Genenta Science, a clinical-stage immuno-oncology company listed on Nasdaq, has announced a strategic collaboration with Anemocyte, an Italian biotech manufacturing organization, to produce critical starting materials for cutting-edge cell-based cancer therapies. The partnership marks a significant milestone in advancing Genenta's proprietary hematopoietic stem cell therapy platform.
Manufacturing Partnership Delivers Critical Components
The collaboration encompasses the successful production of essential starting materials, including the establishment of cell banks and manufacturing of plasmids for viral vector production. These components are fundamental to Genenta's cell-based therapeutic development and clinical trial progression.
"Thanks to Anemocyte, Genenta has achieved significant milestones in the progression of its clinical trials," stated Carlo Russo, M.D., Chief Medical Officer & Head of Development of Genenta Science. "The expertise and knowledge of Anemocyte's team have been instrumental throughout the entire manufacturing process of these critical starting materials."
Dr. Russo emphasized that subsequent manufacturing steps confirmed expectations regarding Anemocyte's plasmid DNA quality in producing high-quality therapeutic products, establishing Anemocyte as "a top-quality, cost-effective, and reliable partner."
Supporting Temferon™ Development
The manufacturing partnership directly supports Genenta's first-in-class product candidate Temferon™, designed to allow expression of immune-therapeutic payloads within the tumor microenvironment by bone marrow-derived myeloid cells. This approach aims to enable a durable and targeted response against solid tumor cancers.
Genenta has completed a Phase 1 trial for newly diagnosed Glioblastoma Multiforme patients with an unmethylated MGMT gene promoter, which suggests potential reprogramming of the tumor microenvironment and inhibition of myeloid-induced tolerance while allowing induction of T cell responses. The company initiated a Phase 1/2a metastatic Renal Cell Carcinoma study in Q4 2024 that will include combination with immune checkpoint inhibitors.
Italian Biotech Innovation Leadership
Marco Ferrari, CEO of Anemocyte, highlighted the significance of partnering with Genenta as the first Italian company listed on Nasdaq. "Genenta's status as the first Italian company listed on Nasdaq is a testament to its innovation and leadership in the immuno-oncology space," Ferrari expressed. "We are immensely proud of this collaboration with Genenta supporting its pioneering product and technology, facilitating further progress in the next phase of trials."
Ferrari noted that Genenta symbolizes the concerted efforts of Italian industry and academia to accelerate advancements in the cell and gene therapeutic field, while the collaboration confirms Anemocyte's strategic direction built around pillars of flexibility, quality, and sustainability.
Manufacturing Expertise and Capabilities
Anemocyte brings over 25 years of expertise in manufacturing innovative therapies and related starting materials. The biotech manufacturing organization specializes in development and production of plasmid DNA and mRNA, offering comprehensive development and manufacturing services from research and development through good manufacturing practice (GMP) standards.
Genenta's treatments are designed as one-time monotherapies with additional potential to significantly enhance the efficacy of other approved therapeutics when used in combination. The company's proprietary hematopoietic stem cell therapy platform targets treatment of various solid tumor cancers through innovative immune-oncology approaches.