Second collaboration between Moderna and Vertex
based on Moderna’s proprietary mRNA and LNP technology
Collaboration will leverage Vertex’s
investments and capabilities in genetic technologies for CF
Moderna to receive $75 million upfront, with
potential for additional development, regulatory and commercial
milestones and royalty payments
Moderna, Inc. (Nasdaq:MRNA) and Vertex Pharmaceuticals
Incorporated (Nasdaq:VRTX) announced today a new strategic research
collaboration and licensing agreement aimed at the discovery and
development of lipid nanoparticles (LNPs) and mRNAs for the
delivery of gene-editing therapies for the treatment of cystic
fibrosis (CF). The three-year research collaboration initially will
focus on the discovery and optimization of novel LNPs and mRNAs
that can deliver gene-editing therapies to cells in the lungs,
enabling functional cystic fibrosis transmembrane conductance
regulator (CFTR) protein to be produced.
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“We are pleased to enter into this second collaboration with
Vertex aimed at delivering potentially novel treatments for
patients with cystic fibrosis using gene editing,” said Stéphane
Bancel, Chief Executive Officer of Moderna. “Our first
collaboration with Vertex to deliver mRNA coding for cystic
fibrosis protein in lung cells is advancing well and this second
collaboration aims at using Moderna’s technologies to explore the
use of gene editing in lung cells.”
"Vertex’s CFTR modulator therapies have the potential to treat
the vast majority of CF patients and address the underlying cause
of their disease. However, approximately 10 percent of patients do
not produce any CFTR protein and so are unlikely to benefit from
our existing medicines. Over the past 5 years, we have made
important progress in our research efforts aimed at the creation of
genetic therapies for CF, with the delivery of such therapies
remaining the most significant technological and scientific
challenge,” said David Altshuler, M.D., Ph.D., Vertex's Executive
Vice President, Global Research and Chief Scientific Officer. “The
combination of Moderna’s unique expertise in the discovery and
manufacturing of novel LNP delivery systems and mRNA technologies,
combined with Vertex’s scientific, clinical and regulatory
capabilities in CF, will accelerate the development of
groundbreaking genetic therapies for people with CF and supports
our commitment to developing therapies for all people living with
CF.”
Under the terms of the agreement, Moderna will conduct research
activities to discover and optimize novel LNPs for the delivery of
gene-editing therapies to lung cells for the treatment of CF.
Moderna will receive $75 million upfront and will be eligible to
receive up to $380 million in development, regulatory and
commercial milestones, plus tiered royalties on any products that
result from the collaboration. Moderna will be responsible for the
discovery and manufacturing of LNPs and mRNA constructs encoding
gene-editing endonucleases. Vertex will be responsible for
providing other components of the gene-editing therapies to be
formulated into LNPs, as well as subsequent preclinical and
clinical development and potential commercialization efforts. This
new collaboration adds to the existing relationship between Moderna
and Vertex in their recently extended collaboration aimed at the
discovery and development of mRNA therapeutics for the treatment of
CF.
About Moderna
Moderna is advancing messenger RNA (mRNA) 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. Moderna’s platform builds on continuous
advances in basic and applied mRNA science, delivery technology and
manufacturing, providing the Company the capability to pursue in
parallel a robust pipeline of new development candidates. Moderna
is developing therapeutics and vaccines for infectious diseases,
immuno-oncology, rare diseases, cardiovascular diseases, and
autoimmune and inflammatory diseases, independently and with
strategic collaborators.
Headquartered in Cambridge, Mass., 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 U.S. Department of
Defense; the Biomedical Advanced Research and Development Authority
(BARDA), a division of the Office of the Assistant Secretary for
Preparedness and Response (ASPR) within the U.S. Department of
Health and Human Services (HHS) and the Coalition for Epidemic
Preparedness Innovations (CEPI). Moderna has been named a top
biopharmaceutical employer by Science for the past five years.
About Vertex Pharmaceuticals
Vertex is a global biotechnology company that invests in
scientific innovation to create transformative medicines for people
with serious diseases. The company has multiple approved medicines
that treat the underlying cause of cystic fibrosis (CF) — a rare,
life-threatening genetic disease — and has several ongoing clinical
and research programs in CF. Beyond CF, Vertex has a robust
pipeline of investigational small molecule medicines in other
serious diseases where it has deep insight into causal human
biology, including pain, alpha-1 antitrypsin deficiency and
APOL1-mediated kidney diseases. In addition, Vertex has a rapidly
expanding pipeline of genetic and cell therapies for diseases such
as sickle cell disease, beta thalassemia, Duchenne muscular
dystrophy and type 1 diabetes mellitus.
Founded in 1989 in Cambridge, Mass., Vertex's global
headquarters is now located in Boston's Innovation District and its
international headquarters is in London, UK. Additionally, the
company has research and development sites and commercial offices
in North America, Europe, Australia and Latin America. Vertex is
consistently recognized as one of the industry's top places to
work, including 10 consecutive years on Science magazine's Top
Employers list and top five on the 2019 Best Employers for
Diversity list by Forbes.
Special Note Regarding Forward-looking Statements
This press release contains forward-looking statements as
defined in the Private Securities Litigation Reform Act of 1995,
including, without limitation, Mr. Bancel's statements in the
second paragraph of the press release, Dr. Altshuler's statements
in the third paragraph of the press release, and the information
provided regarding the future development of therapies to treat the
underlying cause of CF, and the potential commercialization
opportunities from those therapies. While Vertex and Moderna each
believes the forward-looking statements contained in this press
release are accurate, these forward-looking statements represent
the companies’ beliefs only as of the date of this press release
and there are a number of risks and uncertainties that could cause
actual events or results to differ materially from those expressed
or implied by such forward-looking statements. Those risks and
uncertainties include, among other things, that data may not
support further development of the therapies subject to the
collaboration due to safety, efficacy or other reasons, and other
risks listed under the heading “Risk Factors” in Vertex's annual
report and subsequent quarterly reports filed with the Securities
and Exchange Commission (SEC) and available through Vertex’s
website at www.vrtx.com and on the SEC’s website at www.sec.gov, as
well as those risks listed under the heading “Risk Factors” in
Moderna’s most recent quarterly report on Form 10-Q filed with the
SEC and in subsequent filings made by Moderna with the SEC, which
are available on Moderna’s website at www.modernatx.com and on the
SEC’s website at www.sec.gov. Except as required by law, Vertex and
Moderna each disclaim 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.
(VRTX – GEN)
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Moderna Contacts
Investors:
Lavina Talukdar Head of Investor Relations 617-209-5834
Lavina.Talukdar@modernatx.com
Media:
Colleen Hussey Senior Manager, Corporate Communications
617-335-1374 Colleen.Hussey@modernatx.com
Vertex Contacts
Investors:
Michael Partridge, 617-341-6108 or Zach Barber, 617-341-6470 or
Brenda Eustace, 617-341-6187
Media:
Heather Nichols, 617-839-3607 mediainfo@vrtx.com
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