Evaluation of the Interest to Combine a CD4 Th1-inducer Cancer Vaccine Derived From Telomerase and Atezolizumab Plus Bevacizumab in Unresectable Hepatocellular Carcinoma: a Proof of Concept Randomized Phase II Study (TERTIO - Prodige 82)

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 / Active, not recruitingPhase 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 / Active, not recruitingPhase 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)

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

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

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

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.

31 Dec 2022·Oncoimmunology

Synergistic effect of combining sunitinib with a peptide-based vaccine in cancer treatment after microenvironment remodeling

Article

Author: Kaboré, Christelle ; Mercier, Erwan ; Tartour, Eric ; Adimi, Yasmine ; Terme, Magali ; Méjean, Fanny ; Mougel, Alice ; Galy-Fauroux, Isabelle ; Tanchot, Corinne ; Tran, Thi ; Urquia, Pauline

Although it has proven difficult to demonstrate the clinical efficacy of therapeutic vaccination as a monotherapy in advanced cancers, its combination with an immunomodulatory treatment to reduce intra-tumor immunosuppression and improve vaccine efficacy is a very promising strategy. In this context, we are studying the combination of a vaccine composed of peptides of the tumor antigen survivin (SVX vaccine) with the anti-angiogenic agent sunitinib in a colorectal carcinoma model. To this end, we have been focusing on administration scheduling and have highlighted a therapeutic synergy between SVX vaccine and sunitinib when the vaccine was administered at the end of anti-angiogenic treatment. In this setting, a prolonged control of tumor growth associated with an important percentage of complete tumor regression was observed. Studying the remodeling induced by each therapy on the immunological and angiogenic tumor microenvironment over time we observed, during sunitinib treatment, a transient increase in polymorphonuclear myeloid-derived suppressor cells (PMN-MDSCs) and a decrease in NK cells in the tumor microenvironment. In contrast, after sunitinib treatment was stopped, a decrease in PMN-MDSC populations has been observed in the tumor, associated with an increase in NK cells, pericyte coverage of tumor vessels and CD8⁺ T cell population and functionality. In conclusion, sunitinib treatment results in the promotion of an immune-favorable tumor microenvironment that can guide the optimal sequence of vaccine and anti-angiogenic combination to reinforce their synergy.

01 Jun 2020·Lancet (London, England)Q1 · MEDICINE

Safety and immunogenicity of a mosquito saliva peptide-based vaccine: a randomised, placebo-controlled, double-blind, phase 1 trial

Q1 · MEDICINE

Article

Author: Stoloff, Gregory ; Han, Alison ; Reed, Susan ; Memoli, Matthew J ; Athota, Rani ; James, Emma ; Valenzuela, Jesus G ; Kamhawi, Shaden ; Herbert, Samantha ; Rosas, Luz Angela ; Manning, Jessica E ; Oliveira, Fabiano ; Hunsberger, Sally ; Coutinho-Abreu, Iliano V ; Baus, Holly Ann ; Meneses, Claudio ; Mateja, Allyson ; Pleguezuelos, Olga ; Czajkowski, Lindsay ; Cervantes-Medina, Adriana

BACKGROUND:

In animal models, immunity to mosquito salivary proteins protects animals against mosquito-borne disease. These findings provide a rationale to vaccinate against mosquito saliva instead of the pathogen itself. To our knowledge, no vector salivary protein-based vaccine has been tested for safety and immunogenicity in humans. We aimed to assess the safety and immunogenicity of Anopheles gambiae saliva vaccine (AGS-v), a peptide-based vaccine derived from four A gambiae salivary proteins, in humans.

METHODS:

In this randomised, placebo-controlled, double-blind, phase 1 trial, participants were enrolled at the National Institutes of Health Clinical Center in Bethesda, MD, USA. Participants were eligible if they were healthy adults, aged 18-50 years with no history of severe allergic reactions to mosquito bites. Participants were randomly assigned (1:1:1), using block randomisation and a computer-generated randomisation sequence, to treatment with either 200 nmol of AGS-v vaccine alone, 200 nmol of AGS-v with adjuvant (Montanide ISA 51), or sterile water as placebo. Participants and clinicians were masked to treatment assignment. Participants were given a subcutaneous injection of their allocated treatment at day 0 and day 21, followed by exposure to feeding by an uninfected Aedes aegypti mosquito at day 42 to assess subsequent risk to mosquito bites in a controlled setting. The primary endpoints were safety and immunogenicity at day 42 after the first immunisation. Participants who were given at least one dose of assigned treatment were assessed for the primary endpoints and analysis was by intention to treat. The trial was registered with ClinicalTrials.gov, NCT03055000, and is closed for accrual.

FINDINGS:

Between Feb 15 and Sept 10, 2017, we enrolled and randomly assigned 49 healthy adult participants to the adjuvanted vaccine (n=17), vaccine alone (n=16), or placebo group (n=16). Five participants did not complete the two-injection regimen with mosquito feeding at day 42, but were included in the safety analyses. No systemic safety concerns were identified; however, one participant in the adjuvanted vaccine group developed a grade 3 erythematous rash at the injection site. Pain, swelling, erythema, and itching were the most commonly reported local symptoms and were significantly increased in the adjuvanted vaccine group compared with both other treatment groups (nine [53%] of 17 participants in the adjuvanted vaccine group, two [13%] of 16 in the vaccine only group, and one [6%] of 16 in the placebo group; p=0·004). By day 42, participants who were given the adjuvanted vaccine had a significant increase in vaccine-specific total IgG antibodies compared with at baseline than did participants who were give vaccine only (absolute difference of log₁₀-fold change of 0·64 [95% CI 0·39 to 0·89]; p=0·0002) and who were given placebo (0·62 [0·34 to 0·91]; p=0·0001). We saw a significant increase in IFN-γ production by peripheral blood mononuclear cells at day 42 in the adjuvanted vaccine group compared with in the placebo group (absolute difference of log₁₀ ratio of vaccine peptide-stimulated vs negative control 0·17 [95% CI 0·061 to 0·27]; p=0·009) but we saw no difference between the IFN-γ production in the vaccine only group compared with the placebo group (0·022 [-0·072 to 0·116]; p=0·63).

INTERPRETATION:

AGS-v was well tolerated, and, when adjuvanted, immunogenic. These findings suggest that vector-targeted vaccine administration in humans is safe and could be a viable option for the increasing burden of vector-borne disease.

FUNDING:

Office of the Director and the Division of Intramural Research at the National Institute of Allergy and Infectious Diseases, and National Institutes of Health.

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

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Non-Small Cell Lung Cancer	Phase 2	FR	Centre hospitalier régional universitaire de Besançon（CHU de Besançon）	03 Oct 2020
Glioblastoma Multiforme	Phase 2	FR	Centre Hospitalier Universitaire de Besancon	26 May 2020
Glioblastoma, IDH-Wildtype	Phase 2	FR	Centre Hospitalier Universitaire de Besancon	26 May 2020

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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	(mqsvixffcj) = tcieziezbt phuwhsigyv (javzyxmgzs ) 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)	wbtqeevfvi(ngcysycbac) = jbkensdumz qoaoodzakw (layoinzvhk )	Positive	14 Sep 2024
NCT04280848 (ASCO2023) Manual	Phase 2	Glioblastoma First line	31	UCPVax	feruerypyx(xeouninzbq) = ieoghjcztl fibumgjzao (norgpjtuja ) View more	Positive	26 May 2023

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