Solid Biosciences Announces Licensing Agreement with Andelyn Biosciences for the Use of Proprietary Next-Generation Capsid AAV-SLB101

Rhea-AI Summary

Solid Biosciences (Nasdaq: SLDB) announced a non-exclusive worldwide license and collaboration with Andelyn Biosciences for Solid’s proprietary next-generation capsid AAV-SLB101 on Nov 17, 2025. The agreement lets Andelyn offer AAV-SLB101 to gene therapy clients via its AAV Curator® Platform; financial terms were not disclosed. AAV-SLB101 has shown robust preclinical cardiac and skeletal muscle transduction and, as of the safety cutoff on Oct 31, 2025, was generally well tolerated in 23 pediatric participants dosed in the Phase 1/2 INSPIRE DUCHENNE trial (NCT06138639). Solid reports >30 existing agreements/licenses for AAV-SLB101, and the deal aims to broaden access to the capsid for early-stage programs.

Positive

• Non-exclusive worldwide license granted to Andelyn
• AAV-SLB101 generally well tolerated in 23 pediatric participants (safety cutoff Oct 31, 2025)
• >30 agreements already executed for AAV-SLB101
• Preclinical and early clinical data show robust cardiac and skeletal muscle transduction

Negative

• Financial terms of the Andelyn license were not disclosed
• Clinical safety data are limited to 23 participants, a small sample size
• Non-exclusive licensing may limit exclusivity and potential long-term revenue per partner

Insights

Cell & Gene Therapy Commercialization Analyst

Non-exclusive license expands AAV-SLB101 access; early clinical tolerability in 23 pediatric subjects supports commercial interest.

Solid granted Andelyn a non-exclusive worldwide license to use the next-generation capsid AAV-SLB101 within Andelyn’s AAV Curator® Platform, broadening manufacturing access for gene therapy developers while preserving Solid’s ability to sign additional partners. The agreement leverages Solid’s existing commercialization approach, which already includes more than 30 agreements, and pairs a clinically used capsid with a configurable CDMO process to lower operational friction for client programs.

Clinical and safety context matters: AAV-SLB101 was described as generally well tolerated in the 23 pediatric participants dosed as of the safety cutoff on October 31, 2025, and early data plus preclinical biodistribution point to strong skeletal muscle and cardiac transduction with reduced liver biodistribution. These facts support ongoing commercial interest but do not by themselves prove long-term safety or efficacy for broader use.

Key dependencies and near-term monitors include integration of the capsid into Andelyn’s manufacturing workflows, any disclosed financial terms, and upcoming clinical readouts from the Phase 1/2 INSPIRE DUCHENNE program; expect meaningful updates on operational scale-up or clinical milestones within the next 6–18 months.

- Non-exclusive license providing Solid’s proprietary, next-generation capsid, AAV-SLB101, to Andelyn Biosciences, a full-service cell and gene therapy Contract Development and Manufacturing Organization (CDMO) -

- AAV-SLB101 has been generally well tolerated in the 23 participants dosed in the Phase 1/2 INSPIRE DUCHENNE clinical trial as of a safety cutoff of October 31, 2025 -

- Solid continues to expand collaborative efforts for AAV-SLB101 with over 30 agreements including licenses executed -

CHARLESTOWN, Mass., Nov. 17, 2025 (GLOBE NEWSWIRE) -- Solid Biosciences Inc. (Nasdaq: SLDB) (the “Company” or “Solid”), a life sciences company developing precision genetic medicines for neuromuscular and cardiac diseases, today announced a non-exclusive worldwide license and collaboration agreement with Andelyn Biosciences (Andelyn), a pioneering and patient-focused cell and gene therapy Contract Development and Manufacturing Organization (CDMO), for the use of Solid’s proprietary, next-generation capsid, AAV-SLB101.

Under the terms of the agreement, Solid grants Andelyn a non-exclusive worldwide license to provide its gene therapy clients with access to utilize AAV-SLB101 in combination with Andelyn’s suspension and adherent modular platform process, the AAV Curator® Platform, which brings a modular approach to gene therapy CMC processes by optimizing manufacturing and using configurable materials. Specific financial terms of the agreement have not been disclosed.

AAV-SLB101 is Solid’s rationally designed capsid developed for enhanced skeletal muscle and cardiac tropism and reduced biodistribution to the liver. As of the recently reported safety cutoff of October 31, 2025, AAV-SLB101 has been generally well tolerated in the 23 pediatric participants who have been dosed in Solid’s Phase 1/2 INSPIRE DUCHENNE clinical trial (NCT06138639) evaluating investigational Duchenne muscular dystrophy gene therapy SGT-003, which utilizes AAV-SLB101. Robust cardiac and skeletal muscle transduction and biodistribution have been demonstrated in preclinical studies as well as in early clinical data from INSPIRE DUCHENNE.

Bo Cumbo, President and CEO of Solid Biosciences, said, “We are excited to announce a new non-exclusive license for AAV-SLB101 with Andelyn Biosciences. This collaboration reflects our shared mission to accelerate the next generation of gene therapies built upon cutting-edge technologies designed to enhance safety and efficacy. With more than 30 agreements and licenses already in place for the use of AAV-SLB101, we expect our partnership with Andelyn to help trailblaze a brighter future for gene therapy. Their pioneering and configurable CDMO model will broaden access to our proprietary capsid, enabling early-stage gene therapy programs to harness next-generation technology and benefit from the differentiated profile of AAV-SLB101.”

Matt Niloff, Chief Commercial Officer of Andelyn, said, “We are eager to provide our clients with access to Solid’s novel capsid, AAV-SLB101. By integrating this next-generation technology into our AAV Curator® Platform, we can offer an advanced gene therapy vector that has been clinically validated and ultimately may allow for faster and more cost-effective development. Our collaboration with Solid underscores our commitment to providing best-in-class solutions for our clients, empowering researchers and helping to advance transformative medicines for patients.”

About AAV-SLB101
AAV-SLB101 is a proprietary, rationally designed capsid developed for enhanced skeletal muscle and cardiac tropism and reduced liver biodistribution. With a robust preclinical package in mice and nonhuman primates, AAV-SLB101 has demonstrated increased transduction speed, enhanced skeletal and cardiac muscle tropism, decreased liver biodistribution and improved efficiency when compared to first generation capsids. The incorporation of AAV-SLB101 into AAV delivered therapies has the potential to be a step forward in the treatment of neuromuscular and cardiac diseases. Solid Biosciences aims to license AAV-SLB101 broadly to both companies and academic institutions pursuing treatments for rare diseases. Solid has existing agreements, including licenses, with more than 30 corporations, institutions and academic labs for the use of AAV-SLB101.

About Solid Biosciences
Solid Biosciences is a precision genetic medicine company focused on advancing a portfolio of gene therapy candidates targeting rare neuromuscular and cardiac diseases, including SGT-003 for Duchenne muscular dystrophy (Duchenne), SGT-212 for Friedreich’s ataxia (FA), SGT-501 for catecholaminergic polymorphic ventricular tachycardia (CPVT), SGT-601 for TNNT2-mediated dilated cardiomyopathy and additional fatal, genetic cardiac diseases. The Company is also focused on developing innovative libraries of genetic regulators and other enabling technologies with promising potential to significantly impact gene therapy delivery cross-industry. Solid is advancing its diverse pipeline and delivery platform in the pursuit of uniting experts in science, technology, disease management, and care. Patient-focused and founded by those directly impacted by Duchenne, Solid’s mission is to improve the daily lives of patients living with devastating rare diseases. For more information, please visit www.solidbio.com.

About Andelyn Biosciences, Inc.
Andelyn Biosciences is a full-service cell and gene therapy CDMO focused on the development, characterization, and production of viral vectors for gene therapy. With more than 20 years of experience, Andelyn's deep scientific expertise has resulted in the production of cGMP material for more than 450 clinical batches and 75 global clinical trials. Operating out of its development and manufacturing facilities in Columbus, Ohio, Andelyn supports its clients in developing cell and gene therapies from concept through plasmid engineering and manufacturing, process and analytical development, and cGMP clinical and commercial manufacturing. Andelyn can accelerate programs and deliver high-quality products by developing and manufacturing processes on its configurable, data-driven AAV Curator^® Platform or tech transfer in an established client program. Capabilities include cGMP manufacturing for suspension processes up to a 2,000-liter and adherent processes. A rigorous quality system, regulatory support, and supply chain vertical integration further advantages clients in bringing their critical therapies to market. For more information, visit andelynbio.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 future expectations, plans and prospects for the Company; the ability to successfully achieve and execute on the company’s goals, priorities and achieve key clinical milestones; the Company’s pipeline of capsid products, including SLB-101, and programs for neuromuscular and cardiac diseases, including its SGT-003 candidate and other clinical and pre-clinical programs and expectations for clinical development, initiation and enrollment in clinical trials, dosing, availability of clinical trial data and potential accelerated approval;; 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 the company’s ability to advance and license AAV-SLB101 and advance SGT-003 and its other clinical and preclinical programs and capsid libraries on the timelines expected or at all; obtain and maintain necessary approvals from the FDA and other regulatory authorities; replicate in clinical trials positive results found in preclinical studies and early-stage clinical trials of the company’s product candidates; obtain, maintain or protect intellectual property rights related to its capsid libraries and product candidates; compete successfully with other companies that are seeking to develop capsids, capsid libraries, Duchenne, Friedreich’s ataxia and other neuromuscular and cardiac treatments and gene therapies;, 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 the company’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 the company’s most recent filings with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the company’s views as of the date hereof and should not be relied upon as representing the company’s views as of any date subsequent to the date hereof. The company anticipates that subsequent events and developments will cause the company's views to change. However, while the company may elect to update these forward-looking statements at some point in the future, the company specifically disclaims any obligation to do so.

Solid Biosciences Investor Contact:
Nicole Anderson
Director, Investor Relations and Corporate Communications
Solid Biosciences Inc.
investors@solidbio.com

Media Contact:
Glenn Silver
FINN Partners
glenn.silver@finnpartners.com

FAQ

What did Solid Biosciences announce on November 17, 2025 regarding AAV-SLB101 (SLDB)?

Solid announced a non-exclusive worldwide license with Andelyn Biosciences to let Andelyn offer AAV-SLB101 via its AAV Curator® Platform; financial terms were not disclosed.

How many participants had been dosed with AAV-SLB101 in the INSPIRE DUCHENNE trial as of Oct 31, 2025?

As of the safety cutoff on Oct 31, 2025, 23 pediatric participants had been dosed in the Phase 1/2 INSPIRE DUCHENNE trial.

What clinical or preclinical benefits has AAV-SLB101 demonstrated for SLDB?

AAV-SLB101 has shown robust cardiac and skeletal muscle transduction in preclinical studies and early clinical data, and was generally well tolerated in the reported participants.

Does the Andelyn license give exclusive rights to AAV-SLB101 for gene therapy developers?

No, the agreement is described as a non-exclusive worldwide license, allowing other partners to access AAV-SLB101.

How widespread is adoption of AAV-SLB101 according to the announcement?

Solid reported that there are more than 30 agreements and licenses in place for use of AAV-SLB101.