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MB-107, Mustang’s lentiviral gene therapy for X-linked severe combined immunodeficiency (“XSCID”), also known as bubble boy disease, in newly diagnosed infants under the age of two.
Lead Product(s): MB-107
Therapeutic Area: Genetic Disease Product Name: MB-107
Highest Development Status: IND Enabling Product Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 19, 2022
Details:
All 23 treated patients are alive and 20 patients with follow-up greater than 4 months recovered from pre-existing infections, are off protective isolation and prophylactic antimicrobials, and have normal growth velocity.
Lead Product(s): MB-107,Busulfan
Therapeutic Area: Genetic Disease Product Name: MB-107
Highest Development Status: Phase I/ Phase II Product Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 03, 2022
Details:
FDA removes clinical hold for pivotal Phase 2 MB-107 clinical trial. Mustang will proceed with its plans to initiate the pivotal Phase 2 trial in newly diagnosed XSCID patients.
Lead Product(s): MB-107,Busulfan
Therapeutic Area: Genetic Disease Product Name: MB-107
Highest Development Status: Phase I/ Phase II Product Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 02, 2021
Details:
The companies 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, also known as bubble boy disease, in Europe.
Lead Product(s): MB-107,Busulfan
Therapeutic Area: Genetic Disease Product Name: MB-107
Highest Development Status: Phase I/ Phase II Product Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Minaris Regenerative Medicine
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement November 23, 2020
Details:
U.S. FDA has granted Orphan Drug Designation to MB-107, Mustang’s lentiviral gene therapy for the treatment of X-linked severe combined immunodeficiency, also known as bubble boy disease, in newly diagnosed infants under the age of two.
Lead Product(s): MB-107,Busulfan
Therapeutic Area: Genetic Disease Product Name: MB-107
Highest Development Status: Phase I/ Phase II Product Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 02, 2020
Details:
U.S. Food and Drug Administration (“FDA”) has granted Rare Pediatric Disease Designation to MB-107, Mustang’s lentiviral gene therapy for the treatment of X-linked severe combined immunodeficiency (“XSCID”), also known as bubble boy disease, in newly-diagnosed infants.
Lead Product(s): MB-107,Busulfan
Therapeutic Area: Genetic Disease Product Name: MB-107
Highest Development Status: Phase I/ Phase II Product Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 17, 2020
Details:
European Medicines Agency has granted Advanced Therapy Medicinal Product classification to MB-107, Mustang’s lentiviral gene therapy for the treatment of X-linked severe combined immunodeficiency.
Lead Product(s): MB-107,Busulfan
Therapeutic Area: Genetic Disease Product Name: Undisclosed
Highest Development Status: Phase I/ Phase II Product Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 20, 2020
