Lonza, a global leader in the field of viral therapy manufacturing, and Celladon Corporation, a biopharmaceutical company focused on the discovery and development of innovative treatments for cardiovascular diseases, have entered into a process transfer and GMP manufacturing agreement. Under the terms of the agreement, Lonza will manufacture cGMP-grade Mydicar (AAV1/SERCA2a) for use in future clinical trials.
In the event Celladon intends to commence commercial scale manufacture of Mydicar, Celladon and Lonza have agreed to negotiate a commercial scale supply agreement.
“We are pleased to partner with Celladon in the manufacture of Mydicar,” said David Enloe, Lonza’s Head of Viral-based Therapeutics. “In particular, this is an exciting project for Lonza in that we will be producing materials for Celladon beginning at the 1,000 liter scale and likely expanding to 2,000 liters, which our recently completed and validated GMP suite was specifically designed to support.”
Lonza offers a full range of services that cell and gene therapy clients rely upon for commercial success. Each client is provided with a team of scientists equipped with the knowledge and experience required to translate therapies into scalable, clinical-grade products complete with process development activities, product quality testing, product storage, and distribution.
”This is an important milestone in the Mydicar development programme,” said Krisztina Zsebo, president and CEO of Celladon Corporation. “Lonza’s large scale viral manufacturing expertise will greatly complement and support our future development and commercialization efforts for Mydicar.”
Mydicar is a genetically targeted enzyme replacement therapy intended to restore levels of SERCA2a, a regulator of calcium cycling in the heart and cardiac contractility. SERCA2a levels decline in all forms of late-stage Heart Failure resulting in deficient heart function. With Mydicar , the SERCA2a gene is delivered using recombinant adeno-associated virus (AAV) as the vector. AAV is a naturally occurring virus not associated with any disease in humans. Mydicar red in a single dose directly to the heart during a routine outpatient cardiac catheterization procedure, similar to an angiogram. Mydicar is currently under clinical investigation in a 200 patient phase II b clinical trial in NYHA Class III/IV heart failure patients.