Celgene has exercised its option to develop and commercialize Juno Therapeutics’ CD19-directed Chimeric Antigen Receptor Technology (CAR-T) product candidates program outside North America and China, the companies said.

In return, Celgene agreed to pay a $50 million fee to Juno, which will retain CD19 program rights in North America and China. Celgene also agreed to pay Juno a royalty at a percentage in the mid-teens on any future net sales of therapeutic products developed through the CD19 program in Celgene’s territories, which include the rest of Asia and all of Europe.

The companies said they will also share global development expenses for products in the CD19 program.

Celgene and Juno last year launched a 10-year global collaboration to develop and commercialize cancer and autoimmune diseases immunotherapies, focusing on CAR-T as well as T-cell receptor (TCR) technologies. The deal could generate about $1 billion for Juno, which could see Celgene's investment stake in the company grow from 10% to almost one-third.

In a statement by the companies yesterday, Juno said it has three CD19-directed product candidates in clinical development:

  • JCAR015, which is in a Phase II trial for adults with relapsed or refractory (r/r) acute lymphoblastic leukemia (ALL).
  • JCAR017 is in two separate Phase I trials, one in pediatric patients with r/r ALL and another in patients with r/r non-Hodgkin lymphoma (NHL).
  • JCAR014 is in a Phase I trial in three different indications: adult r/r/ ALL, r/r NHL, and r/r chronic lymphocytic leukemia (CLL), as well as a trial in combination with AstraZeneca’s investigational programmed death ligand 1 (PD-L1) immune checkpoint inhibitor durvalumab.

“Celgene’s development and commercial expertise, particularly in hematologic malignancies, make them our ideal partner and will accelerate our global development capabilities for patients with ALL, CLL, and NHL,” stated Hans Bishop, Juno’s President and CEO.

Added Celgene CSO Robert Hershberg, M.D., Ph.D., “Our decision to move forward with the Juno CD19 program underscores our commitment to the long-term collaboration with Juno, and our strong desire to deliver important new treatment options to patients with serious hematologic malignancies.”