Delving into the Latest Updates on Rocapuldencel-T with Synapse

Overview

Basic Info

Drug Type

Therapeutic vaccine, Dendritic cell vaccine

Synonyms

Target

CD40L

Action

stimulants

Mechanism

CD40L stimulants(CD40 ligand stimulants)

Therapeutic Areas

NeoplasmsUrogenital DiseasesRespiratory Diseases

Active Indication-

Inactive Indication

Advanced Renal Cell CarcinomaMetastatic Renal Cell CarcinomaNon-Small Cell Lung Cancer

Originator Organization

Argos Therapeutics, Inc.

Active Organization-

Inactive Organization

Argos Therapeutics, Inc.GU Research Network, LLC

Drug Highest PhaseDiscontinuedPhase 3

First Approval Date-

Regulation-

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This is a trial of AGS-003, which is being studied as a possible treatment for Advanced Renal Cell Carcinoma. The purpose of this study is to determine whether there is an overall survival (OS) benefit between subjects treated with AGS-003 in combination with standard treatment versus subjects treated with standard treatment alone.

Start Date01 Nov 2012

Sponsor / Collaborator

Argos Therapeutics, Inc.

NCT01482949

/ TerminatedPhase 2

A Rollover Phase II Study Testing the Biologic Activity and Safety of AGS-003 in Renal Cell Carcinoma Subjects With Prolonged Response or Stable Disease and Ongoing AGS-003 Treatment in Protocol AGS-003-004 or AGS-003-006

The purpose of this study is to evaluate clinical response to AGS-003 alone or in combination with sunitinib therapy.

Start Date01 Sep 2011

Sponsor / Collaborator

Argos Therapeutics, Inc.

100 Clinical Results associated with Rocapuldencel-T

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100 Translational Medicine associated with Rocapuldencel-T

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100 Patents (Medical) associated with Rocapuldencel-T

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13

Literatures (Medical) associated with Rocapuldencel-T

01 Aug 2023·Human Vaccines & Immunotherapeutics

A review of the clinical experience with CMN-001, a tumor RNA loaded dendritic cell immunotherapy for the treatment of metastatic renal cell carcinoma

Review

Author: Horvatinovich, Joe ; DeBenedette, Mark ; Gamble, Alicia ; Nicolette, Charles A ; Norris, Marcus

Engineering dendritic cells (DCs) to treat cancer is a long sought-after goal for cell-based immunotherapies. In this review, we focus on the experience with CMN-001, formally AGS-003, a DC-based immunotherapy, employing autologous DC electroporated with autologous tumor RNA to treat subjects with metastatic renal cell carcinoma (mRCC). We will review the early clinical development of CMN-001 up to and including deployment in a multicenter phase 3 study and provide a rationale to continue the development of CMN-001 in an ongoing randomized phase 2 study. The synergy between CMN-001 and everolimus observed in the phase 3 study provides an opportunity to design a phase 2b study building on the mechanism of action of CMN-001 and underlying immune and clinical outcomes revealed in the earlier studies. The design of the phase 2b study combines CMN-001 with first-line checkpoint inhibition therapy and second line lenvatinib/everolimus in poor-risk mRCC subjects.

15 May 2020·Clinical Cancer ResearchQ1 · MEDICINE

Results of the ADAPT Phase 3 Study of Rocapuldencel-T in Combination with Sunitinib as First-Line Therapy in Patients with Metastatic Renal Cell Carcinoma

Q1 · MEDICINE

Article

Author: Bratslavsky, Gennady ; Plachco, Ana ; Vaena, Daniel ; Norris, Marcus S. ; Master, Viraj ; Wood, Christopher G. ; Kapoor, Anil ; Nicolette, Charles A. ; Figlin, Robert A. ; Tannir, Nizar M. ; Chen, David Y.T. ; DeBenedette, Mark ; Tcherepanova, Irina Y. ; Lowrance, William ; Horvatinovich, Joe ; Uzzo, Robert G. ; Gamble, Alicia ; Tykodi, Scott S.

AbstractPurpose:Rocapuldencel-T is an autologous immunotherapy prepared from mature monocyte-derived dendritic cells (DC), coelectroporated with amplified tumor RNA plus CD40L RNA. This pivotal phase III trial was initiated to investigate the safety and efficacy of a combination therapy dosing regimen of Rocapuldencel-T plus sunitinib in patients with metastatic renal cell carcinoma (mRCC).Patients and Methods:Patients received either Rocapuldencel-T plus standard of care (SOC) or SOC treatment alone. The primary objective compared overall survival (OS) between groups. Secondary objectives included safety assessments, progression-free survival (PFS), and tumor responses based on RECIST 1.1 criteria. Exploratory analyses included immunologic assessments and correlates with OS.Results:Between 2013 and 2016, 462 patients were randomized 2:1, 307 to the combination group and 155 to the SOC group. Median OS in the combination group was 27.7 months [95% confidence interval (CI) 23.0–35.9] and 32.4 months (95% CI, 22.5–) in the SOC group HR of 1.10 (95% CI, 0.83–1.40). PFS was 6.0 months and 7.83 months for the combination and SOC groups, respectively [HR = 1.15 (95% CI, 0.92–1.44)]. The ORR was 42.7% (95% CI, 37.1–48.4) for the combination group and 39.4% (95% CI, 31.6–47.5) for the SOC group. Median follow up was 29 months (0.4–47.7 months). On the basis of the lack of clinical efficacy, the ADAPT trial was terminated on February 17, 2017. Immune responses were detected in 70% of patients treated with Rocapuldencel-T, and the magnitude of the immune response positively correlated with OS. In addition, we report the survival-predictive value of measuring IL-12 produced by the DC vaccine and the observation that high baseline numbers of T regulatory cells are associated with improved outcomes in DC-treated patients, but are associated with poor outcomes in patients receiving SOC treatment. No serious adverse events attributed to the study medication have been reported to date.Conclusions:Rocapuldencel-T did not improve OS in patients treated with combination therapy, although the induced immune response correlated with OS. Moreover, we identified two potential survival-predictive biomarkers for patients receiving DC based immunotherapy, IL-12 produced by the DC vaccine and higher numbers of T regulatory cells present in the peripheral blood of patients with advanced RCC.

06 Jun 2017·Magyar onkologia

[Immunotherapy of renal cell cancer].

Review

Author: Nagyiványi, Krisztián ; Géczi, Lajos ; Maráz, Anikó

The authors briefly highlight the results of targeted therapy and present new solutions in kidney cancer immunotherapy. The important checkpoint inhibitors (anti-CTLA-4, -PD-1 and -PD-L1/2) and their combinations, together with the combinations of targeted drugs and immunotherapy are discussed. The newest checkpoint agents, vaccination and pegylated interleukin-2 are also presented. The most promising clinical trials (CheckMate-025, AGS-003, IMA 901) and the on-going first line phase III trials are shown in metastatic clear cell renal carcinoma.

100 Deals associated with Rocapuldencel-T

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Advanced Renal Cell Carcinoma	Phase 3	Italy	Argos Therapeutics, Inc.	01 Nov 2012
Advanced Renal Cell Carcinoma	Phase 3	Czechia	Argos Therapeutics, Inc.	01 Nov 2012
Metastatic Renal Cell Carcinoma	Phase 3	Italy	Argos Therapeutics, Inc.	01 Nov 2012
Metastatic Renal Cell Carcinoma	Phase 3	United States	Argos Therapeutics, Inc.	01 Nov 2012
Metastatic Renal Cell Carcinoma	Phase 3	United Kingdom	Argos Therapeutics, Inc.	01 Nov 2012
Metastatic Renal Cell Carcinoma	Phase 3	Czechia	Argos Therapeutics, Inc.	01 Nov 2012
Metastatic Renal Cell Carcinoma	Phase 3	Canada	Argos Therapeutics, Inc.	01 Nov 2012
Metastatic Renal Cell Carcinoma	Phase 3	Spain	Argos Therapeutics, Inc.	01 Nov 2012
Metastatic Renal Cell Carcinoma	Phase 3	Hungary	Argos Therapeutics, Inc.	01 Nov 2012
Metastatic Renal Cell Carcinoma	Phase 3	Israel	Argos Therapeutics, Inc.	01 Nov 2012

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01582672 (ADAPT, ASCO2018)	Phase 3	Metastatic Renal Cell Carcinoma \| Advanced Renal Cell Carcinoma	462	Rocapuldencel-T + sunitinib	(dadlutxrat) = cjfynbddno zlccjrgqgj (tlxusxbcrm )	-	01 Jun 2018
NCT01582672 (ADAPT, ASCO2018)	Phase 3		462	Standard-of-care + sunitinib	(dadlutxrat) = ohsrszaxiv zlccjrgqgj (tlxusxbcrm )	-	01 Jun 2018
NCT01582672 (ADAPT Trial, SITC2017)	Phase 3	Metastatic Renal Cell Carcinoma CD28+/CD45RA- \| IL-12	146	Rocapuldencel-T + standard-of-care (SOC)	ajhgqujnpd(lipwcfmauu) = oflsqrujif nyjqokjzfc (zzwguuwnxs )	Positive	07 Nov 2017
NCT01582672 (ADAPT Trial, SITC2017)	Phase 3	Metastatic Renal Cell Carcinoma CD28+/CD45RA- \| IL-12	146	Standard-of-care (SOC) alone	ajhgqujnpd(lipwcfmauu) = vndyreptuk nyjqokjzfc (zzwguuwnxs )	Positive	07 Nov 2017
NCT01582672 (ADAPT, SITC2016)	Phase 3	-	-	AGS-003	cgxkrdnvvr(opsxsgypyz) = htvmawtaax rufbibnrse (wzrwvwlqvm )	Positive	16 Nov 2016
NCT01582672 (ADAPT, SITC2016)	Phase 3	-	-	PD-1 checkpoint inhibitor	cgxkrdnvvr(opsxsgypyz) = wrwjwmadyl rufbibnrse (wzrwvwlqvm )	Positive	16 Nov 2016
NCT00678119 (Pubmed \| J Immunother Cancer) Manual	Phase 2	Advanced Renal Cell Carcinoma	21	sunitinib+AGS-003	(hwqswymcrd) = upxijbwcoy nxhhrtpqom (jltjrjhwmi ) View more	Positive	21 Apr 2015
NCT00678119 (ASCO_GU2013)	Phase 2	Metastatic Renal Cell Carcinoma	21	AGS-003 plus sunitinib	(hosvweuhgn) = nxsyjysucs xytzuzxxio (ucxgxklfzq ) View more	-	20 Feb 2013
AGS-003-006 (ASCO_GU2012)	Phase 2	Metastatic Renal Cell Carcinoma	25	AGS-003	(znomrekwyx) = yehmlcbxmd xjnhyxlbkc (shbdshppaf ) View more	-	10 Feb 2012