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1.
Cell Rep Med ; 5(5): 101516, 2024 May 21.
Artículo en Inglés | MEDLINE | ID: mdl-38626769

RESUMEN

Non-small cell lung cancer (NSCLC) is known for high relapse rates despite resection in early stages. Here, we present the results of a phase I clinical trial in which a dendritic cell (DC) vaccine targeting patient-individual neoantigens is evaluated in patients with resected NSCLC. Vaccine manufacturing is feasible in six of 10 enrolled patients. Toxicity is limited to grade 1-2 adverse events. Systemic T cell responses are observed in five out of six vaccinated patients, with T cell responses remaining detectable up to 19 months post vaccination. Single-cell analysis indicates that the responsive T cell population is polyclonal and exhibits the near-entire spectrum of T cell differentiation states, including a naive-like state, but excluding exhausted cell states. Three of six vaccinated patients experience disease recurrence during the follow-up period of 2 years. Collectively, these data support the feasibility, safety, and immunogenicity of this treatment in resected NSCLC.


Asunto(s)
Antígenos de Neoplasias , Vacunas contra el Cáncer , Carcinoma de Pulmón de Células no Pequeñas , Diferenciación Celular , Células Dendríticas , Neoplasias Pulmonares , Linfocitos T , Vacunación , Humanos , Células Dendríticas/inmunología , Neoplasias Pulmonares/inmunología , Neoplasias Pulmonares/patología , Vacunas contra el Cáncer/inmunología , Carcinoma de Pulmón de Células no Pequeñas/inmunología , Carcinoma de Pulmón de Células no Pequeñas/patología , Carcinoma de Pulmón de Células no Pequeñas/terapia , Masculino , Femenino , Persona de Mediana Edad , Antígenos de Neoplasias/inmunología , Diferenciación Celular/inmunología , Anciano , Linfocitos T/inmunología
2.
Cytotherapy ; 24(2): 213-222, 2022 02.
Artículo en Inglés | MEDLINE | ID: mdl-34696961

RESUMEN

Messenger RNA (mRNA) has become a promising tool in therapeutic cancer vaccine strategies. Owing to its flexible design and rapid production, mRNA is an attractive antigen delivery format for cancer vaccines targeting mutated peptides expressed in a tumor-the so-called neoantigens. These neoantigens are rarely shared between patients, and inclusion of these antigens in a vaccine requires the production of individual batches of patient-tailored mRNA. The authors have developed MIDRIXNEO, a personalized mRNA-loaded dendritic cell vaccine targeting tumor neoantigens, which is currently being evaluated in a phase 1 clinical study in lung cancer patients. To facilitate this study, the authors set up a Good Manufacturing Practice (GMP)-compliant production process for the manufacture of small batches of personalized neoantigen-encoding mRNA. In this article, the authors describe the complete mRNA production process and the extensive quality assessment to which the mRNA is subjected. Validation runs have shown that the process delivers mRNA of reproducible, high quality. This process is now successfully applied for the production of neoantigen-encoding mRNA for the clinical evaluation of MIDRIXNEO. To the authors' knowledge, this is the first time that a GMP-based production process of patient-tailored neoantigen mRNA has been described.


Asunto(s)
Vacunas contra el Cáncer , Neoplasias Pulmonares , Neoplasias , Antígenos de Neoplasias/genética , Humanos , Inmunoterapia , Neoplasias/genética , Neoplasias/terapia , Péptidos , ARN Mensajero/genética
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