Pharma Strategy Blog

Commentary on Pharma & Biotech Oncology / Hematology New Product Development

Posts tagged ‘biomarkers’

This year’s American Association for Cancer Research (AACR) annual meeting grew by 8% to approximately 18,000 attendees with 25% from 75 foreign countries, it is truly becoming a more global event for cancer researchers.

Over the next few days I plan to cover some of my highlights (basic, translational and clinical) in depth here on the blog and also with additional notes for email subscribers.  If you haven’t signed up for the PSB email alerts, there’s still time before the AACR notes go out.

After highlighting the interesting biomarker program associated with AVEO’s tivozanib in renal cell and triple negative breast cancers in the last post, several people wrote in asking about other biomarker programs that have piqued my interest. Regular PSB readers will know that I’m not a fan of catch-all trials at all because the population being studied is too heterogeneous – use of biomarkers can help select which patients are more likely to respond to a particular drug and thus produce greater efficacy.

Another small biotech doing some interesting and compelling biomarker work is Array BioPharma, based in Boulder, Colorado.

One way to potentially improve long term cancer statistics is earlier detection, and in high risk patients, appropriate initiation of earlier treatment, since it is well known that the survival in stage II or III breast cancer is noticeably better than that for stage IV metastatic disease.

A critical question then, is how do we improve earlier detection?

There are a number of ways to achieve this:

  1. Imaging techniques
  2. Prognostication
  3. Diagnostics
  4. Biomarkers

I’ve been following the development of Oncogenex’s custirsen for a while based on various posters presented at meetings such as ASCO and AUA, but with the publication of phase II data in prostate cancer, it seems a good time to discuss the compound in more detail.

According to Oncogenex:

“OGX-011, also known as custirsen sodium, inhibits the production of clusterin, a protein that is associated with treatment resistance in a number of solid tumors, including prostate, breast, non-small cell lung, ovarian, and bladder cancers.”


This morning I was pondering a triangulation of several random thoughts that appeared in my Twitter stream, many from BIO, about various topics:

  1. Discussing the patent cliffs and lack of revenue generation some companies such as Lilly will no doubt be facing with John Carroll (Fierce Biotech) and Matt Herper (Forbes Health)
  2. Christiane True (PharmaLive) at the annual BIO meeting quoted a speaker as saying “doing more with less” which seems pretty much de rigeur these days
  3. Ron Leuty tweeted a quote from Chris Viehbacher’s (Sanofi) presentation at BIO, “Not doing more with less, but doing different things.”

Over the rest of this week I’m going to take some topics related to oncology and discuss them in more detail as part of a mini series about how cancer research is changing.

We all know that cancer isn’t one disease, but actually a myriad of different subsets, often even within each tumour type.  You can see the gradual shift aware from treating a type of cancer eg breast, lung, lymphoma, leukemia, melanoma etc to finding the driving the mutations and matching the patient to the therapy.

London Eye and Houses of Parliament


Every year I attend a numerous annual meetings associated with oncology and hematology, but the American Association of Cancer Research (AACR) event in April is one of my personal favourites.

It may be April Fool’s Day today, but this meeting is no joke – it’s for serious cancer researchers and a lot of fun to boot!

Many regular readers will remember the interview with Dr Sue Desmond-Hellmann, the Chancellor of UCSF, on the I-SPY2 trial, a large neoadjuvant study that seeks to accelerate the pace of identifying effective novel agents for early breast cancer by incorporating biomarkers from the beginning and an adaptive conjoint design. Biomarkers is definitely something that is very much to the fore these days.

A great resource for scientists involved with research in the biomarker field is Biomarker Commons, curated by my friend Walter Jessen, who describes himself as,

“a computational biologist focused on biomarker discovery and prioritization”

I’m on a lung cancer and systems biology roll at the moment, although partly that’s just how the interesting data rolls in the literature.

Here’s some new food for thought.  A group of respectable scientists published some fascinating data in PLOS Medicine (free article see reference below) entitled, “Nuclear Receptor Expression Defines a Set of Prognostic Biomarkers for Lung Cancer.”

Using PCR, they evaluated NR expression patterns associated with good and poor outcomes in patients with non-small cell lung cancer (NSCLC) and then validated the findings in lung adenocarcinomas (n=550) and squamous cell carcinoma (n=130) samples in three different analyses by comparing normal and lung cancer cells.  Two important factors emerged from the analysis:

At the AACR meeting on Molecular Diagnostics and Cancer Therapeutics meeting in Denver, there was quite a bit of interesting scientific data coming out on cancer biology and biomarkers, so here is a quick synopsis of what appealed to me:

1. IGF-1R is over expressed in a subset of triple negative breast cancers (TNBC)

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