Genenta Science Strengthens Partnership with AGC Biologics for Enhanced Manufacturing Capabilities

• Genenta Science has amended its agreement with AGC Biologics, adding an exclusive GMP suite at AGC’s Cell and Gene Center of Excellence in Milan to enhance its cell therapy manufacturing capabilities.

• This partnership supports Genenta’s metastatic Renal Cell Cancer (mRCC) and Glioblastoma Multiforme (GBM) trials, with projections to manufacture 27 autologous drug products in 2025.

Genenta Science has strengthened its partnership with AGC Biologics, a global contract development and manufacturing organization (CDMO), by amending their Development and Master Services Agreement. This amendment includes the introduction of an exclusive GMP suite at AGC Biologics’ Cell and Gene Center of Excellence in Milan, which will be dedicated to the manufacturing of Genenta’s cell therapy product. The new facility will ensure compliance with cGMP standards, thereby enhancing the efficiency and reliability of the manufacturing process.

Genenta Science, a leader in cell-based therapeutics, is advancing its Phase 1/2a trial for metastatic Renal Cell Cancer (mRCC), which began in the fourth quarter of 2024. The company expects to treat six patients by mid-2025, continuing its progress with the Glioblastoma Multiforme (GBM) study. In total, Genenta plans to manufacture 27 autologous drug products in 2025.

“Our strengthened partnership with AGC Biologics represents our unwavering commitment to patients participating in our GBM and mRCC trials,” said Pierluigi Paracchi, CEO and Co-founder of Genenta. He added that the enhanced capacity would allow the company to treat more patients and further validate its therapeutic approach.

Prof. Luigi Naldini, Co-founder of Genenta, highlighted the promising results of preclinical and clinical studies for Temferon, a key part of their treatment approach. Temferon has demonstrated the potential to reprogram the tumor microenvironment, improving immune responses and enhancing treatment efficacy when combined with other immunotherapies.