Genenta ASGCT Clinical Data Highlights Temferon™ Biological Effects in Glioblastoma
Fifteen patients have been dosed with up to 2.0x106 Temferon™ cells/kg. Based on the persistence of cells in the peripheral blood and bone marrow up to 18 months we conclude that Temferon successfully engrafts, and no drug-limiting toxicities have been identified. The ability of Temferon cells to find their way from bone marrow to the tumor site is supported by the presence of gene-marked cells in the tumor resected specimens of the 3 out of the 4 patients who underwent routine 2nd surgical procedures. A ‘Temferon signature’ – markers of interferon-alpha responses and macrophage repolarization – was also highlighted in Temferon-treated patients compared to patients who received current standard-of-care for GBM.
Pierluigi Paracchi, CEO of Genenta, said: "Genenta is currently working to complete the dose-escalation phase of Phase 1/2a study of Temferon in GBM. The TEM-GBM study has generated a considerable body of human data in line with the results of our preclinical work.”
The presentation “Autologous Cell & Gene Therapy for the Therapeutic Targeting of Immune Payloads to the Solid Tumor Microenvironment. Preliminary results of the TEM-GBM study” (Abstract 1190) will be given by Dr.
Genenta (www.genenta.com) is a clinical-stage biotechnology company pioneering the development of a proprietary hematopoietic stem cell gene therapy for the treatment of a variety of solid tumor cancers. Temferon™ is based on ex-vivo gene transfer into autologous hematopoietic stem/progenitor cells (HSPCs) to deliver immunomodulatory molecules directly via tumor-infiltrating monocytes/macrophages (Tie2 Expressing Monocytes - TEMs). Temferon™, which is under investigation in a phase 1/2a clinical trial in newly diagnosed Glioblastoma Multiforme patients who have an unmethylated MGMT gene promoter (uMGMT-GBM), is based on our platform technology, which is designed to reach solid tumors, induce a durable immune response not restricted to pre-selected tumor antigens nor type, and avoid systemic toxicity, which are some of the main unresolved challenges in immuno-oncology.
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Source: Genenta Science