Delving into the Latest Updates on Rasdegafusp alfa with Synapse

Overview

Basic Info

Drug Type

Monoclonal antibody

Synonyms

DEC-205/NY-ESO-1 vaccine

Target

NY-ESO-1

Mechanism

NY-ESO-1 inhibitors(Cancer/testis antigen 1 inhibitors)

Therapeutic Areas

NeoplasmsDigestive System DisordersEndocrinology and Metabolic Disease+ [1]

Active Indication

Platinum-Resistant Fallopian Tube CarcinomaPlatinum-Resistant Ovarian CarcinomaPlatinum-Resistant Primary Peritoneal Carcinoma+ [2]

Inactive Indication

Acute Myeloid LeukemiaAnemia, RefractoryChronic Myelomonocytic Leukemia+ [1]

Originator Organization

Ludwig Institute for Cancer Research Ltd.

Active Organization

National Cancer Institute

Inactive Organization

Celldex Therapeutics, Inc.

Incyte Corp.

Drug Highest PhasePhase 1/2

First Approval Date-

Regulation-

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Gene Sequence

Sequence Code 616714522H

Source: *****

Sequence Code 315622825L

Source: *****

This phase I trial studies the side effects of DEC-205/NY-ESO-1 fusion protein CDX-1401, poly ICLC, decitabine, and nivolumab in treating patients with myelodysplastic syndrome or acute myeloid leukemia. DEC-205/NY-ESO-1 fusion protein CDX-1401 is a vaccine that may help the immune system specifically target and kill cancer cells. Poly ICLC may help stimulate the immune system in different ways and stop cancer cells from growing. Drugs used in chemotherapy, such as decitabine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as nivolumab, may interfere with the ability of cancer cells to grow and spread. Giving DEC-205/NY-ESO-1 fusion protein CDX-1401, poly ICLC, decitabine, and nivolumab may work better in treating patients with myelodysplastic syndrome or acute myeloid leukemia.

Start Date27 Mar 2018

Sponsor / Collaborator

Roswell Park Comprehensive Cancer Center

[+1]

NCT03206047 / Active, not recruitingPhase 1/2IIT

A Randomized Phase 2 Trial of Atezolizumab (MPDL3280A), SGI-110 and CDX-1401 Vaccine in Recurrent Ovarian Cancer

This randomized phase I/IIb trial studies side effects and best dose of atezolizumab when given together with guadecitabine and CDX-1401 vaccine and to see how well they work in treating patients with ovarian, fallopian tube, or primary peritoneal cancer that has come back. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. CDX-1401 vaccine may enhance the expression of the genes encoding tumor antigens on the surface of tumor cells and enhance the activity of tumor-killing T cells against those tumor cells. Vaccines made from monoclonal antibodies combined with tumor cells may help the body build an effective immune response to kill tumor cells. Giving atezolizumab, guadecitabine, and CDX-1401 vaccine may work better than CDX-1401 alone in treating patients with ovarian, fallopian tube, or primary peritoneal cancer.

Start Date08 Nov 2017

Sponsor / Collaborator

National Cancer Institute

NCT02661100 / WithdrawnPhase 1/2IIT

A Phase I/II Trial of CDX-1401 (a Vaccine Consisting of a Human Monoclonal Antibody Specific for DEC-205, Fused to Full-length Tumor Antigen NY-ESO-1) in Combination With Poly-ICLC and Pembrolizumab, in Previously Treated Advanced Solid Tumor Patients

This study will look at the safety of the combination of three drugs (CDX-1401, Poly-ICL, and Pembrolizumab) and its effect on decreasing tumors. Pembrolizumab is an experimental cancer drug. CDX-1401 is a tumor specific antigen and Poly-ICL is a Toll-like receptor agonist tumor specific antigens which when combined with Pembrolizumab may increase the tumor response to this drug.

Start Date01 Jan 2017

Sponsor / Collaborator

The Case Comprehensive Cancer Center

100 Clinical Results associated with Rasdegafusp alfa

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100 Translational Medicine associated with Rasdegafusp alfa

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100 Patents (Medical) associated with Rasdegafusp alfa

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3

Literatures (Medical) associated with Rasdegafusp alfa

01 Mar 2018·Clinical Cancer ResearchQ1 · MEDICINE

NY-ESO-1 Vaccination in Combination with Decitabine Induces Antigen-Specific T-lymphocyte Responses in Patients with Myelodysplastic Syndrome

Q1 · MEDICINE

Article

Author: Martens, Brandon L. ; Srivastava, Pragya ; Miller, Austin ; Paluch, Benjamin E. ; Kocent, Justin ; Odunsi, Kunle ; Lutgen-Dunckley, Linda G. ; Nemeth, Michael J. ; Brumberger, Zachary ; Wong, Hong Yuen ; Karpf, Adam R. ; Roloff, Gregory W. ; Wang, Eunice S. ; Hourigan, Christopher S. ; Griffiths, Elizabeth A. ; Matsuzaki, Junko

AbstractPurpose: Treatment options are limited for patients with high-risk myelodysplastic syndrome (MDS). The azanucleosides, azacitidine and decitabine, are first-line therapy for MDS that induce promoter demethylation and gene expression of the highly immunogenic tumor antigen NY-ESO-1. We demonstrated that patients with acute myeloid leukemia (AML) receiving decitabine exhibit induction of NY-ESO-1 expression in circulating blasts. We hypothesized that vaccinating against NY-ESO-1 in patients with MDS receiving decitabine would capitalize upon induced NY-ESO-1 expression in malignant myeloid cells to provoke an NY-ESO-1–specific MDS-directed cytotoxic T-cell immune response.Experimental Design: In a phase I study, 9 patients with MDS received an HLA-unrestricted NY-ESO-1 vaccine (CDX-1401 + poly-ICLC) in a nonoverlapping schedule every four weeks with standard-dose decitabine.Results: Analysis of samples serially obtained from the 7 patients who reached the end of the study demonstrated induction of NY-ESO-1 expression in 7 of 7 patients and NY-ESO-1–specific CD4+ and CD8+ T-lymphocyte responses in 6 of 7 and 4 of 7 of the vaccinated patients, respectively. Myeloid cells expressing NY-ESO-1, isolated from a patient at different time points during decitabine therapy, were capable of activating a cytotoxic response from autologous NY-ESO-1–specific T lymphocytes. Vaccine responses were associated with a detectable population of CD141Hi conventional dendritic cells, which are critical for the uptake of NY-ESO-1 vaccine and have a recognized role in antitumor immune responses.Conclusions: These data indicate that vaccination against induced NY-ESO-1 expression can produce an antigen-specific immune response in a relatively nonimmunogenic myeloid cancer and highlight the potential for induced antigen-directed immunotherapy in a group of patients with limited options. Clin Cancer Res; 24(5); 1019–29. ©2017 AACR.See related commentary by Fuchs, p. 991

01 Jul 2014·Cancer DiscoveryQ1 · MEDICINE

Cancer Vaccine Shows Benefit in Solid Tumors

Q1 · MEDICINE

Article

AbstractIn a phase I clinical trial, the cancer vaccine CDX-1401 was well tolerated in 45 patients with solid tumors and produced some immune responses.

01 Dec 2012·Human vaccines & immunotherapeutics

CDX-1401 combined with TLR agonist: positive phase 1 results.

Author: Riedmann, Eva M

100 Deals associated with Rasdegafusp alfa

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External Link

KEGG	Wiki	ATC	Drug Bank
-	-	-	DB15185

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Ovarian Cancer	Phase 3	US	Incyte Corp.	10 Oct 2014
Platinum-Resistant Fallopian Tube Carcinoma	Phase 2	US	National Cancer Institute	08 Nov 2017
Platinum-Resistant Primary Peritoneal Carcinoma	Phase 2	US	National Cancer Institute	08 Nov 2017
Recurrent ovarian cancer	Phase 2	US	National Cancer Institute	08 Nov 2017
Recurrent Primary Peritoneal Carcinoma	Phase 2	US	National Cancer Institute	08 Nov 2017
Fallopian Tube Carcinoma	Phase 2	US	Celldex Therapeutics, Inc.	10 Oct 2014
Fallopian Tube Carcinoma	Phase 2	US	Incyte Corp.	10 Oct 2014
Ovarian Cancer	Phase 2	US	Celldex Therapeutics, Inc.	10 Oct 2014
Primary peritoneal carcinoma	Phase 2	US	Celldex Therapeutics, Inc.	10 Oct 2014
Primary peritoneal carcinoma	IND Application	US	Incyte Corp.	10 Oct 2014

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02166905 (CTgov)	Phase 1/2	Ovarian Cancer \| Primary peritoneal carcinoma \| Fallopian Tube Carcinoma	40	Poly ICLC+INCB024360+CDX-1401 (Phase I (CDX-1401, Poly ICLC, and a Fixed Daily Dose of INCB024360 ))	cddltwuspu(izkpcxbbmy) = qckyfplvcn dlyzjwpgdu (jkbtimytkc, slpxjsvokr - uvgaeghmrx) View more	-	24 Feb 2023
				Poly ICLC+CDX-1401 (Phase IIb arm1 (CDX-1401, Poly ICLC, IDO1 Without Inhibitor INCB024360))	vpjcwphvkn(ysrrobcgke) = davcbpcwmy hliuygordh (hknughscbe, vegelamwbu - okxmrdzlhl)
NCT02129075 (CDX-1401, CTgov)	Phase 2	Mucosal Melanoma \| Melanoma, Cutaneous Malignant \| Malignant melanoma of eye \| Unknown Primary Neoplasms	60	Poly-ICLC+CDX-301+CDX-1401 (Arm I (CDX-301, CDX-1401, and Poly-ICLC))	dlirasunnl(ohohdihdng) = abggjpgxor ibkfozwuwa (bebozfiiem, lqsfykdkyu - istgyklarx) View more	-	16 Nov 2021
				Poly-ICLC+CDX-1401 (Arm II (CDX-1401 and Poly-ICLC))	dlirasunnl(ohohdihdng) = yhsikpuglb ibkfozwuwa (bebozfiiem, gxeygxoqrw - lbyqhbtzed) View more
NCT00948961 (Pubmed \| Sci Transl Med) Manual	Phase 1/2	Neoplasms	45	CDX-1401	(lpyxfvjfrn) = bfepqawrzw fwzxmkoxxd (rhdxgudqhn ) View more	Positive	16 Apr 2014