Delving into the Latest Updates on Vx-001 with Synapse

Overview

Basic Info

Drug Type

Therapeutic vaccine

Synonyms

Human telomerase reverse transcriptase 572Y

+ [2]

Target

TERT

Action

inhibitors

Mechanism

TERT inhibitors(Telomerase reverse transcriptase inhibitors)

Therapeutic Areas

NeoplasmsRespiratory Diseases

Active Indication-

Inactive Indication

metastatic non-small cell lung cancer

Originator Organization

VAXON Biotech SA

Active Organization-

Inactive Organization

VAXON Biotech SA

License Organization-

Drug Highest PhasePendingPhase 2

First Approval Date-

Regulation-

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Structure/Sequence

Sequence Code 73162

Patients with stage IV or recurrent stage I-III NSCLC with documented disease control (objective response or stable disease) within 3 weeks after platinum based 1st line chemotherapy; only HLA-A*0201 positive patients with TERT expressing tumors will be included.
The objective of the trial is survival rate at 12 months.

Start Date01 Aug 2012

Sponsor / Collaborator

VAXON Biotech SA

EUCTR2006-005032-25-GR

/ Unknown statusNot Applicable

A multi-centre phase II controlled study of Vx-001 in Non Small Cell Lung Cancer (NSCLC)

Start Date08 May 2007

Sponsor / Collaborator

VAXON Biotech SA

100 Clinical Results associated with Vx-001

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100 Translational Medicine associated with Vx-001

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100 Patents (Medical) associated with Vx-001

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10

Literatures (Medical) associated with Vx-001

12 May 2020·British Journal of CancerQ1 · MEDICINE

Clinical activity of a htert (vx-001) cancer vaccine as post-chemotherapy maintenance immunotherapy in patients with stage IV non-small cell lung cancer: final results of a randomised phase 2 clinical trial

Q1 · MEDICINE

Article

Author: Vetsika, Eleni- Kyriaki ; Georgoulias, Vassilis ; Kentepozidis, Nikolaos ; Kosmatopoulos, Kostas ; Gridelli, Cesare ; Correale, Pierpaolo ; Kazarnowisz, Andrzej ; Majem, Margarita ; Domine, Manuel ; Jamet, Jeanne- Menez ; Gallou, Catherine ; de Las Penas, Ramon ; Zarogoulidis, Konstantinos ; Griesinger, Frank ; Sadjadian, Parvis ; Chella, Antonio ; Szczesna, Aleksandra ; Cobo, Manuel ; Korozan, Magdalena ; Bover, Isabel ; Bournakis, Evangelos ; Syrigos, Kostantinos N ; Kalofonos, Charalabos ; Ciuleanu, Tudor ; Chinet, Thierry ; Kotsakis, Athanasios

AbstractBackgroundThe cancer vaccine Vx-001, which targets the universal tumour antigen TElomerase Reverse Transcriptase (TERT), can mount specific Vx-001/TERT572 CD8 + cytotoxic T cells; this immune response is associated with improved overall survival (OS) in patients with advanced/metastatic non-small cell lung cancer (NSCLC).MethodsA randomised, double blind, phase 2b trial, in HLA-A*201-positive patients with metastatic, TERT-expressing NSCLC, who did not progress after first-line platinum-based chemotherapy were randomised to receive either Vx-001 or placebo. The primary endpoint of the trial was OS.ResultsTwo hundred and twenty-one patients were randomised and 190 (101 and 89 patients in the placebo and the Vx-001 arm, respectively) were analysed for efficacy. There was not treatment-related toxicity >grade 2. The study did not meet its primary endpoint (median OS 11.3 and 14.3 months for the placebo and the Vx-001, respectively; p = 0.86) whereas the median Time to Treatment Failure (TTF) was 3.5 and 3.6 months, respectively. Disease control for >6months was observed in 30 (33.7%) and 26 (25.7%) patients treated with Vx-001 and placebo, respectively. There was no documented objective CR or PR. Long lasting TERT-specific immune response was observed in 29.2% of vaccinated patients who experienced a significantly longer OS compared to non-responders (21.3 and 13.4 months, respectively; p = 0.004).ConclusionVx-001 could induce specific CD8+ immune response but failed to meet its primary endpoint. Subsequent studies have to be focused on the identification and treatment of subgroups of patients able to mount an effective immunological response to Vx-001.Clinical trial registrationNCT01935154

13 Apr 2020·Current Topics in Medicinal ChemistryQ4 · MEDICINE

Telomerase-based Cancer Therapeutics: A Review on their Clinical Trials

Q4 · MEDICINE

Review

Author: Gemma, Sandra ; Brogi, Simone ; Brindisi, Margherita ; Zisterer, Daniela ; Khan, Tuhina ; Butini, Stefania ; Saraswati, Akella P. ; Campiani, Giuseppe ; Federico, Stefano ; Relitti, Nicola

Telomeres are protective chromosomal ends that shield the chromosomes from DNA damage, exonucleolytic degradation, recombination, and end-to-end fusion. Telomerase is a ribonucleoprotein that adds TTAGGG tandem repeats to the telomeric ends. It has been observed that 85 to 90% of human tumors express high levels of telomerase, playing a crucial role in the development of cancers. Interestingly, the telomerase activity is generally absent in normal somatic cells. This selective telomerase expression has driven scientists to develop novel anti-cancer therapeutics with high specificity and potency. Several advancements have been made in this area, which is reflected by the enormous success of the anticancer agent Imetelstat. Since the discovery of Imetelstat, several research groups have contributed to enrich the therapeutic arsenal against cancer. Such contributions include the application of new classes of small molecules, peptides, and hTERT-based immunotherapeutic agents (p540, GV1001, GRNVAC1 or combinations of these such as Vx-001). Many of these therapeutic tools are under different stages of clinical trials and have shown promising outcomes. In this review, we highlight the current status of telomerase-based cancer therapeutics and the outcome of these investigations.

01 Jul 2016·Annals of Translational MedicineQ4 · MEDICINE

Optimized tumor cryptic peptides: the basis for universal neo-antigen-like tumor vaccines

Q4 · MEDICINE

Review

Author: Kosmatopoulos, Kostas ; Gallou, Catherine ; Menez-Jamet, Jeanne ; Rougeot, Aude

The very impressive clinical results recently obtained in cancer patients treated with immune response checkpoint inhibitors boosted the interest in immunotherapy as a therapeutic choice in cancer treatment. However, these inhibitors require a pre-existing tumor specific immune response and the presence of tumor infiltrating T cells to be efficient. This immune response can be triggered by cancer vaccines. One of the main issues in tumor vaccination is the choice of the right antigen to target. All vaccines tested to date targeted tumor associated antigens (TAA) that are self-antigens and failed to show a clinical efficacy because of the immune self-tolerance to TAA. A new class of tumor antigens has recently been described, the neo-antigens that are created by point mutations of tumor expressing proteins and are recognized by the immune system as non-self. Neo-antigens exhibit two main properties: they are not involved in the immune self-tolerance process and are immunogenic. However, the majority of the neo-antigens are patient specific and their use as cancer vaccines requires their previous identification in each patient individualy that can be done only in highly specialized research centers. It is therefore evident that neo-antigens cannot be used for patient vaccination worldwide. This raises the question of whether we can find neo-antigen like vaccines, which would not be patient specific. In this review we show that optimized cryptic peptides from TAA are neo-antigen like peptides. Optimized cryptic peptides are recognized by the immune system as non-self because they target self-cryptic peptides that escape self-tolerance; in addition they are strongly immunogenic because their sequence is modified in order to enhance their affinity for the HLA molecule. The first vaccine based on the optimized cryptic peptide approach, Vx-001, which targets the widely expressed tumor antigen telomerase reverse transcriptase (TERT), has completed a large phase I clinical study and is currently being tested in a randomized phase II trial in non-small cell lung cancer (NSCLC) patients.

100 Deals associated with Vx-001

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
metastatic non-small cell lung cancer	Phase 2	Italy	VAXON Biotech SA	01 Aug 2012
metastatic non-small cell lung cancer	Phase 2	Czechia	VAXON Biotech SA	01 Aug 2012
metastatic non-small cell lung cancer	Phase 2	Germany	VAXON Biotech SA	01 Aug 2012
metastatic non-small cell lung cancer	Phase 2	Poland	VAXON Biotech SA	01 Aug 2012
metastatic non-small cell lung cancer	Phase 2	Romania	VAXON Biotech SA	01 Aug 2012
metastatic non-small cell lung cancer	Phase 2	France	VAXON Biotech SA	01 Aug 2012
metastatic non-small cell lung cancer	Phase 2	Greece	VAXON Biotech SA	01 Aug 2012
metastatic non-small cell lung cancer	Phase 2	Spain	VAXON Biotech SA	01 Aug 2012

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ASCO2008	Phase 1/2	HR-positive/HER2-low Solid Tumors	71	Vx-001	(yuvkqogvnx) = xdokoctqgr ljnmnrgupj (dwygrlmksq )	-	20 May 2008
ASCO2007	Not Applicable	Advanced Lung Non-Small Cell Carcinoma	22	Vx-001	(lvqnjiwbbx) = ofxakphqes ttdeesfesz (ucqvjfruit ) View more	Positive	20 Jun 2007