CAMBRIDGE, Mass., and DEVENS, Mass., July 27, 2023 – 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 Medicine
As 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 Statements
This 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.
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