Andelyn Biosciences Partners with Evolyra Therapeutics to Develop Gene Therapy for Limb-Girdle Muscular Dystrophy

Andelyn Biosciences Partners with Evolyra Therapeutics for the Clinical Manufacturing of Gene Therapies for the Treatment of Limb-Girdle Muscular Dystrophies 

It is a leading and patient-focused cell and gene therapy Contract Development and Manufacturing Organisation (CDMO), announced a partnership with Evolyra Therapeutics to manufacture clinical-grade AAV gene therapies for treating types 2C and 2D Limb-Girdle Muscular Dystrophies (LGMDs). 

Chief Commercial Officer at Andelyn Biosciences, Matt Niloff, said Evolyra exemplifies the kind of transformative science we are eager to support. Their approach in 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. 

According to Towards Healthcare, the rare disease-focused cell & gene therapy CDMO market is projected to experience significant growth, with estimates suggesting the market size will increase from USD 8.07 billion in 2026 to approximately USD 37.76 billion by 2035, representing a compound annual growth rate (CAGR) of 18.7% from 2026 to 2035. Growth is driven by the rising demand for personalised medicine solutions, which are often tailored to individual patient genetic information. The emergence of new therapies for rare diseases is creating a need for specialised contract development and manufacturing organisations (CDMOs) to meet the specific requirements of these therapies. 

About Evolyra 

Partnership was announced with Evolyra Therapeutics to manufacture clinical-grade AAV gene therapies for treating types 2C and 2D Limb-Girdle Muscular Dystrophies (LGMDs). Andelyn will utilise 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. 

MD, CEO of Evolyra Therapeutics, Nicholas Johnson, stated 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. 

A recent report by Towards Healthcare highlights that the rare disease-focused cell & gene therapy CDMO market is witnessing growth due to the increasing prevalence of genetic disorders and the need for personalised medicine. The integration of advanced platforms that enable efficiency, scalability, and compliance in manufacturing is crucial for the growth of the CDMO market. 

The North American market is currently the dominant and fastest-growing region for Rare Disease-Focused Cell & Gene Therapy CDMOs. This growth is driven by the increasing demand for innovative and personalised therapies, particularly in the treatment of rare diseases.