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Moderna continues to expand its mRNA platform for a number of additional clinical programs and routes of administration, adding a pulmonary delivery modality.
Moderna’s fifth annual science and technology day highlights the continued attention, protection and innovation of our formula for delivering intramuscular lipid nanoparticles (NPLs) in vaccines
CAMBRIDGE, MA / ACCESSWIRE / May 17, 2022 / Moderna, Inc. (NASDAQ:MNR), a biotechnology company pioneering messenger RNA (mRNA)-based treatments and vaccines, today announced the findings of new studies as part of the 5th. Moderna continues to highlight investments in expanding the application of the mRNA platform, characterizing corporate vaccines, vaccine biodistribution, and clinical knowledge to wait for vaccine doses.
“Science and Technology Day gives us the opportunity to showcase our leadership in mRNA-based medicines. Having frequently invested in our mRNA platform for over 10 years, Moderna is well placed to continue providing cutting-edge medicines globally through state-of-the-art technology. studies and manufacturing. I am excited about the progress made through our more than 700 experienced study scientists on the intramuscular and pulmonary drug delivery platform for vaccines, and I am confident that moderna’s monetary resources and expertise will enable Moderna to remain the world leader in mRNA. “said Stéphane Bancel, CEO of Moderna.
Extending the application of the mRNA platform
Multiple biological barriers will need to be overcome to deliver mRNA-based drugs and maximize their clinical potential. In most cases, effective delivery of mRNA-based drugs is made imaginable by encapsulating the mRNA into tiny lipid droplets (fats), called lipid nanoparticles. (LNP) to protect it from degradation and facilitate absorption through mobile phones. Moderna announces advances in the progression of many patented LNPs, each adapted to target other types of mobiles and optimized for other management routes. Moderna has invested in the progression of NPL for systemic, intramuscular, intratumoral and pulmonary management of mRNA.
With Moderna’s focus on respiratory diseases, the company has invested in designing mRNA delivery systems tailored to treat lung diseases. of the drug in the lungs. Moderna researchers have developed new LNP formulations that address many of the demanding situations associated with lung mRNA delivery. This pulmonary LNP formulation is administered by inhalation, utilizes multiple lipids, and is lung capable. Moderna’s optimization of pulmonary mRNA delivery provides opportunities to address a variety of unmet medical needs.
Moderna participates with Vertex to deliver mRNA directly into the lungs by aerosolization to enable the production of a functional protein that regulates the transmembrane conductance (CFTR) of cystic fibrosis (CF). CFTR is a vital target for the remedy because it is a defect in the CFTR Gene that leads to the accumulation of thick mucus in the respiratory tract, chronic lung infections, inflammation and imaginable respiratory failure. To date, corporations have completed IND studies that aid progress toward clinical progression. Vertex plans to introduce an IND for this program in the current part of this year. In a momentary collaboration, the companies are participating to expand a portfolio of remedies for mRNA cystic fibrosis, through the discovery and progression of new LNPs and mRNAs for the delivery of gene-editing treatments for the treatment of cystic fibrosis. fibrosis.
Moderna mRNA Characterization
mRNA is inherently unstable; however, through continued investment in cutting-edge science, Moderna researchers have developed a detailed description of the reactions that cause instability and lead to inactivation and degradation of mRNA. The stability of mRNA has practical implications for the storage and shelf life of products.
In addition to the chemical reactions known to contribute to the storage of the mRNA instability product, Moderna researchers have known and elucidated some other mechanism that leads to the loss of mRNA activity: the formation of lipid-mRNA complexes, called adducts. Since the mRNA will have to be intact to be translated, the formation of adducts makes the mRNA untranslatable, which reduces the expression of proteins needed to treat or save the disease.
In addition to the clinical benefits of stabilizing mRNA integrity, production protocols that restrict the formation of lipid mRNA adducts can prolong the shelf life of the product. and the main activity in NLP management systems. Moderna’s adduct formation studies have led to the progression of production processes designed to identify and mitigate lipid-induced impurities that would otherwise disrupt mRNA translation and decrease product shelf life. As a result, the new production controls have d service life, d product activity and higher garage temperatures.
With billions of COVID-19 vaccines administered, observational studies, and extensive animal research, existing knowledge verifies the protection of vaccination in relation to fertility, pregnancy, and lactation. In addition to reviewing observational and real-world knowledge, Moderna revised the rules of various fitness agencies, adding the U. S. Centers for Disease Control and Prevention (CDC). The UK Health Safety Agency (UK), the COVID-19 Task Force (ETF) of the European Medicines Agency (EMA), the Joint Committee on Vaccination and Immunization (JCVI). Taken together, existing knowledge verifies the protection of COVID-19 vaccination for pregnant or lactating women and does not recommend any protective consideration with respect to fertility. Currently, there is no evidence that COVID-19 vaccines cause fertility disorders. in women or men. Observational knowledge of vaccinated pregnant women showed no accumulation of adverse pregnancy outcomes and no threat of miscellaneous accumulation was observed marriage.
Observational data from women who breastfed after COVID-19 vaccination showed no risk of adverse events in breastfed infants/infants. According to the CDC, COVID-19 VACCINATION is for other people who are pregnant, breastfeeding, and looking to become pregnant now, or who would possibly become pregnant in the future.
Moderna Vaccine Biodistribution
To better characterize Moderna’s IM vaccines, biodistribution studies have been conducted to demonstrate where mRNA enters the frame after injection. Studies show that the injected mRNA remains mainly in the injection and near the drainage of the lymph nodes. In addition, according to its summary nature, mRNA is undetectable in the frame five days after injection, with minimal mRNA detectable after only 3 days.
Using Clinical Knowledge to Wait for Vaccine Dose
The variety of an optimal dose for new vaccine applicants is vital to achieving maximum vaccine efficacy at a desirable point of safety. Well-informed decisions about dose variety can reduce progression time and expense for new applicants. Moderna presented an immunostimulator/immunodynamic (SI/ID) design technique that simulates the immune reaction through vaccination (SI) and the resulting measured immune reaction dynamics (DI). (mRNA-1273).
In an effort to maximize immunogenicity and decrease the threat of adverse effects, Moderna will apply style to the dose variety for long-term clinical studies.
Science Day webcast information
Moderna will host its annual Science and Technology Day for analysts and investors at 9:00 a. m. m. , Eastern Time, May 17. There will be a live webcast under the heading “Events and Presentations” in the investor segment of Moderna’s online investor page. modernatx. com. Se will archive a repeat of the webcast on moderna’s online page for one year after the submission.
About Moderna
In more than 10 years since its inception, Moderna has grown from a research-stage company advancing systems in the messenger RNA (mRNA) box to a company with a diverse clinical portfolio of vaccines and treatments in seven modalities, a broad portfolio of experts active in spaces such as mRNA formulas and lipid nanoparticles, and a built-in production facility that enables immediate large-scale clinical and advertising production. Moderna maintains alliances with a wide variety of national and foreign government and business partners, which has allowed it to innovate science and immediate scale up production. More recently, Moderna’s features have been combined to enable the legal use and approval of one of the oldest and most effective vaccines in the face of the COVID-19 pandemic.
Moderna’s mRNA platform builds on continuous advances in the basic and implemented science of mRNA, generation and delivery manufacturing, and has enabled the progression of treatments and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases and autoimmune diseases. Moderna has been named one of Science’s top biopharmaceutical employers for the past seven years. For more information, visit www. modernatx. com.
Forward-Looking Statements
This press release comprises forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, and adds statements about: the Company’s ability to continue to introduce new mRNA-based drugs; the ability to deliver mRNA-based drugs for pulmonary programs through the lungs; the Company’s leadership position in advancing mRNA-based drugs; the ability to treat multiple diseases, including cystic fibrosis, through pulmonary NLP and gene-editing interactions; the timing of a potential IND application through Vertex; the protection of lung mRNA delivery; the ability of the Company’s platform to achieve greater ability, adding to refrigeration temperatures, for its medications; the protection of the Company’s medicines for pregnant and lactating women and the absence of adverse effects on fertility in men or women; the rate of degradation of the mRNA drug once in the body; and the Company’s ability to expect dose levels of efficacy and protection. In some cases, forward-looking statements would possibly be known by words such as “may”, “possibly”, “deserve”, “may also just”, “expect”, “intend”, “anticipate”, “targets”. “, “anticipates”, “believes”, “estimates”, “expects”, “prospective”, “continues” or the negative form of those terms or other comparable terms, not all forward-looking statements involve those words. Forward-looking statements included in this press release are not promises or guarantees, and you deserve not to place undue reliance on such forward-looking statements because they involve known and unknown dangers, uncertainties and other matters, many of which are beyond the control of Moderna and which may also cause actual effects to differ materially from those expressed or implied by such forward-looking statements. These dangers, uncertainties and other items include, but are not limited to, the dangers and uncertainties described under “Risk Factors” in Moderna’s most recent Annual Report on Form 10-K filed with the US Securities and Exchange Commission (SEC). Moderna’s filings with the SEC, which can be found on the SEC’s website at www. sec. gov. Except as required by law, Moderna disclaims any purpose or duty to update or revise any forward-looking statements contained in this press release by reason of new form, long-term progressions or otherwise. These forward-looking statements are based on Moderna’s existing expectations and speak only as of the date of this press release.
Modern Contacts
Media: Mary Beth WoodinSenior Director of Communications617-899-3991[email protected]
Investors:Lavina TalukdarSepident Vice President and Chief Investor Relations Officer617-209-5834[email protected]
SOURCE: Moderna, Inc.
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