- 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
- Forge to provide cGMP manufacturing and development services for Life Biosciences’ novel adeno-associated virus (AAV) gene therapy platform for aging-related diseases, including in ophthalmic indications
BOSTON and COLUMBUS, Ohio – May 08, 2023 – Life Biosciences (“Life Bio”), a biotechnology company advancing innovative cellular rejuvenation technologies to reverse diseases of aging and injury and ultimately restore health for patients, and Forge Biologics (“Forge”), a genetic medicines manufacturing organization, today announced a manufacturing partnership to help advance Life Bio’s partial epigenetic reprogramming platform to address aging-related diseases, including its lead program targeting ophthalmic indications.
“Life Bio is an emerging leader in the development of novel therapies for aging-related diseases, and we are thrilled to serve as their cGMP manufacturing partner to help advance the manufacturing of AAV for their innovative cellular rejuvenation technology, which has the potential to benefit millions of aging patients worldwide,” said Timothy J. Miller, Ph.D., CEO, President, and Co-Founder of Forge.
Through this partnership, Forge will provide adeno-associated virus (AAV) process development, toxicology, cGMP manufacturing, and analytical services to Life Bio. The company will utilize Forge’s platform processes including its proprietary HEK293 suspension Ignition™ Cells and pEMBR™ adenovirus helper plasmid. All development and AAV manufacturing activities will occur at the Hearth, Forge’s 200,000 square foot gene therapy facility in Columbus, Ohio.
“We are delighted to be working with the Forge team, whose expertise in gene therapy manufacturing is unmatched,” said Jerry McLaughlin, Chief Executive Officer of Life Biosciences. “We believe we’re on the cusp of revolutionizing medicine with our cellular rejuvenation capabilities across a range of aging-related diseases, including ophthalmic disorders that involve retinal ganglion cell dysfunction. We are confident our partnership with Forge will have a tremendous impact on our ability to enhance the speed and quality with which we can manufacture our therapeutic candidates as we progress toward the first human clinical trials and continue to develop treatments to reverse diseases of aging by restoring cells to a more youthful state.”
About Life Biosciences
Life Biosciences is a biotechnology company advancing innovative cellular rejuvenation platforms to reverse diseases of aging and injury and ultimately restore health for patients. The company is focusing on two platforms targeting key mechanisms underlying aging biology, epigenetic reprogramming and chaperone-mediated autophagy, to restore cells to a more youthful state. Therapies developed within these platforms have the potential to prevent, treat, and/or reverse multiple aging-related diseases. For more information, please visit lifebiosciences.com or follow us on Twitter and LinkedIn.
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 dedicated to AAV manufacturing and hosts scalable, end-to-end manufacturing services. Offerings include process and analytical development, plasmid DNA manufacturing, viral vector manufacturing, final fill, as well as regulatory consulting support 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
Justin Perry, Ph.D. – Life Biosciences
Account Executive, LifeSci Communications
jperry@lifescicomms.com
Marina Corleto – Forge Biologics
Associate Director, Marketing and Communications
media@forgebiologics.com
Client Development
Taleen Barsoumian – Forge Biologics
Vice President, Client Development
CD@forgebiologics.com
- Innovative collaboration advances the development of novel gene therapies for patients by providing coordinated services across Forge’s leading AAV manufacturing capabilities and Labcorp’s scientific and drug development expertise
COLUMBUS, Ohio – May 3, 2023 – Forge Biologics, a leading manufacturer of genetic medicines, today announced a gene therapy development and manufacturing collaboration with Labcorp (NYSE: LH), a leading global life sciences company.
As a result of this strategic collaboration, gene therapy clients across the industry will gain access to manufacturing capabilities, drug development services, and coordinated scientific expertise, creating greater accessibility to services for adeno-associated virus (AAV) mediated gene therapy programs. Working together, Labcorp and Forge are positioned to accelerate clinical timelines, reduce analytical development constraints, and mitigate potential regulatory challenges related to manufacturing and development processes.
“Labcorp is committed to solving challenges that are critical to addressing patients’ needs and delivering positive health outcomes. Through this strategic partnership with Forge, we can make significant progress to help patients access novel, potentially life-saving drugs,” said Dr. Maryland Franklin, Vice President and Enterprise Head of Cell and Gene Therapy at Labcorp. “Labcorp’s comprehensive gene therapy drug development capabilities and scientific expertise, combined with the full suite of AAV manufacturing capabilities from Forge, will enable us to enhance and accelerate the AAV gene therapy development experience for our customers.”
Forge’s 20 cGMP suites make it one of the largest global AAV manufacturers. Forge’s leadership team has a combined 200 years of hands-on gene therapy experience, providing the specialized skill sets required to design, develop, build, and run gene therapy manufacturing from early clinical stage through commercial scales. Labcorp is an industry leader in drug development solutions for advanced therapies across a variety of disciplines, including preclinical pharmacology, safety and toxicology, comprehensive clinical trials and commercialization services.
“We are delighted to announce this strategic collaboration, which leverages Forge’s extensive AAV manufacturing services and Labcorp’s deep scientific and drug development expertise to provide a more integrated CRO-CDMO experience supporting the advancement of genetic medicines,” said John Maslowski, Chief Commercial Officer of Forge Biologics. “This strategic relationship will allow us to address the unique needs of complex gene therapy development efficiently and consistently to meet our clients’ goal of accelerating the development of these transformational therapies to reach patients in need.”