Mustang Bio Inc. (NASDAQ:MBIO) and Minaris Regenerative Medicine GmBH have entered an agreement for technology transfer and GMP clinical manufacturing of MB-107. MB-107 is Mustang’s lentiviral gene therapy program under development for X-linked severe combined immunodeficiency (bubble boy disease) treatment in Europe.
Agreement for transfer of technology to support MB-107 clinical studies
According to the agreement terms, Minaris will transfer manufacturing technology and analytical processes and also their adoption to the EU regulatory environment. The objective is to supply clinical trials in the EU for the GMP manufacturing site in Ottobrunn, Germany.
Dusan Kosijer, Minaris’ Managing Director, said that they are looking forward to a successful and productive partnership with Mustang. Minaris will support Mustang with extensive commercial manufacturing and clinical experiences for autologous gene therapies. Dusan said that they are eager to collaborate with Mustang in fighting XSCID.
Commenting on the agreement, Manuel Litchman, Mustang’s CEO, said that the partnership is a huge step in supporting expanding the MB-107 pivotal clinical study in Europe. Litchman said that they are looking forward to collaborating with Minaris to expand their geographic footprint and deliver potentially life-saving therapy to patients with XSCID. Currently, Mustang is assessing MB-107 in a Phase 1/2 clinical study in newly diagnosed XSCID infants in the US. The company submitted an IND to commence Phase 2 clinical studies in the same patient group.
European Commission provides positive opinion on MB-107 in XSCID
Recently Mustang announced that the EC had issued a positive opinion regarding its Orphan Drug Application for its lentiviral gene therapy for XSCID treatment. The designation covers MB-107 for treatment of newly diagnosed XSCID infants between two months and two tears. It also applies to MB-2017 to treat previously treated patients with hematopoietic stem cell transplantation and those with indicated retreatment.
In April this year, the EMA granted MB-107 Advanced Medicinal Product classification. The US FDA gave MB-107 and MB-207 Rare Paediatric Disease and Orphan Drug Designations and granted MB-107 Regenerative Medicine Advanced Therapy Designation.