Replicate Bioscience is testing novel self-replicating RNA (srRNA) technology in a vaccine aimed at preventing rabies.
The Sorrento Valley-based clinical-stage company has begun dosing participants in a Phase 1 trial of its new RBI-4000 vaccine, marking the first time a human has been dosed with Replicate’s srRNA technology. The trial results will serve as a benchmark for using the srRNA to fight other complex infectious diseases and may pave the way for future trials targeting cancer and autoimmune diseases.
“First and foremost, this trial represents an ideal opportunity to tackle an unmet medical need for a National Institute of Allergy and Infectious Disease (NIAID) priority pathogen. This also provides an ideal opportunity to demonstrate our technology clinically,” Replicate CEO and Cofounder Nathaniel Wang, PhD said.
The company launched during the pandemic, when RNA-related vaccine technology proved pivotal, and has so far received $53 million in funding from Apple Tree Partners (ATP).
“Conventional mRNA technology has shown huge promise during the COVID-19 pandemic, showing that the technology was scalable, safe, and effective,” Wang said. “However, while we were globally fortunate for these successes, it also revealed some opportunities for further improvement of RNA technology in infectious diseases.”
A Deadly Infection
The trial plans to evaluate the safety, tolerability and effectiveness of its rabies vaccine in 84 participants across the country. Rabies is a vaccine-preventable disease transmitted from animals (mostly dogs) to humans that can cause progressive and deadly inflammation of the brain and spinal cord. According to the World Health Organization, it’s found in more than 150 countries and territories and leads to tens of thousands of deaths every year, mainly in Asia and Africa where 40% of whom are children younger than 15 years old.
Compared to the market’s current rabies vaccines, the company states that srRNA vaccines provide an opportunity to reduce the number of doses, enhance the durability of protection, and increase compliance and accessibility to the vaccine in endemic areas.
Dr. Wang explained that rabies has attributes which make studies of vaccines targeting it easier to interpret. One major attribute is that the participating population has no pre-existing immunity to the rabies virus, unlike the flu or COVID, where most people have already been exposed or vaccinated.
“This makes interpretation of the clinical data more challenging to distinguish what the contribution was from previous immunity versus newly generated vaccine-induced immunity. With rabies, there is minimal previous exposure to the pathogen in the U.S. population, meaning that any immunity against the virus has been generated by our vaccine,” he added.
Beyond Rabies Treatment
Replicate reports that it can administer its technology at lower doses, minimizing unwanted side effects and maximizing its capabilities.
“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,” said Replicate CMO Dr. Zelanna Goldberg, MD.
The company is also harnessing its RNA platform to try to fight cancer, with clinical trials on the way. Beyond cancer, Replicate’s scientists are trying to tackle inflammatory diseases.
“We are using a patient’s own bodily cells to produce a therapeutic protein that would dampen the inflammation and restore healthy immune function. We are currently in the process of conducting preclinical proof-of-concept studies here,” added Dr. Wang.
Replicate Bioscience
FOUNDED: 2020
COFOUNDER & CEO: Nathaniel Wang, PhD
HEADQUARTERS: Sorrento Valley
EMPLOYEES: 21
BUSINESS: biopharma
FUNDING: Series A is a $53M commitment from Apple Tree Partners (ATP)
WEBSITE: replicatebioscience.com
CONTACT: info@replicatebioscience.com or 619- 786-7702
NOTABLE: Replicate Bioscience’s mission is to surpass the expectations for the field of RNA treatments with safe and effective srRNA immunotherapies.