Swiss biotechnology company Virometix AG announced the successful completion of enrollment in its Phase I clinical trial of V-212, a fully synthetic, serotype-independent vaccine candidate designed to combat Streptococcus pneumoniae infections. The milestone represents a significant advancement in pneumococcal vaccine development, with the potential to address current limitations of existing pneumococcal conjugate vaccine (PCV) approaches.
"Completing enrollment in this Phase I trial marks a significant milestone for V-212," said Anna Sumeray, CEO of Virometix. "This fully synthetic, serotype-independent vaccine candidate is designed to advance our mission of delivering scalable, safe, and broad-spectrum protection against pneumococcal disease, while addressing the current limitations of existing PCV approaches."
Novel Synthetic Vaccine Platform
V-212 represents a departure from traditional vaccine approaches, utilizing Virometix's proprietary Synthetic Virus-Like Particle (SVLP) platform. The vaccine employs conformational synthetic peptide mimetics displayed on self-assembling lipopeptidic nanoparticles that incorporate built-in adjuvant elements, including T-helper epitopes and Toll-like receptor (TLR) ligands. This design eliminates dependence on biological components and simplifies manufacturing processes.
The vaccine candidate is specifically engineered as a serotype-independent, peptide-based immunogen. Multiple conserved antigenic epitopes from key Streptococcus pneumoniae surface proteins are synthesized and conjugated to SVLP nanoparticles, aiming to induce broad immunity across diverse serotypes.
Promising Preclinical Results
Preclinical studies have demonstrated robust, long-lasting immunogenicity in mouse and rabbit models. V-212 prevented lethal sepsis in a serotype 3 challenge, inhibited bacterial dissemination into blood, and reduced pulmonary burden. The vaccine also conferred protection against serotype 8 infections. Notably, antisera elicited by V-212 recognized multiple pneumococcal serotypes, including non-PCV-13 types, underscoring its serotype-independent potential.
Phase I Trial Design
The randomized, double-blind, placebo-controlled, first-in-human Phase I trial (Study ID: NCT06975319) has enrolled 60 healthy subjects aged 18-45 years. The study is being conducted in collaboration with CEVAC (Centre for Vaccinology) at Ghent University Hospital, a leading European clinical trial unit with extensive expertise in vaccine development.
Subjects receive three intramuscular injections of either V-212 or placebo across low, medium, and high dose groups. The primary objective is to evaluate safety and tolerability across dose levels, while the secondary objective focuses on assessing immunogenicity to identify an optimal dose for subsequent studies.
Prof. Isabel Leroux-Roels, Principal Investigator at CEVAC, emphasized the clinical significance of the research: "Pneumococcal infections remain a major global health challenge, underscoring the urgent need for next-generation vaccines with broader and more durable protection. V-212's fully synthetic, serotype-independent approach is highly innovative, and we look forward to advancing the clinical evaluation of this important candidate."
Addressing Unmet Medical Needs
The development of V-212 addresses significant limitations in current pneumococcal vaccination strategies. Traditional conjugate vaccines target specific serotypes, potentially leaving gaps in protection as pneumococcal strains evolve and non-vaccine serotypes emerge. The serotype-independent approach of V-212 could provide broader, more durable protection against pneumococcal disease.
Virometix AG, a privately held Swiss biotechnology company, focuses on developing fully synthetic vaccines to generate targeted and protective immune responses against infectious diseases and cancer. The company's rational molecular design and chemical synthesis approach, combined with the proprietary SVLP platform technology, enables rapid production and optimization of vaccine candidates with potential advantages in safety, efficacy, manufacturing ease and cost, and stability.
Topline safety and immunogenicity data from the Phase I trial are expected in the first quarter of 2026, marking the next critical milestone in V-212's clinical development program.
