Coronavirus /Biotechnology Stock
News Bites - Moderna (NASDAQ:
$MRNA) Announces First Participant Dosed in NIH-led Phase 1 Study of mRNA
Vaccine (mRNA-1273) Against Novel Coronavirus
Investorideas.com
(www.investorideas.com) _ Coronavirus
/Biotechnology (COVID-19) Stock News Bites- CAMBRIDGE,
MassModerna, Inc., (Nasdaq: MRNA) a clinical stage biotechnology company pioneering messenger
RNA (mRNA) therapeutics and vaccines to create a new generation of
transformative medicines for patients, today announced that the first
participant has been dosed in the Phase 1 study of the Company’s mRNA vaccine
(mRNA-1273) against the novel coronavirus (SARS-CoV-2). This Phase 1 study is
being conducted by the National Institutes of Health (NIH) under its
own Investigational New Drug (IND) application.
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 the Vaccine Research
Center (VRC) at the National Institute of Allergy and Infectious
Diseases (NIAID), a part of NIH. Manufacture of the first clinical
batch was funded by the Coalition for Epidemic Preparedness
Innovations (CEPI).
The Phase 1 study is evaluating the safety and immunogenicity of
three dose levels of mRNA-1273 (25, 100, 250 μg) administered on a two-dose
vaccination schedule, given 28 days apart. A total of 45 healthy adults will be
enrolled in the study. Participants will be followed through 12 months after
the second vaccination. The primary objective is to evaluate the safety and
reactogenicity of a two-dose vaccination schedule of mRNA-1273. The secondary
objective is to evaluate the immunogenicity to the SARS-CoV-2 S protein.
“This study is the first step in the clinical development of an
mRNA vaccine against SARS-CoV-2, and we expect it to provide important
information about safety and immunogenicity. We are actively preparing for a
potential Phase 2 study under our own IND,” said Tal Zaks, M.D., Ph.D.,
Chief Medical Officer at Moderna. “We are grateful to NIH for
their ongoing collaboration and to CEPI for funding the initial manufacturing
of mRNA-1273 and are proud to be included with the many companies, worldwide
health agencies and NGOs working on a possible response to the novel
coronavirus outbreak.”
On January 11, 2020, the Chinese authorities shared the
genetic sequence of the novel coronavirus. On January 13, 2020 the
VRC and Moderna’s infectious disease research team finalized the sequence for
the SARS-CoV-2 vaccine and Moderna mobilized toward clinical
manufacture. The first clinical batch was completed on February 7,
2020 and underwent analytical testing; it was shipped on February 24,
2020 from Moderna and delivered to NIH from the
Company’s manufacturing facility in 42 days from sequence selection.
Next Steps for mRNA-1273
The Company is actively preparing for a potential Phase 2 study
under its own IND to build on data from the ongoing Phase 1 study being
conducted by the NIH. In order to continue to progress this potential
vaccine during the ongoing global public health
emergency, Moderna intends to work with the FDA and other government
and non-government organizations to be ready for a Phase 2 and any subsequent
trials, which are anticipated to include a larger number of subjects and which
will seek to generate additional safety and immunogenicity data. Manufacture of
the mRNA-1273 material for the potential Phase 2 trial, which could begin in a
few months, is underway. Moderna continues to prepare for rapid
acceleration of its manufacturing capabilities that could allow for the future
manufacture of millions of doses should mRNA-1273 prove to be safe and
effective.
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