Genenta and IAG, Image Analysis Group Announce Partnership

Genenta Imaging Partnership with IAG Optimizes Phase I/IIa Study of Temferon in Glioblastoma

MILAN (Italy) / LONDON (UK),  February, 2021 – Genenta Science srl (“Genenta”) a clinical-stage biotechnology company, pioneering the development of hematopoietic stem progenitor cell immuno-gene therapy for cancer (Temferon™), today announced a scientific partnership with Image Analysis Group (“IAG”) for its Phase I/IIa study (TEM-GBM) of Temferon in patients affected by glioblastoma multiforme (GBM).

Genenta Science is leveraging its Temferon™ technology platform to treat cancers using a novel immuno-gene therapy approach. The TEM-GBM study is evaluating the safety and efficacy of autologous CD34+-enriched hematopoietic progenitor cells genetically modified with a lentiviral vector encoding for the human interferon-α2 in patients with GBM who have an unmethylated O-6-methylguanine-DNA methyltransferase gene promoter.

Carlo Russo, CMO & Head of Development of Genenta, said:

“Using IAG’s cutting edge non invasive technology provides Genenta with greater clarity in understanding how Temferon affects patients with glioblastoma. In particular, we can monitor how patients react to our treatment in real time while also differentiating between the effects of Temferon on the tumor and on surrounding tissues. This means we can fully explore the potential of this exciting drug candidate.”

Immunotherapies such as Temferon may lead to the phenomenon of pseudo-progression in GBM, an inflammatory response which could be misinterpreted as tumor growth using traditional and routine clinical MRI assessments. IAG’s advanced AI-driven non invasive methodologies allow accurate measurement of tumor volume within brain tissue, providing reliable early efficacy readouts.

Dr. Diana Dupont-Roettger, Chief Scientific Allicance Officer at IAG commented,

“We are excited to partner with Genenta in this Phase I/II study and beyond. Advanced imaging and AI based analysis allow for quantitative assessment of the tumour volume and are therefore able to identify early treatment related changes in GBM. This information is vital in cases where conventional criteria such as RANO overestimate the tumour burden.”

During the partnership, IAG, a leading medical imaging company, will work closely with Genenta to provide critical imaging services, using its proprietary platform DYNAMIKA and imaging data analysis. IAG has deep expertise in partnering with biotech, and specifically oncology companies, to provide a centralized reading and analysis of patient responses in real time. IAG’s scientific and clinical imaging expertise in the field of GBM will be coupled with IAG’s proprietary AI and quantitative image-based assessments to allow Genenta to review efficacy assessments, objective responses and to thoroughly explore the advanced treatment manifestations.

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 cancer. 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). TemferonTM, which is under investigation in a Phase I/IIa clinical trial in newly diagnosed Glioblastoma Multiforme patients, is not restricted to pre-selected tumor antigens nor type and may reach solid tumors, one of the main unresolved challenge in immuno-oncology. Based in Milan, Italy, and New York, USA, Genenta has raised more than €33.6 million (~$40 million) in three separate rounds of financing.

About Image Analysis Group

Image Analysis Group (IAG) is a unique clinical development partner to life sciences companies.  IAG broadly leverages it’s proprietary image analysis methodologies, power of our cloud platform DYNAMIKA, years of experience in AI and Machine Learning as well as bespoke co-development business models to ensure higher probability for promising therapeutics to reach the patients. Our independent Bio-Partnering division fuses risk-sharing business models and agile culture to accelerate novel drug development. For more information see www.ia-grp.com

Genenta Investor Relations

Stefania Mazzoleni, PhD: Italy;  Stefania.mazzoleni@genenta.com

Mary-Ann Chang, CFA: US & Europe; mchang@lifesciadvisors.com

IAG, Image Analysis Group Bio-Partnering

Dr. Diana Roettger, PhD; UK; diana.roettger@ia-grp.com

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