A Phase 2, Single-Arm, Open-Label Clinical Trial on Adjuvant Peptide-Based Vaccination in Dogs with Aggressive Hemangiosarcoma Undergoing Surgery and Chemotherapy

To test the antitumor effect and safety of peptide-based anticancer vaccination in dogs with hemangiosarcoma undergoing the standard of care (SOC; surgery and doxorubicin), canine hemangiosarcoma cells were infected with Salmonella typhi Ty21a to release immunogenic endoplasmic reticulum stress-rela...

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Veröffentlicht in:Cancers 2023-08, Vol.15 (17), p.4209
Hauptverfasser: Marconato, Laura, Tiraboschi, Luca, Aralla, Marina, Sabattini, Silvia, Melacarne, Alessia, Agnoli, Chiara, Balboni, Andrea, Salvi, Marta, Foglia, Armando, Punzi, Sofia, Romagnoli, Noemi, Rescigno, Maria
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container_issue 17
container_start_page 4209
container_title Cancers
container_volume 15
creator Marconato, Laura
Tiraboschi, Luca
Aralla, Marina
Sabattini, Silvia
Melacarne, Alessia
Agnoli, Chiara
Balboni, Andrea
Salvi, Marta
Foglia, Armando
Punzi, Sofia
Romagnoli, Noemi
Rescigno, Maria
description To test the antitumor effect and safety of peptide-based anticancer vaccination in dogs with hemangiosarcoma undergoing the standard of care (SOC; surgery and doxorubicin), canine hemangiosarcoma cells were infected with Salmonella typhi Ty21a to release immunogenic endoplasmic reticulum stress-related peptides into the extracellular milieu via CX43 hemichannels opening. The infected tumor cell secretome constituted the vaccine. Following the SOC, dogs with biologically aggressive hemangiosarcoma were vaccinated a total of five times, once every 3 weeks, and were followed up with serial imaging. A retrospective population of dogs undergoing the SOC alone served as controls. The primary endpoints were the time to progression (TTP) and overall survival (OS), and the secondary endpoints were toxicity and immune responses. A total of 28 dogs were vaccinated along with the SOC, and 32 received only the SOC. A tumor-specific humoral response along with a vaccine-specific T-cell response was observed. Toxicity did not occur. The TTP and OS were significantly longer in vaccinated versus unvaccinated dogs (TTP: 195 vs. 160 days, respectively; p = 0.001; OS: 276 vs. 175 days, respectively; p = 0.002). One-year survival rates were 35.7% and 6.3% for vaccinated and unvaccinated dogs, respectively. In dogs with hemangiosarcoma undergoing the SOC, the addition of a peptide-based vaccine increased the TTP and OS, while maintaining a safe profile. Moreover, vaccinated dogs developed a tumor-specific response, supporting the feasibility of future phase three studies.
doi_str_mv 10.3390/cancers15174209
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The infected tumor cell secretome constituted the vaccine. Following the SOC, dogs with biologically aggressive hemangiosarcoma were vaccinated a total of five times, once every 3 weeks, and were followed up with serial imaging. A retrospective population of dogs undergoing the SOC alone served as controls. The primary endpoints were the time to progression (TTP) and overall survival (OS), and the secondary endpoints were toxicity and immune responses. A total of 28 dogs were vaccinated along with the SOC, and 32 received only the SOC. A tumor-specific humoral response along with a vaccine-specific T-cell response was observed. Toxicity did not occur. The TTP and OS were significantly longer in vaccinated versus unvaccinated dogs (TTP: 195 vs. 160 days, respectively; p = 0.001; OS: 276 vs. 175 days, respectively; p = 0.002). One-year survival rates were 35.7% and 6.3% for vaccinated and unvaccinated dogs, respectively. In dogs with hemangiosarcoma undergoing the SOC, the addition of a peptide-based vaccine increased the TTP and OS, while maintaining a safe profile. Moreover, vaccinated dogs developed a tumor-specific response, supporting the feasibility of future phase three studies.</description><identifier>ISSN: 2072-6694</identifier><identifier>EISSN: 2072-6694</identifier><identifier>DOI: 10.3390/cancers15174209</identifier><identifier>PMID: 37686485</identifier><language>eng</language><publisher>Basel: MDPI AG</publisher><subject>Angiosarcoma ; Antibodies ; Antitumor activity ; Bacteria ; Blood ; Bone cancer ; Cancer ; Cancer therapies ; Cancer vaccines ; Cells ; Chemotherapy ; Clinical trials ; Comparative analysis ; Connexin 43 ; Dogs ; Doxorubicin ; Endoplasmic reticulum ; Health aspects ; Immune response ; Immune response (humoral) ; Immunogenicity ; Immunotherapy ; Infections ; Lymphocytes T ; Medical prognosis ; Metastasis ; Peptides ; Salmonella ; Secretome ; Surgery ; Toxicity ; Tumors ; Vaccination ; Vaccines</subject><ispartof>Cancers, 2023-08, Vol.15 (17), p.4209</ispartof><rights>COPYRIGHT 2023 MDPI AG</rights><rights>2023 by the authors. Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/). 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subjects Angiosarcoma
Antibodies
Antitumor activity
Bacteria
Blood
Bone cancer
Cancer
Cancer therapies
Cancer vaccines
Cells
Chemotherapy
Clinical trials
Comparative analysis
Connexin 43
Dogs
Doxorubicin
Endoplasmic reticulum
Health aspects
Immune response
Immune response (humoral)
Immunogenicity
Immunotherapy
Infections
Lymphocytes T
Medical prognosis
Metastasis
Peptides
Salmonella
Secretome
Surgery
Toxicity
Tumors
Vaccination
Vaccines
title A Phase 2, Single-Arm, Open-Label Clinical Trial on Adjuvant Peptide-Based Vaccination in Dogs with Aggressive Hemangiosarcoma Undergoing Surgery and Chemotherapy
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