Genenta Science (NASDAQ: GNTA) has announced a strengthened partnership with AGC Biologics to enhance the manufacturing of its cell therapies. The amended Development and Master Services Agreement introduces an exclusive Good Manufacturing Practice (GMP) suite at AGC Biologics' Cell and Gene Center of Excellence in Milan, dedicated to producing Genenta's cell therapy product, ensuring compliance with current GMP standards.
This strategic move aims to bolster Genenta's production capabilities, potentially improving the efficiency and reliability of its manufacturing processes. The company anticipates manufacturing 27 autologous drug products in 2025.
Clinical Trials and Therapeutic Focus
Genenta's pipeline includes Temferon, a cell-based therapy designed to express immune-therapeutic payloads within the tumor microenvironment. The newly approved Phase 1/2a trial for metastatic Renal Cell Cancer (mRCC) commenced in Q4 2024, and Genenta plans to treat six patients by the end of the first half of 2025. The company is also continuing its Glioblastoma Multiforme (GBM) study.
"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. "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."
Temferon's Mechanism and Potential
According to Prof. Luigi Naldini, Co-founder of Genenta, preclinical and clinical studies suggest Temferon's potential to reprogram the tumor microenvironment by inhibiting myeloid cell-induced immune suppression and fostering T-cell responses. This mechanism may enhance Temferon's efficacy as a monotherapy and create synergies when combined with immunotherapeutic strategies, including immune checkpoint inhibitors and CAR-T cell therapies.
Upcoming Engagements
Genenta will participate in Biotech Showcase 2025 during JPM Healthcare Week in San Francisco to present its technology for treating solid tumors through genetically modified cell therapy. CEO Pierluigi Paracchi will also speak at "Italy on the Move," an event promoting Italy's life sciences sector.
