Further steps towards developing its peculiar dual business model: higher focus on cell & gene therapies research and development plus high level GMP services for third parties: fulfilling market demand for Zalmoxis®, confirming CD44v6 CAR-T potential in tumours and expanding manufacturing agreements with International partners
In the 2017 MolMed takes fundamental steps towards maximizing Zalmoxis®’ full potential, and exploiting the European CMA obtained in 2016.
To conduct all activities aimed at promoting, distributing and selling Zalmoxis® in the European Economic Area plus UK after-Brexit (and an option right for Australia, Switzerland and Turkey), MolMed entered into a 15 year exclusive license and distribution agreement with Dompé, one of the first Italian and European players who believed in biotech and in advanced therapies.
With the same purpose, MolMed and TTY Biopharm Company Ltd signed an exclusive license and distribution agreement to import, use, market, sell and distribute Zalmoxis® in Asia (Taiwan, Hong Kong, Singapore, Thailand, Philippines, Vietnam and Malaysia) and with Megapharm Ltd in Israel.
MolMed, naturally, will continue market access activities, pricing and reimbursement negotiations in Italy, in order to obtain market authorization, price and reimbursement for Zalmoxis®.
In parallel to these activities, the development of the proprietary cancer immune-gene therapy project CD44v6 CAR-T pursued in order to demonstrate its antitumour activity.
CD44v6 CAR-T therapy has demonstrated in pre-clinical tests to be potentially efficient and safe in leukaemia and, even more importantly, in human lung adenocarcinoma, one of the “big killers” among solid tumours.
Managing CAR-T cells and abrogating their potential toxicity, including cytokine release syndrome, has become indeed a critical step in the successful application of this technology and for its clinical development. At the 22nd Annual Congress of the European Haematology Association (EHA) held in Madrid in June, MolMed announces new safety in vitro data of CD44v6-CAR-T. In particular, the attention was focused on the safety profile: it was showed how, although expressing the CD44v6 target at detectable levels, keratinocytes are highly resistant to CAR-T cell killing. These data suggest a wide enough therapeutic window for exploiting the antitumour activity of CD44v6 CAR-T cells, without incurring in unbearable skin toxicity.
In June, and following additional and constructive interactions with EMA, MolMed announced the decision to withdraw the Conditional Marketing Authorisation (CMA) application submitted in December 2016 for Zafiride (NGR-hTNF), its investigational anticancer drug, for the treatment of adult patients with advanced malignant pleural mesothelioma who progressed within six months after the first-line pemetrexed-based therapy. Based on several clinical outcomes, MolMed believes that Zafiride is a valuable anti-cancer therapy and will keep on scouting potential financial partners for both clinical and industrial development of the product, confirming both its confidence on NGR-hTNF potential and its increased focus on internally investing in cell & gene therapies.
In the manufacturing for third parties sector, MolMed has expanded its customer base from the established partnership with GSK (for the commercial approved Strimvelis®, RV/LV and transduces HSC), Telethon (vectors and transduced cells for the clinical programs of several genetic diseases), Genenta (development and manufacturing of a leading program on haematological malignancies part of an agreement with Amgen). In 2017 two further important contracts were signed: the first with Rocket Pharmaceuticals Ltd it to develop and manufacture lentiviral vectors to be used for the ex vivo transduction of hematopoietic stem cells for the treatment of Fanconi Anemia, and the second with Cellectis, a very relevant clinical-stage biopharmaceutical French company, to develop and manufacture lentiviral vectors and genetically engineered T cells encoding for allogenic CAR-T.


A new era opens for Zalmoxis and CD44v6 CAR-T. On August 18th, the European Commission formally granted a Conditional Marketing Authorisation (CMA) for Zalmoxis® as adjunctive treatment to haplo-transplants of haematopoietic stem cells for the treatment of severe haematological malignancies, following the positive opinion released on June 23rd by EMA’s CHMP. This was indeed the most beautiful and rewarding gift for MolMed’s 20th birthday on July 11th. Following a pre-subission meeting with European Medicine Agency (EMA), MolMed filed a dossier for the Conditional Marketing Authorization (CMA) for its anti cancer Zafiride (NGR-hTNF) in December 2016. Encouraged by the exciting results of preclinical studies presented at the 58th Annual Meeting of the American Society of Hematology (ASH December 3, San Diego, USA), supporting the feasibility of a future exploitation of the CD44v6 CAR-T in the therapy of solid tumours too, and MolMed expresses the intention to develop the path to initiate trials in man.

On December 12th the European Commission, within the Horizon 2020 – Research and Innovative Framework Programme section reserved to the new therapies for chronic diseases including cancer –, awarded a 5,903,146 Euro grant to the project EURE-CART (EURopean Endeavour for Chimeric Antigen Receptor Therapies) of which MolMed is coordinator. EURE-CART is a consortium of nine different partners from six different EU countries, including clinical, scientific and industrial groups, representing excellences in their specific fields. The aim of EURE-CART is conduct in the 2018 a multicentre, first-in-man Phase I/IIa clinical trial to demonstrate the safety and the efficacy of CD44v6 CAR T-cell immunotherapy in acute myeloid leukaemia and multiple myeloma.



On April 13 , the Company has announced having exercised its option right for the purchase of the San Raffaele Hospital (OSR) immune-gene therapy project against cancer developed using the Chimeric Antigen Receptor CD44v6 (CAR-CD44v6) with potential application in several haematological and solid tumour indications. The CAR-CD44v6 is part of the CAR-T family: lymphocytes armed with chimeric receptors that have demonstrated high anti-tumour potential, also against tumours - above all haematological - which are particularly aggressive and resistant to traditional therapies. On April 9 2015 was concluded capital increase ( 4 new shares for every 5 ordinary shares held) with the full subscription of 187,711,408 newly issued ordinary shares with no par value, for an aggregate amount equal to Euro 50 million, gross of costs directly related to the operation. On March 19 2015, MolMed has entered into a strategic agreement with GlaxoSmithKline (GSK), under which MolMed will supply development, manufacturing and technology transfer services aimed at the clinical application of gene therapies based on viral vector cellular transduction.

On March 7 2014, the Company has filed to the European Medicines Agency an application for Conditional Marketing Authorisation for TK, its novel investigational cell-gene therapy. The Conditional Marketing Authorisation application is supported by cumulative efficacy and safety results obtained from a completed Phase I-II, multicentre trial (TK007). Results show that TK can reduce transplant-related mortality and increase overall survival in high risk leukaemia patients transplanted from a mismatched HSCT donor.

Share capital increase (1 newly issued share for each outstanding share), resulting in 58 million Euro gross proceeds. Total outstanding shares: 210,415,616 (100% ordinary shares with no par value).

IPO of 25% of shares, resulting in 56 million Euro gross proceeds. Shares traded on the Milan Stock Exchange (MTA, standard segment) since March 5, 2008. Total outstanding shares: 105,207,808 (100% ordinary shares with no par value).

Capital increase of 10 million Euro.

Capital increase of 16 million Euro.

Entrance of  three major Italian private investors: Fininvest, Herule Finance (now H-Equity S.r.l.) and La Leonardo Finanziaria (now Delfin S. à r.l.) as new shareholders, generating a capital increase of 20 million Euro.

Acquisition and incorporation of Genera S.p.A., the research company of the San Raffaele Institute.

Evolution of business model: from service company to biopharmaceutical product company.

Acquisition of Boehringer Mannheim by Roche, which then sells its equity stake to EDCP venture capital fund.

Foundation as a joint venture between Boehringer Mannheim and Science Park Raf to provide cell therapy services.

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Share capital € 21,819,020.83 fully paid - Office of Milan Company Registry number 1506630 - Tax identification number 11887610159