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Replicate Bioscience Initiates a Phase 1 Trial of its Next-Generation srRNA Vaccine

Wednesday, September 13, 2023

Replicate Bioscience, a clinical-stage company specializing in novel self-replicating RNA (srRNA) technology to address the limitations of current mRNA methods and broaden the application of RNA treatments in infectious disease, oncology, and autoimmune diseases, has announced the initiation of a Phase 1 trial for its RBI-4000 vaccine designed for rabies prevention. This milestone marks the first administration of Replicate's next-generation srRNA technology to a human subject, serving as an important benchmark for its potential utility in rabies prevention and other intricate infectious diseases. It will also provide foundational insights to guide future clinical trials, particularly in the fields of oncology and autoimmune diseases.

Nathaniel Wang, Ph.D., the founder, and CEO of Replicate, emphasized the significance of this step, stating, "Rabies represents an ideal opportunity to provide rapid clinical validation of our novel vaccine technology given the large exposure-naïve population and established correlates for protection as measured by the World Health Organization."

Zelanna Goldberg, M.D., CMO of Replicate, highlighted the potential benefits of srRNA technology, saying, Replicate's srRNA technology offers the potential for more robust and durable immune responses, and improved tolerability at lower doses than existing mRNA approaches. In infectious disease specifically, our srRNA technology unlocks opportunities to effectively address more complex infectious disease indications and allows us to rapidly develop vaccine candidates to treat or prevent illness — a crucial capability for future pandemic readiness.

Regarding rabies, RBI-4000, and the Phase 1 trial: Rabies remains a public health concern in various regions and is classified as an NIAID Priority Pathogen. A next-generation rabies vaccine with improved immunogenicity and simplified manufacturing processes could increase global access to rabies prevention. Replicate's initial vaccine product, RBI-4000, is an srRNA vaccine developed to stimulate virus-neutralizing immune responses for rabies prophylaxis. The Phase 1 trial will assess the safety, tolerability, and immunogenicity of RBI-4000 in 84 participants in the U.S. Preclinical studies have shown that intramuscular administration of RBI-4000 provides enduring protection against the rabies virus, inducing antibody production and robust virus-specific T cells.

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