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Posts by Pieter Droppert

ASH 2012: CTL019 chimeric antigen receptor technology emerging as a new leukemia treatment

For many attendees, the most exciting news at the 2012 annual meeting of the American Society of Hematology (ASH) held last December in Atlanta was the prospect of personalized T cell therapy for the treatment of patients with B cell cancers such as chronic lymphocytic leukemia (CLL) and acute lymphoblastic leukemia (ALL).

The potential of this new treatment option was recognized at ASH 2012 by the award to Dr Bruce R. Blazar, MD and Carl H. June, MD of the Ernest Beutler Lecture and Prize for research that generated major translational advances in T-Cell Infusions.

ASH 2012 Carl June MD 1024x576 ASH 2012: CTL019 chimeric antigen receptor technology emerging as a new leukemia treatment

ASH 2012: Carl June, MD receives Ernest Beutler Prize

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ASH 2012: ABT-199 shows promise in CLL and MCL

The “Hallmarks of Cancer” paper by Douglas Hanahan and Robert Weinberg is a classic, and a must read (allow plenty of time) for anyone interested in cancer drug development.

The original 2000 paper, updated in 2011, identified six hallmarks of cancer, “distinctive and complementary capabilities that enable tumour growth and metastatic dissemination:”

  • Sustaining Proliferative Signaling
  • Evading Growth Suppressors
  • Activating Invasion and Metastasis
  • Enabling Replicative Immortality
  • Inducing Angiogenesis
  • Resisting Cell Death
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Court rules Medivation has no IP rights to Aragon Pharmaceuticals ARN-509 $MDVN

Medivation investors hoping for a windfall will be disappointed to hear that on December 20, 2012 a California judge ruled the company had no rights to what is now known as Aragon Pharmaceuticals’ ARN-509, a next-generation androgen receptor (AR) antagonist for advanced prostate cancer, similar in chemical structure to enzalutamide (Xtandi).

Enzalutamide (formerly MDV3100) was developed in the UCLA laboratory of Drs. Charles Sawyers and Michael Jung and licensed by Medivation from the University of California. Medivation believed their licensing and sponsored research agreements gave them rights to any follow-on compounds. However, instead of giving Medivation first right of refusal, the University licensed what is now ARN-509 to Aragon Pharmaceuticals, a privately-held company whose owners include Sawyers and Jung.

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2012 was a Grand Cru year for the FDA with 39 NMEs approved

As we herald in a New Year, it is time to reflect a little on the past year. 2012 was, to paraphrase Professor Bertrand Tombal’s quote about prostate cancer drug development, “a Grand Cru year” for the United States Food & Drug Administration (FDA) with 39 new molecular entitites (NMEs) approved. This is the highest approval number in the last 10 years, beating the previous high of 36 obtained in 2004. Reuters report it is a 16 year high.FDA 2012 New Molecular Entity NME Approvals Biotech Strategy Blog 2012 was a Grand Cru year for the FDA with 39 NMEs approved

Unfortunately, I don’t think can we can draw many conclusions about the state of drug development innovation from this 2012 high.

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Who to follow at #SABCS San Antonio Breast Cancer Symposium

The San Antonio Breast Cancer Symposium (#SABCS) starts next week (Dec 4 – 8).

Dr Jose Baselga Interview SABCS 2011 300x225 Who to follow at #SABCS San Antonio Breast Cancer SymposiumLast year at SABCS, Dr Jose Baselga presented the results of the CLEOPATRA phase III trial in HER2+ metastatic breast cancer.

An impressive 6.1 months increase in progression free survival (PFS) of 18.5 vs. 12.4 months was seen by the addition of pertuzumab (Perjeta) to the combination of trastuzumab (Herceptin) and chemotherapy (docetaxel). You can read more on Pharma Strategy Blog.

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Who to follow at #ASH12 American Society of Hematology Annual Meeting in Atlanta

I’m not a great fan of Twitter lists, especially those that imply you are a “Top Cat,” because they can end up being divisive and generate resentment in those not included.

ASH LOGO 300x286 Who to follow at #ASH12 American Society of Hematology Annual Meeting in AtlantaThat said, without wishing to offend anyone, here’s my initial starting point of those I will be following at the 2012 annual meeting of the American Society of Hematology in Atlanta from December 8 – 11 (#ASH12):

American Society of Hematology

Publications

Patient Advocacy

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The Evolving Multiple Myeloma Landscape

New treatments for multiple myeloma (MM) are changing the treatment landscape and that is set to continue over the next few years as several new products come to market.

This year we have seen the FDA approval of subcutaneous bortezomib (Velcade®) and carfilzomib (Kyprolis®). Approval for pomalidomide is anticipated soon.

Sundar Jagannath MD 2012 Chemotherapy Foundation Symposium 300x225 The Evolving Multiple Myeloma LandscapeEarlier this week at the 2012 Chemotherapy Foundation Symposium in New York, Sundar Jagannath, M.D., Professor of Medicine at Mt. Sinai School of Medicine presented on “New IMiD and Proteasome Inhibitors.”

Dr Jagannath told a large audience at the Symposium (also known as the Greenspan Meeting) that he hoped “pomalidomide will get accelerated approval and be in your hands by New Year”

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The Evolving CML Market – which drug to give when?

One of the enduring legacies from the development of imatinib (Gleevec®/Glivec®) for the treatment of chronic myeloid leukemia (CML) is the long-term survival data from the IRIS (International Randomized Interferon versus STI571) trial that enrolled 1106 patients between June 2000 and January 2001.

Hagop Kantarjian MD CFS 2012 300x225 The Evolving CML Market – which drug to give when?Hagop Kantarjian, M.D. Professor and Chair, Department of Leukemia at The University of Texas MD Anderson Cancer Center in Houston told the 2012 Chemotherapy Foundation Symposium (also known as the Greenspan Meeting in honor of the late Ezra Greenspan, M.D.) that:

the 10 year survival rate is 85% in patients treated with imatinib, and that this rises to 90% if you exclude deaths not related to CML.

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Will dasatinib be effective in prostate cancer?

TlogoSprycelHome Will dasatinib be effective in prostate cancer?he results of the phase 3 clinical trial of dasatinib (Sprycel) plus docetaxel/prednisone versus placebo and docetaxel/prednisone in men with castration-resistant metastatic prostate cancer (CRPC) are expected soon.

BMS recently updated the clinicaltrials.gov website to show that the dasatinib phase 3 randomized prostate cancer “READY” trial (NCT00744497) of 1500 men completed data collection in August.

Data is expected before year end and, If positive, could be a late breaker at the ASCO Genitourinary Cancers Symposiusm (ASCO GU) in Orlando from Feb 14-16, 2013.

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AB Science files for Pancreatic Cancer approval

AB Science confirms the filing for the Marketing Authorization Application to the European Medicines Agency of Masitinib in the treatment of Pancreatic Cancer.

ab science logo AB Science files for Pancreatic Cancer approval Paris based biopharmaceutical company AB Science announced in an October 16 news release that the company has applied to the European Medicines Agency (EMA) for approval of masitinib in pancreatic cancer.

Masitinib is a tyrosine kinase inhibitor of PDGF, PDGFR, FGFR, FAK, c-KIT. A phase 3 clinical trial (NCT00789633) in pancreatic cancer is underway that compares masitinib with gemcitabine to placebo with gemcitabine.  The trial started in November 2008 with an estimated enrollment of 320 patients at 68 study locations. As far as I am aware no data has yet been presented for this trial.

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