Genenta ASGCT Clinical Data Highlights Temferon™ Biological Effects in Glioblastoma

Rhea-AI Summary

Genenta Science (NASDAQ: GNTA) announced preliminary findings from its Phase 1/2a study of Temferon™ for glioblastoma multiforme (uMGMT-GBM). The results show Temferon's potential to modulate the tumor microenvironment, with a positive safety profile. Fifteen patients received the treatment, showing successful engraftment and no drug-limiting toxicities. Preliminary signals of biological activity were observed, including gene-marked cells in tumors of patients who underwent surgery. The findings will be presented at the ASGCT meeting on May 19, 2022.

Positive

• Initial evidence of Temferon's potential for modulating tumor microenvironment.
• Temferon shows a positive safety profile with no drug-limiting toxicities identified.
• Fifteen patients dosed with up to 2.0x10^6 Temferon cells/kg.
• Presence of gene-marked cells in tumors of 3 out of 4 patients suggests effectiveness.

Negative

• None.

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 25^th 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 2^nd 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.

Investor Relations - LifeSci Advisors: Mary-Ann Chang, CFA +44 7483 28 48 53 mchang@lifesciadvisors.com

Genenta Media Contact Tiziana Pollio +39 3482315143 tiziana.pollio@genenta.com

FAQ

What are the preliminary findings of Temferon in the Phase 1/2a study?

The preliminary findings indicate Temferon's potential to modulate the tumor microenvironment and demonstrate a positive safety profile.

How many patients were involved in the Temferon study for glioblastoma?

Fifteen patients were dosed with Temferon in the study.

When will the findings of the Temferon study be presented?

The findings will be presented at the ASGCT meeting on May 19, 2022.

What is the significance of gene-marked cells found in the tumors?

The presence of gene-marked cells in tumors suggests Temferon's ability to reach the tumor site effectively.

What is Genenta Science's focus in biotechnology?

Genenta Science focuses on developing hematopoietic stem progenitor cell immuno-gene therapy for various solid tumor cancers.