recombinant 14 valent human papillomavirus vaccine (SCT1000) / Sinocelltech - LARVOL DELTA

Immunogenicity Assessment of a 14-Valent Human Papillomavirus Vaccine Candidate in Mice. (PubMed, Vaccines (Basel)) - "SCT1000 elicited robust, durable, and consistent humoral immune responses across all 14 HPV types, indicating its potential as a broad-spectrum vaccine candidate against HPV types 6/11/16/18/31/33/35/39/45/51/52/56/58/59. The significant correlations observed between PBNA and total IgG LIA support the use of the Luminex-based total IgG method as a reliable and effective alternative for immunogenicity assessment in preclinical and future clinical vaccine development."

Journal • Preclinical • Cervical Cancer • Oncology • Solid Tumor • LIAS

Sinocell's revenue increased by 60% in the first half of the year, with a net profit of 126 million yuan [Google translation] (Sina Corp) - "Sinocell's R&D expenses in the first half of the year were 476 million yuan, a slight decrease from the same period last year. The R&D direction is more focused on accelerating the commercialization of existing products and the echelon R&D construction of high-quality and high-potential innovative drugs. During the reporting period, R&D investment was mainly used for mid- and late-stage clinical research of products such as SCT1000, SCT-I10A, and SCTV01, early clinical investment in newly approved clinical research products, and preclinical development of many products...in terms of products under development, SCT1000....has completed the third dose of Phase III clinical trials and is currently in the follow-up stage with smooth progress..."

Commercial • Trial status • Infectious Disease • Oncology • Solid Tumor

Validation of a triple-color pseudovirion-based neutralization assay for immunogenicity assessment of a 14-valent recombinant human papillomavirus vaccine. (PubMed, J Med Virol) - "This paper introduces an improved triple-color PBNA method, capable of simultaneous detection of two or three human papillomavirus (HPV types for use in the development of a 14-valent HPV vaccine candidate...This innovative triple-color PBNA offers an improved approach for large-scale immunogenicity assessment in vaccine development. This study lays a solid foundation that can serve as a guiding paradigm for assessing vaccine responses in preclinical and clinical phases, providing valuable insights to the field."

Journal • Developmental Disorders • Oncology

A Study to Evaluate the Efficacy, Safety, and Immunogenicity of SCT1000 in Healthy Women Aged 18-45 Years (clinicaltrials.gov) - P3 | N=18000 | Active, not recruiting | Sponsor: Sinocelltech Ltd.

New P3 trial • Human Papillomavirus Infection • Infectious Disease • Oncology

Validation of Luminex immunological and competitive Luminex immunological assays for clinical immunogenicity assessment of a 14-valent recombinant human papillomavirus vaccine. (PubMed, J Med Virol) - "LIA showed higher sensitivity than cLIA, and due to limited epitopes of mAb, cLIA detected lower antibody responses, and therefore, fewer antibodies. This work not only supports clinical trials of 14-valent HPV vaccines more efficiently and reliably, but also provides a set of validation strategies and usable standards for general vaccine immunogenicity testing."

Journal • Oncology

A Phase II Study of SCT1000 in Healthy Women Aged 18 to 45 Years (clinicaltrials.gov) - P2; N=1800; Recruiting; Sponsor: Sinocelltech Ltd.; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open

A Phase II Safty and Immunogenicity Study of SCT1000 in Healthy Women Aged 18 to 45 Years (clinicaltrials.gov) - P2; N=1800; Not yet recruiting; Sponsor: Sinocelltech Ltd.

Clinical • New P2 trial

A Phase I Safty and Immunogenicity Study of SCT1000 in Healthy Women Aged 18 to 45 Years (clinicaltrials.gov) - P1; N=240; Recruiting; Sponsor: Sinocelltech Ltd.; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Infectious Disease

A Phase I Safty and Immunogenicity Study of SCT1000 in Healthy Women Aged 18 to 45 Years (clinicaltrials.gov) - P1; N=240; Not yet recruiting; Sponsor: Sinocelltech Ltd.

Clinical • New P1 trial • Infectious Disease