Genenta Expands AGC Biologics Partnership for Cell Therapy Production

Genenta Science, a prominent player in the realm of immuno-oncology and cell-based therapeutics, has announced a significant development in its partnership with AGC Biologics, a well-regarded contract development and manufacturing organization. The partnership has been bolstered by an amendment to their Development and Master Services Agreement, which includes the allocation of an exclusive GMP suite at AGC Biologics' Cell and Gene Center of Excellence located in Milan. This dedicated suite is poised to manufacture Genenta's cell therapy product, adhering to current Good Manufacturing Practice (cGMP) standards, which is expected to boost Genenta's manufacturing capabilities by enhancing efficiency and reliability.

Genenta has recently commenced a Phase 1/2a trial for metastatic Renal Cell Cancer (mRCC), which started in the fourth quarter of 2024. The company has set a target to treat six patients by the middle of 2025, while also advancing its studies on Glioblastoma Multiforme (GBM). In total, Genenta plans to manufacture 27 autologous drug products throughout 2025.

Pierluigi Paracchi, CEO and Co-founder of Genenta, expressed the importance of the partnership with AGC Biologics, emphasizing their commitment to patients involved in the GBM and mRCC trials. This collaboration aims to treat more patients and further validate Genenta's innovative therapeutic approach, taking a significant step towards revolutionizing cancer treatment with cell-based therapies.

Co-founder Prof. Luigi Naldini highlighted the potential of Temferon, Genenta's lead product candidate, which has shown promising results in both preclinical and clinical studies. Temferon's unique ability to reprogram the tumor microenvironment by counteracting myeloid cell-induced immune suppression and enhancing T-cell responses positions it as a potent monotherapy. Furthermore, there is potential for synergy when combined with other immunotherapeutic approaches, including immune checkpoint inhibitors and CAR-T cell therapies. These findings pave the way for developing more effective treatments for solid tumors, inching closer to providing new cancer treatment options.

In terms of future endeavors, Genenta is set to participate in Biotech Showcase 2025, scheduled for January 13-15 in San Francisco, where the company will present its advanced technology aimed at treating solid tumors through genetically modified cell therapy. Pierluigi Paracchi will also be speaking at "Italy on the Move", an event organized by the Italian Ministry of Foreign Affairs and International Cooperation, designed to highlight Italy’s life sciences sector and attract international investment. This event, to be held on January 15, 2025, at INNOVIT – Italian Innovation and Culture Hub in San Francisco, will feature notable speakers such as Karthic Jayaraman, Co-Head of Global Healthcare at TPG Capital, and Frederick Beddingfield, CEO of Rubedo Life Sciences, with moderation by Audrey Greenberg, Co-Founder and Executive Managing Director of the Center for Breakthrough Medicines.

Genenta, listed on Nasdaq under the ticker GNTA, is a clinical-stage company focused on developing proprietary hematopoietic stem cell therapies for various solid tumor cancers. The company's foremost product candidate, Temferon™, is engineered to allow the expression of immune-therapeutic payloads within the tumor microenvironment by bone marrow-derived myeloid cells, facilitating a durable and targeted immune response. Genenta has completed a Phase 1 trial for patients with newly diagnosed Glioblastoma Multiforme with an unmethylated MGMT gene promoter, suggesting potential in reprogramming the tumor microenvironment and overcoming myeloid-induced tolerance while promoting T-cell responses. The company is also conducting a Phase 1/2a study on metastatic Renal Cell Carcinoma, which includes combination therapy with immune checkpoint inhibitors. Their strategies are primarily designed as one-time monotherapies, with the potential to significantly enhance the efficacy of other approved treatments when used in combination.