Moderna Inc., (Nasdaq: MRNA), the clinical stage biotechnology company pioneering messenger RNA (mRNA)-based therapeutics and vaccines, secured a commitment of up to $483 million from the Biomedical Advanced Research and Development Authority (BARDA), a division of the Office of the Assistant Secretary for Preparedness and Response (ASPR) with the U.S. Department of Health and Human Services, to accelerate development of the company’s mRNA vaccine candidate (mRNA-1273) against the novel coronavirus (SARS-CoV-2).
Lots Going On
The federal government-backed award will fund the full development of mRNA-1273 all the way to FDA licensure. The award factors in the expenditure for manufacturing processes and scale-up to support large scale production in 2020 in response to the pandemic.
Meanwhile, the National Institute’s of Health (NIH)-led Phase I clinical trial of mRNA-1273 has completed enrollment of 3 dose cohorts (25µg and 250µg) and will now expand to an additional 6 cohorts of older adults and elderly adults. The clinical sponsor hopes to commence Phase II clinical trial in Q2 2020 following safety data from the ongoing Phase I study.
A Phase III clinical trial could begin as soon as fall 2020 if the data produces from Phase I lead to a Phase II study in the second half of the year.
The funds will go to hire up to 150 new team members to support these parallel efforts. Much of this talent centers on skilled manufacturing staff to expand their production capacity from two shifts per day, five days per week to three shifts per day, seven days per week. Additionally, they require engineers to manage the scale-up process and clinical and regulatory staff to support intensive clinical development schedules.
The Phase I Study: Ongoing
The ongoing Phase I study should produce safety data soon. Based on recent company announcement, a Phase II study can commence second half of 2020 should safety data for this study look good. The overall Phase I won’t be wrapped up till June 2021. Study sites include the Emory Vaccine Center (the Hope Clinic); National Institutes of Health—Clinical Center (Vaccine Research Center Clinical Trials Program); and Kaiser Permanente Washington Health Research Institute (Vaccines and Infectious Diseases).
mRNA-1273 is an mRNA vaccine against SARS-CoV-2 encoding for a prefusion stabilized from the Spike (S) protein, which was selected by Moderna in collaboration with investigators from the Vaccine Research Center (VRC) at the National Institute of Allergy and Infectious Disease (NIAID)—part of the NIH. 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 shipped to NIH on February 24, 42 days from sequence selection.
The first participant in the NIH-led Phase I study of mRNA-1273 was dosed on March 16, 63 days from sequence to Phase I study dosing. A summary of the company’s work to date on SARS-CoV-2 can be fond here.
Moderna’s Prophylactic Vaccines Modality
The company’s scientists designed the prophylactic vaccines modality to prevent infectious diseases. More than 1,400 participants have been enrolled in their infectious disease vaccine clinical studies under health authorities in the U.S., Europe and Australia.
Overall, clinical data demonstrate the proprietary vaccine technology to be well-tolerated and able of eliciting durable immune responses to viral antigens. Based on clinical experience across six Phase I studies, Moderna designated prophylactic vaccines a core modality and is working to accelerate the development of its vaccine pipeline.
What is the purported advantage of an mRNA approach?
Moderna declared that 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 platform nature of mRNA vaccine design and production. The company has built a fully integrated manufacturing plant which enable the promise of the technology platform. Currently, they also have nine development candidates in its prophylactic vaccines’ modality (see list here).
TrialSite News profiled the company developing “the software of life.” Based in Cambridge, Massachusetts, Moderna works furiously to advance messenger RNA (mRNA) science to create a new class of transformative medicines for patients. These investigational medicines are designed to direct the body’s cells to produce intracellular, membrane or secreted proteins that can have therapeutic or preventive benefit and have the potential to address a broad spectrum of diseases.
They have inked alliance deals with AstraZeneca PLC and Merck & Co., Inc., as well as the U.S. Defense Advanced Research Projects Agency (DARPA)—part of the U.S. Department of Defense—and the Biomedical Advanced Research and Development Authority (BARDA). The company has been ranked in the top ten of Science’s list of top biopharma industry employers for the past five years.
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