Celgene Corporation (CELG - Free Report) and partner bluebird bio, Inc. (BLUE - Free Report) announced the completion of enrollment in the KarMMa pivotal study on the companies’ lead investigational anti-B-cell maturation antigen (BCMA) chimeric antigen receptor (CAR) T cell therapy candidate, bb2121 for patients with relapsed and refractory multiple myeloma. KarMMa is a phase 2 study evaluating the efficacy and safety of bb2121 in patients with relapsed and refractory multiple myeloma.
We remind investors that Celgene has a development and co-promotion agreement with bluebird bio. Both companies have entered into a deal to co-develop and co-promote bb2121 in the United States. Both companies entered into a broad, global strategic research collaboration in 2013 to discover, develop and commercialize novel therapies in oncology. Currently, bluebird bio and Celgene are collaborating to develop CAR-T cell therapies targeting BCMA.
Per the agreement, both the companies will share the costs and profits in the United States equally. Celgene and bluebird have the joint responsibility of developing, manufacturing and commercializing bb2121 in the United States. In addition, Celgene will assume sole responsibility for drug product manufacturing and commercialization outside the United States. In addition, bluebird will receive milestones and royalties on ex-U.S. sales.
bb2121 was granted Breakthrough Therapy Designation (BTD) by the FDA and Priority Medicines (PRIME) eligibility by the European Medicines Agency. The BTD designation and PRIME eligibility were based on preliminary clinical data from the phase I CRB-401 study.
The FDA action date for the bb2121 NDA is expected in 2020. Shares of Celgene have declined 33.7% year to date compared with the industry’s decline of 17.6%.
Celgene has another CAR T therapy candidate, JCAR017, which was added to the company’s portfolio when it acquired Juno Therapeutics. The candidate is also being evaluated to treat relapsed lymphoma.
Other CAR T therapies that are available in the market are Gilead’s (GILD - Free Report) Yescarta, which is approved for the treatment of adult patients with relapsed or refractory large B-cell lymphoma, and Novartis’ (NVS - Free Report) Kymriah suspension for the treatment of patients up to 25 years of age with B-cell precursor acute lymphoblastic leukemia (ALL) that is refractory, or in second or later relapse.
Celgene carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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