FOUNDATION MEDICINE, INC

Our platform includes proprietary methods and algorithms for analyzing tumor tissue samples across all types of cancer, as well as information aggregation and concise reporting capabilities. Our products provide genomic information about each patient’s individual cancer, enabling physicians to optimize treatments in clinical practice and enabling biopharmaceutical companies to develop targeted oncology therapies more effectively.

Main

Publications

meaning all scientific publications submitted by the members / employees / management of the Company

Levi Garraway and Matthew Meyerson publications

02/11/2007 - 02/12/2007

The science underlying Foundation Medicine had its roots in a 2007 paper published by Levi Garraway and Matthew Meyerson, cancer researchers at the Broad Institute, in Cambridge, Massachusetts.

They came up with a speedy way to find 238 DNA mutations then known to make cells cancerous. At the time, DNA sequencing was still too expensive for a consumer test, but their strategy was to allow screening for a reasonable cost.”

http://www.nature.com/ng/journal/v39/n3/abs/ng1975.html

Garraway’s team, which included first authors Roman Thomas, Alissa Baker, and Ralph DeBiasi, and a collaboration with Matthew Meyerson, HMS associate professor of pathology at DFCI, created assays for 238 known mutations found in 17 human oncogenes. The DNA from 1,000 tumor samples collected at a variety of institutions was analyzed for mutations using mass spectrometry, which can detect point mutations in small pieces of DNA using the predicted mass corresponding to the bases examined. Advantages of the method include its low cost and sensitivity—it can detect a variant base present in the sample at a level of 10 percent or less. Garraway said that sensitivity is important since many tumor samples contain a heterogeneous mix of tissue, only part of which may be cancerous.

Garraway said his next step is to create a version that includes more than a thousand assays for mutations in 90 different genes. The cost of the technology—less than $100 per sample in this analysis, but more for a more comprehensive scan—is within reason for clinical use. Part of the challenge of making this technique widely usable, however, is developing software to collect and analyze data from the assays. Currently, the technique can look only for mutations that switch on oncogenes, not those that turn off tumor suppressors; the first approach is more manageable since fewer ways exist to switch genes on than to turn them off. The method also misses other genomic events, like amplifications and deletions of DNA. But Garraway hopes that the basic concept can be tweaked to make it possible to study efficiently a range of genomic events in cancer.

Patents

meaning any patent submitted by the Company or licensed exclusively to the Company by any of its direct member / counterpart

Methods for identifying and using SNP panels

06/08/2007 - 06/09/2007

Described are methods for identifying single nucleotide polymorphism (SNPs) that are useful for analyzing genetic samples, and for using said SNPs to determine genetic identity of samples.

https://www.google.com/patents/US20090004652?hl=ru&dq=Levi+Garraway&ei=26IhU_L6KeXJ4ATgsYGIBw&cl=en

Compositions and methods useful 16p chromosomal disruptions

12/10/2009 - 12/11/2009

The invention provides an isolated nucleic acid comprising one or more of A2BP1 exons A, B, C, or D (SEQ ID NOs: 1, 2, 3, and 4, respectively) fused in frame with one or more of A2BP1 exons 2, 3, 5, 7-15, 17, 19 or 20 (SEQ ID NOs: 5-19, respectively), wherein the A2BP1 exons are located 5' of the A2BP1 exons. In another aspect, the invention provides a method of detecting cancer, particularly mesothelioma, non-small cell lung cancer, or gastric cancer, comprising detecting a deletion at 16p13.3-13.2.

https://www.google.com/patents/WO2010068757A1?cl=en&dq=Levi+Garraway&hl=ru&sa=X&ei=XKMhU7SKFKio4AS85YGwBA&ved=0CEcQ6AEwAjgK

BRAF mutations conferring resistance to BRAF inhibitors

02/22/2011 - 02/23/2011

The present invention relates to methods, compositions and kits concerning resistance to treatment with an anti-cancer agent, specifically an inhibitor of BRAF. In particular embodiments, the invention concerns mutations in a BRAF sequence that confer resistance to a BRAF inhibitor. Identification of such mutations in a BRAF sequence allows the identification and design of second-generation BRAF inhibitors. Methods and kits for detecting the presence of a mutant BRAF sequence in a sample are also provided.

https://www.google.com/patents/US8637246?dq=Levi+Garraway&hl=ru&sa=X&ei=26IhU_L6KeXJ4ATgsYGIBw&ved=0CD8Q6AEwAQ

Diagnosing cancer in patients with resistance to a first cancer therapy

03/09/2011 - 03/10/2011

A method of identifying a subject having cancer who is likely to benefit from treatment with a combination therapy with a RAF inhibitor and a second inhibitor is provided. A method of treating cancer in a subject in need thereof is also provided and includes administering to the subject an effective amount of a RAF inhibitor and an effective amount of a second inhibitor, wherein the second inhibitor is a MEK inhibitor, a CRAF inhibitor, a CrkL inhibitor or a TPL2/COT inhibitor. A method of identifying a kinase target that confers resistance to a first inhibitor is also provided.

https://www.google.com/patents/CA2791247A1?cl=en&dq=Levi+Garraway&hl=ru&sa=X&ei=26IhU_L6KeXJ4ATgsYGIBw&ved=0CGwQ6AEwBg

A mek1 mutation conferring resistance to raf and mek inhibitors

06/09/2011 - 06/10/2011

Nucleic acids and proteins having a mutant MEK sequence, and methods concerning identification of patients having resistance to treatment with anti-cancer agents, specifically inhibitors of RAF or MEK are provided. Methods of treatment and for optimizing treatment for patients having a mutation in a MEKl sequence are also provided.

https://www.google.com/patents/CA2799790A1?cl=en&dq=Levi+Garraway&hl=ru&sa=X&ei=26IhU_L6KeXJ4ATgsYGIBw&ved=0CH4Q6AEwCA

Compositions and methods of treating head and neck cancer

07/25/2012 - 07/26/2012

The present invention provides methods related to the treatment of head and neck squamous cell carcinoma (HNSCC) and its associated premalignant lesions. In particular, the invention features methods which may specifically target HNSCC-associated genes and alter gene expression to treat or alleviate a symptom of HNSCC, or its related premalignant lesions. These methods may involve decreasing the function of an HNSCC-associated gene with aberrant gain-of-function; or increasing the function of an HNSCC-associated gene with aberrant loss-of- function.

https://www.google.com/patents/WO2013016434A1?cl=en&dq=Levi+Garraway&hl=ru&sa=X&ei=26IhU_L6KeXJ4ATgsYGIBw&ved=0CFEQ6AEwAw

C-raf mutants that confer resistance to raf inhibitors

03/07/2013 - 03/08/2013

Nucleic acids and proteins having a mutant C-RAF sequence, and methods of identifying patients having cancer who are likely to benefit from a combination therapy and methods of treatment are provided.

https://www.google.com/patents/WO2013148100A1?cl=en&dq=Levi+Garraway&hl=ru&sa=X&ei=26IhU_L6KeXJ4ATgsYGIBw&ved=0CGMQ6AEwBQ

Collaboration

meaning any commercial / R&D purposes partnerships established

Foundation Medicine, Novartis team up on cancer diagnostics

01/04/2011 - 01/05/2011

Foundation Medicine Inc., a cancer diagnostics startup, has inked a collaboration deal with Swiss drug giant Novartis AG to tailor Foundation’s genome-based tests to Novartis’ needs. The agreement comes less than a year after Cambridge-based Foundation was launched by life sciences venture firm Third Rock Ventures, also based in Cambridge.

“This collaboration is an important step forward for Foundation and could provide us with the basis for building successful cancer genome analysis platforms for future collaborations and partners,” said CEO Alexis Borisy said in a statement.

http://www.bizjournals.com/boston/blog/mass-high-tech/2011/01/foundation-medicine-novartis-team-up.html

Foundation Medicine, Novartis Ink New Deal for Clinical Oncology Programs

06/07/2012 - 06/08/2012

Foundation Medicine today said it and Novartis have reached a new agreement to use Foundation's clinical grade, next-generation sequencing to support the drug firm's clinical oncology programs.

Novartis plans to use Foundation Medicine’s molecular information platform across many of Novartis’ Phase 1 and 2 oncology clinical programs. The pilot program established between Novartis and Foundation Medicine 18 months ago has generated very interesting data, and this type of tumor genomic profiling has become an essential component of Novartis’ clinical trials. The partnership consists of running Foundation Medicine’s comprehensive genomic profiling on most Phase 1 and 2 clinical trial enrollees over the next three years. The partnership aims to accelerate the development of Novartis’ broad portfolio of targeted cancer therapeutics and ultimately expand treatment options for patients.

http://www.reuters.com/article/2012/06/07/idUS97117+07-Jun-2012+BW20120607

Fundraising

meaning different types of investments / grants / funds provided to the Company

Meyerson asked E.Lander to help with fundraising

03/01/2007 - 03/02/2007

Meyerson asked E.Lander (Third Rock Ventures) help with fundraising and leading the technology to the market.

Lander previously had helped start Millennium Pharmaceuticals, a genomics company that had boldly promised to revolutionize oncology using similar genetic research. Ultimately, Millennium abandoned the idea—but Lander was ready to try again and began contacting former colleagues to “discuss next steps in the genomics revolution,” recalls Mark Levin, who had been Millennium’s CEO

Third Rock Ventures co-founded Foundation Medicine Inc. with $25 mln

04/01/2010 - 04/02/2010

Third Rock Ventures (E.Lander) co-founded Foundation Medicine with the initial investment of $25 mln

The main cautious was — diagnostics businesses are difficult to build and sometimes offer low returns. What followed was nearly two years of strategizing between Broad scientists and a parade of patent lawyers, oncologists, and insurance experts, which Garraway describes as being “like a customized business-school curriculum around how we’re going to do diagnostics in the new era.”

In 2010, Levin’s firm put $18 million into the company; Google Ventures and other investors have since followed suit with $15.5 million more.
В основном стратегия выхода на рынок базировалась на предположении, что стоимость получения DNA data будет сильно падать – и не ошиблись.

Foundation Medicine raises $33.5M in expanded Series A

10/19/2011 - 10/20/2011

Foundation Medicine has closed an expanded Series A financing, bringing the total raised in the round to $33.5 million. Investors included Third Rock Ventures, Kleiner Perkins Caufield & Byers (KPCB) and Google Ventures. Concurrent with the financing, Brook Byers, partner, KPCB, and Krishna Yeshwant, partner, Google Ventures, will join the company's board of directors.

http://www.fiercemedicaldevices.com/story/foundation-medicine-raises-335m-expanded-series/2011-10-19

Foundation Medicine has closed a $42.5m Series B funding.

09/20/2012 - 09/21/2012

Backers include new investors Deerfield Management Company, Casdin Capital, Redmile Group, Roche Venture Fund and WuXi Corporate Venture Fund. They joined founding investor Third Rock Ventures and existing investor Google Ventures and Kleiner Perkins Caufield & Byers. One undisclosed fund and one undisclosed strategic investor also joined the round.

The company intends to use the funding to expand commercial operations, scale laboratory capabilities and develop additional genomic profiling and information services.

http://www.finsmes.com/2012/09/foundation-medicine-closes-42-5m-series-funding.html

FOUNDATION MEDICINE EXPANDS SERIES B FINANCING TO $56 MILLION

01/08/2013 - 01/09/2013

Foundation Medicine, Inc. today announced an expansion of its Series B financing, raising an additional $13.5 million and bringing the total raised in the round to $56 million. The new investors include Bill Gates, Evan Jones and Yuri Milner.

The proceeds from the expanded Series B financing will help Foundation Medicine continue to expand commercial operations and clinical trials, scale laboratory capabilities, and develop additional genomic profiling and information services.

http://investors.foundationmedicine.com/releasedetail.cfm?ReleaseID=786813

Foundation Medicine raises $108M in IPO

09/25/2013 - 09/26/2013

Foundation Medicine will today become the eighth local biotech this year to go public, pricing its shares even higher than the high end of the range it proposed as late as last week.

The Cambridge biotech announced on Tuesday evening the pricing of 6 million shares at $18 a share, up from the $14-$16 range in its earlier filing with the Securities and Exchange Commission. The sales of those shares grossed $108 million. Including another possible 883,000 shares to cover overallotments, the company could gross as much as $119 million in the offering, minus discounts for its underwriters, and was scheduled to begin trading on the Nasdaq exchange Wednesday under the ticker, “FMI”.

http://www.bizjournals.com/boston/blog/bioflash/2013/09/foundation-medicine-raises-119m-in-ipo.html

Validation

meaning any response of the market / community to the Company's development / product

Product Development

Foundation Health announced launch of FoundationOne platform

06/01/2010 - 05/30/2012

Foundation Medicine announced today the commercial launch of FoundationOne™, the first pan-cancer, fully informative genomic profile designed to help oncologists expand their patients’ treatment options. FoundationOne is optimized to fit current oncology practice. It uses clinical-grade, next-generation sequencing to interrogate hundreds of cancer-related genes from routine, formalin-fixed, paraffin-embedded tumor samples. Test results are provided in a straightforward report that aligns detected genomic alterations with potential treatment options and clinical trials.
FoundationOne interrogates all genes somatically altered in human solid tumors that are validated targets for therapy or drivers of oncogenesis based on current knowledge. It reveals all classes of genomic alterations, including base substitutions, insertions, deletions, copy number alterations and select rearrangements.

http://www.businesswire.com/news/home/20120530005435/en/Foundation-Medicine-Launches-FoundationOne%E2%84%A2#.UyMwTWQW06o

FOUNDATION MEDICINE launches FOUNDATIONONE™ HEME - 2nd Platform

05/30/2012 - 12/07/2013

Foundation Medicine announced today the launch of its second clinical product, FoundationOne™ Heme, a fully informative genomic profile for hematologic cancers (leukemia, lymphoma and myeloma), as well as many sarcomas and pediatric cancers. The test has been developed in collaboration with Memorial Sloan-Kettering Cancer Center, and is designed to provide physicians with clinically actionable1 information to guide treatment options for patients based on the genomic profile of their cancer.

FoundationOne Heme uses comprehensive, clinical next-generation sequencing (NGS) to assess routine cancer specimens for all genes that are currently known to be somatically altered and unambiguous drivers of oncogenesis in hematologic malignancies, as well as many sarcomas and pediatric cancers. Utilizing NGS, FoundationOne Heme simultaneously detects all classes of genomic alterations, including base pair substitutions, insertions and deletions, copy number alterations and select gene rearrangements in 405 cancer-related genes. In addition to DNA sequencing, FoundationOne Heme employs RNA sequencing across 265 genes to capture a broad range of gene fusions, a type of alteration that is a common driver of hematologic cancers, sarcomas and pediatric cancers.

http://investors.foundationmedicine.com/releasedetail.cfm?ReleaseID=812380

Appointments

meaning any top management appointments in the Company

Series A Board of Directors

10/19/2011 - 10/20/2011

Concurrent with the financing, Brook Byers, partner, KPCB, and Krishna Yeshwant, partner, Google Ventures, will join the company's board of directors.

Brook was the founding president and then chairman of four biotechnology companies that were incubated in KPCB's offices and went on to become public companies with an aggregate market value of more than US$8 billion. He serves on the board of directors of CardioDX, Crescendo, Elcelyx, Foundation Medicine, Oculeve, Pacific Biosciences, Inc., Veracyte, XDx, Inc. and Zephyr Health.

http://www.kpcb.com/partner/brook-byers

Dr. Krishna Yeshwant is a physician, programmer, and entrepreneur who has been working with Google Ventures since its inception. He has worked with the technology transfer offices of MIT, Harvard, and Massachusetts General Hospital.

http://www.gv.com/team/krishna-yeshwant

Evan Jones to Join Board of Directors SERIES B Financing

01/08/2013 - 01/09/2013

Foundation Medicine today announced that Evan Jones has been nominated to join Foundation Medicine's Board of Directors. Mr. Jones is the managing member of jVen Capital, LLC and previously was the co-founder, chairman and CEO of Digene Corporation.

Prior to forming jVen Capital Mr. Jones was co-founder, Chairman and CEO of Digene Corporation, a publicly traded biotechnology company focused on women’s health and molecular diagnostic testing. Mr. Jones has more than 25 years of operating and investment experience in the life sciences industry.

http://jvencapital.com/about/

Events

meaning attendance of any scientific or commercial events