Moderna Announces First Participant Dosed in Phase 1 Study of Its IL-2 mRNA Therapeutic
August 02 2021 - 8:44AM
Business Wire
mRNA-6231 is Moderna’s first autoimmune
therapeutic candidate to enter the clinic
Moderna now has clinical programs in five
different therapeutic areas
Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering
messenger RNA (mRNA) therapeutics and vaccines, today announced the
first participant has been dosed in the Phase 1 study of mRNA-6231,
the Company’s mRNA-encoded IL-2 modified for the expansion of
regulatory T cells. mRNA-6231 is Moderna’s first autoimmune
candidate to enter the clinic. It is also Moderna’s first
subcutaneously administered therapeutic program.
“The initiation of the Phase 1 study of mRNA-6231 is an
important milestone for Moderna, as we now look to bring the
potential of mRNA therapeutics to people living with autoimmune
diseases,” said Ruchira Glaser, MD, Sr. Vice President and
Therapeutic Area Head, Rare Disease, Autoimmune &
Cardiovascular. “This is our first mRNA autoimmune candidate, and
the first to be subcutaneously administered. Today marks another
important step in our mission to deliver on the promise of mRNA to
help patients across diseases.”
Moderna now has active clinic programs in five different
therapeutic areas: infectious disease, oncology, cardiovascular,
rare disease and autoimmune disease.
About mRNA-6231
mRNA‑6231 is a lipid nanoparticle (LNP)‑encapsulated mRNA-based
therapeutic that encodes for mutein human interleukin 2, fused to
human serum albumin (HSA‑IL2m), with the goal of achieving enhanced
selectivity toward T regulatory cells. IL-2 through preferential
expansion of Tregs is hypothesized to play a central role in
restoring immune homeostasis.
The trial is a Phase 1, first‑in‑human, dose‑escalation study to
evaluate the safety, tolerability, pharmacokinetics, and
pharmacodynamics of mRNA‑6231 in healthy adult participants
(between 18 and 50 years of age), following subcutaneous
administration of a single dose of mRNA‑6231.
About Moderna
In 10 years since its inception, Moderna has transformed from a
science research-stage company advancing programs in the field of
messenger RNA (mRNA), to an enterprise with a diverse clinical
portfolio of vaccines and therapeutics across six modalities, a
broad intellectual property portfolio in areas including mRNA and
lipid nanoparticle formulation, and an integrated manufacturing
plant that allows for both clinical and commercial production at
scale and at unprecedented speed. Moderna maintains alliances with
a broad range of domestic and overseas government and commercial
collaborators, which has allowed for the pursuit of both
ground-breaking science and rapid scaling of manufacturing. Most
recently, Moderna’s capabilities have come together to allow the
authorized use of one of the earliest and most-effective vaccines
against the COVID-19 pandemic.
Moderna’s mRNA platform builds on continuous advances in basic
and applied mRNA science, delivery technology and manufacturing,
and has allowed the development of therapeutics and vaccines for
infectious diseases, immuno-oncology, rare diseases, cardiovascular
diseases and auto-immune diseases. Today, 24 development programs
are underway across these therapeutic areas, with 16 programs
having entered the clinic. Moderna has been named a top
biopharmaceutical employer by Science for the past six years. To
learn more, 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 regarding: the Company’s conduct of
clinical trials for IL-2 (mRNA-6231); and the potential for
mRNA-6231 to achieve enhanced selectivity toward T regulatory
cells. The forward-looking statements in this press release are
neither promises nor 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 by
these forward-looking statements. These risks, uncertainties, and
other factors include those other risks and uncertainties described
under the heading “Risk Factors” in Moderna’s most recent Annual
Report on Form 10-K filed with the U.S. Securities and Exchange
Commission (SEC) and in subsequent filings made by Moderna with the
SEC, which are available on the SEC’s website at www.sec.gov.
Except as required by law, Moderna disclaims any intention or
responsibility for updating or revising any forward-looking
statements 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 speak only as of the date hereof.
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version on businesswire.com: https://www.businesswire.com/news/home/20210802005403/en/
Moderna Contacts:
Media: Colleen Hussey Director, Corporate Communications
617-335-1374 Colleen.Hussey@modernatx.com
Investors: Lavina Talukdar Senior Vice President &
Head of Investor Relations 617-209-5834
Lavina.Talukdar@modernatx.com
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