Replicate Bioscience is a clinical-stage biotechnology company pioneering self-replicating RNA (srRNA) technology for applications in infectious diseases, oncology, and autoimmune disorders. The company's proprietary srRNA platform aims to overcome limitations of existing mRNA approaches by offering potential improvements in bioactivity at lower doses, more robust and durable immune responses, and improved tolerability. Replicate's srRNA technology contains two key components: virally derived genetic code for controlled and self-limiting amplification, and RNA encoding therapeutic proteins.
The company's lead product candidate is RBI-4000, an srRNA-based rabies vaccine. In February 2024, Replicate announced positive Phase 1 results for RBI-4000, demonstrating that it elicited protective immune responses meeting WHO thresholds at ultra-low doses (as low as 0.1 mcg) with a single administration. The vaccine was well-tolerated across all dose levels tested. This data validated the potential of Replicate's srRNA platform to achieve broad therapeutic windows and expand RNA treatments to complex diseases.
Replicate is also developing RBI-1000, an srRNA-based candidate targeting acquired resistance mutations in estrogen receptor-positive breast cancer. preclinical studies showed RBI-1000 primed T cell responses and improved survival in mouse models. Additionally, the company is exploring srRNA for protein drug replacement, as demonstrated by its RBI-2000 program.
To support manufacturing of its srRNA candidates, Replicate partnered with Curia in June 2022 to develop processes for GMP production of srRNA vectors up to 8-liter scale for clinical trials. This collaboration aims to address the technical challenges of manufacturing longer RNAs required for Replicate's customized srRNA approach.
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