Genenta, a clinical-stage biotechnology company engaged in the development of hematopoietic stem progenitor cell immuno-gene therapy for cancer, has entered into a development and manufacturing service agreement (MSA) with AGC Biologics. to manufacture cell therapy lentivirus-based product for Genenta's ongoing clinical programs.
"The expansion of our existing relationship with AGC Biologics underscores the progress of our platform's clinical development. Based on results from the Phase 1 of the ongoing Phase 1/2 clinical trial, we are scaling up the manufacturing process to be ready for the Phase 2 of the trial," said Pierluigi Paracchi, Chief Executive Officer 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."
Genenta had an existing manufacturing services agreement with Molecular Medicine S.p.A.'s facility in Milan, which was subsequently acquired by AGC Biologics in 2020. The Milan site has been manufacturing LVV (Lenti Viral Vectors) and drug product for Genenta's ongoing programs since 2016, starting with the initial process development steps. The services provided under this existing agreement are in addition to the services that will be provided under the AGC Biologics MSA.
"This is the next step in our partnership with Genenta and we are proud to be supporting this innovative product and technology, and helping It reach the next phase of trials. It has been inspiring to watch this once small Italian biotech company reach new heights as they work to bring important treatments to patients around the world," said Luca Alberici, General Manager, AGC Biologics Milan. "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."
AGC Biologics offers end-to-end global viral vector and cell therapy development, manufacturing and quality/regulatory services, supported by scientists with 30 years of knowledge and experience. The team at AGC Biologics has supported four commercial viral vector products, three commercial cell therapies and more than 30 cell and gene therapy clinical trials across Europe and the United States. The CDMO operates a facility in Milan and a new campus in Longmont, Col. USA, and the company uses the latest technology and platforms to help navigate the growing advanced therapies market.