Leukemia Treatment Achieves Promising Results

GuruFocus.com
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- By Alberto Abaterusso

Juno Therapeutics Inc. (JUNO) communicated through the Business Wire on Dec. 3 that the results from the study undertaken in patients affected with lymphocytic leukemia (CLL) and treated with JCAR014 were promising.

The results were presented by the biopharmaceutical company during the 58th American Society of Hematology (ASH) Annual Meeting.


The company says that the previous treatment of these patients with ibrutinib, AbbVie's (ABBV) Imbruvica, was unsuccessful and the observations collected "from studies of the translational product, JCAR014, are being applied to the development of JCAR017 for the treatment of B-cell malignancies."

The development of a translational product is a project that likely will be launched on the market upon its advancement and which purpose is "to form a startup company or create a license agreement with an established commercial entity," according to the University of Minnesota's website.

Juno Therapeutics says that "both JCAR014 and JCAR017 use a 4-1BB co-stimulatory domain and defined 1:1 cell ratio of CD4:CD8 T cells."

In JCAR014 and JCAR017, CAR stands for "Chimeric Antigen Receptor Technology" according to Juno Therapeutics' website.

JCAR014 and JCAR017 are engineered T cells which receptors are directed against tumor antigens. They include costimulatory domains derived from 4-1BB molecules that increase the response of T lymphocytes after the activation. Without co-stimulation, the immune response would otherwise be slow and therefore less efficient.

In the context of the different strategies of cellular immunotherapy, CAR technology represents a new and particularly promising approach for the rapid generation of a high number of tumor-specific lymphocytes.

In the phase I study, JCAR014 was assessed on 24 patients affected with chronic lymphocytic leukemia (CLL) and who were unsuccessfully treated with ibrutinib. This group includes three patients on whom the allogeneic stem cell transplants were also unsuccessful. The patients underwent lymphodepletion before they received the immunotherapy of JCAR014.

Eight out of 24 patients (33.33%) had complications related to the treatment with a severity ranging from grade 3 to grade 5. The most recurrent complication related to the treatment was febrile neutropenia and one patient, who developed CRS and cerebral oedema, died.

Fifteen patients out of 17 (88%) with bone marrow disease got a complete marrow response after a flow cytometry analysis was performed and in 50% of these patients (seven patients) any sign of the disease was observed when a IgH deep sequencing method was performed. The company says that "all seven of these patients are alive and progression free with follow-up ranging from three to 26 months."

Juno Therapeutics intends to start a study in early 2017 in which JCAR014 together with ibrutinib will be assessed on lymphocytic leukemia (CLL) patients. Juno is considering using the data that it will obtain from the JCAR014 studies "in support of a potential Juno-sponsored trial with JCAR017 in CLL," says the company.

Juno Therapeutics is trading at $20.51, up eight cents (or 0.39%) from the previous trading day.

The company has a market capitalization of $2.23 billion and 105.87 million of shares outstanding.

Cash and securities that can be readily converted to cash amounted to $820.66 million and the total long-term debt amounted to $31.58 million as of the third quarter.

AbbVie is trading at $60.78, up $1.35 (or plus 2.26%) from the previous trading day.

During the third quarter Ron Baron (Trades, Portfolio) increased his position in Juno Therapeutics with 340.79%.

NWQ Managers (Trades, Portfolio), Joel Greenblatt (Trades, Portfolio), David Dreman (Trades, Portfolio), Mario Gabelli (Trades, Portfolio) and Ken Fisher (Trades, Portfolio) reduced their positions in AbbVie by 73.90%, 24.43%, 5.52%, 42.78% and 1.35%.

Disclosure: I have no positions in Juno Therapeutics or AbbVie.

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This article first appeared on GuruFocus.


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