Moderna Announces Dosing of the First Monoclonal Antibody Encoded by mRNA in a Clinical Trial
Antibody against Chikungunya virus (mRNA-1944) is the first development candidate from Moderna’s systemic therapeutics modalities to start human dosing
“We believe this trial will give us important information about how mRNA may be used to make systemically-available complex therapeutic proteins in a consistent, dose-dependent fashion,” said
mRNA-1944 encodes a fully human IgG antibody originally isolated from B cells of a patient with a prior history of potent immunity against Chikungunya infection. It is composed of two mRNAs that encode the heavy and light chains of this anti-Chikungunya antibody within Moderna’s proprietary lipid nanoparticle (LNP) technology. Preclinical studies of mRNA-1944 showed linear dose-dependence, meaning increases in the dose of mRNA led to nearly proportionate increases in antibody production.
The research and development of mRNA-1944 was financially supported by the
About the Study
The randomized, placebo-controlled Phase 1 study is designed to evaluate the safety and tolerability of up to four ascending dose levels (0.1, 0.3, 0.6, 1 mg/kg cohorts with 8 subjects per cohort) of mRNA-1944 in healthy adults, administered via intravenous infusion. Other objectives are to determine pharmacodynamics in the form of serum antibody expression and whether the antibodies produced against the Chikungunya virus are sufficiently active to neutralize viral infection in vitro. More information about the study can be found at ClinicalTrials.gov.
About Moderna’s Systemic Therapeutics Modalities
Moderna has 21 mRNA development candidates in its pipeline, with 12 programs now in clinical development. These investigational medicines are grouped together into six modalities based on similar mRNA technologies, delivery technologies and manufacturing processes. Typically, programs within a modality will also share similar pharmacology profiles, including the desired dose response, the expected dosing regimen, the target tissue for protein expression, safety and tolerability goals as well as their pharmaceutical properties.
The systemic intracellular therapeutics modality uses the same delivery technology and was designed to achieve a therapeutic effect in one or more tissues or cell types by producing proteins encoded by mRNA inside the cell, either located in the cytosol or specific organelles, like the mitochondria. The goal of this modality is to provide intracellular proteins, such as intracellular enzymes and organelle-specific proteins, as safe, tolerable and efficacious therapies.
Chikungunya is a mosquito-borne virus that poses a significant public health problem in tropical and subtropical regions. The disease is characterized by an acute onset of fever, rash, muscle pain, and sometimes debilitating pain in multiple joints. There are currently no effective therapies or approved vaccines to treat or prevent Chikungunya infection or disease, and effective mosquito control is challenging. Currently, people infected with Chikungunya are treated with non-steroidal anti-inflammatory drugs to relieve some symptoms. In addition to a systemic secreted antibody that could provide passive immunity,
Special Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended including, but not limited to, statements concerning: the belief that mRNA therapies can make complex secreted proteins; Moderna’s ability to move further programs into clinical trials; the expected outcomes of the Phase 1 clinical trial for antibody against Chikungunya virus (mRNA-1944); and the expected outcomes of the Moderna’s other clinical trials. In some cases, forward-looking statements can be identified by terminology such as “will,” “may,” “should,” “expects,” “intends,” “plans,” “aims,” “anticipates,” “believes,” “estimates,” “predicts,” “potential,” “continue,” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties and other factors, many of which are beyond Moderna’s control and which could cause actual results to differ materially from those expressed or implied by these forward-looking statements. These risks, uncertainties and other factors include, among others: whether preclinical results for mRNA-1944 will be predictive of future clinical study results; whether mRNA-1944 could be unsafe or intolerable during clinical studies; preclinical and clinical development is lengthy and uncertain, especially for a new class of medicines such as mRNA, and therefore our preclinical programs or development candidates may be delayed, terminated, or may never advance to or in the clinic; no mRNA drug has been approved in this new potential class of medicines, and may never be approved; mRNA drug development has substantial clinical development and regulatory risks due to the novel and unprecedented nature of this new class of medicines; and those described in Moderna’s Prospectus filed with the U.S. Securities and Exchange Commission (