Minaris Regenerative Medicine will produce
Mustang Bio’s MB107 lentiviral gene therapy for the treatment of SCID
Mustang Bio, a US clinical-stage biopharmaceutical company focused on cell and gene therapies for the treatment of hematologic cancers, solid tumors and rare genetic diseases, and Minaris Regenerative Medicine, a leading global contract development and manufacturing organization for cell and gene therapies, wholly owned by Showa Denko Materials, have signed an agreement to enable technology transfer and GMP clinical manufacturing of Mustang’s MB-107 lentiviral gene therapy program for the treatment of X-linked severe combined immunodeficiency (“XSCID”), also known as bubble boy disease, in Europe (1). Under the terms of the agreement, Minaris will perform technology transfer of the manufacturing and analytical processes, as well as their adoption to the European regulatory environment, for the GMP-compliant manufacturing of the drug product at its site in Ottobrunn, Germany, with the goal of supplying clinical trials in Europe. MB-107 is currently being assessed in a Phase 1/2 clinical trial for XSCID in newly diagnosed infants under the age of two at St. Jude Children’s Research Hospital, UCSF Benioff Children’s Hospital in San Francisco and Seattle Children’s Hospital. Mustang submitted an investigational new drug application (“IND”) to the FDA to initiate a pivotal multi-center Phase 2 clinical trial of MB-107 in this same patient population. The trial is expected to enroll 10 patients who, together with 15 patients enrolled in the current multi-center trial led by St. Jude, will be compared with 25 matched historical control patients who have undergone hematopoietic stem cell transplantation. The primary efficacy endpoint will be event-free survival. The initiation of this trial is expected soon. Mustang is targeting topline data from this trial in the second half of 2022.
Minaris to significantly expand manufacturing capacity
Earlier in November, Minaris announced a total investment of US$64.5 million to significantly expand its facilities in Europe and Asia. A new state of the art facility will be built in the proximity of the existing site in Ottobrunn near Munich, Germany with a total investment of US$40.7 million.
The new facility will operate according to GMP standards and be dedicated to clinical and commercial manufacturing as well as development services for cell and gene therapies. The multi-storey building with a total of 6,650 sqm will initially more than double Minaris’ existing capacity in Europe by providing additional clean rooms, quality control laboratories, warehousing, cryo-storage and office space. It will have a modular design with the possibilities to go from single room to ball room design and to flexibly change between grade B and grade C configuration. The new facility is expected to be operational early 2023 and will allow for additional expansion of clean rooms according to client demand and specifications, thus more than tripling the current clean room capacity.
A new facility will also be established adjacent to the existing facility in Yokohama, Japan allowing for an additional 4,000 sqm which will double the capacity for commercial manufacturing of regenerative medicine. The new facility is scheduled to start operations in October 2022. The investment of US$ 23.8 million is part of a strategy to establish a center for cancer immunotherapy and somatic stem cells. The European and Asian expansions complement the opening of the new commercial facility in Allendale, New Jersey, USA announced in January this year.
(1) Hitachi Chemical, the parent company of Minaris Regenerative Medicine, has been renamed Showa Denko Materials, Co., Ltd. on October 1, 2020. Minaris Regenerative Medicine is the new name of Hitachi Chemical and this new name has been adopted last September to better represent Hitachi Chemical’s global development and manufacturing services business for the cell and gene therapy industry. The wholly-owned regional subsidiary companies and entities within Minaris Regenerative Medicine, encompassing a global footprint of over 200,000 square feet and employee base of over 500, have adopted the same name:
• North America: Hitachi Chemical Advanced Therapeutics Solutions, is renamed Minaris Regenerative Medicine
• Europe: apceth Biopharma GmbH is renamed Minaris Regenerative Medicine GmbH
• Asia: Hitachi Chemical’s Yokohama regenerative medicine facility adopted the use of Minaris Regenerative Medicine as its brand name.
Anne-Lise Berthier (23/11/2020)