{
  "abstract": "Human papillomavirus (HPV) infection and related cancers remain significant public health concerns worldwide. Among high-risk HPV genotypes, HPV16 demonstrates the highest epidemiological prevalence. The viral oncoproteins E6 and E7 are crucial drivers of HPV16-associated carcinogenesis and have become key therapeutic targets for treating HPV16-related cervical intraepithelial neoplasia and cancers. HPV prophylactic vaccines have been widely implemented in clinical practice; however, effective therapeutic interventions for infected individuals remain limited. Therefore, the development of therapeutic HPV vaccines is urgently needed. LY01620 is an investigational mRNA therapeutic vaccine targeting HPV16 E6/E7 antigens. To support LY01620’s clinical trial application and development, comprehensive nonclinical studies were conducted, including immunogenicity evaluations in mice and rats, anti-tumor activity and mechanistic studies in C3.43 tumor-bearing mice, single-dose tissue distribution study in rats, and a GLP-compliant repeated-dose toxicity study in rats combined with toxicokinetics, local irritation, and immunotoxicity assessments. LY01620 demonstrated strong immunogenicity in mice and rats and exhibited significant anti-tumor activity through inducing a strong Th1-polarized immune response, increasing frequency of antigen-specific T cells, and enhancing infiltration of CD8+ T cells and mature macrophages into tumors. LY01620 mRNA exhibited sustained accumulation in inguinal lymph nodes and spleens, potentially facilitating persistent antigen presentation and prolonged immunological effects. In the repeated-dose toxicity study in SD rats, LY01620 exhibited a favorable safety profile, with the no observed adverse effect level was the highest dose of 300 μg/animal. In conclusion, preclinical studies have demonstrated that LY01620 exhibited favorable mechanism of action-related efficacy and a well-tolerated safety profile, supporting its further development.",
  "abstract_shown": true,
  "affiliations": [],
  "article_type": "Original Research",
  "arxiv": null,
  "author_total": 5,
  "authors": [
    {
      "name": "Guangying Du"
    },
    {
      "name": "Nouredine Behloul"
    },
    {
      "name": "Chunjie Sha"
    },
    {
      "name": "Wenzhong Chen"
    },
    {
      "name": "Jingwei Tian"
    }
  ],
  "bibtex": "https://research.draconitic.com/paper/brrvx3vxpt3js.bib",
  "cited_by": 0,
  "doi": "10.3389/fimmu.2026.1978903",
  "fulltext_url": null,
  "id": "brrvx3vxpt3js",
  "issns": [
    "1664-3224"
  ],
  "landing_url": "https://www.frontiersin.org/articles/10.3389/fimmu.2026.1978903",
  "language": null,
  "licence": "CC-BY-4.0",
  "licence_label": "CC BY 4.0",
  "licence_source": "article",
  "licence_url": "https://creativecommons.org/licenses/by/4.0/",
  "metadata_licence": null,
  "native_subjects": [
    [
      "feed-journal",
      "biology/immunology"
    ]
  ],
  "openalex": null,
  "pdf_url": null,
  "pmcid": null,
  "pmid": null,
  "published": "2026-11-04",
  "publisher": "Frontiers Media SA",
  "ris": "https://research.draconitic.com/paper/brrvx3vxpt3js.ris",
  "sources": [
    {
      "first_seen": "2026-11-04T06:20:39Z",
      "native_id": "10.3389/fimmu.2026.1978903",
      "source": "feed-frontiers",
      "url": "https://www.frontiersin.org/articles/10.3389/fimmu.2026.1978903"
    },
    {
      "first_seen": "2026-11-04T12:21:26Z",
      "native_id": "10.3389/fimmu.2026.1978903",
      "source": "crossref",
      "url": "https://www.frontiersin.org/articles/10.3389/fimmu.2026.1978903/full"
    }
  ],
  "subjects": [
    {
      "field": "biology",
      "origin": "feed-journal:biology/immunology",
      "subfield": "immunology"
    }
  ],
  "title": "Nonclinical pharmacology and toxicology studies of LY01620, a therapeutic mRNA vaccine against human papillomavirus 16-related cancers",
  "title_text": "Nonclinical pharmacology and toxicology studies of LY01620, a therapeutic mRNA vaccine against human papillomavirus 16-related cancers",
  "type": "peer-reviewed",
  "updated_at": "2026-11-04T12:21:26Z",
  "url": "https://research.draconitic.com/paper/brrvx3vxpt3js",
  "venue": "Frontiers in Immunology",
  "versions": []
}