Replicate Bioscience, a clinical-stage company pioneering novel self-replicating RNA (srRNA) technology for applications across infectious disease, immunology, and other therapeutic areas, and Instituto Butantan, Sao Paulo, Brazil, a leading non-profit producer of immunobiologic products for Brazil and other markets,  announced a collaboration agreement under which Instituto Butantan will obtain exclusive rights to develop and commercialize Replicate's novel srRNA rabies vaccine RBI-4000 in Brazil and other Latin American countries.

In a Phase 1 clinical study conducted by Replicate, RBI-4000 demonstrated a high therapeutic index showing durable bioactivity at low doses accompanied by mild/moderate reactogenicity, in contrast with other RNA-based vaccine technologies. 

Under the terms of the newly announced agreement, Instituto Butantan will fund the development of RBI-4000 for post-exposure and pre-exposure prophylaxis. In addition, Replicate is eligible to receive tiered royalties on future product sales in Latin America and will retain rights for RBI-4000 in other markets and to all data generated under the agreement.

The collaboration will also accelerate improvement of cold chain storage and thermostability, which may bolster adoption of srRNA technology and support a cost advantage versus conventional vaccine technologies.

"We are very enthusiastic about the partnership with Replicate, which brings cutting-edge technology, innovation, and science to the fight against rabies," said the director of Instituto Butantan, Esper Kallás. "It is a partnership that can bring great benefits to public health and that reinforces the strategic role of Instituto Butantan as a hub for innovation and science."

"We are honored to collaborate with Instituto Butantan, a global leader in the fight against deadly infectious diseases," said Replicate CEO Nathaniel Wang, Ph.D. "We view this as an exciting opportunity to clinically advance Replicate's srRNA rabies vaccine with Butantan and expand our scientific, operational, and manufacturing frameworks that can be applied to other diseases."