Positive Early Clinical Results for Replicate's Innovative srRNA Vaccine

Replicate Bioscience has reported promising initial clinical outcomes for its self-replicating RNA (srRNA) vaccine, RBI-4000, which is designed to combat rabies. The vaccine has successfully triggered a protective immune response that surpasses the World Health Organization's (WHO) benchmark for protection, even at remarkably low dosages. Notably, the protective threshold was reached with just a single dose, and the vaccine was found to be well-tolerated across all tested dosages.
The Phase 1 trial, which focused on the safety and immunogenicity of RBI-4000, involved participants receiving either one or two doses at varying low levels (0.1 mcg, 1 mcg, or 10 mcg). The vaccine demonstrated a robust immune response, with virus-neutralizing antibody levels surpassing the WHO's protective threshold. The company's srRNA technology has shown a broad therapeutic range, which could potentially extend its application to a variety of complex diseases, including cancer vaccines and protein production platforms.
Replicate's CEO, Nathaniel Wang, Ph.D., expressed that the results exceeded expectations and highlighted the potential of their srRNA platform. The preliminary data revealed that the majority of subjects in the ultra-low dosage group (0.1 mcg) achieved the protective surrogate metric (RVNA≥0.5), marking the lowest dose of any RNA technology to do so in humans. The vaccine was also well-tolerated, with no severe adverse events reported.
The study's findings are being prepared for publication and will be presented at future scientific gatherings. Michael Ehlers, M.D., Ph.D., co-Founder and Board Chair of Replicate, and Chief Scientific Officer at Apple Tree Partners, emphasized the significance of these results in advancing the company's vision for RNA therapeutics that can treat a wider range of diseases and benefit more patients.
Rabies, the target of RBI-4000, is a significant public health concern in certain regions and is recognized as a priority pathogen by the FDA and NIAID. The next-generation vaccine aims to improve immunogenicity and simplify manufacturing, thereby expanding global access to rabies prevention. The Phase 1 trial of RBI-4000 is assessing its safety, tolerability, and immunogenicity in 84 participants in the U.S., with preclinical studies indicating durable protection against the virus and robust immune responses.
Replicate Bioscience, part of the Apple Tree Partners portfolio, is a clinical-stage company that is enhancing RNA therapeutics through its innovative srRNA technology. The company's srRNAs consist of two components: genetic code for controlled amplification and RNA encoding for therapeutic proteins. Their viral vector library is designed for robust and sustained protein expression, significantly outperforming linear mRNA, and is poised to develop treatments for various applications, including oncology, infectious diseases, and autoimmunity. With a team of srRNA experts and a customizable vector library, Replicate is well-positioned to expand the scope of RNA treatments for broader use in various disease areas.

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