Genenta ASGCT Clinical Data Highlights Temferon(TM) Biological Effects in Glioblastoma

Initial evidence of potential to modulate tumor microenvironment

MILAN, Italy and NEW YORK, May 02, 2022 (GLOBE NEWSWIRE) -- Genenta Science (NASDAQ: GNTA), a clinical-stage biotechnology company pioneering the development of hematopoietic stem progenitor cell immuno-gene therapy for cancer, announces that preliminary findings from its Phase 1/2a of Temferon™ in the treatment of patients with glioblastoma multiforme patients who have an unmethylated MGMT gene promoter (uMGMT-GBM) provide initial evidence of Temferon’s potential for modulating the tumor microenvironment as well as details of Temferon’s continuing positive safety profile and signals of biological activity. The findings will be given as an oral presentation at the forthcoming 25th annual meeting of the American Society of Gene and Cell Therapy (ASGCT) to be held in Washington. D.C., May 16-19, 2022.

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. Benhard Gentner from Genenta’s partner, the San Raffaele Telethon Institute for Gene Therapy (SR-Tiget), on Thursday May 19, 2022 at 8:00 AM - 9:45 AM EDT (14.00- 15.45 CET).

About Genenta Science

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.