Therapy Areas: AIDS & HIV
Moderna Receives FDA Fast Track Designation for mRNA Vaccine Against Novel Coronavirus
12 May 2020 - - The US Food and Drug Administration has granted Fast Track designation for US-based RNA therapeutics and vaccines developer Moderna, Inc's (NASDAQ: MRNA) mRNA vaccine candidate (mRNA-1273) against the novel coronavirus (SARS-CoV-2), the company said.

Fast Track is designed to facilitate the development and expedite the review of therapies and vaccines for serious conditions and fill an unmet medical need.

Programs with Fast Track designation may benefit from early and frequent communication with the FDA, in addition to a rolling submission of the marketing application.

The company previously received Fast Track designation for its investigational Zika vaccine (mRNA-1893) and its methylmalonic acidemia (MMA; mRNA-3704) and propionic acidemia (PA; mRNA-3927) programs.

On May 6, the US Food and Drug Administration completed its review of the company's Investigational New Drug application for mRNA-1273 allowing it to proceed to a Phase 2 study, which is expected to begin shortly.

Moderna is finalizing the protocol for a Phase 3 study, expected to begin in early summer of 2020. Funding from the Biomedical Advanced Research and Development Authority (BARDA), a division of the Office of the Assistant secretary for Preparedness and Response within the US Department of Health and Human Services, supported the planning for these studies and will also support the late-stage clinical development programs, as well as the scale-up of mRNA-1273 manufacturing both at the company's facilities and that of its strategic collaborator, Lonza Ltd.

Moderna has received initial feedback from the FDA on the design of the planned Phase 2 study, which will evaluate the safety, reactogenicity and immunogenicity of two vaccinations of mRNA-1273 given 28 days apart.

The company intends to enroll 600 healthy participants across two cohorts of adults ages 18-55 years (n=300) and older adults ages 55 years and above (n=300).

Each participant will be assigned to receive placebo, a 50 μg or a 250 μg dose at both vaccinations.

Participants will be followed through 12 months after the second vaccination.

mRNA-1273 is an mRNA vaccine against SARS-CoV-2 encoding for a prefusion stabilized form of the Spike (S) protein, which was selected by Moderna in collaboration with investigators from Vaccine Research Center at the National Institute of Allergy and Infectious Diseases (NIAID), a part of the NIH.

The first clinical batch, which was funded by CEPI, 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 NIAID-led Phase 1 study of mRNA-1273 was dosed on March 16, 63 days from sequence selection to Phase 1 study dosing. A summary of the company's work to date on SARS-CoV-2 can be found here.

Moderna scientists designed the company's prophylactic vaccines modality to prevent infectious diseases. More than 1,400 participants have been enrolled in Moderna's infectious disease vaccine clinical studies under health authorities in the US, Europe and Australia.

Clinical data demonstrate that Moderna's proprietary vaccine technology has been generally well-tolerated and can elicit durable immune responses to viral antigens.

Based on clinical experience across Phase 1 studies, the company designated prophylactic vaccines a core modality and is working to accelerate the development of its vaccine pipeline.

The potential advantages 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 platform nature of mRNA vaccine design and production.

Moderna has built a fully integrated manufacturing plant which enables the promise of the technology platform.

Moderna currently has nine development candidates in its prophylactic vaccines modality.

Moderna is advancing messenger RNA science to create a new class of transformative medicines for patients. mRNA medicines are designed to direct the body's cells to produce intracellular, membrane or secreted proteins that can have a therapeutic or preventive benefit and have the potential to address a broad spectrum of diseases.

The company is developing therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases and cardiovascular diseases, independently and with strategic collaborators.

Headquartered in Cambridge, Mass., Moderna currently has strategic alliances for development programs with AstraZeneca PLC and Merck and Co., Inc., as well as the Defense Advanced Research Projects Agency (DARPA), an agency of the US Department of Defense, and BARDA.
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