date01 May 2004

Sponsor / Collaborator

University of Southern California

[+1]

NCT00003792 / CompletedPhase 1IIT

Dendritic Cell Immunotherapy of Metastatic Melanoma - A Phase I Trial

RATIONALE: Vaccines made from a person's white blood cells and melanoma cells may make the body build an immune response and kill tumor cells.
PURPOSE: Phase I trial to study the effectiveness of vaccine therapy in treating patients who have metastatic melanoma.

Start Date01 Apr 1999

Sponsor / Collaborator

Baylor Health Care System (Texas)

[+1]

100 Clinical Results associated with Recombinant MAGE-3.1 antigen(NCI)

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100 Translational Medicine associated with Recombinant MAGE-3.1 antigen(NCI)

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100 Patents (Medical) associated with Recombinant MAGE-3.1 antigen(NCI)

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5

Literatures (Medical) associated with Recombinant MAGE-3.1 antigen(NCI)

01 Jan 2006·The Korean Journal of ParasitologyQ4 · MEDICINE

Usefulness of the recombinant liver stage antigen-3 for an early serodiagnosis of Plasmodium falciparum infection

Q4 · MEDICINE

Article

Author: Chung, Kyung-Suk ; Moon, Sung-Ung ; Na, Byoung-Kuk ; Kong, Yoon ; Chung, Gyung-Tae ; Lee, Hyeong-Woo ; Ryu, Hye-Sun ; Kim, Tong-Soo ; Lin, Khin ; Kim, Yeon-Joo ; Cho, Shin-Hyeong

In order to develop tools for an early serodiagnosis of Plasmodium falciparum infection, we evaluated the usefulness of P. falciparum liver stage antigen-3 (LSA-3) as a serodiagnostic antigen. A portion of LSA-3 gene was cloned, and its recombinant protein (rLSA-3) was expressed in Escherichia coli and purified by column chromatography. The purified rLSA-3 and 120 test blood/serum samples collected from inhabitants in malaria-endemic areas of Mandalay, Myanmar were used for this study. In microscopic examinations of blood samples, P. falciparum positive rate was 39.1% (47/120) in thin smear trials, and 33.3% (40/120) in thick smear trials. Although the positive rate associated with the rLSA-3 (30.8%) was lower than that of the blood stage antigens (70.8%), rLSA-3 based enzyme-linked immunosorbent assay could detect 12 seropositive cases (10.0%), in which blood stage antigens were not detected. These results indicate that the LSA-3 is a useful antigen for an early serodiagnosis of P. falciparum infection.

20 Nov 2005·International Journal of CancerQ1 · MEDICINE

Phase 1/2 study of subcutaneous and intradermal immunization with a recombinant MAGE-3 protein in patients with detectable metastatic melanoma

Q1 · MEDICINE

Article

Author: Wim H.J. Kruit ; Marie-Françoise Avril ; Brigitte Dréno ; Poulam Patel ; Vincent G. Brichard ; Heidi H. van Ojik ; Sophie Piperno ; Pierre van der Bruggen ; Thierry Dorval ; Thierry Boon ; Marie Marchand ; Francis Brasseur ; Marguerite Stas ; Alexander M.M. Eggermont ; Bernard Lethé ; Amir Khammari ; Yi Zhang ; Gerd Ritter ; Nicolas van Baren ; Danièle Godelaine ; Bernard Escudier

The purpose of this phase 1/2 study was to evaluate toxicity, tumor evolution and immunologic response following administration of a fixed dose of a recombinant MAGE-3 protein by subcutaneous and intradermal routes in the absence of immunologic adjuvant. Thirty-two patients with detectable metastatic melanoma expressing gene MAGE-3 were included and 30 received at least one injection with a fixed dose of a ProtD-MAGE-3 fusion protein. The immunization schedule included 6 intradermal and subcutaneous injections at 3-week intervals. Afterward, patients without major tumor progression who required other treatments received additional vaccinations at increasing time intervals. The vaccine was generally well tolerated. Among the 26 patients who received at least 4 vaccinations, we observed 1 partial response and 4 mixed responses. For these 5 responding patients, time to progression varied from 3.5 to 51+ months. An anti-MAGE-3 CD4 T-lymphocyte response was detected in 1 out of the 5 responding patients. The majority of patients had no anti-MAGE-3 antibody response. The clinical and immunologic responses generated by the vaccine are rather limited. Nevertheless, given the potential antitumor efficacy and the very mild toxicity of vaccinations, further studies combining MAGE proteins and/or peptides with potent immunologic adjuvants are warranted, not only in metastatic melanoma, but also in the adjuvant setting.

01 Jan 2004·Journal of ImmunotherapyQ4 · MEDICINE

Immunologic Analysis of a Phase I/II Study of Vaccination with MAGE-3 Protein Combined with the AS02B Adjuvant in Patients with MAGE-3-Positive Tumors

Q4 · MEDICINE

Article

Author: Marchand, Marie ; Keilholz, Ulrich ; Delire, Marcel ; Dantinne, Christine ; Lamers, Cor H. J. ; Permanne, Philippe ; Gheysen, Dirk ; Gueguen, Maryse ; Amrani, Noreddine ; Bruck, Claudine ; Britten, Cedrik M. ; Stoter, Gerrit ; Vantomme, Valerie

In a phase I/II study, patients with solid metastatic MAGE-3-positive tumors, mainly melanoma, were vaccinated with recombinant MAGE-3 protein combined with the immunologic adjuvant AS02B comprised of MPL and QS21 in an oil-in-water emulsion. The recombinant MAGE-3 protein was made up of a partial sequence of the protein D (ProtD) antigen of Haemophilus influenzae fused to the MAGE-3 sequence. The vaccine was given intramuscularly at 3-week intervals. Patients whose tumors stabilized or regressed after 4 vaccinations received 2 additional vaccinations at 6-week intervals. MAGE-3 and ProtD antibody and cellular immune responses were monitored after vaccination. Ninety-six percent (23/24) of the patients vaccinated with MAGE-3 protein in AS02B adjuvant elicited a significant anti-MAGE-3 IgG antibody response after 4 vaccinations, and all developed anti-ProtD IgG antibodies. For the detection of T-cell activity, total peripheral blood mononuclear cells were restimulated in vitro with MAGE-3- or ProtD-loaded autologous mature dendritic cells. In 30% of the evaluable patients vaccinated with the adjuvanted recombinant protein, IFNgamma production was increased in response to MAGE-3, and 2 patients (14% of evaluable patients) had a concomitant increase in IL-5 production. In 37% and 43% of the patients, respectively, IFNgamma or IL-5 production was increased in response to ProtD. It is concluded that vaccination of advanced cancer patients with MAGE-3 self-antigen in AS02B adjuvant is able to elicit MAGE-3-specific antibody and a T-cell response.

100 Deals associated with Recombinant MAGE-3.1 antigen(NCI)

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Melanoma, Cutaneous Malignant	Phase 2	US	National Cancer Institute	01 Feb 2011
Extranodal Extension	Phase 2	US	National Cancer Institute	01 May 2004
Melanoma recurrent	Phase 2	US	National Cancer Institute	01 May 2004
Metastatic melanoma	Phase 2	US	National Cancer Institute	01 May 2004
Mucosal Melanoma	Phase 2	US	National Cancer Institute	01 May 2004
Uveal Melanoma	Phase 2	US	National Cancer Institute	01 May 2004

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01307618 (CTgov)	Phase 2	Melanoma, Cutaneous Malignant \| Melanoma recurrent \| Metastatic melanoma	10	Laboratory Biomarker Analysis+NA17.A2 Peptide Vaccine+Recombinant MAGE-3.1 Antigen+MART-1 Antigen (Arm I (Vaccine Therapy))	(thvdyzuvbo) = nlolltcaom wvkkajxswj (xqsfwqsmrr, cnedprusph - rhcoyesdgj) View more	-	24 Oct 2016
				Recombinant Interleukin-12+NA17.A2 Peptide Vaccine+Recombinant MAGE-3.1 Antigen (Arm II (Vaccine Therapy, IL-12))	(thvdyzuvbo) = eomsyqxwqi wvkkajxswj (xqsfwqsmrr, mvniwzwegm - tltnawtytd) View more