Delving into the Latest Updates on MART-1 antigen(NCI) with Synapse

Overview

Basic Info

Drug Type

Therapeutic vaccine

Synonyms-

Target

melan-A

Mechanism

melan-A inhibitors(Melanoma antigen recognized by T-cells 1 inhibitors)

Therapeutic Areas

NeoplasmsEye DiseasesSkin and Musculoskeletal Diseases+ [1]

Active Indication-

Inactive Indication

Malignant melanoma stage IVMelanoma recurrentMelanoma, Cutaneous Malignant+ [2]

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 pilot clinical trial studies melanoma antigen recognized by T-cells 1 (MART-1) antigen with or without toll-like receptor 4 (TLR4) agonist glucopyranosyl lipid A-stable oil-in-water emulsion (GLA-SE) in treating patients with stage II-IV melanoma that has been removed by surgery. Vaccines made from MART-1a peptide or antigen may help the body build an effective immune response to kill tumor cells. Giving TLR4 agonist GLA-SE with MART-1 antigen may help increase the immune response to MART-1a antigen.

Start Date27 Jan 2015

Sponsor / Collaborator

Mayo Clinic

[+1]

NCT01748747 / CompletedEarly Phase 1IIT

Peptide Vaccine With Resiquimod as an Immune Modulator for Patients With Resected Melanoma: A Pilot Study

This pilot clinical trial studies vaccine therapy and resiquimod in treating patients with stage II-IV melanoma that has been removed by surgery. Vaccines made from peptides may help the body build an effective immune response to kill tumor cell tumor cells. Biological therapies, such as resiquimod, may stimulate the immune system in different ways and stop tumor cells from growing. It is not yet known whether Gag:267-274 peptide vaccine and resiquimod are more effective when given together or separately

Start Date01 Oct 2012

Sponsor / Collaborator

Mayo Clinic

[+1]

NCT01307618 / TerminatedPhase 2IIT

A Randomized Phase II Study of Multipeptide Vaccination With or Without IL-12, Then Combined With Regulatory T Cell Depletion Using Daclizumab in Patients With Metastatic Melanoma

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

100 Clinical Results associated with MART-1 antigen(NCI)

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100 Translational Medicine associated with MART-1 antigen(NCI)

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100 Patents (Medical) associated with MART-1 antigen(NCI)

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12

Literatures (Medical) associated with MART-1 antigen(NCI)

01 May 2021·Journal for ImmunoTherapy of CancerQ2 · MEDICINE

Randomized phase II trial of lymphodepletion plus adoptive cell transfer of tumor-infiltrating lymphocytes, with or without dendritic cell vaccination, in patients with metastatic melanoma

Q2 · MEDICINE

ArticleOA

Author: Bernatchez, Chantale ; Najjar, Amer M ; Amaria, Rodabe N ; Haymaker, Cara L ; Faria, Silvana C ; Tawbi, Hussein A ; Davies, Michael A ; Saberian, Chantal ; Patel, Sapna ; Bassett, Roland L ; Yee, Cassian ; McQuade, Jennifer L ; Glitza, Isabella C ; Wong, Michael K ; Alvarez, Enrique ; Radvanyi, Laszlo G ; Diab, Adi ; Parshottam, Sapna ; Forget, Marie-Andrée ; Shpall, Elizabeth J ; Hwu, Patrick ; Prieto, Victor ; Lizée, Gregory

BackgroundThe adoptive transfer of tumor-infiltrating lymphocytes (TIL) has demonstrated robust efficacy in metastatic melanoma patients. Tumor antigen–loaded dendritic cells (DCs) are believed to optimally activate antigen-specific T lymphocytes. We hypothesized that the combined transfer of TIL, containing a melanoma antigen recognized by T cells 1 (MART-1) specific population, with MART-1-pulsed DC will result in enhanced proliferation and prolonged survival of transferred MART-1 specific T cells in vivo ultimately leading to improved clinical responses.DesignWe tested the combination of TIL and DC in a phase II clinical trial of patients with advanced stage IV melanoma. HLA-A0201 patients whose early TIL cultures demonstrated reactivity to MART-1 peptide were randomly assigned to receive TIL alone or TIL +DC pulsed with MART-1 peptide. The primary endpoint was to evaluate the persistence of MART-1 TIL in the two arms. Secondary endpoints were to evaluate clinical response and survival.ResultsTen patients were given TIL alone while eight patients received TIL+DC vaccine. Infused MART-1 reactive CD8+ TIL were tracked in the blood over time by flow cytometry and results show good persistence in both arms, with no difference in the persistence of MART-1 between the two arms. The objective response rate was 30% (3/10) in the TIL arm and 50% (4/8) in the TIL+DC arm. All treatments were well tolerated.ConclusionsThe combination of TIL +DC showed no difference in the persistence of MART-1 TIL compared with TIL therapy alone. Although more patients showed a clinical response to TIL+DC therapy, this study was not powered to resolve differences between groups.Trial registration numberNCT00338377.

01 Dec 2014·Journal of Translational MedicineQ2 · MEDICINE

MART-1 peptide vaccination plus IMP321 (LAG-3Ig fusion protein) in patients receiving autologous PBMCs after lymphodepletion: results of a Phase I trial

Q2 · MEDICINE

ArticleOA

Author: Daniel E Speiser ; Alexandre Harari ; Pedro Romero ; Serge Leyvraz ; Verena Voelter ; Frédéric Triebel ; Athina Stravodimou ; Olivier Michielin ; Emanuela Romano ; Hélène Bichat ; Julien Laurent

BACKGROUNDImmunotherapy offers a promising novel approach for the treatment of cancer and both adoptive T-cell transfer and immune modulation lead to regression of advanced melanoma. However, the potential synergy between these two strategies remains unclear.METHODSWe investigated in 12 patients with advanced stage IV melanoma the effect of multiple MART-1 analog peptide vaccinations with (n = 6) or without (n = 6) IMP321 (LAG-3Ig fusion protein) as an adjuvant in combination with lymphodepleting chemotherapy and adoptive transfer of autologous PBMCs at day (D) 0 (Trial registration No: NCT00324623). All patients were selected on the basis of ex vivo detectable MART-1-specific CD8 T-cell responses and immunized at D0, 8, 15, 22, 28, 52, and 74 post-reinfusion.RESULTSAfter immunization, a significant expansion of MART-1-specific CD8 T cells was measured in 83% (n = 5/6) and 17% (n = 1/6) of patients from the IMP321 and control groups, respectively (P < 0.02). Compared to the control group, the mean fold increase of MART-1-specific CD8 T cells in the IMP321 group was respectively >2-, >4- and >6-fold higher at D15, D30 and D60 (P < 0.02). Long-lasting MART-1-specific CD8 T-cell responses were significantly associated with IMP321 (P < 0.02). At the peak of the response, MART-1-specific CD8 T cells contained higher proportions of effector (CCR7⁻ CD45RA⁺/⁻) cells in the IMP321 group (P < 0.02) and showed no sign of exhaustion (i.e. were mostly PD1⁻CD160⁻TIM3⁻LAG3⁻2B4⁺/⁻). Moreover, IMP321 was associated with a significantly reduced expansion of regulatory T cells (P < 0.04); consistently, we observed a negative correlation between the relative expansion of MART-1-specific CD8 T cells and of regulatory T cells. Finally, although there were no confirmed responses as per RECIST criteria, a transient, 30-day partial response was observed in a patient from the IMP321 group.CONCLUSIONSVaccination with IMP321 as an adjuvant in combination with lymphodepleting chemotherapy and adoptive transfer of autologous PBMCs induced more robust and durable cellular antitumor immune responses, supporting further development of IMP321 as an adjuvant for future immunotherapeutic strategies.

01 Sep 2013·International Journal of PharmaceuticsQ2 · MEDICINE

Long term stability of lyophilized plasmid DNA pDERMATT

Q2 · MEDICINE

Article

Author: Bastiaan Nuijen ; Jos H. Beijnen ; Iris van der Heijden

In this short note we report on the shelf-life stability of pDERMATT (plasmid DNA encoding recombinant MART-1 and tetanus toxin fragment-c) 2mg lyophilized powder for reconstitution for intradermal administration, used in an in-house, investigator-initiated clinical phase I study. pDERMATT was stored at 25°C/60% relative humidity (6 months), 2-8°C (24 months), and -20°C (66 months) in the dark and analyzed at several timepoints during the conduct of the clinical study for appearance, identity, purity (plasmid topology), content and residual water content. pDERMATT appeared stable at all storage conditions for the periods tested which, although patient inclusion in the study was significantly delayed, ensured the clinical supply needs. This study shows that lyophilization is an useful tool to preserve the quality of the pDNA and can prevent the need for costly and time-consuming additional manufacture of drug product in case of study delays, not uncommon at the early stage of drug development. To our knowledge, this is the first study reporting shelf life stability of a pDNA formulation for more than 5 years.

100 Deals associated with MART-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
Malignant melanoma stage IV	NDA/BLA	US	National Cancer Institute	01 Jun 2004
Melanoma recurrent	Phase 2	US	National Cancer Institute	01 Feb 2011
Melanoma, Cutaneous Malignant	Phase 2	US	National Cancer Institute	01 Feb 2011
Metastatic melanoma	Phase 2	US	National Cancer Institute	01 Feb 2011
Uveal Melanoma	Phase 2	US	National Cancer Institute	01 Jun 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))	(xplhgioeif) = hbiyixlbwh rhvlsnzlne (pvafmidyxb, crwtsipkbx - zwpqgbnkga) View more	-	24 Oct 2016
				Recombinant Interleukin-12+NA17.A2 Peptide Vaccine+Recombinant MAGE-3.1 Antigen (Arm II (Vaccine Therapy, IL-12))	(xplhgioeif) = gewebgpxlv rhvlsnzlne (pvafmidyxb, qdqwsfrana - ykrvikbgdk) View more