• Four oral presentations and four scientific poster presentations highlight Forge’s AAV manufacturing capabilities and a clinical update on its FBX-101 AAV gene therapy for patients with Krabbe disease

COLUMBUS, Ohio – May 11, 2023 – Forge Biologics, a leading manufacturer of genetic medicines, announced today that eight presentations, including four oral presentations, will be delivered during the upcoming 26th Annual Meeting of the American Society of Gene and Cell Therapy (ASGCT), taking place May 16-20, 2023, in Los Angeles, California.

“Forge’s presentations at ASGCT highlight the 2023 accomplishments of our team, particularly cell line and plasmid developments, as we expand our bespoke AAV manufacturing platform capabilities to deliver advanced solutions for gene therapy developers,” said Timothy J. Miller, Ph.D., CEO, President, and Co-Founder of Forge Biologics.  “We are delighted to showcase our team’s contributions and Forge’s progress for patients as well we continue to provide solutions for industry-wide gene therapy manufacturing challenges.”

SESSION PRESENTATIONS
Title: The CDMO-Developer Partnership: Solving Complex Challenges in Gene Therapy Development & Manufacturing, Together 
Moderator: Timothy J. Miller, Ph.D., CEO, President, and Co-Founder, Forge Biologics
Panelists:

  • Paul Bresge, Chief Executive Officer​, Ray Therapeutics
  • David Dismuke, Ph.D., Chief Technical Officer, Forge Biologics
  • Sadik Kassim, Ph.D., Chief Technical Officer​, Danaher
  • Shen Shen, Ph.D., Senior Director, AAV Technologies​, Vertex Pharmaceuticals​

Session: Exhibitor Showcase  
Date and Time: Wednesday, May 17, 2023, 9:15-9:45 a.m. PT
Room: 409 AB

Title: Building an Improved Platform Process for AAV Manufacturing 
Presenter: David Dismuke, Ph.D., Chief Technical Officer, Forge Biologics
Session: Tools & Technology Forum  
Date and Time: Wednesday, May 17, 2023, 3:45-4:00 p.m. PT
Room: Presentation Theater in the Exhibit Hall

Title: Strategic Collaborations Today for the Gene Therapies of Tomorrow 
Presenter: Panel hosted by Labcorp featuring John Maslowski, Chief Commercial Officer, Forge Biologics
Session: Industry Sponsored Symposium  
Date and Time: Friday, May 19, 2023, 12:00-1:30 p.m. PT
Room: 409 AB

Title: RESKUE: First in Human Phase 1/2 Clinical Trial of Intravenous FBX-101 (AAVrh10.hGALC) Administered After Cord Blood Transplantation in Patients with Infantile Krabbe Disease
Presenter: Maria Escolar, M.D., Chief Medical Officer, Forge Biologics
Session: Gene and Cell Therapy Trials in Progress
Date and Time: Saturday, May 20, 2023, 11:30-11:45am PT
Room: Concourse Hall 150 and 151

POSTER PRESENTATIONS
Title: Development of Chromatography Based Separation of Empty and Full Capsids in rAAV Manufacturing Process 
Presenter/poster: Corben Davis, Senior Scientist, Downstream Process Development (Poster Board no. 398)
Date and Time: Wednesday, May 17, 2023, 12:00 p.m. PT  

Title: The Impact of the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 on Advanced Therapy Medicinal Product Developers 
Presenter/poster: Claire Marasco, Senior Manager, Regulatory Affairs (Poster Board no. 995)
Date and Time: Thursday, May 18, 2023, 12:00 p.m. PT  

Title: Navigating the EU Clinical Trial Regulation (536/2014): Key Considerations for ATMP Developers 
Presenter/poster: Claire Marasco, Senior Manager, Regulatory Affairs (Poster Board no. 799)
Date and Time: Wednesday, May 17, 2023, 12:00 p.m. PT  

Title: Advanced Characterization of DNA Molecules in rAAV Vector and Plasmid DNA Manufacturing Preparations by Next Generation Preparations Sequencing 
Presenter/poster: Esko Kautto, Ph.D., Scientist II, Bioinformatics (Poster Board no. 1345)
Date and Time: Friday, May 19, 2023, 12:00 p.m. PT  

Full abstracts are available on the ASGCT Annual Meeting website, and conference participants can also access posters through the ASGCT website.

Forge Biologics will be at booth #540 in the Exibitor Hall.

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
Marina Corleto – Forge Biologics
Associate Director, Marketing and Communications
media@forgebiologics.com   

Business Development  
Magdalena Tyrpien – Forge Biologics
Senior Vice President, Head of Business Development  
BD@forgebiologics.com   

Client Development
Taleen Barsoumian – Forge Biologics
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

 

 
  • Forge to provide manufacturing and development services for Oculogenex’s novel AAV gene therapy to improve vision in patients with macular degeneration

LA HABRA, Calif., and COLUMBUS, Ohio – January 10, 2023 – Oculogenex, a biotech company developing a novel adeno-associated viral (AAV) gene therapy treatment to stop the degeneration of central vision in patients, and Forge Biologics, a gene therapy-focused contract development and manufacturing organization, today announced a manufacturing partnership to help support the advancement of Oculogenex’s gene therapy program for dry age-related macular degeneration (AMD) toward clinical trials.

Forge will provide AAV process and analytical development, and manufacturing services for Oculogenex. The program will utilize Forge’s platform process, including its proprietary HEK 293 suspension Ignition™ cell line and pEMBR™ adenovirus helper plasmid. All AAV development and manufacturing activities will occur at the Hearth, Forge’s 200,000 square foot gene therapy cGMP production facility in Columbus, Ohio.

“We are excited to announce our partnership supporting Oculogenex’s efforts in developing a gene therapy that has the potential to dramatically change and improve the quality of life for patients suffering from dry AMD,” said John Maslowski, Chief Commercial Officer of Forge Biologics. “Their work is incredibly important to patients, and we look forward to delivering the resources and scale as their preferred AAV manufacturing partner on this endeavor.”

Oculogenex’s investigational approach is a novel ocular regenerative AAV gene therapy that is delivered as a one-time injection into the eye. Preclinical data demonstrate that this approach makes retinal cells more resistant to stress, helps cells repair damage, and increases the cells’ lifespans. The approach has the potential to activate dormant stem cells in the retina to replace lost tissue. Post-administration benefits have been demonstrated in preclinical research, and the company is completing additional preclinical research to prepare for entry into Phase I clinical trials.

“We started this company because there were no treatments available for patients with dry age-related macular degeneration,” said Hema Ramkumar, M.D., CEO and Founder of Oculogenex. “I am thrilled to be partnering with Forge to be able to offer better options to these patients, with promise for other patients living with degenerative blinding retinal diseases.”

About Age-Related Macular Degeneration
Age-related macular degeneration (AMD) is the leading cause of irreversible vision loss in patients over 60 in the United States and a leading cause of vision loss in the world. Patients with early forms of the disease may see wavy lines or distorted vision and have difficulty seeing and reading. Those affected by advanced disease have loss of central vision and cannot see the object they are trying to focus on. For elderly patients, the inability to read correlates with loss of independence, disability, depression, increased risk of falls, and mortality. Advanced age-related macular degeneration is either geographic atrophy (the dry type) or wet macular degeneration, which is treated with frequent injection therapy. There are no current treatments for dry age-related macular degeneration. 

About Oculogenex
Oculogenex is a biotech company utilizing gene therapy to improve vision in patients with degenerative retinal diseases. The California-based company is developing a gene therapy treatment to stop the degeneration of central vision in patients with age-related macular degeneration. The therapy has the potential to dramatically improve the quality of life of patients living with blinding retinal diseases and no treatment options. To learn more, visit www.oculogenex.com.

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
Ram Ramkumar, Ph.D. – Oculogenex
ram@oculogenex.com

Marina Corleto – Forge Biologics
Associate Director, Marketing and Communications
media@forgebiologics.com  

Client Development
John Maslowski – Forge Biologics
Chief Commercial Officer
CD@forgebiologics.com

 

 

  • Five scientific poster presentations highlight scalable process and analytical developments for AAV manufacturing

COLUMBUS, Ohio – May 2, 2022 – Forge Biologics, a gene therapy-focused contract development and manufacturing organization, announced today that it will deliver seven presentations during the upcoming American Society of Gene and Cell Therapy’s (ASGCT) 25th Annual Meeting, taking place May 16-19, 2022, in Washington, D.C. Timothy J. Miller, Ph.D., CEO, President, and Co-Founder of Forge Biologics, and David Dismuke, Ph.D., Chief Technical Officer, will give two oral presentations in addition to five manufacturing-focused scientific poster presentations delivered by additional Forge team members.

“Finding safer, more efficient, and accurate manufacturing processes are critical for successful AAV manufacturing campaigns, and we are delighted to showcase Forge’s advances over the past year at ASGCT,” said Dr. Miller. “The upcoming presentations highlight how AAV platform process development can accelerate a program from research to clinical stage cGMP manufacturing at large scale, and we are pleased to share analytical assays that can increase confidence in product safety.”

SESSION PRESENTATIONS
Title: How to Raise Seed/Series A Funding from Institutional Biotech VCs for a CGT Startup
Presenter: Timothy J. Miller, Ph.D., CEO, President, and Co-Founder, Forge Biologics
Session: Scientific Symposia, Translating Science into Medicine: Moving from Bench to Startup (Session 1 of 2), Salon G
Date and time: Monday, May 16, 2022, 8:48–9:36 a.m.

Title: Platform Process Development for AAV Manufacturing
Presenter: David Dismuke, Ph.D., Chief Technical Officer, Forge Biologics
Session: Industry Interactions, Tools and Technology Forum III, Room 209
Date and time: Wednesday, May 18, 2022, 4:15–4:30 p.m.

POSTER PRESENTATIONS
Title: Development of a qPCR Assay Targeting Alu Repeat Elements as a More Sensitive Method for the Detection of Residual Host Cell DNA in rAAV Drug Product
Presenter/poster: Julianne Bartz, Scientist II, Analytical Development (poster board no. M-278)
Date and time: Monday, May 16, 2022, 5:30 p.m.

Title: Clarification Studies on HEK293 Cell Lysate for AAV Production
Presenter/poster: Blake Gursky, Scientist I, Process Development (poster board no. M-281)
Date and time: Monday, May 16, 2022, 5:30 p.m.

Title: Downstream Process Development for AAV Manufacturing from 1L to 500L Batch Sizes
Presenter/poster: Corben Davis, Scientist II, Process Development (poster board no. Tu-264)
Date and time: Tuesday, May 17, 2022, 5:30 p.m.

Title: Platform Process Development for AAV Production
Presenter/poster: Frank Agbogbo, Ph.D., Vice President, Process Development (poster board no. Tu-265)
Date and time: Tuesday, May 17, 2022, 5:30 p.m

Title: Transient Transfection and Scale-Up of AAV Production from 1L to 500L in Bioreactors
Presenter/poster: Steven Wesel, Associate Director, Process Development (poster board no. Tu-263)
Date and time: Tuesday, May 17, 2022, 5:30 p.m.

Full abstracts are available on the ASGCT Annual Meeting website, and conference participants can also access posters through the ASGCT 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 has a 200,000 square foot facility in Columbus, Ohio, the Hearth, to serve as its headquarters. The Hearth is a custom-designed cGMP facility dedicated to AAV vector manufacturing and will 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   

Business Development  
Magdalena Tyrpien – Forge Biologics
Senior Vice President, Head of Business Development  
BD@forgebiologics.com   

Client Development
John Maslowski – Forge Biologics
Chief Commercial Officer
CD@forgebiologics.com

Investor Relations  
Christina Perry – Forge Biologics
Senior Vice President, Finance and Investor Relations  
Investors@forgebiologics.com   

 

  • Partnership to support GentiBio’s cell therapy pipeline with AAV process development, scale up and GMP manufacturing services

BOSTON, SEATTLE, and COLUMBUS, Ohio – July 15, 2021 – GentiBio, Inc., an emerging biotherapeutics company developing best-in-class engineered regulatory T cells programmed to treat autoimmune, alloimmune, autoinflammatory, and allergic diseases, and Forge Biologics, a cell and gene therapy-focused contract development and manufacturing organization (CDMO), announced a strategic development and manufacturing partnership today to advance GentiBio’s unique immune tolerance platform.

Forge will provide adeno-associated viral (AAV) vector process and analytical development, scale-up engineering and GMP manufacturing services for GentiBio’s engineered Tregs therapeutic candidates. The program will employ both Forge’s Blaze™ Vector production platform and HEK 293 Suspension Ignition™ Cells to facilitate GentiBio’s development process. All development and GMP activities will occur at The Hearth, Forge’s 175,000 ft2 gene therapy GMP production facility in Columbus, Ohio.

“We are thrilled to partner with Forge Biologics and their experienced team to further develop our lead engineered Treg program and take a critical step in advancing our therapies to patients in need,” said Andy Walker, Ph.D., co-founder and Chief Technology Officer of GentiBio. “Forge offers a broad array of services ranging from process development to GMP manufacturing, making them a strong partner for GentiBio’s cell therapies with capacity to support GentiBio as we advance programs through clinical development.”

Forge’s Hearth is the home of a state-of-the-art cGMP facility dedicated to AAV viral vector manufacturing and will host end-to-end manufacturing services to accelerate cell and gene therapy programs from preclinical through clinical and commercial stage manufacturing. Forge offers product and analytical development services, cGMP manufacturing and regulatory support services.

“Our team is excited to embark on this partnership with GentiBio to meet their viral vector manufacturing needs and help them advance to clinical trials,” said Timothy J. Miller, Ph.D., Chief Executive Officer, President, and Co-Founder of Forge. “Forge is committed to providing quality AAV manufacturing to all stages of program development, and this partnership highlights the Forge team’s capabilities to help innovators such as the GentiBio team on their path to success.”

About GentiBio
GentiBio, Inc., is an emerging biotherapeutics company co-founded by pioneers in Treg biology and synthetic immunology to develop engineered regulatory T cells programmed to treat autoimmune, alloimmune, autoinflammatory and allergic diseases. GentiBio’s proprietary autologous and allogeneic EngTregs platform integrates key complementary technologies needed to successfully restore immune tolerance and overcome major limitations in existing regulatory T cell therapeutics. GentiBio is at the forefront of leveraging a unique therapeutic modality that can be used to address the fundamental cause of many diseases that result from overactivity and/or malfunctioning of the immune system. To learn more, visit https://www.gentibio.com

About Forge Biologics
Forge Biologics is a hybrid gene therapy contract manufacturing and therapeutics development company. Forge’s mission is to enable access to life changing gene therapies and help bring them from idea into reality. Forge has a 175,000 ft2 facility in Columbus, Ohio, The Hearth, to serve as their headquarters. The Hearth is the home of a custom-designed cGMP facility dedicated to AAV viral vector manufacturing and will 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 is building on the theme of “Hope in Ohio” to accelerate the timelines of these transformative medicines for those who need them the most. To learn more, visit www.forgebiologics.com

Media Inquiries
Marites Coulter – GentiBio
Verge Scientific, Inc.
mcoulter@vergescientific.com

Dan Salvo – Forge Biologics
Director of Communications and Community Development
media@forgebiologics.com

Business Development
Magdalena Tyrpien – Forge Biologics
Vice President and Head of Business Development
BD@forgebiologics.com

Investor Relations
Christina Perry – Forge Biologics
Vice President, Finance and Operations
Investors@forgebiologics.com