Press Release Details

MolMed S.p.A. (MLM.MI) and Genenta Science (Genenta) signed an agreement on a multi-year cooperation to develop and manufacture a gene therapy product for the treatment of multiple myeloma.

In accordance to this agreement, MolMed will develop and validate the manufacturing and analytical methods of the Genenta product that constitute part of the preparatory activities to enter in the clinical trials. Furthermore, MolMed will support Genenta to file the application dossier required for the authorisation to proceed with trials.

The agreement extends the collaboration by ensuring MolMed exclusive product manufacturing for the clinical trials, in which the gene therapy for multiple myeloma will be investigated.

“We are pleased to be able to follow up so soon on the development expectations anticipated in our recent press release on the approval of 2015 results: this new collaboration agreement signed with an industrial partner once again confirms our Company’s excellence in developing and manufacturing cell and gene therapies.” Riccardo Palmisano, MolMed’s CEO commented, “We are confident that the partnership signed today with Genenta will be both fruitful and successful. A further reason for our satisfaction lies in the fact that this agreement with such a promising Italian biotech, as Genenta, allows MolMed to play an active role in promoting the strengthening and growth of the biotech sector in Italy”.

“The aim of Genenta Science is to rapidly translate the preclinical results of its gene therapy approach against tumors to the patients, while ensuring scientific excellence and patients’ safety.” Pierluigi Paracchi, Chairman and CEO of Genenta Science said, “The agreement signed with MolMed allows us to effectively reach this purpose.”

***

About Multiple Myeloma
Multiple myeloma is a bone marrow cancer consisting in malignant plasma cells with a damaged DNA. Normally, plasma cells produce antibodies for the host immune response. In case of Multiple Myeloma, the malignant plasma cells accumulate in the bone marrow crowding out healthy blood cells, secreting inflammatory cytokines, thus causing anemia and immune suppression. Moreover, an abnormal synthesis of osteoclasts, cells deputed to the bone resorption, determines bone fragility and bone fractures.

About Genenta Science
Genenta Science develops a gene transfer strategy into autologous hematopoietic stem cells (HSCs) to target interferon-α expression to tumor-infiltrating monocytes/macrophages. An HIV-derived and genetically disabled viral vector – Lentivirus – delivers the gene into the HSCs. Interferon is a protein usually produced by the body in response to infections that also exhibits a pleiotropic anti-tumor activity. However, the clinical use of interferon-α as a drug has been limited by its high toxicity. The innovative therapy of Genenta Science, by combining transcriptional and microRNA-mediated control, enables tumor-infiltrating monocytes/macrophages to selectively express interferon-α limited to the tumor area, thus reducing its toxicity.

The founders of the company are:

• Pierluigi Paracchi – former investor and board member at Ethical Oncology Science (EOS), an Italian start up acquired by Clovis Oncology (Nasdaq: CLVS) for USD 420 million
• San Raffaele Hospital – the leading Italian research institute
• Luigi Naldini – Director of the San Raffaele-Telethon Institute for Gene Therapy (TIGET) and of the Division of Regenerative Medicine, Stem Cells and Gene Therapy at the San Raffaele Hospital, Professor of Histology and Gene and Cell Therapy, at the San Raffaele University
• Bernhard Gentner – Haematologist and Physician Scientist at the San Raffaele Hospital and TIGET In March 2015, Genenta Science banked a Euro 10 million (USD 11 million) Series A round with Banca Esperia as financial advisor.

About MolMed
MolMed S.p.A. is a medical biotechnology company focused on research, development and clinical validation of novel anticancer therapies. MolMed’s pipeline includes anti-tumour therapeutics in clinical and preclinical development: Zalmoxis® (TK) is a cell-based therapy enabling bone marrow transplants from partially compatible donors, in absence of post-transplant immune-suppression, currently in Phase III in high-risk acute leukaemia and under evaluation by EMA for a Conditional Marketing Authorization; NGR-hTNF is a novel therapeutic agent for solid tumours which displays antitumor activity through its specific binding to blood vessels feeding the tumour mass, currently investigated in a broad clinical programme; CAR-CD44v6, an immuno-gene therapy project potentially effective for many haematological malignancies and several epithelial tumours, currently in preclinical development. MolMed also offers top-level expertise in cell and gene therapy to third parties to develop, conduct and validate projects from preclinical to Phase III trials, including scale-up and cGMP production of clinical-grade viral vectors, and manufacturing of patient-specific genetically engineered cells. MolMed has its headquartered at the San Raffaele Biotechnology Department (DIBIT) in Milan, Italy, and a local unit at OpenZone, in Bresso (Milan). MolMed is listed on the main market (MTA) of the Milan stock exchange managed by Borsa Italiana (ticker Reuters: MLMD.MI).