Delving into the Latest Updates on Renal cancer vaccine(Immatics Biotechnologies GmbH) with Synapse

Overview

Basic Info

Drug Type

Therapeutic vaccine

Synonyms

Renal cancer vaccine

Target-

Action

stimulants

Mechanism

CD4-positive T-lymphocytes stimulants, CD8-positive T-Lymphocytes stimulants

Therapeutic Areas

NeoplasmsUrogenital Diseases

Active Indication-

Inactive Indication

Advanced Renal Cell CarcinomaMetastatic Renal Cell Carcinoma

Originator Organization

Immatics Biotechnologies GmbH

Active Organization-

Inactive Organization

Immatics Biotechnologies GmbH

License Organization-

Drug Highest PhasePendingPhase 3

First Approval Date-

Regulation-

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The primary objective of the phase III study is to investigate whether IMA901 can prolong overall survival in patients with metastatic and/or locally advanced renal cell carcinoma (RCC) when added to standard first-line therapy with sunitinib.
Secondary objectives include a subgroup analysis of overall survival in patients defined by a certain biomarker signature, the investigation of progression-free survival, best tumor response, safety, and immunological parameters.

Start Date01 Dec 2010

Sponsor / Collaborator

Immatics Biotechnologies GmbH

EUCTR2008-000213-30-DE

/ Not yet recruitingNot Applicable

Extension study to evaluate long-term-safety of IMA901 plus GM-CSF in advanced renal cell carcinoma patients who achieved a decrease in tumor load or stabilization of their disease after participation in the open-label, multicenter IMA901-202 Phase 2 study

Start Date21 Apr 2008

Sponsor / Collaborator

Immatics Biotechnologies GmbH

NCT00523159

/ CompletedPhase 2

Phase 2, Randomized, Open Label, Multicenter Study of Intradermal IMA901 Plus GM-CSF With or Without Low Dose Cyclophosphamide Pre-treatment in Advanced Renal Cell Carcinoma Patients With Measurable Disease

This study was conducted in order to evaluate the efficacy and safety of the cancer vaccine IMA901 and GM-CSF as adjuvant in the treatment of advanced renal cell carcinoma.
Patients received vaccination with GM-CSF followed by IMA901 during the study period of 9 months. Patients received pre-treatment with a single i.v. infusion of cyclophosphamide prior to the first vaccination.

Start Date01 May 2007

Sponsor / Collaborator

Immatics Biotechnologies GmbH

100 Clinical Results associated with Renal cancer vaccine(Immatics Biotechnologies GmbH)

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100 Translational Medicine associated with Renal cancer vaccine(Immatics Biotechnologies GmbH)

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100 Patents (Medical) associated with Renal cancer vaccine(Immatics Biotechnologies GmbH)

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18

Literatures (Medical) associated with Renal cancer vaccine(Immatics Biotechnologies GmbH)

01 Feb 2023·International Journal of Urology

Editorial Comment to Phase I/II study of multipeptide cancer vaccine IMA901 after single‐dose cyclophosphamide in Japanese patients with advanced renal cell cancer with long‐term follow up

Communications

Author: Obara, Wataru ; Kato, Renpei

01 Feb 2023·International Journal of Urology

Phase I/II study of multipeptide cancer vaccine IMA901 after single‐dose cyclophosphamide in Japanese patients with advanced renal cell cancer with long‐term follow up

Article

Author: Tamada, Satoshi ; Hongo, Fumiya ; Miki, Tsuneharu ; Ukimura, Osamu ; Nakatani, Tatsuya ; Ueda, Takashi ; Takaha, Natsuki

AbstractBackgroundIMA901 is the first therapeutic vaccine for renal cell cancer (RCC). It contains multiple tumor‐associated peptides (TUMAPs) that are naturally present in human cancers.MethodsIn a phase I/II study, we treated a total of 10 Japanese patients with advanced RCC who were human leukocyte antigen A (HLA‐A)*02 +. Vaccination involved i.d. injection of GM‐CSF (75 μg), followed within 15–30 min by i.d. injection of IMA901 (containing 413 μg of each peptide). No treatment with either anticancer agents or immunosuppressants was allowed within 4 weeks before entering the trial. Patients were scheduled to receive 7 vaccinations during the first 5 weeks of treatment (induction period), followed by 10 further vaccinations at 3‐week intervals for up to 30 weeks (maintenance period). The primary endpoints were safety and tolerability, while the secondary endpoints were PFS, OS, and immunogenicity.ResultsThere were no treatment‐related serious adverse events or deaths during the study period. When the response was assessed after 4 months, 10% of patients showed a partial response, 80% had stable disease, and 10% had progressive disease. Among patients in whom the T‐cell response was analyzed, five patients showed a vaccine‐induced T‐cell response against at least one HLA class I‐restricted TUMAP and two patients had T‐cell responses to multiple TUMAPs. PFS was 5.5 months and OS was 18 months.ConclusionsThis study demonstrated the safety and tolerability of IMA901 vaccine in Japanese RCC patients, and also showed that vaccination elicited an immune response.

01 Jan 2022·Immunotherapy Advances

De-risking clinical trial failure through mechanistic simulation

Article

Author: Darley, Rachel ; Gaffney, Eamonn A ; Elliott, Tim ; van Hateren, Andy ; Coles, Mark C ; Brown, Liam V ; Wagg, Jonathan

AbstractDrug development typically comprises a combination of pre-clinical experimentation, clinical trials, and statistical data-driven analyses. Therapeutic failure in late-stage clinical development costs the pharmaceutical industry billions of USD per year. Clinical trial simulation represents a key derisking strategy and combining them with mechanistic models allows one to test hypotheses for mechanisms of failure and to improve trial designs. This is illustrated with a T-cell activation model, used to simulate the clinical trials of IMA901, a short-peptide cancer vaccine. Simulation results were consistent with observed outcomes and predicted that responses are limited by peptide off-rates, peptide competition for dendritic cell (DC) binding, and DC migration times. These insights were used to hypothesise alternate trial designs predicted to improve efficacy outcomes. This framework illustrates how mechanistic models can complement clinical, experimental, and data-driven studies to understand, test, and improve trial designs, and how results may differ between humans and mice.

100 Deals associated with Renal cancer vaccine(Immatics Biotechnologies GmbH)

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Metastatic Renal Cell Carcinoma	Phase 3	United Kingdom	Immatics Biotechnologies GmbH	01 Dec 2010
Metastatic Renal Cell Carcinoma	Phase 3	Netherlands	Immatics Biotechnologies GmbH	01 Dec 2010
Metastatic Renal Cell Carcinoma	Phase 3	Germany	Immatics Biotechnologies GmbH	01 Dec 2010
Metastatic Renal Cell Carcinoma	Phase 3	Italy	Immatics Biotechnologies GmbH	01 Dec 2010
Metastatic Renal Cell Carcinoma	Phase 3	France	Immatics Biotechnologies GmbH	01 Dec 2010
Metastatic Renal Cell Carcinoma	Phase 3	Russia	Immatics Biotechnologies GmbH	01 Dec 2010
Metastatic Renal Cell Carcinoma	Phase 3	Hungary	Immatics Biotechnologies GmbH	01 Dec 2010
Metastatic Renal Cell Carcinoma	Phase 3	United States	Immatics Biotechnologies GmbH	01 Dec 2010
Metastatic Renal Cell Carcinoma	Phase 3	Romania	Immatics Biotechnologies GmbH	01 Dec 2010
Metastatic Renal Cell Carcinoma	Phase 3	Poland	Immatics Biotechnologies GmbH	01 Dec 2010

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01265901 (IMPRINT, Pubmed \| Lancet Oncol) Manual	Phase 3	Renal Cell Carcinoma First line	339	sunitinib+IMA901	(hqlavafygk) = lrjhslslga jkvjbiuobh (xjetvnsghg ) View more	Non-superior	01 Nov 2016
				sunitinib	(hqlavafygk) = tjwypjmxal jkvjbiuobh (xjetvnsghg ) View more
ASCO2010	Phase 2	Advanced Renal Cell Carcinoma	68	IMA901	(fkswcmmcnb) = fttxvvosfz usvkzgzbmd (tvjargqroa )	Positive	20 May 2010
				Control peptide	(fkswcmmcnb) = ntcsnsrdsh usvkzgzbmd (tvjargqroa )
IMA901 (ASCO2007)	Phase 1	Renal Cell Carcinoma	30	IMA901	owdkhyawal(hkjrtyhijl) = erwxkfgvyx gxkmdnrmex (ltfnrwlwoi ) View more	Positive	20 Jun 2007