MONTREAL, April 23, 2019 — ExCellThera Inc., an advanced clinical stage biotechnology company delivering molecules and bioengineering solutions to expand stem and immune cells for therapeutic use, announced today that the U.S. Food and Drug Administration (FDA) has granted regenerative medicine advanced therapy (RMAT) designation to its lead technology, ECT-001, in the treatment of hematologic malignancies. The RMAT designation is based on strong data from Phase I/II clinical trials using ECT-001 to expand stem and immune cells for the treatment of blood cancers. [Read more…]
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Talaris Therapeutics Receives RMAT, Raises $100M, Announces Promising Phase II Data for Kidney Transplant
Talaris Therapeutics’ RMAT and Promising Phase 2 Data of Cell Therapy for Living Donor Kidney Transplant Recipients
BOSTON & LOUISVILLE, Ky.–Apr 18, 2019–Talaris Therapeutics, Inc., formerly Regenerex, a privately held biotechnology company developing transformative cell therapies that have the potential to eliminate the burden of chronic immunosuppression for organ transplant recipients, today announced full results of its Phase 2 trial of FCR001 in living donor kidney transplant (LDKT) recipients. The therapy’s strong durability of benefit and safety profile support the initiation of a Phase 3 clinical trial in LDKT later this year.
MaSTherCell SA Enters Belgium Lease to Expand Manufacture of Cell & Gene Therapies
MaSTherCell S.A.’s lease agreement for a 5,700m2 (61,354ft²) facility in Belgium will expands its European manufacturing capacity for late-stage and commercially-approved cell and gene therapy products.
GOSSELIES, BELGIUM – March 26, 2019 – MaSTherCell S.A. a subsidiary of Masthercell Global Inc., a cell and gene therapy-dedicated Contract Development and Manufacturing Organization (CDMO) announces that it has signed a lease agreement for a 5,700m2 (61,354ft²) facility located in Belgium. The new facility will become a state-of-the-art manufacturing and production site designed for late-stage and commercially-approved cell and gene therapy products. The commercial facility is expected to be operational in early 2021.
This new site will significantly expand MaSTherCell’s current European manufacturing capacity. MaSTherCell will continue to use its existing site for both industrialization and early to mid-stage clinical programs.
The facility will include industry 4.0 precepts such as software integration, intelligent equipment and integrated processes with the objective to provide the cell and gene therapy community a lean solution for giving its partners a competitive advantage.
“As a leading CDMO, MaSTherCell has a role to play in solving the current lack of commercial manufacturing capacities in Europe and we believe this facility will be a game changer for market access worldwide,” said Dr. Denis Bedoret, CEO of MaSTherCell SA and President of Masthercell Global. “With this new site, we aim to be the first CDMO in Europe to have a dedicated area for large-scale commercial manufacturing.”
“It was natural for us to set up this state-of-the-art plant in the Gosselies Biopark. Not only will we remain close to our current site and centre of excellence, but also because operating in this world-leading biotechnology cluster will enable us to benefit from a first-class environment in terms of skills, people and know-how.
This new production plant will create several hundred jobs and in addition to being able to count on Belgian expertise to train our teams, being in the heart of Europe will undoubtedly be very attractive for our international recruitment,” said Eric Mathieu, Chief of Operations of MaStherCell SA.
Source: MaStherCell SA (PDF)
To learn about other market competitors to MaStherCell SA, view BioInformant’s “Database of Cell and Gene Therapy CMOs / CDMOs.”
Up Next: What is an RMAT and Who Has One?
Thermo Fisher Scientific to Acquire Cell & Gene Therapy CMO Brammer Bio for $1.7B
Thermo Fisher Scientific Inc. (NYSE: TMO) has entered a definitive agreement to acquire Brammer Bio, a contract manufacturing organization (CMO) specializing in cell and gene therapies (CGT). Valued at approximately $1.7 billion in cash, the transaction represents one of the most lucrative acquisitions of a cell and gene therapy CMO to date. [Read more…]
Cellectis Secures 82,000 Sq Ft Manufacturing Facility in Raleigh to Compliment Paris Facility
Cellectis, a leading French biopharmaceutic company, has signed a lease agreement for an 82,000 sq. ft. manufacturing facility in Raleigh, North Carolina, to complement its existing 14,000 sq. ft. manufacturing facility in Paris, France.
Located at 2500 – 2540 Sumner Boulevard in Raleigh, NC, the new USA facility is owned by Equus Capital Partners and will be used for clinical and commercial production of Cellectis’ leading allogeneic UCART products.
Importantly, the decision will combine the capabilities of Cellectis’ two facilities to advance its manufacturing processes and prepare for potential commercialization of its UCART products in the future. [Read more…]
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