MolMed and Genenta Science confirm and extend their partnership in the oncology field.

Milan (Italy), March, 7th 2019 - MolMed S.p.A. ("MolMed", MLMD.MI), clinical stage biotechnology company focusing on research, development, manufacturing and clinical validation of cell & gene therapies for the treatment of cancer and rare diseases, and Genenta Science, ("Genenta"), biotechnology company developing a new generation of hematopoietic stem cell immuno-gene therapies, announce to have renewed and extended their collaboration in the oncology field, launched in March 2016.

These years of activities and collaboration allowed Genenta and MolMed to successfully develop and validate the analytical manufacturing methods of Genenta's proprietary product Temferon™, an advanced medicinal product for an innovative immuno-gene therapy that could be apply both to hematologic malignancies and solid tumors.

Today, Genenta has entrusted MolMed for the exclusive supply of the drug product to be used in in-human trials.

Luca Alberici, MolMed's Chief Business Officer, commented: "Genenta Science is rapidly establishing itself as a solid reality in the cell and gene therapy arena, also thanks to the very innovative approach to treat tumours and, thus, we are very pleased to be confirmed as partner in this key development stage to the treatment of patients in clinical programs".

Riccardo Palmisano, MolMed's CEO added: "The extension of the collaboration between MolMed and Genenta Science once again validate the excellence of the Italian biotech cell & gene, and further reinforces one of the two pillars of MolMed's business model: GMP development and manufacturing activities for third parties, that is confirming its continuous two digits growth".

Pierluigi Paracchi, Genenta Science CEO, commented: "This partnership is bringing our therapy to patients, the quality of MolMed together with our science and clinical expertise can impact patients' life".

About MolMed

MolMed S.p.A. is a clinical stage biotech company focused on research, development, manufacturing and clinical validation of innovative therapies. MolMed's product portfolio includes proprietary anti-tumor therapies in both clinical and preclinical development: Zalmoxis® (TK) is a cell therapy based on donor T cells genetically engineered to enable bone marrow transplants from partially compatible donors for patients with high-risk hematological malignancies, eliminating post-transplant immunosuppression prophylaxis and inducing a rapid immune reconstitution. Zalmoxis®, that received orphan drug designation and is currently in Phase III in a high-risk population of acute leukemia patients, but has already obtained a Conditional Marketing Authorization by the European Commission in the second half of 2016 as well as reimbursement conditions in Italy and in Germany at the beginning of 2018. Still focusing on this cell & gene technology, the Company is developing a

FROM GENES TO THERAPY

new therapeutic platform based on Chimeric Antigen Receptor (CAR), both autologous and allogeneic; the most advanced product, CAR-T CD44v6, is looking forward to obtain the authorization to start human clinical trials in onco-hematologic indications (AML and MM), following an extensive pre-clinical phase; the product is potentially effective also in several epithelial solid tumors. With regards to allogeneic CARs, MolMed is developing a pipeline based on NK (Natural Killer) cells, following a research agreement signed in 2018 with Glycostem. MolMed is also the first company in Europe to have obtained the GMP manufacturing authorization for cell & gene therapies for its proprietary products (Zalmoxis®) as well as for third parties and/or in partnership (Strimvelis, an Orchard gene therapy for the ADA-SCID). With reference to GMP development and manufacturing activities for third parties, MolMed signed numerous partnership agreements with leading European and US companies. In the field of innovative oncological therapies MolMed pipeline also includes NGR-hTFN, a therapeutic agent for the treatment of solid tumors. MolMed, founded in 1996 as an academic spin-off of the San Raffaele Scientific Institute, is listed on the main market (MTA) of the Milan stock exchange managed by Borsa Italiana since March 2008. MolMed is headquartered and based in Milan, at the San Raffaele Biotechnology Department (DIBIT) and has an operating unit at OpenZone in Bresso.

About Genenta Science

Genenta develops an ex-vivo immuno-gene transfer strategy into autologous hematopoietic stem/progenitor cells (HSPCs) to target immunomodulatory molecules to tumor-infiltrating monocytes/macrophages (Tie2 Expressing Monocytes - TEMs).

The targeted expression of the immunomodulatory molecules in TEMs is achieved combining a transcriptional and a microRNA-mediated post-transcriptional control. Thanks to these mechanisms, TEMs become capable to express the immunomodulatory molecule (Interferon-alpha - IFN-α) into the tumor microenvironment.

TEMs are spontaneously and actively recruited by developing tumors to sustain their growth and thanks to the immune-gene transfer, TEMs become the tool for the local delivery of the immunomodulatory molecule. The local IFN-α release triggers both direct and indirect anti-tumor effects including an immune-response.

In contrast to antigen-restricted Chimeric Antigen Receptor T cells (CAR-T), Temferon™ may reach also solid tumors and exerts its immune-modulatory functions triggering a long-lasting immune response towards multiple antigens.

As a result, Temferon™ is able to break the tumor immune-tolerance by reprogramming the tumor immune microenvironment.

Genenta has offices is in Milano (Italy) and in Alexandria Center's in New York city (US). And raised €17 Million in Series A+B Round of financing.

FROM GENES TO THERAPY

For further information:

Molmed

Ilaria Candotti

Investor Relations & Communication Manager

MolMed S.p.A.

+39 02 21277.205 +39 02 21277.325investor.relations@molmed.com

Genenta Science

Pierluigi Paracchi

Chairman & CEO +39.335.73.51.868pierluigi.paracchi@genenta.com

FROM GENES TO THERAPY

Tommasina Cazzato Press Office

Community Group +39 345 7357751tommasina.cazzato@communitygroup.it

Attachments

  • Original document
  • Permalink

Disclaimer

MolMed S.p.A. published this content on 07 March 2019 and is solely responsible for the information contained herein. Distributed by Public, unedited and unaltered, on 07 March 2019 14:22:11 UTC