Editas Medicine and Azzur Group Announce a Multi-year Agreement for EDIT-301 and EDIT-201 Manufacturing
CAMBRIDGE, Mass., and WALTHAM, Mass., July 07, 2020 (GLOBE NEWSWIRE) — Editas Medicine, Inc. (Nasdaq: EDIT), a leading
genome editing company, and Azzur Cleanrooms on Demand™ (COD), an Azzur Group company, today announced the companies have entered a multi-year agreement for current Good Manufacturing Practice (cGMP)-compliant cleanroom space for Editas Medicine in Azzur’s Waltham site. Editas Medicine will utilize the space and Azzur’s services to execute pre-clinical and early-phase clinical manufacturing activities for its cell medicines, including EDIT-301 in development for the treatment of sickle cell disease and beta thalassemia and EDIT-201, a healthy donor natural killer (HDNK) cell medicine, in development for solid tumor cancers.
“Manufacturing and quality management are both essential components of making medicines. As we advance several innovative cell medicines towards the clinic and to the patients who are living with diseases of unmet medical need, Azzur Cleanrooms on Demand gives us dedicated manufacturing space for our pre-clinical and early-phase clinical manufacturing activities while providing us with flexibility and control, all in a cGMP-compliant space,” said Harry Gill, Senior Vice President, Operations, Editas Medicine. “Azzur Cleanrooms on Demand supports production for early-phase partners, helping accelerate their time to clinic and eventually to market, while providing cGMP services, including facility management, asset management, consulting, and materials management services, as needed. We are excited our solution can help Editas as they advance several innovative medicines to the clinic,” said Ravi Samavedam, President, Azzur Cleanrooms on Demand™.AboutEditas Medicine
As a leading genome editing company, Editas Medicine is focused on translating the power and potential of the CRISPR/Cas9 and CRISPR/Cpf1 (also known as Cas12a) 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. For the latest information and scientific presentations, please visit www.editasmedicine.com. About Azzur Cleanrooms on Demand™
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. Along with all the other service areas in the Azzur Group portfolio, including Azzur Labs, Azzur Consulting, Azzur Technical Services, and Azzur IT Advisory Services, Azzur COD enables companies to focus on groundbreaking science and early-phase cGMP manufacturing without the burden of facility ownership and maintenance. About Azzur Group
A nationwide network of experts delivering professional services across the life sciences industry, Azzur Group is dedicated to providing clients with efficient, innovative quality and compliance solutions from Discovery to Delivery™. With more than 250 industry partners, including 80% of the top pharma/biotech manufacturers in the U.S., Azzur Group provides carefully calibrated and efficiently executed project management, process engineering, and compliance services. As one of the fastest-growing private companies in America, Azzur Group provides clients with the consulting, engineering, validation, IT, technical, training, and laboratory services and cGMP manufacturing solutions they need to remain innovative and competitive. Learn more at Azzur.com. Follow us on LinkedIn, Twitter, and Facebook.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. The Company 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 factors, including: uncertainties inherent in the initiation and completion of pre-clinical studies and clinical trials and clinical development of the Company’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 the Company’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 the Company’s most recent Quarterly Report on Form 10-Q, which is on file with the Securities and Exchange Commission, and in other filings that the Company 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 the Company expressly disclaims any obligation to update any forward-looking statements, whether because of new information, future events or otherwise.
genome editing company, and Azzur Cleanrooms on Demand™ (COD), an Azzur Group company, today announced the companies have entered a multi-year agreement for current Good Manufacturing Practice (cGMP)-compliant cleanroom space for Editas Medicine in Azzur’s Waltham site. Editas Medicine will utilize the space and Azzur’s services to execute pre-clinical and early-phase clinical manufacturing activities for its cell medicines, including EDIT-301 in development for the treatment of sickle cell disease and beta thalassemia and EDIT-201, a healthy donor natural killer (HDNK) cell medicine, in development for solid tumor cancers.“Manufacturing and quality management are both essential components of making medicines. As we advance several innovative cell medicines towards the clinic and to the patients who are living with diseases of unmet medical need, Azzur Cleanrooms on Demand gives us dedicated manufacturing space for our pre-clinical and early-phase clinical manufacturing activities while providing us with flexibility and control, all in a cGMP-compliant space,” said Harry Gill, Senior Vice President, Operations, Editas Medicine. “Azzur Cleanrooms on Demand supports production for early-phase partners, helping accelerate their time to clinic and eventually to market, while providing cGMP services, including facility management, asset management, consulting, and materials management services, as needed. We are excited our solution can help Editas as they advance several innovative medicines to the clinic,” said Ravi Samavedam, President, Azzur Cleanrooms on Demand™.About
Editas MedicineAs a leading genome editing company, Editas Medicine is focused on translating the power and potential of the CRISPR/Cas9 and CRISPR/Cpf1 (also known as Cas12a) 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. For the latest information and scientific presentations, please visit www.editasmedicine.com. About Azzur Cleanrooms on Demand™
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. Along with all the other service areas in the Azzur Group portfolio, including Azzur Labs, Azzur Consulting, Azzur Technical Services, and Azzur IT Advisory Services, Azzur COD enables companies to focus on groundbreaking science and early-phase cGMP manufacturing without the burden of facility ownership and maintenance. About Azzur Group
A nationwide network of experts delivering professional services across the life sciences industry, Azzur Group is dedicated to providing clients with efficient, innovative quality and compliance solutions from Discovery to Delivery™. With more than 250 industry partners, including 80% of the top pharma/biotech manufacturers in the U.S., Azzur Group provides carefully calibrated and efficiently executed project management, process engineering, and compliance services. As one of the fastest-growing private companies in America, Azzur Group provides clients with the consulting, engineering, validation, IT, technical, training, and laboratory services and cGMP manufacturing solutions they need to remain innovative and competitive. Learn more at Azzur.com. Follow us on LinkedIn, Twitter, and Facebook.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. The Company 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 factors, including: uncertainties inherent in the initiation and completion of pre-clinical studies and clinical trials and clinical development of the Company’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 the Company’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 the Company’s most recent Quarterly Report on Form 10-Q, which is on file with the Securities and Exchange Commission, and in other filings that the Company 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 the Company expressly disclaims any obligation to update any forward-looking statements, whether because of new information, future events or otherwise.
