AGC and Genenta expand manufacturing agreement

AGC Biologics has entered into a development and manufacturing services agreement with Genenta to produce its cell therapy lentivirus-based product.

The agreement, of which financial details have not been divulged, builds on the existing relationship between hematopoietic stem progenitor cell therapy developer Genenta and contract development manufacturing organization (CDMO) AGC.

Genenta already had an existing manufacturing services agreement with Molecular Medicine’s (MolMed’s) Milan, Italy facility, which AGC acquired for $284 million in August 2020. Since 2016, the site has been manufacturing lentiviral vectors as well as drug product for various Geneta programs.

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The services provided under this existing agreement are addition to those that will be required under the AGC manufacturing services agreement.

Genenta’s lenti-virus based hematopoietic stem progenitor cell immune-therapy, Temferon, enables controlled and specific interferon-a expression within different cancers. It is delivered biologically through engineered tumor infiltrating monocytes and aims to create immune responses to TEMs positive tumors.

“The expansion of our existing relationship with AGC Biologics underscores the progress of our platform’s clinical development. Based on results from the Phase I of the ongoing Phase I/II clinical trial, we are scaling up the manufacturing process to be ready for the Phase II of the trial,” said Pierluigi Paracchi, CEO of Genenta.

“This investment in manufacturing represents a significant step forward based on our expectation that our treatment has the potential to impact the tumor micro-environment and break immune tolerance in solid tumors.”

Luca Alberici, general manager at AGC Milan said “this collaboration highlights the strength of AGC Biologics’ viral vector services, our scientific expertise and the decades of scientific GMP manufacturing knowledge we have here in Milan.”

In January 2023,  Provention Bio selected AGC to commercially manufacture its type 1 diabetes (T1D) monoclonal antibody Tzield (teplizumab).