bluebird bio and Celgene have narrowed the focus of their two-year-old cancer gene therapy collaboration to multiple myeloma, with bluebird collecting another $25 million toward the new research.

The companies said yesterday they agreed to develop product candidates targeting B-cell maturation antigen (BCMA) over three years. BCMA is a cell surface protein expressed in most multiple myeloma cells as well as normal plasma cells.

Celgene and bluebird bio will co-develop their initial, lead anti-BCMA product candidate, bb2121, with a Phase 1 clinical trial expected to begin enrollment in early 2016. The companies added they will also develop next-generation anti-BCMA product candidates.

bluebird bio said it retains sole rights to develop all other chimeric antigen receptor (CAR) T cell programs it developed under the collaboration with Celgene, including ongoing undisclosed preclinical programs with opportunities in both solid tumors and hematologic malignancies.

Under their original collaboration launched in 2013, Celgene and bluebird bio agreed to apply gene therapy technology to genetically modify a patient’s own T cells to target and destroy cancer cells.

“We have successfully achieved the initial goal of our collaboration with Celgene—identifying a promising lead development candidate in the CAR T cell field—and we are excited to focus our Celgene collaboration on the development of anti-BCMA products,” Nick Leschly, bluebird’s president and CEO, said in a statement.

In their amended and restated collaboration agreement, Celgene agreed to pay bluebird bio $25 million to develop bb2121 through a Phase I clinical trial, as well as develop the next-gen anti-BCMA candidates. In return, bluebird bio will oversee development of all anti-BCMA product candidates through the completion of Phase I studies.

Within the anti-BCMA product program, on a product-by-product basis Celgene has an option to develop and commercialize each product candidate worldwide, with bluebird bio having the option to share equally in the development, promotion, and profits of each product candidate in the U.S.

Consistent with the companies’ earlier agreement, Celgene would also pay development and regulatory milestone payments to bluebird bio, as well as royalties on net sales. The original accord gave bluebird bio an undisclosed up-front payment and up to $225 million per product in potential option fees and clinical and regulatory milestones.

bluebird bio also won 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 U.S., in exchange for a reduction of milestones.

“We look forward to continuing to work with bluebird and build on the recent success to advance the anti-BCMA program and ultimately, to succeed on the goal of delivering a high-impact therapeutic in the CAR T arena,” added Tom Daniel, M.D., Celgene’s president of research and early development.

Beyond BCMA, bluebird bio said it is independently developing a portfolio of immuno-oncology therapeutics designed to apply the company’s technologies, including its lentiviral vector platform, gene editing capabilities and internal gene therapy and immuno-oncology expertise.

“Our goal is to initiate multiple clinical trials over the next several years against novel targets in both solid and hematologic malignancies,” stated Rob Ross, M.D., bluebird’s svp, clinical development.








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