Business
Tenaya Therapeutics Launches Operations of New Genetic Medicines Manufacturing Center to Support the Development of Potentially First-In-Class Cardiovascular Therapeutics
Facility to Provide Clinical Supply of Lead Gene Therapy Programs TN-201 and TN-401 for Planned First-in-Human Studies 94,000 sq. ft. Modular Facility has
About this update from Tenaya Therapeutics, Inc.
[{"type":"text","content":"\nFacility to Provide Clinical Supply of Lead Gene Therapy Programs TN-201 and TN-401 for Planned First-in-Human Studies\n\n94,000 sq. ft. Modular Facility has Initial Production Capacity at the 1000L Scale\n\n SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--\nTenaya Therapeutics, Inc. (NASDAQ: TNYA), a biotechnology company with a mission to discover, develop and deliver curative therapies that address the underlying causes of heart disease, today announced that it has completed the build-out and operational launch of its Genetic Medicines Manufacturing Center in Union City, California. Tenaya is advancing a pipeline of therapeutic candidates, including several adeno-associated virus (AAV) gene therapies, for the potential treatment of both rare and prevalent forms of heart disease.\nThis press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20220616005336/en/Tenaya’s Genetic Medicines Manufacturing Center located in Union City, CA (Photo: Business Wire)\n“Tenaya made an early, strategic commitment to internalize several core capabilities to optimize the safety, efficacy, and supply of our product candidates on behalf of patients. With today’s announcement we have made a big leap forward on that commitment by establishing end-to-end in-house manufacturing capabilities for our pipeline of AAV-based gene therapies,” said Faraz Ali, Chief Executive Officer of Tenaya. “The operational launch of Tenaya’s Genetic Medicines Manufacturing Center represents an important milestone as we prepare to advance our robust pipeline of potentially first-in-class cardiovascular therapies into initial clinical studies.”\n\nTenaya’s Genetic Medicines Manufacturing Center is designed to meet regulatory requirements for production of AAV gene therapies from discovery through commercialization under Current Good Manufacturing Practice (cGMP) standards. Initial production efforts will support first-in-human studies of Tenaya’s lead gene therapy, TN-201. TN-201 is being developed for the treatment of genetic hypertrophic cardiomyopathy (HCM) due to MYBPC3 gene mutations. Tenaya plans to submit an Investigational New Drug (IND) application for TN-201 to the U.S. Food and Drug Administration (FDA) in the second half of this year. The facility will also support cGMP production for TN-401, Tenaya’s gene therapy ...