Editas Medicine and Azzur Group Expand Partnership to Accelerate Editas’ Manufacturing Capabilities for Advancing the EDIT-301 Program Through Approval to Commercialization
July 27 2023 - 9:00AM
Editas Medicine, Inc. (Nasdaq: EDIT), a clinical-stage genome
editing company, and Azzur Cleanrooms on Demand™ (COD), an Azzur
Group company, today announced the companies have expanded their
multi-year contract to support the scaling of EDIT-301, Editas
Medicine’s experimental cell therapy medicine under investigation
for the treatment of severe sickle cell disease (SCD) and
transfusion-dependent beta thalassemia (TDT), from approval to
commercialization. The expanded agreement includes compliant
cleanroom space and labs services at Azzur’s COD site in Devens,
Massachusetts. Editas Medicine has utilized Azzur’s services to
execute pre-clinical and early-phase clinical manufacturing
activities for its cell medicines, including EDIT-301 for the
treatment of sickle cell disease and beta thalassemia, since 2020.
Azzur Group recently celebrated the groundbreaking of the Devens
site, which is its third COD facility in the Greater Boston Area.
The building is expected to open in the first quarter of 2024.
“Azzur Cleanrooms on Demand has been a trusted and reliable
partner of Editas Medicine for nearly three years, providing us
with the dedicated, cGMP-compliant space necessary to support our
clinical manufacturing and quality management, which are critical
components to making medicines,” said Harry Gill, Senior Vice
President, Operations, Editas Medicine. “As our partnership has
grown, Azzur has continued to support us and our evolving needs to
manufacture clinical supply to support the advancement of our RUBY
trial and EdiTHAL trial of EDIT-301. The new facility in Devens
will further support and enable us to advance our programs through
the clinic and towards commercialization as we work to achieve our
mission to deliver transformative new medicines to people living
with serious diseases.”
“The Azzur COD model helps our partners accelerate time to
clinic and commercialization with on-demand cleanrooms supported by
GMP wraparound services, allowing our customers to focus on their
science while we focus on compliance,” said Ravi Samavedam, Chief
Innovation Officer, Azzur Group. “Our vision as an organization is
to enable the acceleration of life science innovations that change
patients’ lives, and our partnership with Editas Medicine is a
perfect example of how the industry can come together to achieve a
common goal.”
About Editas MedicineAs a
clinical-stage genome editing company, Editas Medicine is focused
on translating the power and potential of the CRISPR/Cas12a and
Cas9 genome editing systems into a robust pipeline of treatments
for people living with serious diseases around the world. Editas
Medicine aims to discover, develop, manufacture, and commercialize
transformative, durable, precision genomic medicines for a broad
class of diseases. Editas Medicine is the exclusive licensee of
Broad Institute’s Cas12a patent estate and Broad Institute and
Harvard University’s Cas9 patent estates for human medicines. For
the latest information and scientific presentations, please visit
www.editasmedicine.com.
About Azzur Group & Azzur Cleanrooms on
Demand™From Discovery to Delivery™, Azzur Group provides
the life science community full life-cycle solutions for all their
GxP needs. From Azzur Cleanrooms on Demand™ facilities, to our
labs, training centers and consulting offices across the nation,
Azzur Group helps organizations start, scale, and sustain their
growing enterprises. With nearly four decades of service to the
life science community, we have become a trusted partner to the
world's leading pharmaceutical, biotechnology, medical device,
healthcare companies, as well as their supply chain. For more
information, visit Azzur.com.
Originally founded in Waltham, MA., in 2018, the Azzur
Cleanrooms on Demand™ hybrid model includes on-demand cleanrooms
and related services for materials management, asset management,
and supply chain. Azzur COD enables companies to focus on
groundbreaking science and early-phase cGMP manufacturing without
the burden of facility ownership and maintenance. For more
information, visit Azzur.com/cleanrooms.
Editas Medicine Forward-Looking StatementsThis
press release contains forward-looking statements and information
within the meaning of The Private Securities Litigation Reform Act
of 1995. The words ‘‘anticipate,’’ ‘‘believe,’’ ‘‘continue,’’
‘‘could,’’ ‘‘estimate,’’ ‘‘expect,’’ ‘‘intend,’’ ‘‘may,’’ ‘‘plan,’’
‘‘potential,’’ ‘‘predict,’’ ‘‘project,’’ ‘‘target,’’ ‘‘should,’’
‘‘would,’’ and similar expressions are intended to identify
forward-looking statements, although not all forward-looking
statements contain these identifying words. Editas Medicine may not
actually achieve the plans, intentions, or expectations disclosed
in these forward-looking statements, and you should not place undue
reliance on these forward-looking statements. Actual results or
events could differ materially from the plans, intentions and
expectations disclosed in these forward-looking statements as a
result of various important factors, including: uncertainties
inherent in the initiation and completion of pre-clinical studies
and clinical trials and clinical development of Editas Medicine’s
product candidates; availability and timing of results from
pre-clinical studies and clinical trials; whether interim results
from a clinical trial will be predictive of the final results of
the trial or the results of future trials; expectations for
regulatory approvals to conduct trials or to market products and
availability of funding sufficient for Editas Medicine’s
foreseeable and unforeseeable operating expenses and capital
expenditure requirements. These and other risks are described in
greater detail under the caption “Risk Factors” included in Editas
Medicine’s most recent Annual Report on Form 10-K, which is on file
with the Securities and Exchange Commission, as updated by Editas
Medicine’s subsequent filings with the Securities and Exchange
Commission, and in other filings that Editas Medicine may make with
the Securities and Exchange Commission in the future. Any
forward-looking statements contained in this press release speak
only as of the date hereof, and Editas Medicine expressly disclaims
any obligation to update any forward-looking statements, whether
because of new information, future events or otherwise.
Contacts:
Editas Medicine Media and Investor Contact:
Cristi Barnett
(617) 401-0113
cristi.barnett@editasmed.com
Azzur Media Contact:
Emily Steinhauer
CGLife, on behalf of Azzur Group
azzurpr@cglife.com
203-218-9906
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