MolMed received the authorization to start phase I/II clinical investigation with CAR T CD44v6 cells in acute myeloid leukemia and multiple myeloma.
Milan (Italy), March 20th, 2019 - MolMed S.p.A. (MLMD.MI), a biotechnology company focused on research, development, production and clinical validation of gene and cell therapies for the treatment of cancer and rare diseases, announces to have obtained the authorization from AIFA to start phase I-II first in man clinical trials with its own CAR-T CD44v6 for the treatment of patients with acute myeloid leukemia (AML) and multiple myeloma (MM). The authorization from AIFA follows the positive technical opinion expressed by the Italian National Institute of Health – ISS (Istituto Superiore di Sanità) on March 12th, 2019.
The clinical multicenter phase I-II investigation is part of the European project EURE CART Horizon 2020, coordinated and sponsored by MolMed. The trials foresee the participation of 5 clinical centers: two in Italy (San Raffaele Hospital in Milan, clinical trials coordination center, and Bambino Gesù Children's Hospital in Rome) and three clinical centers in other European countries, Spain, Germany and Czech Republic.
The study consists of two phases: a first phase involving adult patients with AML and MM, aimed at identifying the Maximum Tolerated Dose (MTD) among the dose levels foreseen by the clinical protocol, and a second phase, which will include also pediatric patients, with the primary objective to evaluate the therapeutic activity of CAR-T cells in each pathology in a larger number of patients.
CD44v6 is in fact an antigen that has never been used as target in a CAR before, and expressed not only by some hematological tumors such as myeloma and leukemia, but also from several solid tumors, including some big killers, such as pancreatic, head and neck adenocarcinomas and many others.
CAR-T CD44v6 is also characterized by its construct which includes MolMed’s proprietary suicide gene, aimed at increasing and extending the safety profile of the product.
Riccardo Palmisano, MolMed’s CEO commented: "The authorization to start the clinical study with CAR-T CD44v6 represents a main milestone for our Company, and exploits all the effort made by our researchers over the past few years to develop an innovative pipeline in the promising field of CAR therapies. As in its tradition, MolMed wanted to confirm its pioneering approach also in this area, developing a completely original CAR-T: while the only two CARTs currently authorized for trade in the USA and Europe and most of those now undergoing clinical trials, use specific CARs for CD19 antigen, limiting their indications to patients with hematologic diseases of the line lymphocyte B, our CAR-T CD44v6 has a completely different target, expressed in both hematological and solid tumors, as well as a higher promise of safety thanks to the presence of the suicide gene. We are confident that, thanks to the combination of our skills and continuous commitment to research, development and production of innovative gene and cellular therapies, the results of this first phase of the clinical study could confirm our expectations, and those of clinicians and patients, bringing a safe and effective solution to unmet medical needs”.
More information on the EURE CART project at the link https://www.eure-cart.eu/.