• Data validate the strength of CureVac’s RNAntibody® technology to produce high and sustained levels of antibody production in a variety of disease indications

TÜBINGEN, Germany / BOSTON, USA – August 16, 2017

CureVac AG, a fully-integrated biotechnology company pioneering mRNA-based drugs, today announced the publication of a study in the peer-reviewed journal EMBO Molecular Medicine, demonstrating the utility of CureVac’s RNAntibody® technology as a potent novel approach for passive immunization and a potentially ideal platform for applications where a combination of both passive and active immunization is advantageous or required.

The paper, titled “mRNA mediates passive vaccination against infectious agents, toxins and tumors” by Thran et al., reported results of a multifaceted research program that was designed to explore whether CureVac’s RNAntibody® technology, based on chemically unmodified mRNA, is suitable for passive immunization. The results further build on the data included in CureVac’s granted RNAntibody® patent (see press release of July 20, 2017). Investigators from CureVac and Tufts Cummings School of Veterinary Medicine tested various antibodies using different designs to determine expression and characterization in vitro and in vivo in the fields of viral infections, toxin exposure and cancer immunotherapies.

Results indicated that single injections of mRNA formulated in lipid nanoparticles (LNPs) provided by Acuitas Therapeutics were sufficient to establish rapid, strong and long-lasting serum antibody titers in vivo, thereby enabling both prophylactic and therapeutic protection against lethal rabies infection or botulinum intoxication. Additionally, therapeutic mRNA-mediated antibody expression allowed mice to survive an otherwise lethal tumor challenge. Based on this evidence, the researchers concluded that the utility of formulated mRNA could present a novel armamentarium for the development of competitive passive immunization therapies.

Mariola Fotin-Mleczek, Ph.D., Chief Scientific Officer of CureVac and a co-author of the paper, commented, “Multiple experiments have demonstrated the wide-ranging therapeutic applicability of our technology platform using chemically unmodified mRNA. The research published in EMBO Molecular Medicine now adds passive immunization as another potential therapeutic application for mRNA. Using diverse disease models, mRNA-mediated antibody expression, for up to 28 days, proved capable of providing therapeutic benefit, conferring full protection against intoxication and virus challenge while eradicating neoplastic cells in a mouse tumor model. This suggests that mRNA may be the ideal platform for applications requiring antibody-mediated protection. We are very excited to see that our RNAntibody® technology can provide attractive solutions for different kind of antibodies, including functional IgG, single chain camelid and bi-specific antibodies demonstrating that our non-immunogenic mRNA can be used to deliver any protein molecule. Our sequence-engineered mRNA has the potential to revolutionize human protein therapies with a lower cost of goods and streamlined manufacturing in our state-of-the art production facilities that are currently being expanded to meet clinical and commercial demands.”

Charles B. Shoemaker, Ph.D., Professor in the Department of Infectious Disease and Global Health (IDGH) at Tufts Cummings School of Veterinary Medicine and a co-author of the paper, stated, “The study in EMBO Molecular Medicine is very promising and suggests that mRNA may offer an attractive alternative to passive immunization given that mRNA technology appears to enable the in vivosynthesis of antibodies displaying favorable pharmacokinetics in which substantial antibody titers are induced in blood as early as two hours after treatment of mice. Today, passive immunization by antibody injection currently fills only a small niche in preventing or treating infectious diseases and has significant drawbacks. Nevertheless, there is renewed interest in passive immunization due to the emergence of microbial resistance to antibiotics and this has created a demand for alternative therapies. mRNA seems likely to provide a viable new option for meeting this growing need.”

The full study in EMBO Molecular Medicine can be found here.