Biotech Strategy Blog

Commentary on Science, Innovation & New Products with a focus on Oncology, Hematology & Cancer Immunotherapy

Posts tagged ‘foundation medicine’

The 10 abstracts selected here are actually not in order of magnitude, preference or weight… with the lone exception #1, an incredible piece of work that was a decade in the making.

Chicago!

Chicago!

Few of these choices are in the press briefing, none are in the Plenary session – they’re often hidden gems that many will miss in the hurly burly of the data drop and noise.

They’re also 10 abstracts that I feel are worthy of highlighting with some additional commentary.

Some of the ideas here illustrate some intriguing trends that are emerging, others may have a big impact on the cancer immunotherapy space, either because of the novel concept idea, or because the data are very compelling, if you understand the science.

You can decide for yourselves – which ones would you pick and why?

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Today brings the launch of our series on the AACR annual meeting Previews.  A variety of different topics will be covered over the next two weeks, not just by tumour type and pathway, but also to highlight some novel research that is emerging on various driver mutations that not only can cause resistance to occur, but may also be viable targets for therapeutic intervention.

During the recent Miami Breast Cancer Conference, one Twitter follower who is living with metastatic breast cancer, asked me:

Sadly, the short answer was no.

Many of you will remember, however, that during Dr Debu Tripathy’s detailed of ER+ HER2- positive breast cancer, which I wrote about here, he raised several intriguing points including the possibility that somatic HER2 mutations might be present in some of these patients and thus be a potential therapeutic target. There was no mention of ESR1 though. I spoke to him briefly after his talk and learned that ESR1, while widely known, is really only becoming a hot topic of debate and research now with numerous groups looking into the possibilities.

This led me to research the work of Matt Ellis’s group, as well as what Dana Farber are doing, and also to talk about both HER2 and ESR1 mutations with Dr Vince Miller of Foundation Medicine, whose company is actively doing research in these areas. What he had to say was really compelling and exciting. There is also some new publications as well as interesting data in this area at AACR in San Diego.

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Biotech IPOs were a pretty hot topic in 2013, with some of the young stars in oncology seeing very good uptake and prices. Two companies that come to mind are Foundation Medicine and Agios Pharmaceuticals.  Last week, we covered Foundation Medicine (FMI) and their progress with genomic testing, which is used by a number of Pharma companies including Novartis, in their clinical trial program. Interestingly, another company using their platform is Agios (AGIO), a start up biotechnology company focusing on metabolism and its errant mechanisms in cancer related areas. Both Foundation Medicine and Agios are based in Cambridge, MA.

Agios have an impressive Founder list in Lew Cantley, Tak Mak, Craig Thompson, all strong scientists with an interest in biochemistry and metabolism. The Scientific Advisory Board is equally impressive and includes Charles Sawyers, Jeff Engelman, Pier Paolo Pandolfi and David Sabatini, to name a few luminaries. The last two are well known metabolism researchers who have published extensively on the PI3K pathway, as has Lew Cantley. Craig Thompson has published significant research on IDH metabolism and his lectures on the topic are always fascinating and educational.

You can imagine that board meetings at Agios could well be rather different from the average biotech if the founders or the advisory board decided to brainstorm or riff on the science… Whoa, who wouldn’t want to be a fly on the wall and learn from the experts?  For a CEO, though, it might be akin to herding cats!  That said, I’m impressed that the company has such a clear, focused approach.

The company have a number of industry partnerships, including a recent extension last month to their existing agreement with Celgene.

With my background in biochemistry, I’m naturally drawn to follow metabolism-based approaches including the PI3K-AKT-mTOR pathway and anything that involves the TCA cycle.  It’s a highly complex area, not least because most cancers have a high demand for metabolic inputs such as glucose and glutamine in order to constantly drive tumour proliferation and survival.

David SchenkeinAt the recent ASH meeting, they presented interesting preclinical data for AG-221 using IDH2 mutant AML xenografts. While in New Orleans,  I had the opportunity to sit down with the Agios CEO, Dr David Schenkein, and discuss their approach, challenges and direction in some detail. He is also presenting at the JP Morgan Healthcare Conference today and giving a business update on the company’s progress.

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Foundation Medicine ($FMI) will be presenting on Jan 15th at the J.P. Morgan Annual Healthcare Conference, which we will be following remotely on the blog.

Yesterday, Foundation Medicine announced an extension to their agreement with Novartis to provide molecular information and genomic profiling for clinical oncology programs, extending the existing collaboration through September 2016. The agreement also includes an option for Novartis to extend the term for an additional two year period.

A number of readers have written to me over the last couple of months after noting my enthusiasm for this technological approach and asking – what’s so interesting about diagnostics and genomics or – will it become mainstream?

Just after the ASH 2013 annual meeting,  I had the privilege to interview Dr Vincent Miller, Chief Medical Officer of Foundation Medicine and discuss his perspectives on the genomic sequencing field and where they are going.

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That is the interesting question that struck me after reading Sam Kean’s informative article in the February 4 edition of Science.  Ten years on from the sequencing of the Human Genome, the patenting of human genetic information presents unique challenges at the interface of science, law and innovation.

Researchers have obtained patents for isolating different sections of DNA that occur naturally in our bodies.  Whether this should be permitted is still open to debate. Currently, diagnostic companies who want to launch a new cancer test face the challenge that patents now cover many genes.

The Science article cites start-up Foundation Medicine in Cambridge, MA who estimated the cost of investigating possible patent infringement for a new diagnostic test at $35M, a cost that exceeded the company’s $25M of VC funding.

Add in the costs of any royalties or licensing fees and the issue of prior patents is now a nightmare for any diagnostics company.  It is simply not practical to license every gene that may be implicated in a multifactorial disease such as diabetes.  Pre-existing patents have become a barrier to market entry.

As the Science article reports, gene patents cover not only very small snips of DNA, as short as 15 nucleotides, but can prohibit the sequencing of associated DNA. Companies such as 23andMe that sequence an individual’s genome to test for the presence of certain genes may be violating patent rights of others.

What’s more so called “method” patents cover the linking of a gene sequence with a specific medical condition.

As advances in personalized medicine continue, there is a need to balance the competing interests of protecting scientific discovery and rewarding innovation, while at the same time allowing access to human genetic information that many think should be “free to all men and reserved exclusively to none.” Quotation from Bilski v. Kappos, 130 S.Ct. 3218, 3225 (2010)

A law suit currently on appeal to the US Court of Appeals for the Federal Circuit may lead to a change in the current practices of the US Patent & Trademark Office.  The American Association of Pathologists and others have challenged several patents relating to the breast cancer genes BRCA1 and BRAC2 held by Myriad Genetics and the University of Utah Research Foundation.

BRCA1 and BRCA2 genes are associated with an increased risk of breast and ovarian cancer.  The US district court for the Southern District of New York in a surprise decision by Judge Robert Sweet, invalidated Myriad’s patents.  The New York Times article about the case has a link to the Judge’s 156 page opinion.  The decision that isolated but otherwise unaltered DNA should not be patentable is now being appealed by Myriad.

In their legal brief, arguing for the decision to be upheld, the United States Government states:

“The fact that a particular segment of the human genome codes for the BRCA1 protein in a human cell, for example, rather than for adrenaline or insulin or nothing at all, is not within the power of science to alter. Such basic natural relationships may not be the subject of a patent.”

If the District Court’s decision is upheld on appeal, it would represent a fundamental policy shift on what patents can be obtained for human genetic information. Such a decision would prevent Myriad from charging royalties and exclusivity for the genetic testing of BRCA1 and potentially invalidate similar types of patents. Depending on your point of view this will either harm the biotechnology industry or increase the market opportunities.

Given the stakes involved, it is likely the Myriad case will end up being considered by the United States Supreme Court, and what they may decide is anyone’s guess.

To read more in-depth analysis about the Myriad case and the legal issues involved with the patenting of genomic information, I strongly recommend the “Genomics Law Report”, a blog written by Dan Vorhaus and others.

Ten years after the human genome was sequenced we are still working out the intellectual property rights. The question as to whether companies should be allowed to patent unaltered human genes is one that will be answered in the not too distant future.

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