AGC Biologics teams with Pandorum, adds to Genenta cell therapy partnership

Genenta Science has expanded its partnership with AGC Biologics, amending their Development and Master Services Agreement to secure an exclusive GMP suite at AGC Biologics’ Cell and Gene Center of Excellence in Milan, Italy.

The suite will support the production of Genenta’s Temferon, a cell therapy for solid tumors, including glioblastoma multiforme (GBM) and metastatic renal cell carcinoma (mRCC). Genenta plans to manufacture 27 autologous drug products in 2025 for these trials, which include a newly launched mRCC phase 1/2a study. AGC Biologics will support the scaling up of Pandorum’s proprietary modular bioprocess and manufacturing of pharmaceutical-grade exosomes derived from clinical grade mesenchymal stem cells.

“This enhanced capacity ensures that we can treat a larger number of patients and further validate our therapeutic approach, bringing us closer to our vision of transforming cancer treatment through cell-based therapies,” Genenta CEO Pierluigi Paracchi said in a statement. 

Separately, AGC Biologics announced a partnership with Pandorum to produce Kuragenx, a biologic designed to treat advanced neurotrophic keratitis (NK), a severe form of corneal blindness. Kuragenx, awarded Orphan Drug Designation by the FDA, is in preclinical development with plans for an IND submission in 2025.

AGC Biologics’ Milan facility will oversee the scale-up and production of pharmaceutical-grade exosomes for the therapy, ensuring compliance with regulatory standards. The site specializes in cell and gene therapy manufacturing and has facilitated the commercialization of multiple viral vectors and cell therapy products.

Next week, Genenta will present its cell therapy work at Biotech Showcase 2025 during JPM Healthcare Week in San Francisco and participate in a “Italy on the Move” event organized by the Italian Ministry of Foreign Affairs and International Cooperation, highlighting advancements in the country’s life sciences sector.