Lonza wins contract to make gene therapy for heart failure
pharmafile | October 2, 2012 | News story | Manufacturing and Production |Â Â Celladon, Lonza, MydicarÂ
Lonza has been awarded a contract by US firm Celladon for the manufacture of Mydicar, a gene therapy-based drug candidate that has just started Phase IIb clinical trials.
Mydicar (AAV1/SERCA2a) is an adeno-associated virus-based therapy that is designed to restore levels of SERCA2a, a regulator of calcium cycling in the heart and cardiac contractility. The first patient received the therapy in August in a trial which is due to conclude in 2013 if enrolment proceeds on schedule.
Under the terms of the deal with Lonza, the Swiss contract manufacturer will undertake process transfer and Good Manufacturing Practice (GMP) production of the gene therapy for use in clinical trials.
Lonza has developed viral-based therapy manufacturing capacity at its facility in Houston, opening a GMP production suite there earlier this year, and Celladon is one of the first major deals to be announced involving the new unit.
The new suite was specifically designed to address what Lonza has previously said was a lack of production capacity to serve higher-volume viral drug projects.
The cleanroom suite at Houston can support multiple types of viral vector and viral vaccine projects, with working volumes up to 2,000 litres, and was completed just two years after Lonza made the decision to enter the viral manufacturing space.
“This is an exciting project for Lonza in that we will be producing materials for Celladon beginning at the 1,000 litre scale and likely expanding to 2,000 litres, which our recently completed and validated GMP suite was specifically designed to support”, said David Enloe, Lonza’s head of viral-based therapeutics.
In the Phase IIb trial – called CUPID – Mydicar or placebo will be administered to around 200 patients at 50 trial sites around the world.
The primary objective of the study is to see if Celladon’s drug can prolong the time heart failure patients spend before requiring hospitalisation for their condition related to ‘terminal’ events, such as death, a heart transplant or left ventricular assist device (LVAD) implantation.
Phil Taylor
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