Replies to post #211569 on Biotech Values

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NVS > Novartis isn’t messing around with CAR-T, and it has a promising next-gen therapy to help prove it

https://endpts.com/novartis-isnt-messing-around-with-car-t-and-it-has-a-next-gen-therapy-to-help-prove-it/

This new model CAR is made with a humanized CAR protein with, presumably, greater affinity to human proteins than the mouse proteins used in the first wave of CARs built at the University of Pennsylvania.

In a small study to be reviewed at ASCO, investigators added the drug to Imbruvica (ibrutinib) among 9 patients with treatment-resistant chronic lymphocytic leukemia that had not been beaten into remission. All 9 had been on ibrutinib for at least six months prior to adding CD19-targeting CTL119 to their treatment regimen.

After three months, 8 of 9 evaluable patients were free of any sign of cancer in their bone marrow. The 9th had a partial response.

Novartis next generation CAR-T cell therapy CTL119 combined with ibrutinib shows high rate of responses in CLL patients

https://globenewswire.com/news-release/2017/05/30/1000201/0/en/Novartis-next-generation-CAR-T-cell-therapy-CTL119-combined-with-ibrutinib-shows-high-rate-of-responses-in-CLL-patients.html

CTL119 is a humanized CD19-directed chimeric antigen receptor T cell (CAR-T) cell therapy, which is different from typical small molecule or biologic therapies because it is manufactured for each individual patient using their own cells. During the treatment process, T cells are drawn from a patient's blood and reprogrammed in the laboratory to create T cells that are genetically coded to hunt the patient's cancer cells and other B-cells expressing a particular antigen.

Results from the pilot study also showed that eight of nine patients had no signs of CLL in their bone marrow at three months as tested by flow cytometry and/or analysis for minimal residual disease (MRD)[1]. MRD, which measures the presence of residual abnormalities in the blood and bone marrow at the molecular level following treatment, is important because it can be an indicator of potential relapse[2].

CT scans were performed to measure the inclusion of CLL in the spleens and lymph nodes of study patients. A number of patients showed improvements in the burden of disease in their spleens and lymph nodes at three months, though radiologic responses are less clear cut and they require longer follow-up[1].

In the study, 10 patients experienced cytokine release syndrome (CRS), two of which were grade 3. However, no patients required treatment with tocilizumab** and all patients recovered from CRS. One patient developed tumor lysis syndrome and two patients had febrile neutropenia [1].