Macrophage Cell Surface Protein S100A10 may be new target

Posted on November 10, 2011 by Daedalus

Sally Church, PhD on Pharma Strategy Blog has written about research on macrophage cell surface protein S100A10 and the role this plays in cancer metastasis and tumor growth.

As Sally notes, “macrophages are critical in driving tumour growth, invasion and metastasis. Macrophages are like the Pacmen of cells…” What a great visual metaphor!

Recently published research now shows that the macrophage cell surface protein, S100A10 plays an important role in how macrophages move to the site of tumor growth, a process that is key to tumor development and angiogenesis.

Is S100A10 a potential druggable target? You will have to read Sally’s insightful blog post to learn more.

Recent advances in Cancer Imaging

Posted on November 8, 2011 by Daedalus

Richard Steinman from the University of Pittsburgh School of Medicine in “The Oncologist” (the journal of the Society of Translational Oncology), comments on the importance of the noncancerous cells in tumors (the stroma):

“The stroma, including fibroblasts, adipocytes, endothelial cells, and immune cells, had been demonstrated to provide critical metabolites to cancer cells and engages in tumor-promoting crosstalk with cancer cells.”

hi NIDA61733716 300x231 Recent advances in Cancer Imaging

PET scan of enzyme MAO-B Image Source: NIH

Recent research has shown the ability to image metabolic markers of tumor activity. On Biotech Strategy Blog, Pieter Droppert writes about a metabolic marker of malignant glioma cells, 5-ALA (5-Amino-Levulinic-Acid) and how this may help glioblastoma surgery.

Meanwhile on Pharma Strategy Blog, Sally Church discusses the use of folate receptor alpha fluorescence imaging in ovarian cancer.

Imaging of metabolic markers may assist in the identification and targeting of critical mediators of cancer-stromal crosstalk. This is an interesting area to watch.

The forthcoming AACR-NCI-EORTC conference on Molecular Targets and Cancer Therapeutics has a plenary session on “Targeting the Tumor Stroma Interaction.“

PI3-Kinase pathway molecular targets

Posted on November 1, 2011 by Daedalus

The phosophoinositide-3-kinase (PI3K) pathway is a hot area in cancer new product development and is currently attracting a lot of interest in drug development.

Infinity Pharmaceuticals yesterday announced they would begin two Phase 1 trials of their small molecule (IPI-145), previously licensed from Intellikine, that inhibits PI3K delta and PI3K gamma.

A review by Sally Church of the top posts of the past year on Pharma Strategy Blog, showed that the most popular post was, you guessed it on:

PI3K: A hot topic in cancer research

Amongst the 640,000 reads of Pharma Strategy Blog this past year and a choice of over 900 posts, that is certainly quite an achievement. Incidentally, No 9 in the list of top 10 posts for the year, was Sally’s Update on PI3K from ASCO.

The PI3-kinase or PI3K pathway is one of Sally’s favorites, and as she notes it “has been shown to play a major role in proliferation and survival in a wide variety of human cancers, thus making it a potential target for therapeutic intervention.”

In addition to Infinity, an number of biotech and pharma companies are actively involved in clinical research that targets this pathway.

New data and further insights are expected at the forthcoming AACR-NCI-EORTC conference on Molecular Targets and Cancer Therapeutics in San Francisco.

CRKL may be a new molecular target in lung cancer

Posted on October 28, 2011 by Daedalus

One of the services that Icarus Consultants offers pharma & biotech companies is help in identifying molecular targets for new products that have both a valid scientific, clinical rationale and viable commercial opportunity.

Sally Church, PhD is our new products specialist and writes the Pharma Strategy Blog. In a recent post, she discusses research that suggests the protein CRKL “may well be a valid therapeutic target” in a subset of patients in non small cell lung cancer (NSCLC).

One of the interesting observations that Sally makes from this research is that:

“CRKL could act as an oncogene in other cancers with CRKL amplifications”

Sally also notes that it would be:

“very interesting to see what happens in the clinic to a subset of lung cancer patients with CRKL amplification who are treated with an EGFR and PI3K inhibitor to see if this reduces resistance to treatment and improves outcomes.”

Sally Church will be at the forthcoming AACR-IASCL joint conference on the Molecular Origins of Lung Cancer: Biology, Therapy and Personalized Medicine in San Diego from January 8-11, 2012.

What is a drug?

Posted on October 26, 2011 by Daedalus

That sounds like a simple question, but can actually be difficult to answer.

As part of a market entry strategy or overview of the commercial landscape, we often have to look at the regulatory framework in a country.

For many products from pharma or biotech it’s obvious that something is a drug, medicinal product, biological product or device. However, for those involving nanotechnology, tissue engineering, biologics, or combinations of drugs/devices, it can be less clear.

Understanding how a product is classified from a regulatory perspective, something that may differ between countries, will impact a path to market strategy.

In the United States, under the Federal, Food Drug and Cosmetic Act (21 U.S.C. 321), the term “drug” includes:

“articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals.”

Dietary supplements such as vitamins are usually not considered to be drugs.

However, new research is coming out that shows vitamins may be more active than we may have previously thought.

Pieter Droppert on Biotech Strategy Blog has commented on research that showed giving vitamin E supplements to healthy men led to a 17% increased risk of prostate cancer.

In pancreatic cancer, researchers showed that Vitamin E may improve the effectiveness of gemcitabine.

In future it is possible that the regulatory classification for vitamins may change if they end up being given as active compounds for the treatment of a disease. What is a drug remains a simple question, but one that is not always easy to answer.

Why is cabozantinib (XL184) so interesting in cancer?

Posted on October 25, 2011 by Daedalus

As reported by Sally Church, PhD on Pharma Strategy Blog yesterday, Exelixis announced positive phase 3 trial data for cabozantinib in medullary thyroid cancer (MTC).

There are four main types of thyroid cancer:

papillary
follicular
medullary
anaplastic.

According to the NCI there are 48,000 new thyroid cancer cases a year in the United States and 1700 deaths. Medullary thyroid cancer is estimated to be only 5-8% of cases, and thyroidectomy is curative in a high percentage of cases. This low incidence, therefore, makes this a small target market.

As noted on Pharma Strategy Blog, the topline data for cabozantinib in MTC showed an increase in progression free survival (PFS) of 7.2 months.

This is good news for MTC patients. Earlier this year AstraZeneca’s vandentanib (Caprelsa®) was approved by the FDA in medullary thyroid cancer, but as Pharma Strategy Blog mentioned, it has a number of challenges:

“namely prolongation of QT, causing irregular heart beat and thus it was made available under a Risk Evaluation and Mitigation Strategy (REMS).”

What makes cabozantinib (XL184) so interesting in cancer drug development?

As Sally noted in her insightful blog post, cabozantinib “targets MET, RET and VEGFR2.”

It is a targeted therapy that inhibits both MET and VEGFR. MET and its ligand HGF drive tumor cell invasion and metastasis. MET and VEGFR2 synergize to promote angiogenesis.

In approximately half of the patients with sporadic MTC, there are germline mutations of RET (Rearranged during Transfection) gene. MTC mutations activate the RET kinase, and several signaling pathways including the RAS/MEK/ERK/PI3K pathway. This in turn promotes cell proliferation, invasion and survival.

At the annual meeting of the American Society of Clinical Oncology (ASCO) in Chicago earlier this year, phase 2 data for cabozantinib in metastatic castration resistant prostate cancer was presented. The preliminary results showed a dramatic effect on bone pain and narcotic use. Validation of these results that may have a big impact on the quality of life for advanced prostate cancer patients is awaited in a more formal pain study.

Cabozantinib is an interesting broad-acting product to watch out for and further data in ovarian and prostate cancer is expected. You can follow its development on Pharma Strategy Blog.

AACR-NCI-EORTC Molecular Targets Meeting San Francisco

Posted on October 14, 2011 by Daedalus

The favorite scientific meeting of Sally Church, PhD is the American Association for Cancer Research AACR-NCI-EORTC Molecular Targets and Cancer Therapeutics international conference that alternates each year between Europe and the United States.

This year it is being held in San Francisco from November 12-16, 2011, and already AACR has announced that a lot of new data will be presented on early stage new products in development.

On Pharma Strategy Blog, Sally notes the “luminaries” in personalized medicine that she is looking forward to hearing from in San Francisco.

Pieter Droppert on Biotech Strategy Blog also mentions the Molecular Targets conference and his interest in the plenary session chaired by Frank McCormick on “rational cancer drug development for targeted drugs.”

The potential for academia to facilitate combination trials with drugs from different companies was highlighted in Sally Church’s recent video interview with Gordon B Mills, MD PhD from UT MD Anderson Cancer Center.

If you have plans to be in San Francisco for the Molecular Targets conference do let us know. In addition to hearing about great science – networking and meeting people is one of the big reasons to attend.

Personalized Medicine and Cancer Drug Development Strategy

Posted on October 5, 2011 by Daedalus

Making a Difference to the Lives of Cancer Patients

Sally Church has written over 900 blog posts on Pharma Strategy Blog about oncology and hematology new product development.

One series of posts stands out, and that is the “Making a Difference” interviews with thought leaders and business visionaries who are making a difference to the lives of cancer patients.

The latest in the series has just been published – a video interview with Dr Gordon B. Mills MD, PhD of MD Anderson Cancer Center.

Sally interviewed Dr Mills in Stockholm at the European Multidisciplinary Cancer Congress where he gave a keynote presentation on personalized medicine in the presidential, plenary session of the meeting.

Anyone interested in cancer drug development strategy, personalized medicine and how industry and academia can collaborate together in drug development should watch this video.

The other interviews Sally has undertaken in the “Making a Difference” series are with Alain Moussy, Ross Camidge, Sue Desmond-Hellmann and Charles Sawyers.

We look forward to many more in the future.

Understanding the Pharma Biotech Competitive Landscape

Posted on October 3, 2011 by Daedalus

One of the pharma marketing strategy consulting services that we offer clients is a competitive landscape, market opportunity report.

These custom reports analyze a pathway, disease, tumor type or competitive set, and can include a thorough analysis of clinical data, biomarkers, epidemiology, market size and competitor activity. All our work comes with actionable insights and strategic recommendations.

Once our clients understand the competitive landscape, and the market opportunity for their product we often generate a path to market strategy.

One of the ways our consultants keep abreast of current pharma/biotech industry news is through writing about science and clinical data.

Following the recent 2011 European Multidisciplinary Cancer Congress (EMCC 2011), the joint meeting of ESMO, ECCO and ESTRO, Sally Church wrote an in-depth analysis of the phase II data for T-DM1 (trastuzumab emtansine) in first line metastatic breast cancer. You can read more on Pharma Strategy Blog.

Meanwhile on Biotech Strategy Blog, Pieter Droppert interviewed Dr Chris Parker about the phase III, ALSYMPCA trial results for radium-223 (Alpharadin) in advanced prostate cancer.

This radiopharmaceutical provides new treatment options for a neglected group of men who are unable to take chemotherapy. You can read more on Biotech Strategy Blog, and also watch the video interview below: