Business Wire

MA-FORGE-BIO/SOLID-BIO

4.10.2021 14:02:10 CEST | Business Wire | Press release

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

Beacon Acquires Haize Labs to Power AI for the Real Economy17.9.2026 16:30:00 CEST | Press release

Haize Labs leadership will anchor Beacon’s new applied AI research group, accelerating the deployment of AI across the essential businesses Beacon owns Beacon Software (Beacon), the first centralized AI holding company, today announced that it has acquired Haize Labs, an AI reliability company that tests and safeguards AI agents for real-world deployment. The Haize Labs team will join Beacon to form its Applied AI Research Group, with co-founder and CEO Leonard Tang joining as VP of AI Research to lead the AI operating system that is deployed across Beacon’s companies. Beacon believes that the fastest way to bring AI to the traditional economy is through the software businesses that essential industries already use and trust, equipping them with AI infrastructure. Beacon acquires these businesses for long-term growth and connects them to a centralized AI operating system that compounds with each additional acquisition and industry. The addition of the Haize Labs team will strengthen th

TIMELAB Develops OEM/ODM Hair Straightener Reaching 200°C at All Three Measured Points in 15 Seconds17.9.2026 16:00:00 CEST | Press release

Testing at 230 V with a 260°C setting confirmed at least 200°C after 15 seconds at all three measured plate locations (front, center and rear), not just a single point. TIMELAB Co., Ltd., a Japanese beauty-appliance OEM/ODM provider, has developed a hair straightener for OEM/ODM customization for international hair care brands and professional markets. In testing at 230 V with a 260°C setting, all three measured plate locations reached at least 200°C after 15 seconds. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260914187865/en/ Three-Point Plate Testing A European-market development unit with a maximum setting of 260°C was tested at 230 V. Fifteen seconds after power-on, readings at the front, center and rear were 212.5°C, 227.5°C and 200.0°C, respectively. From around 60 seconds onward, temperature differences among the three points narrowed, indicating a stable trend. Precision Temperature Control An NTC sensor inside t

Earnix Brings Agentic AI to the Decisions That Drive Insurance Performance17.9.2026 15:09:00 CEST | Press release

Agent Hub, part of Earnix AIOS, brings more than 25, insurance-specific agents and apps into Earnix’s governed pricing, underwriting, and customer decision solutions- improving workflows and business performance Earnix today announced the introduction of Agent Hub, a curated catalog of insurance-specific AI agents and apps within Earnix AIOS — the AI Orchestration System powering Earnix’s pricing and rating, underwriting, and customer engagement solutions. Agent Hub brings agentic AI directly into these solutions, enabling more intelligent workflows and strengthening the high-stakes decisions that shape pricing, underwriting, customer engagement, growth, and profitability. In an increasingly turbulent insurance environment, the useful life of an insurance decision is getting shorter. Risk and market conditions are changing faster, making growth, profitability, and portfolio performance harder to manage. AI is increasing the speed and scope of what insurers can analyze, recommend, and i

Medisca Launches Global Peptide Division17.9.2026 15:07:00 CEST | Press release

New division brings API-grade peptides and Medisca’s quality-first pharmaceutical expertise to a rapidly evolving area of personalized medicine Medisca today announced the launch of Medisca Peptides, a dedicated global division focused on expanding access to API-grade peptides and building an integrated peptide platform for pharmaceutical and personalized medicine markets worldwide. As the peptide landscape evolves, Medisca is proactively building the capabilities and infrastructure needed to support API-grade peptides within applicable regulatory frameworks. The launch represents a significant long-term commitment to peptides, including the expansion of Medisca’s portfolio, strategic manufacturing relationships, and the pharmaceutical infrastructure needed to support the category’s growth. It also signals Medisca’s ambition to become a leading force in the next generation of peptide innovation. For Medisca, the opportunity is familiar. More than 35 years ago, the company was founded t

Elliptic Launches Its Decode Agent to Answer On-Chain Risk Questions and Shows Its Work17.9.2026 15:00:00 CEST | Press release

Hours of tracing, answered in seconds, with the evidence attached Elliptic, the global leader in on-chain risk, today launched Decode, an AI agent built on Elliptic’s intelligence platform. The Decode agent answers natural-language questions about cryptoasset addresses and their exposure in seconds, and returns the evidence behind every answer. Compliance and investigations teams need answers to questions nobody planned for. Getting them out of the data is now a specialist skill, so the questions wait for someone who has it, or go unasked. Meanwhile illicit actors move at machine speed, and agents are starting to sit on both sides of a payment. General-purpose AI assistants can produce an answer. They cannot show where it came from. A fluent response with nothing behind it cannot be put in front of a second-line reviewer, an auditor, or a regulator. “The market is full of AI that asks to be trusted. That is not good enough when someone asks how you reached a decision,” said Jackson Hul

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