A Randomised, Parallel-group, Open-label Phase II Trial of the Immunological Effects of Three Regimens of GX301 Vaccination in Castration-resistant Prostate Cancer Patients Who Have Achieved Response or Disease Stability With First-line Chemotherapy

GX301 is an experimental therapeutic vaccine directed against human telomerase, an enzyme playing an essential role in cancer cell proliferation.
This clinical trial will test three different GX301 administration regimens in castration-resistant prostate cancer patients who have achieved response or disease stability with first-line docetaxel treatment. This is aimed at identifying an optimal vaccination regimen.
The three regimens will primarily be compared for their efficacy and safety in inducing vaccine-specific immunological responses over a period of 6 months following treatment initiation. In addition, patients will be observed for the occurrence of disease progression and for their vital status up to 24 months.

Start Date01 Nov 2014

Sponsor / Collaborator

Laboratoires Leurquin Mediolanum SA

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100 Clinical Results associated with Telomerase peptide cancer vaccine(Genovax SRL)

100 Translational Medicine associated with Telomerase peptide cancer vaccine(Genovax SRL)

100 Patents (Medical) associated with Telomerase peptide cancer vaccine(Genovax SRL)

Literatures (Medical) associated with Telomerase peptide cancer vaccine(Genovax SRL)

01 Dec 2021·Cancer Immunology, ImmunotherapyQ2 · MEDICINE

Telomerase-based GX301 cancer vaccine in patients with metastatic castration-resistant prostate cancer: a randomized phase II trial

Q2 · MEDICINE

Article

Author: Signori, Alessio ; Zanardi, Elisa ; Tomasello, Laura ; Scagliotti, Giorgio ; Ferrera, Francesca ; Filaci, Gilberto ; Carles, Joan ; Astone, Giuseppina ; Boccardo, Francesco ; Altosole, Tiziana ; Gianese, Francesco ; Kalli, Francesca ; Del Conte, Gianluca ; Parodi, Alessia ; Fenoglio, Daniela ; Guglielmini, Pamela ; Criscuolo, Domenico ; Lamperti, Giuseppina ; Nolè, Franco ; Morales-Barrera, Rafael ; Aglietta, Massimo

AbstractDebate is around the optimal immunization regimen for cancer vaccines since too intense vaccination schedules may exhaust reactive lymphocytes. GX301 is a telomerase-based cancer vaccine whose safety and immunological effects were tested in a phase I trial applying an eight administrations schedule. Main objective of this study was to comparatively analyse safety and immunological response to three GX301 regimens in metastatic castration-resistant prostate cancer patients with response/disease stability after docetaxel chemotherapy. This was a multicentre, randomized, parallel-group, open-label trial registered with EudraCT (2014-000095-26) and ClinicalTrials.gov (NCT02293707, 2014). Ninety-eight patients were randomized to receive either eight (regimen 1), four (regimen 2) or two (regimen 3) vaccine administrations. Sixty-three patients were assessable for the primary immunological end-point. Vaccine-specific immune responses were evaluated by intracellular staining for IFN, elispot and cytotoxic assay at 90 and 180 days from baseline. No major side effects were recorded. A 54% overall immune responder rate was observed with 95% of patients showing at least one vaccine-specific immune response. Rate of immunological responders and number of immunizations were proportionally related, suggesting superiority of regimens 1 and 2 over regimen 3. Overall survival did not differ among regimens in both immunological responders and non-responders and was inversely associated (P = 0.002) with increase in the number of circulating CD8 + T regulatory cells at 180 days. These data indicate that GX301 cancer vaccine is safe and immunogenic in metastatic castration-resistant prostate cancer patients. Schedules with high number of administrations should be preferred in future studies due to their better immunological outcome.

01 Jun 2013·Cancer Immunology, ImmunotherapyQ2 · MEDICINE

A multi-peptide, dual-adjuvant telomerase vaccine (GX301) is highly immunogenic in patients with prostate and renal cancer

Q2 · MEDICINE

Article

Author: Francesca Ferrera ; Francesca Kalli ; Maurizio Setti ; Giorgio Carmignani ; Paolo Traverso ; Francesco Boccardo ; Simone Negrini ; Alessia Parodi ; Giuseppe Murdaca ; Francesco Puppo ; Alberto Sobrero ; Daniela Fenoglio ; Florinda Battaglia ; Domenico Criscuolo ; Stefania Sciallero ; Francesco Indiveri ; Laura Tomasello ; Gilberto Filaci ; Giuseppe Cittadini

BACKGROUNDAnti-tumor vaccination is a new frontier in cancer treatment applicable to immunogenic neoplasms such as prostate and renal cancers. GX301 is a vaccine constituted by four telomerase peptides and two adjuvants, Montanide ISA-51 and Imiquimod.OBJECTIVEThe aim of this study was to analyze safety and tolerability of GX301 in an open-label, phase I/II trial. Immunological and clinical responses were also evaluated as secondary endpoints.EXPERIMENTAL DESIGNGX301 was administered by intradermally injecting 500 μg of each peptide (dissolved in Montanide ISA-51) in the skin of the abdomen. Imiquimod was applied as a cream at the injection sites. The protocol included 8 administrations at days 1, 3, 5, 7, 14, 21, 35, 63. Eligible patients were affected with stage IV prostate or renal cancer resistant to conventional treatments. Patients were clinically and immunologically monitored up to 6 months from the first immunization.RESULTSNo grade 3-4 adverse events were observed. Evidence of vaccine-specific immunological responses was detected in 100 % of patients. Disease stabilization occurred in 4 patients. Prolonged progression-free survival and overall survival were observed in patients showing a full pattern of vaccine-specific immunological responses.CONCLUSIONGX301 demonstrated to be safe and highly immunogenic. Further studies are needed to determine its clinical efficacy.

100 Deals associated with Telomerase peptide cancer vaccine(Genovax SRL)

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Indication	Highest Phase	Country/Location	Organization	Date
Kidney Neoplasms	Phase 2	Italy	Genovax SRL	-
Renal Cell Carcinoma	Phase 2	-	Genovax SRL	-
Renal Cell Carcinoma	Phase 2	-	Mediolanum Farmaceutici SpA	-
Castration-Resistant Prostatic Cancer	Phase 1	Italy	Laboratoires Leurquin Mediolanum SA	01 Nov 2014
Castration-Resistant Prostatic Cancer	Phase 1	Spain	Laboratoires Leurquin Mediolanum SA	01 Nov 2014

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


EUCTR2014-000095-26-ES \| NCT02293707 (Pubmed \| Cancer Immunol Immunother)	Phase 2	Metastatic castration-resistant prostate cancer	99	GX301 (Regimen 1 (eight administrations))	wjoftprryg(xjfzkxybvq) = yzlwbpcrhg zzmqbodvre (cjxfqskvwl )	-	05 Aug 2021

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