Delving into the Latest Updates on hTERT peptide-based vaccine(Invectys SA) with Synapse

Overview

Basic Info

Drug Type

Synthetic peptide vaccine, Therapeutic vaccine

Synonyms

hTERT-derived peptide vaccine, Human telomerase reverse transcriptase peptide-based vaccine, UCP2-UCP4 vaccine

+ [1]

Target

TERT

Action

modulators

Mechanism

TERT modulators(Telomerase reverse transcriptase modulators)

Therapeutic Areas

NeoplasmsNervous System DiseasesDigestive System Disorders+ [3]

Active Indication

Unresectable Hepatocellular CarcinomaGlioblastoma MultiformeGlioblastoma, IDH-Wildtype+ [6]

Inactive Indication-

Originator Organization

Invectys SAS

Active Organization

Centre Hospitalier Universitaire de BesanconInvectys SAS

Inactive Organization

Centre hospitalier régional universitaire de Besançon（CHU de Besançon）

Drug Highest PhasePhase 2

First Approval Date-

Regulation-

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Structure/Sequence

Sequence Code 168523

Target: *****

Sequence Code 1367101

Target: *****

The TERTIO trial will propose to determine the clinical interest and immunological efficacy of a treatment combining the CD4 helper T-inducer cancer anti-telomerase vaccine (UCPVax) with anti-PD-L1 therapy (atezolizumab) and bevacizumab in unresectable HCC by evaluation of the objective response rate at 6 months (randomized phase II, 10 centers, 105 patients)

Start Date27 Sep 2022

Sponsor / Collaborator

Centre Hospitalier Universitaire de Besancon

[+1]

NCT04263051

/ CompletedPhase 2IIT

Evaluation of UCPVax Plus Nivolumab as Second Line Therapy in Advanced Non Small Cell Lung : a Randomized Non Comparative Phase II Trial

Lung cancer is the most commonly diagnosed malignancy and the leading cause of cancer-related mortality both in men and women worldwide.
The past few years have demonstrated great progress in the field of tumor immunotherapy through agents that address mechanisms of immune escape notably, so called immune checkpoint inhibitors (ICB). Indeed, ICB have emerged as a fatal weapon in the anticancer treatment arsenal. Anti-PD-1 and anti-PD-L1 antibodies have shown promising results in several cancers including Non-small Cell Lung Cancer (NSCLC) patients. Although such ICB extend patient's survival compared with conventional systemic therapies, they fail to control cancer progression in a significant proportion of patients which can reach up to 50-60% in NSCLC. Recent literature highlights a range of factors involved in the heterogeneous responses and failures to ICB therapies. The challenge is how can ICB treatment efficacy be extended to majority patients? To respond to this question, to increase the success of immunotherapy, immuno-oncology community develops combinations approaches.
The aim of these project is to evaluate the efficacy of Nivolumab plus a novel CD4Th1 inducer anti-cancer vaccine in NSCLC patients.
Nivolumab (NIVO), which is an anti-PD-1 antibody, has shown promising results in 2nd line treatment for advanced NSCLC.
UCPVax is a therapeutic anti-cancer vaccine based on the telomerase-derived helper peptides designed to induce strong TH1 CD4 T cell responses in cancer patients (NCT02818426).

Start Date09 Sep 2020

Sponsor / Collaborator

Centre Hospitalier Universitaire de Besancon

[+2]

NCT04280848

/ CompletedPhase 2IIT

Anticancer Therapeutic Vaccination Using Telomerase-derived Universal Cancer Peptides in Glioblastoma

Glioblastoma (GBM) is the most frequent primary brain tumor and the brain tumor with the poorest prognosis. The current treatment relies on surgical resection of gross tumor followed by radiochemotherapy and adjuvant therapy with temozolomide.
After such therapy, most patients experiment recurrence and few therapeutic option are available. Despite such therapies, median survival only reaches around fifteen months.
There is a strong rational to develop telomerase vaccine in GBM. Telomerase (TERT) is a major oncogene, particularly in primary brain tumors 24. Alterations in TERT are very frequent in central nervous system tumors, seen most commonly in gliomas25. Mutations in the TERT promoter are found in approximately 80% of primary glioblastoma (GBM). These findings strongly support the rational to develop vaccine targeting telomerase in GBM.
The aim of this project is to evaluate UCPVax treatment in glioblastoma. UCPVax is a therapeutic anti-cancer vaccine based on the telomerase-derived helper peptides designed to induce strong TH1 CD4 T cell responses in cancer patients (NCT02818426).

Start Date26 May 2020

Sponsor / Collaborator

Centre Hospitalier Universitaire de Besancon

100 Clinical Results associated with hTERT peptide-based vaccine(Invectys SA)

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100 Translational Medicine associated with hTERT peptide-based vaccine(Invectys SA)

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100 Patents (Medical) associated with hTERT peptide-based vaccine(Invectys SA)

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6

Literatures (Medical) associated with hTERT peptide-based vaccine(Invectys SA)

01 Jan 2024·International immunopharmacology

Bridging responses to a human telomerase reverse transcriptase-based peptide cancer vaccine candidate in a mechanism-based model

Article

Author: Mangsbo, Sara M ; Friberg, Lena E ; Ellingsen, Espen B ; Ibrahim, Eman I K

Therapeutic cancer vaccines are novel immuno-therapeutics, aiming to improve clinical outcomes with other immunotherapies. However, obstacles to their successful clinical development remain, which model-informed drug development approaches may address. UV1 is a telomerase based therapeutic cancer vaccine candidate being investigated in phase I clinical trials for multiple indications. We developed a mechanism-based model structure, using a nonlinear mixed-effects modeling techniques, based on longitudinal tumor sizes (sum of the longest diameters, SLD), UV1-specific immunological assessment (stimulation index, SI) and overall survival (OS) data obtained from a UV1 phase I trial including non-small cell lung cancer (NSCLC) patients and a phase I/IIa trial including malignant melanoma (MM) patients. The final structure comprised a mechanistic tumor growth dynamics (TGD) model, a model describing the probability of observing a UV1-specific immune response (SI ≥ 3) and a time-to-event model for OS. The mechanistic TGD model accounted for the interplay between the vaccine peptides, immune system and tumor. The model-predicted UV1-specific effector CD4+ T cells induced tumor shrinkage with half-lives of 103 and 154 days in NSCLC and MM patients, respectively. The probability of observing a UV1-specific immune response was mainly driven by the model-predicted UV1-specific effector and memory CD4+ T cells. A high baseline SLD and a high relative increase from nadir were identified as main predictors for a reduced OS in NSCLC and MM patients, respectively. Our model predictions highlighted that additional maintenance doses, i.e. UV1 administration for longer periods, may result in more sustained tumor size shrinkage.

15 May 2023·International journal of cancer

Impact of human telomerase reverse transcriptase peptide vaccine combined with androgen deprivation therapy and radiotherapy in de novo metastatic prostate cancer: Long‐term clinical monitoring

Article

Author: Hole, Knut Håkon ; Lilleby, Wolfgang ; Inderberg, Else Marit ; Seierstad, Therese

Abstract:

Prostate cancer is considered as poorly immunogenic. In a phase I/II study on de novo metastatic prostate cancer we found that a human telomerase reverse transcriptase (hTERT) vaccine induced an early immune response in most of the patients. Here we present the results from the long‐term monitoring of the immune responses and clinical outcomes. Twenty‐two men with ISUP 4 to 5 and lymph node and/or bone metastases were treated with androgen deprivation therapy (ADT), radiotherapy and the hTERT vaccine UV1 between January 2013 and July 2014. Immune response was monitored before, during and after vaccination and continued every 6 months until PSA progression. All patients had magnetic resonance imaging (MRI) at baseline, and after 6 months, 1 and 2 years, and at progression. The clinical outcome was time to progression, overall survival and prostate cancer‐specific survival. The median follow‐up was 62 months (range: 19‐101). At the last observation, nine of the 22 patients were still alive. Six have no progression, two have castration‐resistant disease treated with second‐line ADT and one has castration‐refractory disease. Median time to PSA progression was 21 months, median overall survival was 62 months and median prostate cancer‐specific survival was 84 months. Lack of immune response was an independent marker of prostate cancer death. The long‐term monitoring showed that some patients had unanticipated subsequent high immune responses without developing recurrence. This association indicates that there might be a clinical benefit of hTERT vaccination in a subgroup of men with primary metastatic hormone‐sensitive prostate cancer treated with ADT and radiotherapy.

10 Jan 2023·Journal of clinical oncology : official journal of the American Society of Clinical Oncology

Safety, Immunogenicity, and 1-Year Efficacy of Universal Cancer Peptide–Based Vaccine in Patients With Refractory Advanced Non–Small-Cell Lung Cancer: A Phase Ib/Phase IIa De-Escalation Study

Article

Author: Meurisse, Aurélia ; Guillaume, Yves ; Eberst, Guillaume ; Malfroy, Marine ; Fagnoni-Legat, Christine ; Lagrange, Aurélie ; Clairet, Anne-Laure ; Westeel, Virginie ; Orillard, Emeline ; Kaulek, Vincent ; Mascaux, Céline ; Moltenis, Mélanie ; Hocquet, Didier ; Ghrieb, Zineb ; Favier, Laure ; Jacoulet, Pascale ; Vernerey, Dewi ; Laheurte, Caroline ; Teixeira, Luis ; Almotlak, Hamadi ; Kroemer, Marie ; Quoix, Elisabeth ; Boullerot, Laura ; Borg, Christophe ; Gainet-Brun, Marie ; Limat, Samuel ; Adotévi, Olivier ; Debieuvre, Didier ; Doucet, Ludovic ; Jacquin, Marion

PURPOSE:

Universal cancer peptide–based vaccine (UCPVax) is a therapeutic vaccine composed of two highly selected helper peptides to induce CD4+ T helper-1 response directed against telomerase. This phase Ib/IIa trial was designed to test the safety, immunogenicity, and efficacy of a three-dose schedule in patients with metastatic non–small-cell lung cancer (NSCLC).

PATIENTS AND METHODS:

Patients with refractory NSCLC were assigned to receive three vaccination doses of UCPVax (0.25 mg, 0.5 mg, and 1 mg) using a Bayesian-based phase Ib followed by phase IIa de-escalating design. The primary end points were dose-limiting toxicity and immune response after three first doses of vaccine. Secondary end points were overall survival (OS) and progression-free survival at 1 year.

RESULTS:

A total of 59 patients received UCPVax; 95% had three prior lines of systemic therapy. No dose-limiting toxicity was observed in 15 patients treated in phase Ib. The maximum tolerated dose was 1 mg. Fifty-one patients were eligible for phase IIa. The third and sixth dose of UCPVax induced specific CD4+ T helper 1 response in 56% and 87.2% of patients, respectively, with no difference between three dose levels. Twenty-one (39%) patients achieved disease control (stable disease, n = 20; complete response, n = 1). The 1-year OS was 34.1% (95% CI, 23.1 to 50.4), and the median OS was 9.7 months, with no significant difference between dose levels. The 1-year progression-free survival and the median OS were 17.2% (95% CI, 7.8 to 38.3) and 11.6 months (95% CI, 9.7 to 16.7) in immune responders ( P = .015) and 4.5% (95% CI, 0.7 to 30.8) and 5.6 months (95% CI, 2.5 to 10) in nonresponders ( P = .005), respectively.

CONCLUSION:

UCPVax was highly immunogenic and safe and provide interesting 1-year OS rate in heavily pretreated advanced NSCLC.

100 Deals associated with hTERT peptide-based vaccine(Invectys SA)

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Unresectable Hepatocellular Carcinoma	Phase 2	France	Centre Hospitalier Universitaire de Besancon	27 Sep 2022
Non-Small Cell Lung Cancer	Phase 2	France	Centre hospitalier régional universitaire de Besançon（CHU de Besançon）	03 Oct 2020
Glioblastoma Multiforme	Phase 2	France	Centre Hospitalier Universitaire de Besancon	26 May 2020
Glioblastoma, IDH-Wildtype	Phase 2	France	Centre Hospitalier Universitaire de Besancon	26 May 2020
Anal Canal Carcinoma	Phase 2	France	Centre Hospitalier Universitaire de Besancon	18 Feb 2020
HPV-related carcinoma	Phase 2	France	Centre Hospitalier Universitaire de Besancon	18 Feb 2020
Squamous Cell Carcinoma of Head and Neck	Phase 2	France	Centre Hospitalier Universitaire de Besancon	18 Feb 2020
Uterine Cervical Cancer	Phase 2	France	Centre Hospitalier Universitaire de Besancon	18 Feb 2020
Advanced Lung Non-Small Cell Carcinoma	Phase 2	-	Centre Hospitalier Universitaire de Besancon	23 Jan 2020
metastatic non-small cell lung cancer	Phase 2	France	Invectys SAS	20 Apr 2016

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03946358 (VolATIL, ESMO2024) Manual	Phase 2	Neoplasms HPV-related ctDNA	44	AtezolizumabhTert-derived CD4 TH1 inducing vaccine	eqgrmkauqk(ivnhalkhha) = qbootiatrh lhxomaxlaj (rgyrbemqjz ) View more	Positive	14 Sep 2024
NCT03946358 (VolATIL, ESMO2024) Manual	Phase 2	Neoplasms HPV-related ctDNA	44	Atezolizumab+hTert-derived CD4 TH1 inducing vaccine (HPV-related ctDNA detectable at baseline)	jsyuggsuce(iyftdxicri) = dldzqczmlk epbymgusiz (zxwjmtrwkd )	Positive	14 Sep 2024
NCT04280848 (ASCO 12023 \| ASCO 22023) Manual	Phase 2	Glioblastoma First line	31	UCPVax	ugulwbzofe(srtwqhbjhy) = nasngstqox mddwthcfuj (lcanaioevt ) View more	Positive	26 May 2023