Genenta Science S.p.A.

The company is currently a clinical-stage biotechnology company developing hematopoietic stem cell gene therapies for solid tumors. It is also embarking on a strategic transformation to become a strategic industrial consolidator focused on acquiring privately held businesses in national-security regulated sectors, as contemplated by the "Golden Power" legislation. The company's current technology involves a novel biologic platform for ex-vivo gene transfer of a therapeutic candidate into autologous hematopoietic stem/progenitor cells (HSPCs). This process delivers immunomodulatory molecules directly to tumors via infiltrating monocytes/macrophages, specifically Tie2 Expressing Monocytes (TEMs). The technology aims to transform TEMs, which naturally travel to tumors, into a "Trojan Horse" to counteract cancer progression and prevent tumor relapse. This approach is designed to be effective across a broad variety of cancers because it is not target-dependent. The technology utilizes a Lentiviral Vector (LVV) that combines a therapeutic transgene sequence (payload) with a proprietary platform. This platform includes: (i) the Tie-2 promoter, which specifically drives transgene sequence transcription in TEMs, and (ii) miRNA-126 target sequences, which downregulate transgene expression post-transcription in cells where the Tie-2 promoter is active and miRNA-126 is present. Key advantages of this approach include a "Trojan Horse" mechanism of action, which modifies TEMs to enable the immune system to recognize tumors and deliver therapeutics to the cancer site. The selective regulation of transgene expression is designed to avoid off-target and systemic toxicity. Furthermore, by using hematopoietic stem cells, the therapeutic candidate is designed as a "living therapy" intended to break cancer-induced immune tolerance and establish competent immune surveillance throughout the patient's life.