- Andelyn Biosciences has partnered with Evolyra Therapeutics to manufacture clinical-grade AAV gene therapies targeting LGMDR3 and LGMDR5.
- Evolyra plans to submit an IND in the second half of 2026, followed by Phase I/II clinical trials.
Andelyn Biosciences has entered into a manufacturing partnership with Evolyra Therapeutics to produce clinical-grade adeno-associated viral (AAV) gene therapies targeting types 2C and 2D Limb-Girdle Muscular Dystrophies (LGMDs). The collaboration will support Evolyra’s development programs for LGMDR3 and LGMDR5, two forms of muscular dystrophy for which no cure currently exists.
Under the agreement, the CDMO will utilize its proprietary AAV Curator® Platform to manufacture gene therapy candidates designed to treat these rare genetic disorders. Evolyra is developing therapies using its AAVMYO2 vector, which is designed to improve skeletal muscle expression while reducing liver toxicity compared to earlier-generation vectors.
The partnership is intended to support Evolyra’s clinical development timeline, including an Investigational New Drug (IND) submission planned for the second half of 2026, followed by Phase I/II clinical trials. Evolyra has also completed a $5 million seed funding round and is currently raising a $20 million Series A to advance its programs.
Limb-Girdle Muscular Dystrophies comprise approximately 32 rare genetic disorders that lead to progressive muscle weakness and degeneration. According to the company, the global market for LGMD treatments exceeds $100 billion, with more than 580,000 patients affected worldwide. Evolyra’s initial focus on LGMDR3 and LGMDR5 represents an estimated $11 billion market with around 20,000 patients.
“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.”
Matt Niloff, Chief Commercial Officer at Andelyn Biosciences
