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

Cooler Master Earns Four iF Design Awards 2026 for PC Design Innovation10.3.2026 08:07:00 CET | Press release

COSMOS Alpha, MasterFrame 360 Panorama, Custom GPU Fan Cooling Kit, and MasterFan A120 Recognized for Outstanding Product Design Cooler Master, a global leader in PC components and tech lifestyle solutions, today announced that four of its products have received the iF DESIGN AWARD 2026, one of the world’s most respected design honors presented annually by iF Design in Hamburg, Germany. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260310659475/en/ Cooler Master's winning iF designs: MasterFan A120, MasterFrame 360 Panorama, COSMOS Alpha and Custom GPU Fan Cooling Kit. The award recognizes outstanding achievement in product design, innovation, and user experience. For Cooler Master, the recognition highlights a design philosophy that combines engineering performance with builder-focused creativity. The award-winning products include the COSMOS Alpha, MasterFrame 360 Panorama, Custom GPU Fan Cooling Kit, and MasterFan A120,

GigaDevice Expands GD25UF Series Density Empowering AI Computing with 1.2V Ultra-Low Power Storage10.3.2026 08:00:00 CET | Press release

GigaDevice (HKEX: 3986), a leading semiconductor company specializing in Flash memory, 32-bit microcontrollers (MCUs), sensors, and analog products, today announced the expanded density range of its GD25UF series 1.2V ultra-low power SPI NOR Flash, now spanning from 8Mb to 256Mb. This expansion precisely addresses diverse storage needs across wide range of applications from the advanced high performance AI computing space to the low power battery operated devices. From its intrinsic low-voltage and ultra-low power performance, portable devices like wearables, hearables, AI ASIC platforms, medical devices, and other fast-growing emerging markets can have longer battery life while driving device miniaturization from edge AI to ultra-compact form factors. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260310862079/en/ GD25UF SPI NOR Flash Expanded Density Powering the Low-Voltage SoC Era with a Smarter System Architecture As se

GigaDevice Introduces GD32M531 MCU, Empowering Technological Innovation in Motor Control10.3.2026 08:00:00 CET | Press release

GigaDevice, a leading semiconductor company specializing in Flash memory, 32-bit microcontrollers (MCUs), sensors, and analog products today officially announced the launch of the GD32M531 series 32-bit microcontrollers (MCUs) specifically tailored for motor control applications. Powered by the Arm® Cortex®-M33 core, the series integrates dedicated hardware accelerators for motor control and highly integrated peripheral resources. With exceptional computing performance, precise control capability, and industrial-grade high reliability, it achieves accurate control of dual motors + PFC, providing a high-efficiency and cost-effective solution for various home appliance application scenarios such as air conditioner outdoor units, air source heat pumps, washing machines/dryers, dishwashers, and multi-burner induction cookers. Samples and development boards of the GD32M531 series MCU are now available, and mass production and supply will officially start in April. This press release feature

TTNE Announces the World Sauna Award “SAUNA37 2026”10.3.2026 04:00:00 CET | Press release

TTNE Inc. today announced “SAUNA37 2026”, the world sauna award recognizing 37 sauna destinations worldwide This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260308149186/en/ SAUNA37 Through this initiative, we aim to contribute to the global growth of sauna culture and create a future where people around the world can lead happier and healthier lives through saunas. TTNE was founded by Totonoe Oyakata (Dai Matsuo) and Sauna Master (Daisuke Akiyama), who have personally experienced some of the world's finest saunas. Their desire to establish a similar deep-rooted sauna culture in Japan led to the creation of TTNE. As people once again have the opportunity to explore sauna experiences around the world, SAUNA37 aims to introduce the diverse and unique sauna facilities and cultures across the globe. Through this initiative, we seek to further evolve Japan’s sauna culture while also sharing it with the world. TTNE remains committed

Hexagon Semi’s HX77 AR Display Processor Achieves Ultra-Low Power Consumption with VeriSilicon’s Nano IP Portfolio10.3.2026 01:00:00 CET | Press release

VeriSilicon’s Mature GPU, Display Processing, and DeWarp IPs Collaboratively EnableHighlyIntegrated, Low-Latency AR Display Processing VeriSilicon (688521.SH) today announced that Hefei Hexagon Semiconductor (Hexagon Semi), an image processing SoC provider, has adopted VeriSilicon’s proven IP portfolio in its high-performance HX77 series image processing SoC. The adopted IPs include the GCNanoUltraV 2.5D Graphics Processing Unit (GPU) IP, DW100 DeWarp Processing IP, and DC9200Nano Display Processing IP. The SoC has successfully taped out, achieving a first-pass silicon success. The HX77 series is a highly integrated, low-power image processing SoC based on RISC-V architecture, integrating comprehensive video input/output interfaces, image processing, and system control capabilities. By leveraging an innovative heterogeneous computing architecture and sophisticated power management technology, HX77 has successfully achieved a technological breakthrough that enables 2K@60fps output with

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