Cell therapy weekly: FDA clears Investigational New Drug application for Parkinson’s Disease cell therapy
This week: AGC Biologics (Milan, Italy) completed the expansion of its cell and gene therapy manufacturing site, Mekonos (CA, USA) appointed a new Chief Operating Officer and the US FDA cleared an Investigational New Drug (IND) application for an autologous cell therapy to treat Parkinson’s Disease.
The news highlights:
Expansion completed at Milan cell and gene therapy manufacturing site
AGC Biologics has completed the expansion of its manufacturing facility at the Milan Cell & Gene Center of Excellence. This is one of the company’s two cell and gene facilities within its global network. The expansion added one 50L, two 200L and two 1000L suspension bioreactors to meet the demand of upcoming viral vector manufacturing projects. The facility’s process development lab has also been expanded and a new fully dedicated 100m2 warehouse space has been added.
“This is another important milestone for our site and for the AGC Biologics global Cell and Gene network as we prepare to serve more developers,” said Luca Alberici, General Manager of AGC Biologics Milan. “Thanks to this expansion we have the flexibility to support companies from clinical to commercial stages for in vivo end ex vivo gene therapy applications and can manufacture adeno-associated and lentiviral vectors from medium 50L scales to as large as 2,000L. When you combine this with our development, analytical and fill/finish services, this site can offer cell and gene developers any type of support they need throughout their product’s lifecycle.”
Mekonos appoints new Chief Operating Officer
Benjamin Borgo has been appointed as Chief Operating Officer of Mekonos, a biotechnology platform company building a cell-engineering platform that utilizes scalable silicon technology for the ex vivo delivery of molecules into any cell type. Dr Borgo will be responsible for the development and implementation of operational strategies to support business growth.
“We are delighted to welcome Ben to the Mekonos leadership team during this important phase of the company’s growth,” stated Anil Narasimha, co-founder and CEO of Mekonos. “His forward-looking leadership style and operational experience – which includes building highly effective teams and brokering successful industry partnerships and alliances – will be invaluable as we continue to advance our integrated cell-engineering platform.”
IND clearance for Parkinson’s Disease cell therapy
The US FDA has cleared Aspen Neuroscience’s (CA, USA) IND application for ANPD001, an autologous iPSC-derived neuron replacement to treat Parkinson’s Disease. The therapy utilizes iPSCs, reprogrammed from patient skin cells, to replace dopaminergic neurons that were lost or damaged due to the disease.
This approval enables the company to proceed with a first-in-patient Phase I/IIa clinical trial to evaluate the safety, tolerability and preliminary efficacy of ANPD001 in patients with moderate to severe Parkinson’s Disease.
“The IND clearance of ANPD001 sets in motion a path toward a new treatment for the more than one million Americans and 10 million people worldwide with Parkinson’s disease,” said Damien McDevitt, President and CEO of Aspen Neuroscience. “Our visionary team is working to make personalized regenerative medicine a reality, and we look forward to advancing this cell therapy for patients who are waiting.
