MolMed informs on its decision to withdraw the Conditional Marketing Authorization of Zalmoxis
- Category: DNA RNA and Cells
- Published on Friday, 11 October 2019 10:36
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MILAN, Italy I October 10, 2019 I MolMed S.p.A. (MLMD.MI) (the “Company”), biotechnology company focused on research, development, production and clinical validation of gene and cell therapies for the treatment of cancer and rare diseases, following the communication released on June 27th, informs on its decision to withdraw for commercial reasons the Conditional Marketing Authorization of Zalmoxis, which has been adopted by the European Commission on October 9th 2019.
This Company’s decision takes into account the overall results of the interim analysis voluntarily carried out by the Company as part of the review of the product development plan, as well as the interactions with EMA in the latest months.
The Company will direct its investments and resources, until now destined to Zalmoxis, to activities that better contribute to its business objectives.
MolMed S.p.A. is a clinical stage biotech company focused on research, development, manufacturing and clinical validation of innovative therapies. MolMed is the first company in Europe to have obtained the GMP manufacturing authorization for cell & gene therapies ex vivo for its proprietary products 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’s is also developing a new therapeutic platform based on Chimeric Antigen Receptor (CAR), both autologous and allogeneic; the most advanced product, CAR-T CD44v6, which in March 2019 received the authorization to start human clinical trials in onco-hematologic indications (AML and MM), following an extensive pre-clinical phase. The product, whose innovative spacer incorporated in the CAR protein received in May 2019 the confirmation of grant, is potentially effective also in several epithelial solid tumors. MolMed is also developing a pipeline based on NK (Natural Killer) cells, following a research agreement signed in 2018 with Glycostem. 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.