SABCS San Antonio Breast Cancer Symposium Conference coverage #SABCS

Posted on December 10, 2011 by Daedalus

Deserted River Walk due to San Antonio cold weather

If you are interested in news from the San Antonio Breast Cancer Symposium (SABCS) then Sally Church, PhD has a number of reports on Pharma Strategy Blog that are worth reading.

SABCS Video Preview

In her preview of the SABCS meeting (that you can also watch below), Sally reviews some of the BOLERO-2, CLEOPATRA and NEOSPHERE clinical trials, and what impact positive data may have on breast cancer patients. It is well worth watching.

SABCS Twitter Coverage

Although there is no wifi in the meeting rooms at SABCS, a few scientists, patients advocates and physicians are tweeting from the meeting including @drsteventucker and @teamoncology. You can easily follow the twitter conversation and check-out what’s been said through the #SABCS aggregator on Pharma Strategy Blog. As Sally would say, “check it out!”

As an example of how effective social media can be to share information, Pieter Droppert (@3NT) used storify to share some of the insights posted on twitter during the SABCS plenary lecture he attended on potential of macrophages as breast cancer drug development targets.

Breast Cancer and the Environment

Pieter also commented on the recent Institute of Medicine (IOM) report on “Breast Cancer and the Environment” which was somewhat disappointing to those hoping that it would highlight causal links.

Hot news at SABCS

The Alamo San Antonio Texas 300x225 SABCS San Antonio Breast Cancer Symposium Conference coverage #SABCS This year the San Antonio Breast Cancer Symposium had a lot of exciting new data. Two papers on the BOLERO-2 and CLEOPATRA trial data was published during the meeting.

Some of the interesting early data presented at the meeting included work on Notch inhibition to reduce aromatase inhibitor resistance, HER2 mutants and targeting HER3. You can read more updates from Sally Church on Pharma Strategy Blog.

Overall, this was one of the most interesting SABCS meetings of recent years with a good balance of science and clinical data.

Hopefully next year, there will be more discussants to put the data in context, as this would have made it an even better meeting.

Insights from AACR Molecular Targets Meeting

Posted on November 22, 2011 by Daedalus

San Francisco Transamerica Pyramid © Pieter Droppert 225x300 Insights from AACR Molecular Targets Meeting There was a lot of interesting science at the recent AACR-NCI-EORTC Molecular Targets and Cancer Therapeutics international conference in San Francisco.

In particular, the poster sessions offered the opportunity to discuss pre-clinical and early drug development work, and share insights into pathways and mechanisms of action. If you are in new product development, it’s a key meeting to attend.

What was the news at AACR molecular targets?

Sally Church on Pharma Strategy Blog aggregated the live tweets from the joint AACR-NCI-EORTC meeting, although the absence of wifi in the plenary sessions meant that there were fewer tweets than might have been expected.

Sally has written about some of the data presented on breast cancer at the meeting. In her insightful post she reviews the Syndax data for entinostat in second-line ER/PR+ breast cancer, and also asks whether ALK is a new target in inflammatory breast cancer (IBC)?

From what was heard at the meeting, there will be a lot of new breast cancer data at the forthcoming San Antonio Breast Cancer Symposium (SABCS) that Sally will also be attending.

More insights from AACR molecular targets will be available on Pharma Strategy Blog in the next few days.

Meanwhile on Biotech Strategy Blog, Pieter Droppert has written about some of the sessions he attended in San Francisco on:

Next year’s 2012 molecular targets meeting will be in Dublin, good news for all those who like Guinness!

Opportunities and Challenges with Cancer Immunotherapy

Posted on November 11, 2011 by Daedalus

At Icarus Consultants, we help pharmaceutical and biotechnology companies bring new products to market.

When we look at the market opportunity for a new product, it’s not enough to have a great product, key to success is getting paid for it. Pricing and reimbursement are important in the commercial strategy!

Is it better to obtain the highest price for a new targeted therapy or alternatively have a lower price and obtain more market share? From a marketing strategy perspective, there is sometimes a case to be made for a lower price, but it’s a hard sell to convince senior management they are not leaving money on the table.

As to cancer immunotherapy, Dendreon with sipuleucel-T have shown that it can offer a survival benefits to some cancer patients. Other vaccines and immunotherapies are in development.

However, as Pieter Droppert points out in an insightful post on Biotech Strategy blog about a pilot study for PANVAC (Bavarian Nordic, CV-301), there remain a number of challenges that still have to be overcome. These include:

How do we identify upfront which patients will respond to the vaccine?
How do we evaluate how well patients are doing without clinically validated surrogate markers to aid in assessment?

You can read more on Biotech Strategy Blog.

There is a plenary session on cancer immunotherapy at the AACR-NCI-EORTC Cancer Molecular Targets & Therapeutics conference that starts in San Francisco tomorrow.

We look forward to obtaining further insights on the opportunities and challenges with cancer immunotherapy at this meeting.

PARP inhibition in Prostate Cancer

Posted on November 9, 2011 by Daedalus

The Society for Translational Oncology (STO) recently held a prostate cancer symposium in Belfast.

In a post on Biotech Strategy Blog, Pieter Droppert reviews the STO video discussion on “Prostate Cancer: Progress & Promise”

One of the key insights is that targeting ERG signaling may be key to treating prostate cancer, and that ERG becomes a druggable target by inhibiting PARP.

Sally Church has written about the work of Arul Chinnaiyan’s lab on TMPRSS2:ERG and how this may be a more useful marker than PSA in prostate cancer.

You can read more on Pharma Strategy Blog about whether personalized therapy for prostate cancer is possible?

Sally will be attending the American Association for Cancer Research (AACR) special conference on “Advances in Prostate Cancer Research” in Orlando from February 6-9, 2012.

Co-chaired by Arul Chinnaiyan and Charles Sawyers, the meeting features plenary sessions on genomic and molecular profiling, prognostic signatures, androgen receptor signaling, drug development, ETS gene fusions, prostate cancer initiation and progression, and imaging.

If you have an interest in prostate cancer drug development and translational research this meeting looks well worth attending.

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.“

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.