Genenta Data Presentation at AACR to Describe On-Target Biological Activity of Temferon™ in Unmethylated Glioblastoma Multiforme

Rhea-AI Summary

Genenta Science (NASDAQ: GNTA) announced that it will present clinical data at the 2022 American Association for Cancer Research (AACR) meeting regarding its Temferon™ treatment for glioblastoma multiforme patients with unmethylated MGMT gene promoter (uMGMT-GBM). Data from 15 patients suggest successful engraftment of gene-modified cells and maintained levels for up to 18 months post-treatment.

Safety continues to be a focus, with manageable adverse events linked primarily to chemotherapy. The presentation is scheduled for April 8-13, 2022, in New Orleans.

Positive

• Successful engraftment of up to 30% gene-modified cells in treated patients.
• Gene-modified cells persisted for up to 18 months, indicating potential for long-term effect.
• Temferon™ demonstrates a good safety profile with manageable serious adverse events.

Negative

• The presence of only very low levels of IFNα in plasma and cerebrospinal fluid, which may indicate limited efficacy.

Data to be presented at the 2022 annual meeting of American Association for Cancer Research

MILAN, Italy and NEW YORK, March 09, 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, will present clinical data from its Phase 1/2a dose-escalation study of its clinical-stage candidate Temferon™ in patients with glioblastoma multiforme (GBM) who have an unmthylated MGMT gene promotor (uMGMT-GBM) at the annual meeting of the American Association for Cancer Research (AACR) taking place on April 8-13, 2022 in New Orleans, Louisiana (AACR22).

Data from 15 treated patients to be presented are expected to provide initial evidence of successful engraftment of Temferon-derived cells and of on-target biological activity in patients with uMGMT-GBM. One month after administration of the highest tested dose so far, the hematopoietic system of Temferon-treated patients was composed of up to 30% gene modified cells, as detected in peripheral blood and bone marrow cells. The gene-modified differentiated cells persisted for up to 18 months, albeit at lower levels. Importantly, despite high proportions of differentiated cells, only very low levels of IFNα were detected in plasma or in cerebrospinal fluid, consistent with the Company's expectation that IFNα expression remains tightly regulated outside the tumor sites.

Temferon treatment continues to demonstrate a good safety profile, with manageable serious adverse events attributed to conditioning chemotherapy or due to disease progression. The data cut-off was October 15th, 2021.

The AACR e-poster presentation (#5213) is entitled “Genetically modified Tie-2 Expressing Monocytes target IFN-α2 to the glioblastoma tumor microenvironment (TME): preliminary data from the TEM-GBM Phase 1/2a study.” The poster will be presented throughout the meeting April 8-13, 2022 and will be available through July 13, 2022. The abstract will also be published in the online Proceedings of the AACR.

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:	Genenta Media
Mary-Ann Chang, CFA	Tiziana Pollio
+44 7483 28 48 53	+39 3482315143
mchang@lifesciadvisors.com	tiziana.pollio@genenta.com

FAQ

What data will Genenta Science present at AACR 2022 regarding GNTA?

Genenta Science will present data on its Temferon™ treatment for glioblastoma multiforme patients with unmethylated MGMT gene promoter, showing engraftment and safety profile.

What were the results of the Temferon study in glioblastoma patients?

The study indicated successful engraftment of gene-modified cells in 15 treated patients, with persistence of these cells observed for up to 18 months.

When is the AACR meeting where Genenta Science will present its findings?

The AACR meeting is scheduled for April 8-13, 2022, in New Orleans.

What is the significance of the low levels of IFNα detected in patients after Temferon treatment?

The low levels of IFNα may suggest a limited immune response, raising questions about the treatment's overall effectiveness.