CAMBRIDGE, Mass .– (COMMERCIAL WIRE) – Moderna, Inc. (Nasdaq: MRNA), a biotech company pioneering clinical messenger RNA (mRNA) therapies and vaccines to create a new generation of transforming drugs for patients, today announced a modification to its contract with Biomedical Advanced Research and the Development Authority (BARDA) for an additional commitment of up to $ 472 million to support late-stage clinical development, including the Company’s expanded Phase 3 study of the mRNA vaccine candidate (mRNA-1273) against COVID-19.
A previous BARDA award of up to $ 483 million was awarded to support mRNA-1273 expansion and clinical development, originally with fewer expected participants in the Phase 3 clinical trial. After discussions with the Drug Administration and United States Food (FDA) and consultations with Operation Warp Speed in recent months, the Company decided to conduct a significantly larger Phase 3 clinical trial, leaving a gap in funding for BARDA to be closed with this. . Contract Modification Under the terms of the revised contract, BARDA is expanding its support for the late-stage mRNA-1273 clinical development of the Company, including the execution of a phase 3 study of 30,000 participants in the US The value Total award is now approximately $ 955 million.
“We thank BARDA for this continued commitment to mRNA-1273, our candidate vaccine against COVID-19, “said Stéphane Bancel, Executive Director of Moderna.”Encouraged by the Phase 1 data, we believe that our mRNA vaccine can help tackle the COVID-19 pandemic and prevent future outbreaks. ”
The phase 3 COVE study is being conducted in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH) and is expected to start tomorrow, July 27. The Phase 3 study protocol has been reviewed by the U.S. Food and Drug Administration (FDA) and is aligned with recent FDA guidance on the design of clinical trials for COVID-19 vaccine studies. The randomized, 1: 1 placebo-controlled trial is expected to include approximately 30,000 participants at the 100 µg dose level in the US The primary goal will be prevention of symptomatic disease COVID-19. Key secondary endpoints include prevention of severe COVID-19 disease (as defined by the need for hospitalization) and prevention of SARS-CoV-2 infection. The ClinicalTrials.gov identifier is NCT04470427.
Moderna is working closely with Operation Warp Speed and the NIH, including NIAID’s COVID-19 Prevention Trials Network (CoVPN), to conduct the Phase 3 COVE study. Working together with partners such as NIH, the The Company hopes to achieve a shared goal that the participants in the COVE study be representative of the communities at highest risk of COVID-19 and of our diverse society.
The Company is on track to be able to deliver approximately 500 million doses per year, and possibly up to 1 billion doses per year, as of 2021 from the Company’s in-house manufacturing site in the US And strategic collaboration with Lonza. In addition, Moderna recently announced a collaboration with Catalent for the large-scale, commercial filler finish manufacturing of mRNA-1273 at Catalent’s biological facility in Indiana. The initial $ 1.3 billion financing for Moderna to begin producing the supply of mRNA-1273 at risk was secured by investors in the Company’s most recent public capital offering in May 2020.
BARDA is part of the Office of the Assistant Secretary for Preparedness and Response within the US Department of Health and Human Services This project has been funded in whole or in part by federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Advanced Biomedical Research and Development Authority, under Contract No. 75A50120C00034.
About mRNA-1273
1273 mRNA is a COVID-19 mRNA vaccine that encodes a stabilized form of prefusion of the Spike (S) protein, which was selected by Moderna in collaboration with VRC researchers. The first clinical batch, which was funded by the Coalition for Epidemic Preparedness Innovations, was completed on February 7, 2020 and underwent analytical testing; It was sent to NIH on February 24, 42 days from sequence selection. The first participant in the NIAID-led phase 1 study of mRNA-1273 received the dose on March 16, 63 days from sequence selection to phase 1 study dosing. On May 12, the FDA granted the Fast Track designation mRNA-1273. Both cohorts, healthy adults 18 to 55 years old (n = 300) and adults older than 55 years and older (n = 300), in the Phase 2 study of the 1273 mRNA Company are fully enrolled. A summary of the company’s work to date on COVID-19 can be found here.
About Moderna’s prophylactic vaccine modality
Moderna scientists designed the company’s prophylactic vaccine modality to prevent infectious diseases. More than 1,900 participants have enrolled in Moderna’s infectious disease vaccine clinical trials under health authorities in the US, Europe and Australia. Clinical data shows that Moderna’s proprietary vaccine technology has been generally well tolerated and can elicit long-lasting immune responses to viral antigens. Based on clinical experience in Phase 1 studies, the company has designated prophylactic vaccines as a core modality and is working to accelerate the development of its vaccine line.
The potential benefits of an mRNA approach to prophylactic vaccines include the ability to combine multiple mRNAs into a single vaccine, rapid discovery to respond to emerging pandemic threats, and manufacturing agility derived from the nature of the design platform and production of the mRNA vaccine. Moderna has built a fully integrated manufacturing plant that delivers on the promise of the technology platform.
Moderna currently has nine candidates for development in its prophylactic vaccine modality, including:
Vaccines against respiratory infections.
-
Vaccine against respiratory syncytial virus (RSV) for older adults (mRNA-1777 and mRNA-1172 or V172 with Merck)
-
RSV Vaccine for Young Children (mRNA-1345)
-
Vaccine against human metapneumovirus (hMPV) and parainfluenza virus type 3 (PIV3) (mRNA-1653)
-
COVID-19 vaccine (mRNA-1273)
-
H7N9 influenza (mRNA-1851)
Vaccines against infections transmitted from mother to baby.
-
Cytomegalovirus (CMV) vaccine (mRNA-1647)
-
Zika vaccine (mRNA-1893 with BARDA)
Vaccines against highly prevalent viral infections.
-
Epstein-Barr virus (EBV) vaccine (mRNA-1189)
To date, Moderna has demonstrated positive Phase 1 data readings for eight prophylactic vaccines (H10N8, H7N9, RSV, chikungunya virus, hMPV / PIV3, CMV, Zika, and COVID-19). Moderna’s CMV vaccine is currently in a Phase 2 dose confirmation study. Moderna’s investigational Zika vaccine (mRNA-1893), currently in a Phase 1 study, received the FDA Fast Track designation in August 2019.
About Moderna
Moderna is advancing the science of messenger RNA (mRNA) to create a new class of transformative drugs for patients. MRNA drugs are designed to direct cells in the body to produce intracellular, membrane or secreted proteins that may have a therapeutic or preventive benefit and have the potential to address a broad spectrum of diseases. The company’s platform builds on continuous advancements in basic and applied mRNA science, delivery and manufacturing technology, providing Moderna with the ability to parallel pursue a strong portfolio of new development candidates. Moderna is developing therapies and vaccines for infectious diseases, immuno-oncology, rare diseases and cardiovascular diseases, independently and with strategic partners.
Based in Cambridge, Massachusetts, Moderna currently has strategic alliances for development programs with AstraZeneca PLC and Merck & Co., Inc., as well as the Defense Advanced Research Projects Agency (DARPA), an agency of the Department of Defense of the U.S., and the Advanced Biomedical Research and Development Authority (BARDA), a division of the Office of the Assistant Secretary for Preparedness and Response (ASPR) within the United States Department of Health and Human Services (HHS). Moderna has been ranked in the top ten of The science List of top employers in the biopharmaceutical industry for the past five years. For more information, visit www.modernatx.com.
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 the development of a possible vaccine against the new coronavirus by the Company, the parameters and the time of the study. Phase 3 mRNA. 1273, the Company’s belief that mRNA-1273 can help address the COVID-19 pandemic and prevent future outbreaks, and the Company’s potential manufacturing capabilities and projected vaccine dose production. In some cases, forward-looking statements can be identified by terminology such as “will”, “may”, “should”, “could”, “wait”, “aim”, “plan”, “aim”, “anticipate”, ” “Believe”, “estimate”, “predict”, “potential”, “continue” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. Forward-looking statements in this press release are not promises or 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 in these forward-looking statements These risks, uncertainties, and other factors include, but are not limited to, the fact that there has never been a commercial product using mRNA technology approved for ra its use; the fact that the rapid response technology in use by Moderna is still being developed and implemented; the fact that the safety and efficacy of mRNA-1273 has not yet been established; possible adverse impacts due to the global pandemic of COVID-19, such as delays in regulatory review, manufacturing and clinical trials, disruptions to the supply chain, adverse effects on healthcare systems, and disruption of the global economy; and those other risks and uncertainties described under the heading “Risk Factors” in Moderna’s most recent quarterly report on Form 10-Q filed with the United States Securities and Exchange Commission (SEC) and in subsequent filings made by Moderna to the SEC, which are available on the SEC’s website at www.sec.gov. Except as required by law, Moderna denies any intention or responsibility to update or revise any forward-looking statement 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 only refer to the date hereof.
