Genenta to Provide Update on Lead Product Temferon™

Prof. Luigi Naldini will present updates on the efficacy of Temferon in pre-clinical solid tumor models and preliminary clinical biological data confirming in patients

MILAN, Italy and NEW YORK, May 16, 2023 (GLOBE NEWSWIRE) -- Luigi Naldini, Ph.D., M.D., co-founder and Executive Scientific Board Chairman of Genenta Science S.p.A. (NASDAQ: GNTA), a clinical-stage immuno-oncology company, will be presenting the company cell-based platform harnessing the power of hematopoietic stem cells to provide durable, safe, and well tolerated treatment for solid tumors at several upcoming scientific congresses. Prof. Luigi Naldini will provide updates on the efficacy of Genenta's lead product candidate, Temferon, in pre-clinical solid tumor models and preliminary clinical biological data confirming in patients at these congresses.

Genenta has a deep pipeline of potential candidates and therapeutic combinations at different stages of development. The drug at the most advanced stage of development is called Temferon, and is currently in clinical trials of humans - Phase 1/2a. Temferon uses the patient's own stem cells modified with Genenta's platform to express interferon alpha in the tumor - a well-known immunomodulatory protein that has been used in the clinic for decades for the treatment of a variety of cancers, but with limited current use because of the systemic tolerability. Genenta's platform makes it possible to precisely avoid exposing the whole body to not tolerable concentrations and to selectively bring therapeutic activity into the tumor. From pre-clinical experiments, it has been observed that Temferon allows the immune system to see the tumor and mount an effective immune response. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to Temferon for the treatment of glioblastoma multiforme (GBM). Updated data will be provided during the following congresses.

ASTCT + EBMT Joint Basic and Translational Scientific Meeting

Type: keynote presentation

Date: May 24, 2023

6th Annual Symposium on Macrophage

Type: live keynote presentation

Date: June 1, 2023

EACR 2023 Congress, the Annual Congress of the European Association for Cancer Research

Type: live keynote presentation

Date: June 14, 2023

In addition, Tim Obara, Business Development Consultant and Richard Slansky, Chief Financial Officer, will attend BIO International Convention in Boston, MA on June 5-8, 2023.

About Prof. Luigi Naldini, Ph.D., M.D., co-founder and Executive Scientific Board Chairman of Genenta.
For the past 25 years, he has pioneered the development and the applications of lentiviral vectors for gene therapy, which have become one of the most widely used tools in biomedical research and, upon recently entering clinical testing, are providing a long-sought hope for cures for several currently untreatable and otherwise deadly human diseases. He has published over 280 scientific papers. He has a SCOPUS Author h-index of 101. Prof. Luigi Naldini has won numerous awards, including the Outstanding Achievement Award from the American Society of Gene and Cell Therapy (ASGCT) in 2014, President of ESGCT in 2015, the Beutler Prize from the American Society of Hematology (ASH) in 2017 and the Jeantet-Collen Prize for Translational Medicine in 2019.

He was nominated as “Grande Ufficiale” dell’Ordine “Al Merito della Repubblica Italiana,” one of the highest ranking honors in Italy, by the President of the Republic and the Prime Minister of Italy in 2019. He was also elected “Socio Corrispondente-Classe di Scienze Fisiche, Matematiche e Naturali” at the “Accademia Nazionale dei Lincei” in 2022.

About Genenta and Temferon
Genenta (www.genenta.com) is a clinical-stage biotechnology company engaged in the development of a proprietary hematopoietic stem cell therapy for the treatment of a variety of solid tumor cancers. Temferon™ is based on ex-vivo gene transfer into autologous Tie2+ 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 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.

Forward-Looking Statements
Statements in this press release contain “forward-looking statements,” within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as “anticipate,” “believe,” “contemplate,” “could,” “estimate,” “expect,” “intend,” “seek,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “suggest,” “target,” “aim,” “should,” "will,” “would,” or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on Genenta’s current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict, including risks related to the completion and timing of the phase 1/2a clinical trial or any studies relating to the treatment of glioblastoma multiforme patients who have an unmethylated MGMT gene promoter (uMGMT-GBM). Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. These and other risks and uncertainties are described more fully in the section titled “Risk Factors” in Genenta's Annual Report on Form 20-F for the year ended December 31, 2022 filed with the Securities and Exchange Commission. Forward-looking statements contained in this announcement are made as of the date of this announcement, and Genenta undertakes no duty to update such information except as required under applicable law.

Genenta Media
Tiziana Pollio
+39 348 23 15 143
tiziana.pollio@genenta.com