Development of a Potency Assay for Nous-209, a Multivalent Neoantigens-Based Genetic Cancer Vaccine
Quality control testing of vaccines, including potency assessment, is critical to ensure equivalence of clinical lots. We developed a potency assay to support the clinical advancement of Nous-209, a cancer vaccine based on heterologous prime/boost administration of two multivalent viral vector produ...
| Main Authors: | , , , , , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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MDPI AG
2024-03-01
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| Series: | Vaccines |
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| Online Access: | https://www.mdpi.com/2076-393X/12/3/325 |
| _version_ | 1797239085836795904 |
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| author | Rosa Bartolomeo Fulvia Troise Simona Allocca Giulia Sdruscia Rosa Vitale Veronica Bignone Anna Maria Petrone Giuseppina Romano Anna Morena D’Alise Valentino Ruzza Irene Garzia Guido Leoni Rossella Merone Francesca Lanzaro Stefano Colloca Loredana Siani Elisa Scarselli Gabriella Cotugno |
| author_facet | Rosa Bartolomeo Fulvia Troise Simona Allocca Giulia Sdruscia Rosa Vitale Veronica Bignone Anna Maria Petrone Giuseppina Romano Anna Morena D’Alise Valentino Ruzza Irene Garzia Guido Leoni Rossella Merone Francesca Lanzaro Stefano Colloca Loredana Siani Elisa Scarselli Gabriella Cotugno |
| author_sort | Rosa Bartolomeo |
| collection | DOAJ |
| description | Quality control testing of vaccines, including potency assessment, is critical to ensure equivalence of clinical lots. We developed a potency assay to support the clinical advancement of Nous-209, a cancer vaccine based on heterologous prime/boost administration of two multivalent viral vector products: GAd-209 and MVA-209. These consist of a mix of four Adeno (Great Ape Adenovirus; GAd) and four Modified Vaccinia Ankara (MVA) vectors respectively, each containing a different transgene encoding a synthetic polypeptide composed of antigenic peptide fragments joined one after the other. The potency assay employs quantitative Reverse Transcription PCR (RT-Q-PCR) to quantitatively measure the transcripts from the four transgenes encoded by each product in in vitro infected cells, enabling simultaneous detection. Results showcase the assay’s robustness and biological relevance, as it effectively detects potency loss in one component of the mixture comparably to in vivo immunogenicity testing. This report details the assay’s setup and validation, offering valuable insights for the clinical development of similar genetic vaccines, particularly those encoding synthetic polypeptides. |
| first_indexed | 2024-04-24T17:45:56Z |
| format | Article |
| id | doaj.art-43d45046ce34472eb9d0812940b77c00 |
| institution | Directory Open Access Journal |
| issn | 2076-393X |
| language | English |
| last_indexed | 2024-04-24T17:45:56Z |
| publishDate | 2024-03-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Vaccines |
| spelling | doaj.art-43d45046ce34472eb9d0812940b77c002024-03-27T14:07:09ZengMDPI AGVaccines2076-393X2024-03-0112332510.3390/vaccines12030325Development of a Potency Assay for Nous-209, a Multivalent Neoantigens-Based Genetic Cancer VaccineRosa Bartolomeo0Fulvia Troise1Simona Allocca2Giulia Sdruscia3Rosa Vitale4Veronica Bignone5Anna Maria Petrone6Giuseppina Romano7Anna Morena D’Alise8Valentino Ruzza9Irene Garzia10Guido Leoni11Rossella Merone12Francesca Lanzaro13Stefano Colloca14Loredana Siani15Elisa Scarselli16Gabriella Cotugno17Nouscom Srl, Via di Castel Romano 100, 00128 Rome, ItalyNouscom Srl, Via di Castel Romano 100, 00128 Rome, ItalyNouscom Srl, Via di Castel Romano 100, 00128 Rome, ItalyNouscom Srl, Via di Castel Romano 100, 00128 Rome, ItalyNouscom Srl, Via di Castel Romano 100, 00128 Rome, ItalyNouscom Srl, Via di Castel Romano 100, 00128 Rome, ItalyNouscom Srl, Via di Castel Romano 100, 00128 Rome, ItalyNouscom Srl, Via di Castel Romano 100, 00128 Rome, ItalyNouscom Srl, Via di Castel Romano 100, 00128 Rome, ItalyNouscom Srl, Via di Castel Romano 100, 00128 Rome, ItalyNouscom Srl, Via di Castel Romano 100, 00128 Rome, ItalyNouscom Srl, Via di Castel Romano 100, 00128 Rome, ItalyReiThera Srl, Via di Castel Romano 100, 00128 Rome, ItalyReiThera Srl, Via di Castel Romano 100, 00128 Rome, ItalyReiThera Srl, Via di Castel Romano 100, 00128 Rome, ItalyNouscom Srl, Via di Castel Romano 100, 00128 Rome, ItalyNouscom Srl, Via di Castel Romano 100, 00128 Rome, ItalyNouscom Srl, Via di Castel Romano 100, 00128 Rome, ItalyQuality control testing of vaccines, including potency assessment, is critical to ensure equivalence of clinical lots. We developed a potency assay to support the clinical advancement of Nous-209, a cancer vaccine based on heterologous prime/boost administration of two multivalent viral vector products: GAd-209 and MVA-209. These consist of a mix of four Adeno (Great Ape Adenovirus; GAd) and four Modified Vaccinia Ankara (MVA) vectors respectively, each containing a different transgene encoding a synthetic polypeptide composed of antigenic peptide fragments joined one after the other. The potency assay employs quantitative Reverse Transcription PCR (RT-Q-PCR) to quantitatively measure the transcripts from the four transgenes encoded by each product in in vitro infected cells, enabling simultaneous detection. Results showcase the assay’s robustness and biological relevance, as it effectively detects potency loss in one component of the mixture comparably to in vivo immunogenicity testing. This report details the assay’s setup and validation, offering valuable insights for the clinical development of similar genetic vaccines, particularly those encoding synthetic polypeptides.https://www.mdpi.com/2076-393X/12/3/325viral vectorsquality control testingpotency assessmentcancer vaccineRT-Q-PCR potency assaysynthetic polypeptides |
| spellingShingle | Rosa Bartolomeo Fulvia Troise Simona Allocca Giulia Sdruscia Rosa Vitale Veronica Bignone Anna Maria Petrone Giuseppina Romano Anna Morena D’Alise Valentino Ruzza Irene Garzia Guido Leoni Rossella Merone Francesca Lanzaro Stefano Colloca Loredana Siani Elisa Scarselli Gabriella Cotugno Development of a Potency Assay for Nous-209, a Multivalent Neoantigens-Based Genetic Cancer Vaccine Vaccines viral vectors quality control testing potency assessment cancer vaccine RT-Q-PCR potency assay synthetic polypeptides |
| title | Development of a Potency Assay for Nous-209, a Multivalent Neoantigens-Based Genetic Cancer Vaccine |
| title_full | Development of a Potency Assay for Nous-209, a Multivalent Neoantigens-Based Genetic Cancer Vaccine |
| title_fullStr | Development of a Potency Assay for Nous-209, a Multivalent Neoantigens-Based Genetic Cancer Vaccine |
| title_full_unstemmed | Development of a Potency Assay for Nous-209, a Multivalent Neoantigens-Based Genetic Cancer Vaccine |
| title_short | Development of a Potency Assay for Nous-209, a Multivalent Neoantigens-Based Genetic Cancer Vaccine |
| title_sort | development of a potency assay for nous 209 a multivalent neoantigens based genetic cancer vaccine |
| topic | viral vectors quality control testing potency assessment cancer vaccine RT-Q-PCR potency assay synthetic polypeptides |
| url | https://www.mdpi.com/2076-393X/12/3/325 |
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