Arcturus Therapeutics lines up Phase 1/2/3 trial for next-generation mRNA COVID-19 vaccine

San Diego’s Arcturus, a clinical stage mRNA company focusing on infectious disease vaccines liver and respiratory rare diseases, is developing two COVID-19 candidates in parallel: ARCT-021 (its lead candidate) and ARCT-154 (targeting variants of concern, including the Delta variant). The vaccines have been created using Arcturus’ STARR mRNA technology.

Tackling the Delta variant

Arcturus’ lead mRNA COVID-19 vaccine candidate, ARCT-021, is currently in a Phase 2 study in the US and Singapore, with data on expected in H2 2021.

Today it announced that its manufacturing partner in Vietnam, Vinbiocare, has received approval for a Clinical Trial Application (CTA) from the Vietnam Ministry of Health to advance the variant-focused ARCT-154 into a Phase 1/2/3 study. The randomized, observer-blind, placebo-controlled design is sponsored and funded by Vinbiocare (a subsidiary of Vingroup, the largest private industry conglomerate in the country)

The study will assess the safety, immunogenicity and efficacy of the SARS-CoV-2 self-amplifying mRNA vaccine in adults 18 years or older and will enroll up to 21,000 participants across the three phases, with 20,000 in Phase 3.

Participants will receive two doses 28 days apart. Primary endpoints include safety and efficacy with immunogenicity being evaluated in a subgroup. If the clinical trial proves successful at interim evaluations, Emergency Use Approval (EUA) by the Vietnam Ministry of Health is anticipated by the end of the year.

Preclinical research suggests that non-human primate immunization with ARCT-154 elicits neutralizing antibodies to SARS-CoV-2 variants of concern, including the Delta variant (protection was highest against Alpha, followed by Delta then Gamma then Beta).

Building up manufacturing capability

The two companies have also today announced an agreement for Vinbiocare to establish a manufacturing facility in Vietnam for the investigational vaccines.

Vinbiocare will build out the facility; while Arcturus will provide the company with access to proprietary technologies and processes for the manufacture of its vaccines. Technology transfer is already underway.

Vinbiocare will receive the exclusive license to manufacture the vaccines in Vietnam; while the vaccines will be destined solely for distribution in the country. The license and technology transfer applies toward drug product manufacturing but not toward mRNA drug substance manufacturing.

Vinbiocare will make an upfront payment of $40m and be responsible for costs associated with the technology transfer. Vinbiocare will also pay for mRNA drug substance supplied by Arcturus and royalties on vaccines produced at the facility.