We are developing therapies that, administered just once, have the potential to transform the lives of people with severe genetic and rare diseases and cancer. Our current platform is just the beginning. We are committed to continuing to develop gene therapy technologies and capabilities that have broad potential beyond the core indications.
We are actively seeking collaborators and licensing opportunities in the U.S. and around the world to explore the therapeutic potential of our technologies in new cell types and diseases.
We are actively seeking collaborators, in- and out-licensing opportunities to fully leverage the transformational therapeutic potential of our platforms. Specific areas of interest include:
In December 2016, we entered into a strategic manufacturing agreement with apceth Biopharma for the future European commercial production of our Lenti-D™ product candidate for cerebral adrenoleukodystrophy and our LentiGlobin™ product candidate for transfusion-dependent β-thalassemia.
Under this multi-year agreement, apceth Biopharma will perform clinical manufacturing, process validation activities and commercial manufacturing for LentiGlobin and Lenti-D drug product to support the treatment of European patients with transfusion-dependent beta thalassemia and cerebral adrenoleukodystrophy, respectively. This agreement follows a successful multi-year manufacturing relationship and provides us with European commercial manufacturing capabilities, including dedicated production suites within apceth Biopharma’s state-of-the-art GMP facility.
bluebird bio and Celgene are collaborating to develop CAR T cell therapies targeting BCMA. The collaboration’s lead oncology program, bb2121, is currently being studied for the treatment of relapsed and refractory multiple myeloma. For bb2121, bluebird and Celgene have joint responsibility for development, manufacturing and commercialization in the United States. Celgene will assume sole responsibility for drug product manufacturing and commercialization outside the United States.bluebird bio and Celgene are also working together on a second clinical-stage anti-BCMA CAR T program, bb21217.
In August 2018, we entered into a strategic research and development collaboration with Gritstone Oncology to identify tumor-specific targets and natural T-cell receptors (TCRs) directed to those targets for use in our established cell therapy platforms.
Under the agreement, Gritstone Oncology will provide 10 tumor-specific targets across several tumor types and, in certain cases, TCRs directed to our targeted indications and will utilize its proprietary technology platform to enable patient selection for clinical development of such therapies.
In June 2016, we entered into a strategic manufacturing agreement with Lonza Houston, Inc., providing for the future commercial production of our Lenti-D™ and LentiGlobin™ drug products.
This agreement follows a successful multi-year clinical manufacturing relationship and provides us with a path to commercial supply including dedicated production suites within Lonza’s state-of-the-art facility. Under this multi-year agreement, Lonza will complete the suite design, construction and validation along with process validation prior to anticipated commercial launch.
In September 2016, we entered into a strategic research and development collaboration and licensing agreement with Medigene AG for T cell receptor (TCR) immunotherapies against four targets. In this partnership, Medigene will be responsible for the generation and delivery of the TCRs using its TCR isolation and characterization platform. Following the collaborative preclinical development, bluebird bio will assume sole responsibility for the clinical development and commercialization of the TCR product candidates and will receive an exclusive license for the intellectual property covering the resulting TCRs.
In August 2018, we announced a tactical collaboration with Regeneron to apply our respective technology platforms to the discovery, development and commercialization of novel immune cell therapies for cancer.
Under the agreement, we will each leverage Regeneron’s VelociSuite® platform technologies for the discovery and characterization of fully human antibodies, as well as T-cell receptors directed against tumor-specific proteins and peptides. In addition, we have jointly selected six initial targets and will equally share the costs of research and development up to the point of submitting an IND application. Under this five-year agreement, additional targets may be selected. When an IND is submitted for a potential cell therapy product, Regeneron will have the right to opt-in to a co-development/co-commercialization arrangement for certain collaboration targets.
In December 2017, we entered into a strategic research collaboration and licensing agreement with TC BioPharm to discover and develop gamma delta CAR T cell product candidates for cancer immunotherapy.
Under the terms of the agreement, TC BioPharm is responsible for development of all targets through Phase 1/2, at which point we have the exclusive option to assume sole responsibility for further clinical development and commercialization on a global basis.