Andelyn Biosciences Partners with Evolyra Therapeutics for the Clinical Manufacturing of Gene Therapies for the Treatment of Limb-Girdle Muscular Dystrophies
Andelyn Biosciences, a leading and patient-focused cell and gene therapy Contract Development and Manufacturing Organization (CDMO), announced today a partnership with Evolyra Therapeutics to manufacture clinical-grade AAV gene therapies for treating types 2C and 2D Limb-Girdle Muscular Dystrophies (LGMDs). Andelyn will utilize its proprietary AAV Curator® Platform to support Evolyra's gene therapy development programs targeting LGMDR3 and LGMDR5, two severe forms of muscular dystrophy for which there is currently no cure.
Evolyra is developing next-generation gene therapies using a proprietary muscle-targeting AAV vector (AAVMYO2). This vector substantially improves skeletal muscle expression and significantly decreases liver toxicity compared to first-generation vectors. The company has achieved successful preclinical results, demonstrating complete protein expression and muscle restoration in animal models.
"Evolyra exemplifies the kind of transformative science we are eager to support," said Matt Niloff, Chief Commercial Officer at Andelyn Biosciences. "Their innovative approach to treating LGMDs with an AAV gene therapy aligns with our mission to accelerate access to life-changing treatments for patients with rare and ultra-rare diseases. We are very honored to help bring this breakthrough therapy to the patients who need it most."
“We appreciate the partnership and commitment from Andelyn Biosciences. Their platform will allow a seamless transition between the different phases of our therapeutic development, ultimately accelerating our ability to bring these therapies to individuals living with LGMD as quickly as possible,” said Nicholas Johnson, MD, CEO of Evolyra Therapeutics.
This manufacturing partnership supports Evolyra's development timeline, which includes IND submission in the second half of 2026, followed by Phase I/II clinical trials. Evolyra recently completed a $5 million seed funding round and is currently raising a $20 million Series A to advance these programs.
LGMDs comprise about 32 rare genetic muscle disorders that lead to progressive muscle weakness and wasting, often beginning in the hip and shoulder muscles. The current global market for LGMD treatments exceeds $100 billion and impacts over 580,000 patients worldwide. Evolyra's initial programs focus on LGMDR3 and LGMDR5, which represent an $11 billion market with approximately 20,000 patients worldwide.
Andelyn's AAVCurator® Platform offers flexible, high-quality manufacturing solutions tailored for rare disease therapies, helping biotech companies to advance from preclinical stages to clinical trials with speed and precision.
About Andelyn Biosciences
Andelyn Biosciences is a full-service cell and gene therapy CDMO focused on developing, characterizing, and producing 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 500 clinical batches and 85 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 Curator® Cell and Gene Therapy Platforms, or by tech transfer within an established client program. Capabilities include cGMP manufacturing for suspension and adherent processes. A rigorous, commercial-grade quality system, phase-appropriate manufacturing, and supply chain vertical integration further help clients bring critical therapies to market.
For more information, please visit andelynbio.com and follow Andelyn Bioscienceson LinkedIn.
For Andelyn Biosciences media inquiries, please contact: media@andelynbiosciences.com.