Virometix AG Announces Positive Data from Phase 1 Trial of V-212, a Fully Synthetic, Serotype-Independent Vaccine Development Candidate for the Prevention of Pneumococcal Disease

V-212 was well tolerated and demonstrated an excellent safety profileRobust IgG responses were observed to all three antigens in the vaccineResults support further development of V-212 independently and in combination with approved pneumococcal conjugate vaccines (PCVs)

Virometix AG, a clinical-stage biotechnology company pioneering fully synthetic vaccines, today announced positive topline data from the Company’s Phase 1 trial of its lead asset V-212, a serotype-independent pneumococcal vaccine candidate, in development for the prevention of pneumococcal disease caused by Streptococcus pneumoniae (Spn) infections. The study evaluated safety and immunogenicity in healthy volunteers, with data demonstrating an excellent safety profile and robust immune responses across all three target antigens in the vaccine.

Results support further development of V-212 independently and in combination with an approved PCV.

“With the significant need for an effective serotype-independent vaccine, we are pleased to report positive results, which highlight the excellent safety profile and immunogenicity of V-212 and, more broadly, validate our Synthetic Virus-Like Particle (SVLP) platform approach for the development of broad-spectrum, self-adjuvanted vaccines with highly scalable manufacturing,” said Anna Sumeray, Chief Executive Officer of Virometix. “We believe that V-212 has the potential to overcome the inherent gaps in traditional PCV coverage as a fully synthetic, peptide-based, serotype-independent vaccine for the prevention of pneumococcal disease.”

The trial was a randomized, double-blind, placebo-controlled, first-in-human Phase 1 study conducted at the Centre for Vaccinology (CEVAC), Ghent University Hospital. V-212 was evaluated in 60 healthy volunteers aged 18–45. The primary and secondary objectives of the study were to assess the safety, reactogenicity and immunogenicity, of vaccination with V-212 administered three times at low, intermediate, and high dose levels compared with placebo. All serum IgG responses were quantified using an ELISA performed by an independent GLP-accredited third party laboratory.

Topline Phase 1 Results:

V-212 was well tolerated. Adverse events were predominantly mild to moderate in intensity, with a trend for increasing incidence of systemic reactogenicity with increasing dose level. The incidence of reactogenicity symptoms tended to decrease with subsequent vaccinations. No serious adverse events were reported.

Increases in geometric mean IgG titer (GMT) over baseline ranged from two to six fold across the three antigenic Spn epitopes. In the high dose group, at Day 120, increases in GMT over baseline for at least two of three epitopes were ≥ 2 fold in 14 of 15 (93%) subjects and ≥ 4 fold in 8 of 15 (53%) subjects. Increases in IgG titers after the second and third vaccinations were consistent with a boosting effect. No meaningful changes in IgG titer were observed in the placebo group.

“We are very encouraged by these data,” said Mark Sumeray, Chief Medical Officer of Virometix. “We observed robust increases in IgG titers against all three antigens in V-212 with evidence of a boosting response over time. The data provide a strong rationale for further development of V-212 both as an enhancement to the protective effects of existing PCVs as well as a stand alone vaccine.”

About V-212

V-212 is a fully synthetic, serotype-independent, peptide-based vaccine designed to prevent pneumococcal disease caused by Streptococcus pneumoniae (Spn) infections. The vaccine incorporates multiple conserved antigenic epitopes from key pneumococcal surface proteins conjugated to Virometix proprietary Synthetic Virus-Like Particle (SVLP) nanoparticles, which include built-in adjuvant elements such as T-helper epitopes and Toll-like receptor (TLR) ligands. This unique design eliminates dependence on biological carrier proteins and allows for a streamlined, fully synthetic manufacturing process. V-212 is currently being evaluated as an independent vaccine with plans to be evaluated in combination with an approved pneumococcal conjugate vaccine (PCV).

About Virometix

Virometix AG is a privately held biotechnology company developing a new generation of fully synthetic vaccines to elicit targeted and protective immune responses against infectious diseases. The company’s proprietary Synthetic Virus-Like Particle (SVLP) platform combines rational molecular design, chemical synthesis and conjugation to rapidly generate optimized vaccine candidates with superior safety, immunogenicity, manufacturability and stability profiles. Learn more at www.virometix.com

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