Business Wire

MA-FORGE-BIO/SOLID-BIO

Share
Solid Biosciences and Forge Biologics Announce Viral Vector Contract Development and cGMP Manufacturing Partnership

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.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20211004005324/en/

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™ advenovirus 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.”

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 .

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 .

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.

Link:

ClickThru

Social Media:

https://www.facebook.com/forgebiologics

About Business Wire

Business Wire
Business Wire
101 California Street, 20th Floor
CA 94111 San Francisco

http://businesswire.com

Subscribe to releases from Business Wire

Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from Business Wire

Microsize and Schedio Group to Acquire Lonza’s Micro-Macinazione Site in Switzerland24.11.2025 15:05:00 CET | Press release

Microsize, a leading CDMO specializing in particle size reduction and control technologies, today announced it has signed an agreement to acquire Micro-Macinazione (Mic Mac), a dedicated micronization facility in Monteggio, Switzerland, from Lonza. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251124545344/en/ The agreement represents Microsize’s second acquisition from Lonza, following the successful 2022 divestment of its Quakertown, Pennsylvania site. In this transaction, Schedio Group – a Swiss-based provider of jet mills, isolators, spray dryers, and engineering services – is investing alongside Microsize to strengthen and localize its operational base in Europe, advancing a shared vision to lead the next generation of integrated particle engineering solutions. With more than 30 years of experience, Mic Mac has served the pharmaceutical industry with proven GMP-compliant jet milling and micronization capabilities for b

Hytera to Debut S1 E at PMRExpo 202524.11.2025 14:17:00 CET | Press release

Hytera, a leading global provider of critical communications technologies and solutions, today introduced the S1 E, a business-ready, palm-sized two-way radio designed specifically for the retail sector, expanding the portfolio of S Series and providing one more option for retail users to choose for their daily operations. The S1 E will make its debut at PMRExpo, the Europe's premier trade fair for secure, mission- and business-critical communication, taking place from November 25th to 27th, 2025, at Koelnmesse in Cologne, Germany. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251124768341/en/ Hytera New Released Licence-free Analogue Business Radio S1 E Adhering to the S Series’ signature design language, the S1 E combines a stylish, modern, and minimalist aesthetic with practical functionality. Weighing under 85g, the S1 E provides all-day wearing comfort without tugging or weighing down uniforms. Key enhancements and sta

Merck Takes Patient-Directed Approach to Bring Innovation to the Treatment of Rare Neuromuscular Disorder, Generalized Myasthenia Gravis24.11.2025 14:00:00 CET | Press release

Cladribine capsules have the potential to be the first oral treatment for people living with rare, chronic autoimmune neuromuscular disorder, generalized Myasthenia GravisCladribine capsules has received Fast Track designation and Orphan Drug Designation by the US FDAMerck has established an MG patient council to provide insights on how to best meet the needs of patients in the gMG rare disease community Merck, a leading science and technology company, today announced the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for cladribine capsules for the treatment of the rare, chronic autoimmune neuromuscular disorder, generalized Myasthenia Gravis (gMG). In June 2023, the FDA granted Orphan Drug Designation for cladribine capsules for the treatment of gMG. In addition, the Company is actively collaborating with patient organizations and Ad Scientiam, a medical technology company, to support a patient-directed approach to the future management of gMG. If approved

BENEFIT and Ant International Partner to Launch Alipay+ in Bahrain to Achieve Global E-Wallet Connectivity24.11.2025 13:04:00 CET | Press release

Partnership will integrate Alipay+ with BENEFIT, Bahrain’s national QR payment scheme, to enable all Bahraini merchants to accept cross-border digital payments from leading digital wallets and explore outbound payment capabilities. Both parties will explore developing next-generation digital payment framework to support Bahrain’s digital transformation journey. BENEFIT, the Bahraini innovator and a leading company in fintech and electronic financial transactions service, and Ant International, a leading global digital payment, digitisation and financial technology provider, headquartered in Singapore, have partnered to launch cross-border QR payments between Bahrain’s BENEFIT QR payment scheme and Ant International’s global wallet gateway, Alipay+, during 2026 to support the transition toward a more inclusive digital payments ecosystem. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251124405672/en/ (L-R): Hessa Husain, Depu

NIQ Joins TikTok Marketing Partners Program Earning Media Mix Modeling Badge24.11.2025 12:00:00 CET | Press release

Recognition underscores NIQ’s leadership in delivering advanced analytics and full-funnel outcomes measurement on TikTok. NIQ, a global leader in consumer intelligence, has earned a partner badge in TikTok’s newly launched Media Mix Modeling (MMM) program – a focus area within TikTok’s Marketing Partners Program. The Marketing Partners Program is composed of carefully selected third-party partners across different categories and specialties who have met TikTok’s rigorous standards for quality and expertise. Badging signals advanced proficiency in media analytics, ensuring state-of-the-art MMM measurement for marketers around the world. As a badged MMM Marketing Partner, NIQ can help advertisers measure the full funnel impact of their marketing campaigns on TikTok and TikTok Shop, enabling them to optimize strategies based on data-driven insights that look beyond last click attribution. As part of the Marketing Partners Program, TikTok’s new reporting API is integrated into NIQ, providi

In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.

Visit our pressroom
World GlobeA line styled icon from Orion Icon Library.HiddenA line styled icon from Orion Icon Library.Eye