- Partnership will include cGMP manufacturing services for AFTX-201, Affinia’s investigational gene therapy medicine for BAG3 dilated cardiomyopathy
WALTHAM, MA and COLUMBUS, Ohio – November 13, 2024 – Affinia Therapeutics (“Affinia”), an innovative gene therapy company with a pipeline of rationally designed adeno-associated virus (AAV) gene therapies for devastating cardiovascular and neurological diseases, and Forge Biologics (“Forge”), a leading manufacturer of genetic medicines and member of the Ajinomoto Bio-Pharma Services group, today announced an agreement to tech transfer and manufacture clinical trial material under Current Good Manufacturing Practice (cGMP) standards to help advance Affinia’s pipeline of development candidates into clinical trials. The scope includes Affinia’s investigational medicine program, AFTX-201 for BAG3 dilated cardiomyopathy, a devastating monogenic heart disease affecting more than 70,000 patients in the U.S., Europe, and U.K. regions.
“We’re proud to support Affinia’s vision of bringing hope to patients affected by cardiomyopathy through their innovative gene therapy,” said John Maslowski, President and CEO of Forge. “Forge’s comprehensive AAV development and manufacturing services, including our robust tech transfer capabilities, were designed to empower partners like Affinia as they work to deliver transformative therapies to patients worldwide.”
Affinia’s pipeline of rationally designed gene therapies incorporate the company’s novel tissue-tropic AAV capsids validated in single-clonal nonhuman primate studies and the company’s proprietary plasmid design system validated across a range of novel and conventional capsids and payloads. These innovations confer unique properties that enable the targeted delivery of genetic payloads to tissues of interest, improving efficacy, safety, and cost of goods, as well as the potential treatment of prevalent diseases with first-in-class or best-in-class therapies. The company’s initial programs are intended to help patients affected by devastating cardiovascular or neurological diseases.
“We are pleased to enter into this tech transfer and manufacturing partnership with an initial focus on AFTX-201 utilizing our proprietary cardiac capsid and plasmid design,” said Rob May, Affinia’s Chief Technical Operations Officer. “We are delighted with Forge’s expertise, strong collaboration, and industry-leading capabilities that were evident during the tech transfer process. We look forward to advancing our innovative pipeline of rationally designed gene therapies toward the clinic jointly with Forge.”
Through this partnership, Forge will provide tech transfer services, process and analytical development, toxicology, and cGMP manufacturing services to Affinia. All tech transfer, development, and manufacturing activities will occur at the Hearth, Forge’s 200,000 square foot gene therapy manufacturing facility in Columbus, Ohio.
About Affinia Therapeutics
Affinia Therapeutics is pioneering a shift to a new class of rationally designed gene therapies that treat rare and prevalent diseases. Affinia Therapeutics’ pipeline of first-in-class or best-in-class product candidates in cardiovascular and neurological diseases leverages its proprietary next-generation capsids, payloads, or manufacturing approaches and have shown efficacy, safety, and differentiation in relevant animal models. For more information, visit https://www.affiniatx.com.
About Forge Biologics
Forge Biologics, a member of Ajinomoto Bio-Pharma Services, is a hybrid gene therapy contract manufacturing and clinical-stage therapeutics development company, enabling access to life-changing gene therapies by bringing them from concept to reality. Forge’s 200,000 square foot facility, the Hearth, is headquartered in Columbus, Ohio, and houses 20 custom-designed cGMP suites with 20,000L of bioreactor capacity. Forge’s end-to-end, scalable plasmid and AAV manufacturing services include research-grade manufacturing, process and analytical development, cGMP manufacturing, fill and finish, and integrated regulatory support to help accelerate the timelines of transformative medicines for patients with genetic diseases. To learn more, visit www.forgebiologics.com.
Inquiries
Affinia Therapeutics:
Investors
investors@affiniatx.com
Media
Kathy Vincent
media@affiniatx.com
Forge Biologics:
Media Inquiries
Marina Corleto
Associate Director, Marketing and Communications
media@forgebiologics.com
Client Development
Taleen Barsoumian
Vice President, Client Development
CD@forgebiologics.com
COLUMBUS, Ohio October 11, 2023 – Forge Biologics (Forge), a leading manufacturer of genetic medicines, announced today that it has joined the California Institute for Regenerative Medicine’s (CIRM) Industry Resource Partner Program to help advance the manufacturing of adeno-associated adenovirus (AAV) gene therapy programs from the state of California.
With $5.5 billion in funding from the state of California, CIRM is a recognized leader in the development and funding of regenerative medicine clinical trials focused on cell-based and gene therapies.
Forge joins the CIRM Industry Resource Partner Program and will enable accelerated research and cGMP AAV manufacturing to CIRM-funded programs. As a leader in AAV and plasmid manufacturing, Forge will assist CIRM’s partners—which range from industry to academic investigators—in accelerating gene therapy development and manufacturing. Forge’s bespoke platform process and end-to-end CDMO services, including fill-finish, will enable CIRM programs to receive more efficient services and save time getting through the clinical phases of development to reach commercial potential.
“We are enthusiastic about collaborating with the California Institute for Regenerative Medicine to help advance gene therapy programs through our clinically-proven manufacturing processes, which may help CIRM programs more quickly reach clinical trials in a state fulfilling the promise of gene therapy to help patients in need,” said Timothy J. Miller, Ph.D., CEO, President, and Co-Founder of Forge.
Forge specializes in accelerating AAV gene therapy programs at any stage, from preclinical to clinical and commercial manufacturing. All manufacturing is done at the Hearth, Forge’s 200,000 square foot custom-designed cGMP facility in Columbus, Ohio.
“CIRM’s Industry Resource Partner Program aims to create a force-multiplier effect by bringing in industry partners who possess resources, experience and expertise to accelerate CIRM-funded regenerative medicine research projects,” said Shyam Patel, Ph.D., Senior Director of Business Development and Alliance Management at CIRM. “By agreeing to provide access to its AAV manufacturing services, Forge Biologics joins our collaborative network of partners who share our unwavering commitment to advancing transformative regenerative medicine therapies for patients.”
About the California Institute for Regenerative Medicine (CIRM)
At CIRM, we never forget that we were created by the people of California to accelerate stem cell treatments to patients with unmet medical needs, and act with a sense of urgency to succeed in that mission. To meet this challenge, our team of highly trained and experienced professionals actively partners with both academia and industry in a hands-on, entrepreneurial environment to fast track the development of today’s most promising stem cell technologies. With $5.5 billion in funding and more than 161 active stem cell programs in our portfolio, CIRM is the world’s largest institution dedicated to helping people by bringing the future of cellular medicine closer to reality. For more information go to www.cirm.ca.gov.
About Forge Biologics
Forge Biologics is a hybrid gene therapy contract manufacturing and clinical-stage therapeutics development company focused on enabling access to life-changing gene therapies. Forge was founded in 2020 and is headquartered in the cell and gene therapy hub of Columbus, Ohio. Its 200,000 square foot facility, the Hearth, is dedicated to AAV manufacturing with 20 custom-designed cGMP suites. Offerings include scalable, end-to-end manufacturing services including, process and analytical development, cGMP viral vector manufacturing, final fill, plasmid DNA manufacturing, as well as regulatory consulting support to accelerate gene therapy programs from preclinical through clinical and commercial stage manufacturing. Forge aims to accelerate the timelines of transformative medicines for patients with genetic diseases. To learn more, visit www.forgebiologics.com.
Media Inquiries
Marina Corleto
Associate Director, Marketing and Communications
media@forgebiologics.com
- Enables gene therapy clients to accelerate AAV manufacturing with seamless incorporation into the Company’s HEK 293 platform suspension process with access to end-to-end capabilities
- New offerings of Research-Grade and GMP-Pathway expedite Phase 1/2 clinical trial timelines, with GMP-Grade available in 2023
- Data to support Company’s plasmid production is being presented at BioProcess International East this week
COLUMBUS, Ohio – September 27, 2022 – Forge Biologics, a gene therapy-focused contract development and manufacturing organization, today announced the new availability of plasmid DNA manufacturing to its suite of scalable manufacturing services for gene therapy programs, complementing Forge’s existing AAV process development, analytical development, cGMP manufacturing, and automated final fill capabilities.
Forge’s plasmid manufacturing services encompass three grades to accommodate a phase-appropriate approach: Research-Grade, suitable for discovery, research and development; GMP-Pathway, suitable for early-stage clinical trial cGMP AAV manufacturing, and cGMP, suitable for late-stage clinical and commercial cGMP manufacturing. Forge’s plasmid production services utilize single-use systems that seamlessly integrate into the Company’s platform AAV manufacturing process, allowing continuity of manufacturing for clients and streamlined vendor management. Research-Grade and GMP-Pathway plasmid grades are currently available, with cGMP plasmid production available in 2023. All plasmid production will occur at Forge’s manufacturing facility, the Hearth, in Columbus, OH, and is available exclusively to clients performing their AAV manufacturing at Forge.
“The launch of plasmid DNA manufacturing enables clients to better streamline the production of their AAV programs by vertically integrating plasmids into our manufacturing process,” said John Maslowski, Chief Commercial Officer of Forge. “The ability to streamline vendor management, better control timeline risks, and accelerate end-to-end AAV manufacturing are important differentiators when upscaling to our 5,000L cGMP bioreactors for clients and patients. We are excited to present the data supporting our now-available services at BioProcess International East this week.”
The Company will deliver data presentations highlighting plasmid production in up to 50L fermenters and AAV manufacturing up to 1,000L at the BioProcess International Conference & Exhibition, taking place in Boston, MA, September 27-30, 2022.
Poster Presentations
Title: Process Development and Scale-Up of Plasmid DNA Production in 1-50L Single Use Fermenters for Accelerating AAV Manufacturing
Presenter: Frank Agbogbo, Ph.D., Vice President, Process Development
Title: Development of a Platform Process for AAV Production
Presenter: Frank Agbogbo, Ph.D., Vice President, Process Development
Title: Development of a Scalable Purification Process for High Grade Plasmid DNA
Presenter: Donald Belcher, Ph.D., Senior Scientist, Process Development
Title: Purification of AAV from 1L to 1,000L Batch Sizes
Presenter: Ganesh Krishnamoorthy, Ph.D., Associate Director, Process Development
Title: Production and the Scale-Up of rAAV from 1L to 1,000L in Bioreactors
Presenter: Steven Wesel, Associate Director, Process Development
Posters will be displayed—and participants can also access them—on the BPI conference website.
About Forge Biologics
Forge Biologics is a hybrid gene therapy contract manufacturing and clinical-stage therapeutics development company. Forge’s mission is to enable access to life changing gene therapies and help bring them from idea to reality. Forge’s 200,000 square foot facility utilizes 20 cGMP suites in Columbus, Ohio, the Hearth, to serve as its headquarters. The Hearth is a custom-designed cGMP facility focused on AAV manufacturing and can host end-to-end manufacturing services to accelerate gene therapy programs from preclinical through clinical and commercial stage manufacturing. By taking a patients-first approach, Forge aims to accelerate the timelines of these transformative medicines for those who need them the most. To learn more, visit www.forgebiologics.com.
Media Inquiries
Marina Corleto – Forge Biologics
Senior Manager, Marketing and Communications
media@forgebiologics.com
Client Development
John Maslowski – Forge Biologics
Chief Commercial Officer
CD@forgebiologics.com