• 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.” 

• Manufacturing Partnership to Propel Ray Therapeutics’ Lead Optogenetics Gene Therapy to Phase 1-2 Clinical Trials

SAN DIEGO and COLUMBUS, Ohio – March 1, 2022 – Ray Therapeutics, a biotechnology company developing optogenetic gene therapies for patients with retinal degenerative conditions, and Forge Biologics, a gene therapy-focused contract development and manufacturing organization, announced a manufacturing partnership that will advance Ray Therapeutics’ lead optogenetics gene therapy program, Ray-001, into clinical trials for patients with retinitis pigmentosa.

Forge will provide adeno-associated viral (AAV) process development, scale-up engineering and cGMP manufacturing services for Ray Therapeutics’ program, Ray-001. The program will utilize Forge’s platform process including its proprietary HEK 293 suspension Ignition™ Cells and pEMBR™ adenovirus helper plasmid. All development and cGMP manufacturing activities will occur at The Hearth, Forge’s 200,000 ft² gene therapy cGMP production facility in Columbus, Ohio.

“We have set up Forge to provide end-to-end gene therapy manufacturing services to enable support for clients striving to make significant improvements in patients’ lives,” said Timothy J. Miller, Ph.D., CEO, President, and Co-Founder of Forge. “We look forward to helping Ray Therapeutics advance their AAV manufacturing with an eye towards restoring vision in patients with ophthalmology disorders.”

Ray-001 is intended for use in treating patients with retinitis pigmentosa (RP).  Optogenetics is a promising approach that has the potential to restore useful vision to visually-impaired and blind individuals. Patients with RP have damaged photoreceptors, the primary cells required for vision, which are lost and cannot regenerate. However, inner retinal neurons downstream to photoreceptors, especially retinal ganglion cells (RGCs), persist in significant numbers through late-stage disease.  Ray Therapeutics’ lead candidate Ray-001 uses intravitreal administration, from which the vector diffuses into the retina and transduces primarily the RGCs.

“Ray-001 is a ground-breaking new approach to treat inherited retinal diseases using the power of optogenetics, and working together with Forge, we are one step closer to restoring vision in patients who are going blind,” said Paul Bresge, CEO of Ray Therapeutics.

About Retinitis Pigmentosa
Retinitis pigmentosa (RP), is a heterogeneous group of genetic diseases that cause retinal degeneration leading to near or complete blindness for most patients. The severe loss of photoreceptor cells that occurs in this genetic degenerative disease leads to partial or complete blindness. At present, no effective treatment is available to restore vision once the photoreceptor cells have been lost. Over 100 genetic mutations are known to cause RP and all types of inheritance patterns are recognized.  Patients are typically diagnosed in their late teens, with symptoms including night blindness, reduced visual fields and eventual loss of visual acuity. As the disease progresses, retinal atrophy, and permanent loss of the light sensitive photoreceptors occur.  The prevalence of RP is approximately 100,000 persons affected in the US.

About Ray Therapeutics
Ray Therapeutics is developing novel optogenetics gene therapies for patients with blinding diseases. The company is developing its lead candidate Ray-001 in retinitis pigmentosa, a degenerative retinal disease with significant unmet medical need. The company’s mission is to use optogenetics to restore vision, independent of genetic mutation for patients with inherited retinal diseases. Ray Therapeutics is based in San Diego, CA. For additional information, please visit www.raytherapeutics.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 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
Kimberly Ha – Ray Therapeutics
KKH Advisors
kimberly.ha@kkhadvisors.com

Marina Corleto – Forge Biologics
Senior Manager, Marketing and Communications
media@forgebiologics.com   

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

• Partnership to Bolster Solid Biosciences’ Gene Therapy Pipeline, Including AAV Process Development, Scale Up and cGMP Manufacturing Services

CAMBRIDGE, Mass., and COLUMBUS, Ohio – October 4, 2021 – Solid Biosciences Inc. (Solid, Nasdaq: SLDB), a life sciences company focused on advancing meaningful therapies for Duchenne muscular dystrophy (Duchenne), and Forge Biologics, a cell and gene therapy-focused contract development and manufacturing organization (CDMO), announced a partnership to advance the development and manufacturing of SGT-003, Solid’s next generation gene therapy program for Duchenne. SGT-003 is a preclinical candidate that combines a next-generation and rationally designed capsid with Solid’s proprietary nNOS-containing microdystrophin and has demonstrated enhanced muscle tropism and microdystrophin expression compared to AAV9 in vivo.

Forge will provide an adeno-associated viral (AAV) vector process, scale-up engineering and cGMP manufacturing services for SGT-003. The program will employ Forge’s Blaze™ Vector production platform, and Forge’s proprietary HEK293 suspension Ignition™ Cells and pEMBR™ adenovirus helper plasmid, to support Solid’s clinical development. All development and cGMP manufacturing activities will occur at The Hearth, Forge’s 175,000 ft² gene therapy cGMP production facility in Columbus, Ohio.

“We are excited to partner with Forge, a company who shares our high standards for product purity, potency and reproducibility, to further our ability to bring meaningful therapies to patients with Duchenne,” said Joel Schneider, Ph.D., Chief Operating Officer of Solid Biosciences. “As we continue to develop our pipeline, it is important that we have partners who will enhance our expertise. Uniting Forge’s integrated platforms and cGMP gene therapy manufacturing capabilities with our in-depth knowledge in high dose gene therapy development and manufacturing will introduce an additional method to produce AAV gene therapy at Solid and help to accelerate human proof of concept for SGT-003.”

“We are thrilled to partner with Solid and look forward to providing support and cGMP manufacturing services as they advance their next-generation AAV gene therapy for Duchenne,” said Timothy J. Miller, Ph.D., Chief Executive Officer, President, and Co-Founder of Forge. “Forge’s flexible and scalable manufacturing offerings are an ideal complement to Solid’s development efforts with the shared goal of advancing potential treatments for patients with Duchenne.”

Forward-Looking Statements
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the ability of  Solid to continue dosing patients in the IGNITE DMD trial, the implication of interim clinical data, the safety or potential treatment benefits of SGT-001 in patients with DMD, Solid’s regulatory plans, the Company’s SGT-003 program, including Solid’s expectation for filing an IND, timelines, the sufficiency of Solid’s cash and cash equivalents to fund its operations, and other statements containing the words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “would,” “working” and similar expressions. Any forward-looking statements are based on management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in, or implied by, such forward-looking statements. These risks and uncertainties include, but are not limited to, risks associated with Solid’s ability to continue IGNITE DMD on the timeline expected or at all; obtain and maintain necessary approvals from the FDA and other regulatory authorities; obtain and maintain the necessary approvals from investigational review boards at IGNITE DMD clinical trial sites and the IGNITE DMD independent data safety monitoring board; enroll additional patients in IGNITE DMD and on the timeline expected; Solid’s dosing strategy; replicate in clinical trials positive results found in preclinical studies and earlier stages of clinical development; whether the interim data referenced in this release will be predicative of the final results of the trial or will demonstrate a safe or effective treatment benefit of SGT-001; whether the methodologies, assumptions and applications Solid utilizes to assess particular safety or efficacy parameters will yield meaningful statistical results; advance the development of its product candidates under the timelines it anticipates in current and future clinical trials; successfully optimize and scale its manufacturing process; obtain, maintain or protect intellectual property rights related to its product candidates; compete successfully with other companies that are seeking to develop Duchenne treatments and gene therapies; manage expenses; and raise the substantial additional capital needed, on the timeline necessary, to continue development of SGT-001, SGT-003 and other product candidates, achieve its other business objectives and continue as a going concern. For a discussion of other risks and uncertainties, and other important factors, any of which could cause Solid’s actual results to differ from those contained in the forward-looking statements, see the “Risk Factors” section, as well as discussions of potential risks, uncertainties and other important factors, in Solid’s most recent filings with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent Solid’s views as of the date hereof and should not be relied upon as representing Solid’s views as of any date subsequent to the date hereof. Solid anticipates that subsequent events and developments will cause Solid’s views to change. However, while Solid may elect to update these forward-looking statements at some point in the future, Solid specifically disclaims any obligation to do so.

About Solid Biosciences
Solid Biosciences is a life sciences company focused on advancing transformative treatments to improve the lives of patients living with Duchenne. Disease-focused and founded by a family directly impacted by Duchenne, our mandate is simple yet comprehensive—work to address the disease at its core by correcting the underlying mutation that causes Duchenne with our lead gene therapy candidate, SGT-001. For more information, please visit www.solidbio.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 to reality. Forge has a 175,000 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
Caitlin Lowie – Solid Biosciences
VP, Communications and Investor Relations
clowie@solidbio.com

Marina Corleto – Forge Biologics
Senior Manager, Marketing and Communications
media@forgebiologics.com   

Families and Clinician Inquiries
Dr. Maria Escolar – Forge Biologics
Chief Medical Officer
medicalaffairs@forgebiologics.com

Business Development  
Magdalena Tyrpien – Forge Biologics
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, MSA, CPA – Forge Biologics
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

COLUMBUS and CLEVELAND, Ohio – July 6, 2021 – Forge Biologics, a gene therapy-focused contract development and manufacturing organization (CDMO), has launched the Forge Forward gene therapy workforce development program in partnership with the National Center for Regenerative Medicine (NCRM) at Case Western Reserve University (CWRU). The goal: to train and attract top talent with specialized Good Manufacturing Practice (GMP) training to the company.

“The gene therapy manufacturing boom has created an unmet workforce demand whose training will be foundational for the success of the gene therapy industry. We are especially excited to be partnering with the NCRM to help expand the talent pool of trained gene therapy manufacturers in the Midwest,” said Timothy J. Miller, Ph.D., Chief Executive Officer, President, and Co-Founder of Forge.

Case Western Reserve is a nationally ranked private research university in Cleveland.

The inaugural Forge Forward program will help build and extend Ohio’s leadership in gene and cell therapy manufacturing by enrolling promising students wishing to learn the basics of gene therapy manufacturing. Selected candidates will learn how to work in both research and GMP environments and will gain hands-on experience in cell culture and sterile techniques through both lecture and laboratory teaching.

“The NCRM training environment offers a unique opportunity to respond adeptly to the needs of the regenerative medicine biotechnology industry of the state. We welcome the opportunity to work together to train an outstanding work force,” said Stan Gerson, M.D., Interim Dean of Case Western Reserve’s School of Medicine and NCRM director.

The Forge Forward internship initiative will integrate the experience of NCRM and the Master’s of Regenerative Medicine and Entrepreneurship (RGME), enhancing the educational and experiential exposure to gene therapy technology, manufacturing and clinical development. The goal of the hands-on education program will be to streamline the industry’s workforce development, providing dozens of opportunities for both internship participants and Forge Biologics.    

“This program has the potential to provide the experiential learning our students want and the specific skills they need for employment in this rapidly growing field,” added Cheryl Thompson, Ph.D., Associate Professor and Assistant Dean of Educational Initiatives for the School of Medicine.

About Case Western Reserve University and the NCRM
Case Western Reserve University is one of the country’s leading private research institutions. Located in Cleveland, we offer a unique combination of forward-thinking educational opportunities in an inspiring cultural setting. Our leading-edge faculty engage in teaching and research in a collaborative, hands-on environment. Our nationally recognized programs include arts and sciences, dental medicine, engineering, law, management, medicine, nursing and social work. About 5,100 undergraduate and 6,700 graduate students comprise our student body. Visit case.edu to see how Case Western Reserve thinks beyond the possible. https://case.edu/

The National Center for Regenerative Medicine (NCRM) is a platform to facilitate translational research, clinical application and commercialization of regenerative medicine, tissue engineering, and stem cell therapeutics across a consortium of institutions. NCRM is driven by three nationally ranked, medical research powerhouses, Case Western Reserve University, Cleveland Clinic and University Hospitals. Through this network of researchers and clinicians, research discoveries are actively being translated into cell-based therapies for patient care. https://case.edu/medicine/ncrm

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. www.forgebiologics.com

Media Inquiries
Bill Lubinger – Case Western Reserve University
Associate Vice President of Media Relations and Communications
william.lubinger@case.edu

Dan Salvo – Forge Biologics
Director of Communications and Community Development
Forge Biologics Inc.
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

Careers Inquiries
Mandy Medve – Forge Biologics
Director of Talent Recruitment
Careers@forgebiologics.com