Moderna continues to expand its mRNA platform for a range of additional clinical applications and management methods including the lung delivery method
Moderna 5y Annual Science and Technology Day presentations highlight the continued focus, safety and innovation of muscle lipid nanoparticle delivery system (LNPs) in vaccines.
Cambridge, MA / ACCESSWIRE / May 17, 2022 / Moderna, Inc. has announced. (NASDAQ: mRNA), the biotech company’s leader in messengerRNA (mRNA) therapies and vaccines, today announced new research findings as part of the company’s fifth annual Science and Technology Day. Moderna continues to highlight investments in expanding the utility of the mRNA platform, characterizing the company’s vaccines, biodistributing vaccines, and using clinical data to predict vaccine doses.
“Science and Technology Day gives us an opportunity to showcase our leadership in mRNA pharmaceuticals. After continuously investing in our mRNA platform for over 10 years, Moderna is well positioned to continue bringing innovative medicines to the world through next generation technology, research and manufacturing. I am particularly excited about the developments achieved by more than 700 research scientists with expertise in drug delivery to the lungs and muscles for vaccines, and I am confident that Moderna’s financial resources and expertise will ensure Moderna remains a global leader in mRNA,” said Stephan Bancel, CEO of Moderna. .
Extending the utility of the mRNA platform
Multiple biological barriers must be overcome to deliver mRNA drugs and maximize their clinical potential. In most cases, efficient delivery of mRNA-based drugs is enabled by encapsulating the mRNA in small droplets of lipids (lipids), known as lipid nanoparticles (LNPs) in order to protect them from degradation and facilitate their uptake by cells. Moderna announces advances in the development of several special LNPs, each suitable for targeting different cell types and optimized for different methods of administration. Moderna has invested in the development of LNPs for systemic, muscular, intratumoral and pulmonary delivery.
With Moderna’s focus on respiratory disease, the company has invested in designing mRNA delivery systems designed to target lung disease. For pulmonary applications, delivery of mRNA drugs directly to the lungs by inhalation is the preferred method of administration in order to increase drug concentration locally in the lung. Moderna researchers have developed a new LNP formulation that addresses several challenges associated with lung mRNA delivery. The LNP pulmonary formula is delivered by inhalation, uses multiple lipids, and is able to target specific areas of the lung. Moderna’s optimization of pulmonary mRNA delivery offers opportunities to meet a range of unmet medical needs.
Moderna collaborates with Vertex to deliver mRNA directly to the lungs via aerosol to enable production of the transmembrane conduction regulator (CFTR) protein for cystic fibrosis (CF). CFTR is an important target for treatment because a defect in the CFTR gene leads to a build-up of thick mucus in the airways, chronic lung infections, inflammation, and eventually respiratory failure. To date, companies have completed IND studies that support advances in clinical development. Vertex expects the IND to apply for this program in the second half of this year. In a second collaboration, the companies are collaborating to develop a range of CF mRNA therapies, by discovering and developing new LNPs and mRNAs to deliver gene-editing therapies for the treatment of cystic fibrosis.
Distinguish RNA from Moderna
mRNA is inherently unstable, but with continued investments in innovative science, Moderna researchers have developed a detailed understanding of the reactions that lead to instability and lead to mRNA inactivation and degradation. mRNA stability has practical implications for product storage and shelf life.
In addition to known chemical reactions that contribute to mRNA instability when the product is stored, Moderna researchers have identified and explained another mechanism that leads to the loss of mRNA activity: formation of lipid mRNA complexes, known as adducts. Since mRNA must be intact in order to be translated, adduct formation renders mRNA untranslatable, resulting in a decrease in the expression of proteins needed to treat or prevent disease.
In addition to the clinical benefits of stabilizing the integrity of mRNA, manufacturing protocols that limit the formation of lipid mRNA conjugates can improve product shelf life. It thus remains necessary to ensure robust analytical methods and strict manufacturing controls to ensure mRNA stability and high activity in LNP delivery systems. Moderna’s adduct formation research has led to the development of manufacturing processes designed to identify and mitigate lipid-driven impurities that would disrupt mRNA translation and reduce product shelf life. As a result, new manufacturing controls have resulted in improved shelf life, improved product activity, and higher storage temperatures.
With hundreds of millions of COVID-19 vaccines being administered, numerous observational studies and in-depth animal research, current data support the safety of vaccination with regard to fertility, pregnancy, and breastfeeding. In addition to examining real-world and surveillance data, Moderna reviewed guidance from several health agencies, including the US Centers for Disease Control and Prevention (CDC), the UK Health Security Agency (UK), and the European Medicines Agency (EMA). ) of the COVID-19 Task Force (ETF), the British Joint Committee on Vaccination and Immunization (JCVI). Taken together, the current data support the safety of the COVID-19 vaccine for pregnant or breastfeeding women and do not indicate safety concerns regarding fertility. There is currently no evidence that COVID-19 vaccines cause fertility problems in women or men. Surveillance data from vaccinated pregnant women did not show an increase in adverse pregnancy outcomes and no increased risk of miscarriage was observed.
Surveillance data from women who were breastfeeding after vaccination against COVID-19 showed no risk of adverse effects in the breastfed newborns/infants. According to the Centers for Disease Control and Prevention (CDC), the COVID-19 vaccination is recommended for people who are pregnant, breastfeeding, trying to conceive now, or may become pregnant in the future.
Biodistribution of Moderna vaccine
To further characterize Moderna IM vaccines, biodistribution studies were conducted to clarify where the mRNA goes in the body after injection. Studies show that the injected mRNA remains predominantly at the injection site and in nearby draining lymph nodes. Furthermore, consistent with its transient nature, mRNA could not be detected in the body 5 days after injection, with minimal mRNA detectable only 3 days later.
Using clinical data to predict vaccine doses
Choosing the optimal dose for the new candidate vaccine is important for maximizing the efficacy of the vaccine at a desired safety level. Informed decisions about dose selection can reduce development time and expense for new candidates. Moderna has introduced an immunological/immunological modeling (IS/ID) approach that simulates the immune response by vaccination (IS) and the resulting measured immune response (ID) dynamics. The model was developed, tested, and demonstrated efficacy using data from cytomegalovirus (CMV; mRNA-1647) and COVID (mRNA-1273) vaccines.
With the aim of maximizing immunity and minimizing the risk of adverse reactions, Moderna will apply the model to support dose selection for upcoming clinical studies.
Science Day webcast information
Moderna will host the annual Science and Technology Day for Analysts and Investors at 9:00 AM ET on May 17. A live webcast will be available under “Events and Presentations” in the Investors section of the Moderna website at the address. . The webcast will be archived on the Moderna website for one year after the presentation.
In the more than 10 years since its inception, Moderna has transformed from a research-stage company offering programs in mRNA, to an organization with a diverse clinical portfolio of vaccines and treatments across seven modalities, and a broad range of intellectual property in areas including mRNA and nanoparticle formulation. Fatty, integrated manufacturing plant allowing rapid clinical and commercial production on a large scale. Moderna maintains alliances with a wide range of domestic and foreign government and commercial collaborators, which have allowed the pursuit of both leading science and rapid expansion of manufacturing. Recently, Moderna combined capabilities to allow for the authorized use and approval of one of the earliest and most effective vaccines against the COVID-19 pandemic.
Moderna’s mRNA platform builds on ongoing advances in basic and applied mRNA science, delivery technology, and manufacturing, and has allowed the development of treatments and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases, and autoimmune diseases. Moderna has been selected as the Best Biopharma Employer by Science over the past seven years. To learn more, visit www.modernatx.com.
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including statements regarding: the Company’s ability to continue to offer new mRNA drugs; The ability to deliver mRNA drug for pulmonary applications through the lungs; The company’s leading position in the development of mRNA drugs; The ability to treat many diseases, including cystic fibrosis, through lung LNPs and participate in gene editing; The timing of a possible IND application by Vertex; integrity of pulmonary mRNA delivery; The company’s platform’s ability to achieve greater stability, including at refrigerator temperatures, for its medications; The safety of the company’s medicines for pregnant and lactating women and the absence of any negative effect on the fertility of men or women; The rate at which the mRNA drug is broken down once in the body; and the company’s ability to predict dosage levels for efficacy and safety. In some cases, forward-looking statements may be identified by terms such as “will,” “may,” “should,” “could,” “expect,” “intend,” “plan,” “objective,” “expect,” “believe.” or “estimates,” “expects,” “likely,” “continues,” or the negative of these or other similar terms, although not all forward-looking statements contain these words. The forward-looking statements contained in this press release are neither promises nor warranties, You should not rely excessively 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 could cause actual results to differ materially from those expressed or implied by these forward-looking statements. These risks and uncertainties and other factors include, among other things, those risks and uncertainties described under “Risk Factors” in our Director’s most recent annual report on Form 10-K filed with the US Securities and Exchange Commission (SEC) and subsequent filings filed by Moderna with the SEC , available on the SEC website at www.sec.gov.Except as required by law, disclaimer Moderna disclaims any intention or responsibility to update or revise any forward-looking statements contained in this press release in the event of new information, future developments, or otherwise. These forward-looking statements are based on Moderna’s current expectations and speak only as of the date of this press release.
Mary Beth and Dean
Senior Communications Manager
Senior Vice President and Head of Investor Relations
source: Moderna, Inc.
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