Separately, Celgene and bluebird bio to col­lab­o­rate with the Center for Cell and Gene Therapy to ad­vance new and existing CAR T-cell pro­grams

Cambridge, MA (Press Release) – bluebird bio, a privately-held bio­technology com­pany focused on gene ther­apy, today announced the for­ma­tion of a broad, global strategic col­lab­o­ra­tion with Celgene Corpo­ra­tion to discover, develop and com­mer­cial­ize novel disease-altering gene ther­a­pies in on­col­ogy. The col­lab­o­ra­tion will focus on applying gene ther­apy tech­nology to genetically modify a patient’s own T-cells, known as chi­meric an­ti­gen re­cep­tor (CAR) T-cells, to target and destroy cancer cells. The multi-year research and devel­op­ment col­lab­o­ra­tion has the poten­tial to lead to the devel­op­ment and com­mer­cial­iza­tion of multiple CAR T-cell prod­ucts. Celgene has an option to license any prod­ucts resulting from the col­lab­o­ra­tion after the completion of a Phase 1 clin­i­cal study for each such prod­uct. bluebird bio will be responsible for research and devel­op­ment activity through Phase 1 studies.

Additionally, Celgene has also entered into a separate strategic col­lab­o­ra­tion in the CAR T-cell field with the Center for Cell and Gene Therapy at Baylor College of Medicine, Texas Children’s Hospital and The Methodist Hospital, Houston, led by Malcolm Brenner, M.D., Ph.D., pro­fessor, Department of Molecular and Human Genetics and the director, Center for Cell and Gene Therapy. bluebird bio, Celgene and Dr. Brenner’s team will work col­lab­o­ratively to ad­vance and develop existing and new prod­ucts and pro­grams in the CAR T-cell field.

“The genetic manipulation of au­tol­o­gous T-cells is a new frontier in on­col­ogy, one that shows early promise in emerging clin­i­cal trials,” said Tom Daniel, pres­i­dent, research & early devel­op­ment at Celgene. “We see strong prospects for this col­lab­o­ra­tion be­tween Celgene, bluebird bio and Baylor College of Medicine’s ex­peri­enced leaders in this emerging field, led by Dr. Brenner, to ad­vance this inno­va­tive ap­proach to intractable problems in on­col­ogy.”

“We believe that our recent ad­vances in the industrialization of our gene ther­apy plat­form will drive im­prove­ments in the potency, purity, efficiency and scalability of our lentiviral gene ther­apy pro­grams. These ad­vances provide us with an oppor­tu­ni­ty to apply our plat­form, intellectual property and know-how to the devel­op­ment of addi­tional prod­uct can­di­dates in indi­ca­tions such as CAR T-cells for cancer,” stated Nick Leschly, CEO of bluebird bio. “Celgene is a global leader in on­col­ogy and, com­bined with Baylor’s expertise in the CAR T-cell field, we have created a great oppor­tu­ni­ty to drive inno­va­tion in a new and exciting area.”

Financial terms of the agree­ment in­clude an upfront payment and up to $225 million per prod­uct in poten­tial option fees and clin­i­cal and regu­la­tory mile­stones. bluebird bio also has the right to par­tic­i­pate in the devel­op­ment and com­mercial­i­za­tion of any licensed prod­ucts resulting from the col­lab­o­ra­tion through a 50/50 co-develop­ment and profit share in the United States in exchange for a reduction of mile­stones. Royalties would also be paid in regions where there is no profit share in­­clud­ing in the United States if bluebird bio declines to exercise their co-development and profit sharing rights.

The gene ther­apy prod­ucts cur­rently in clin­i­cal devel­op­ment at bluebird bio for the treat­ment of childhood cerebral adreno­leuko­dystrophy, beta-thalassemia and sickle cell disease are independent of this col­lab­o­ra­tion.

Cowen and Company con­trib­uted as a strategic advisor to bluebird bio on this trans­­action.

About CAR T-Cell Therapy

CAR T-cell ther­apy rep­re­sents a promising, emerging ap­proach to treating cancer. Blood is withdrawn from a patient and the T-cells are then extracted from a patient's blood. These cells are then genetically modified to recog­nize and attack cancer cells and then re-introduced into the patient's blood. The patient’s genetically modified cells are intended to bind to and kill the target cancer cells.

About bluebird bio

bluebird bio is devel­op­ing poten­tially transformative gene ther­a­pies for severe genetic and orphan diseases. bluebird bio has two clin­i­cal-stage pro­grams in devel­op­ment for childhood cerebral adrenoleukodystrophy (CCALD) and beta-thalassemia/​sickle cell disease. Led by a man­agement team with extensive industry ex­peri­ence, bluebird bio is privately held and backed by top-tier life sciences in­­vestors. Its operations are located in Cambridge, Mass., San Francisco, Calif., and Paris, France. For more in­­for­ma­tion, please visit www.bluebirdbio.com.

About Celgene

Celgene Corpo­ra­tion, headquartered in Summit, New Jersey, is an integrated global bio­pharma­ceu­tical com­pany engaged primarily in the discovery, devel­op­ment and com­mer­cial­iza­tion of novel ther­a­pies for the treat­ment of cancer and inflammatory diseases through gene and protein reg­u­la­tion. For more in­­for­ma­tion, please visit www.celgene.com.

Source: bluebird bio.