Molecular Medicine : A new study confirms the high potential of on CAR T CD44v6 also in solid tumors

PRESS RELEASE

MolMed: the results from a new study on CAR T CD44v6 in in-vivo experimental models of lung carcinoma and melanoma confirmed the high therapeutic potential of MolMed's therapy also in solid tumors.

The results have been presented today in Losanna at the Annual Meeting of the European Society of Gene and Cell Therapy (ESGCT).

Milan (Italy), October 17th 2018 - MolMed S.p.A. (MLMD.MI) ("the Company"), clinical stage biotechnology company focusing on research, development, manufacturing, and clinical validation of cell & gene therapies to treat cancer and rare diseases, during the Annual Meeting of the European Society of Gene and Cell Therapy (ESGCT) which took place today in Losanna, presented the abstract titled "In vivo antitumor activity of a hCD44v6-specific chimeric antigen receptor in syngeneic models of solid tumors".

The abstract showed the results of a study conducted on immunocompetent animal models bearing human lung carcinoma and melanoma, and aimed at evaluating and characterizing the activity of CD44v6 CAR T cells, the antitumor immunotherapy of MolMed, in solid tumors.

The results of the study confirmed the high potential of CD44v6 CAR T to treat, in addition to blood cancers, such as acute myeloid leukemia and multiple myeloma, also solid tumors and metastases expressing the CD44v6 antigen.

Catia Traversari, Research Director at MolMed commented: "In these experiments we used murine tumour models grown in animals with an intact immune system, mimicking what happens in humans. The murine tumors have been modified to express the hCD44v6 antigen, the target on which our CAR T acts. This procedure allowed us to observe in vivo the effects of CD44v6 CAR T therapy also on solid tumors and to demonstrate its efficacy in controlling the proliferation of both primary and metastatic lesions. We also observed that combined treatment with CAR T cells against immune check point blockers, drugs successfully used to treat melanoma and lung cancer patients, resulted in a significant increase in survival and in the complete cure of some of the treated animals. Concerning the mechanism of action, we also demonstrated that CD44v6 CAR T cells are able to induce an immune response against new tumor antigens, thus further increasing the efficacy of the treatment."

Based on the several promising preclinical data collected, MolMed is preparing to demonstrate the safety and efficacy of CAR T CD44v6 in haematological tumors, with the start of the first clinical trial in humans, planned in the first quarter of 2019.

ESGCT Lausanne 2018' detailed program is available at the linkhttps://www.esgct.eu.

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PRESS RELEASE

About MolMed

MolMed S.p.A. is a clinical stage biotech company focused on research, development, manufacturing and clinical validation of innovative anticancer 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® 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 at the end of 2017 and in Germany at the beginning of 2018. Still focusing on this cell & gene technology, the company is developing a new CAR pipeline based on Chimeric Antigen Receptor; the most advanced product, the CAR-T CD44v6, currently in advanced preclinical development, and is potentially effective both for some hematological malignancies and several solid epithelial tumors. Following the authorization request submitted to European Regulatory Agencies, MolMed plans to commence during the first half of 2019, human clinical trials in the AML and MM indications. In addition, the Company is developing a new CAR pipeline, both autologous and allogeneic, the last one based on NK (Natural Killer) cells. 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. 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.

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