On June 15, 2016 Exemplar Genetics reported its President, John Swart, Ph.D., will present today at the 15th Annual World Preclinical Congress during the Preclinical Models in Oncology session (Press release, Exemplar Genetics, JUN 15, 2016, View Source [SID:1234513374]). Dr. Swart’s presentation titled ‘Genetically Engineered Miniswine Models of Cancer’ will provide an overview of Exemplar’s novel ExeGen TP53R167H and ExeGen KRASG12D/+/TP53R167H/+ miniswine research models developed for oncology to help bridge the pre-clinical gap from small animal models to humans.

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Dr. Swart commented, "We believe the development of these new genetically engineered miniature swine models will resolve inadequacies with traditional rodent models of cancer, which while valuable in certain aspects of research, have been inefficient at translating to human clinical trials."

As described in the Journal of Clinical Investigation publication, "Development and translational imaging of a TP53 porcine tumorigenesis model", current cancer research models are informative yet fail to accurately recapitulate human disease, and pre-clinical results utilizing these models often have poor translational value to the clinic. In particular, the lack of a large-animal model that accurately replicates human cancer pathologies has been a significant barrier to the development of effective diagnostics, as well as surgical and therapeutic interventions.

Exemplar’s genetically engineered ExeGen TP53R167H model expresses a mutation in the gene that encodes p53 (TP53), which is orthologous to one commonly found in humans. It is estimated p53 function is compromised in the vast majority of human tumors, through either TP53 gene mutation or alterations targeting the numerous regulators of p53 signaling. Studies with the TP53R167H model demonstrated tumor formation and characteristic chromosomal instability similar to what is seen in humans with mutant p53 alleles. Additionally, Exemplar has developed the ExeGen KRASG12D/+/TP53R167H/+ model which contains a conditional KRAS mutation on the background of TP53-targeted pigs that should allow for the inducement of human-like tumors in a tissue specific manner.

In April 2016, the U.S. Food & Drug Administration (FDA) exercised enforcement discretion in regard to Exemplar’s ExeGen low-density lipoprotein receptor (LDLR) miniswine clearing it for commercial use as a research model. As the first genetically engineered miniswine model reviewed and cleared by the FDA, this powerful investigational platform is available to researchers and drug developers helping forge a more reliable, consistent path from pre-clinical testing through human studies. Exemplar continues to work closely with the FDA to make each of the miniswine research models in its broad, extensive pipeline for use in the evaluation of several human health conditions including rare diseases, cancer, cystic fibrosis, neuromuscular/neurodegenerative disorders, and cardiovascular disease, available to researchers working on solutions for these devastating diseases.

On June 14, 2016 Sanofi reported the expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 (HSR) in connection with Sanofi’s intent to acquire Medivation, Inc. (NASDAQ: MDVN) (Press release, Sanofi, JUN 14, 2016, View Source [SID:1234513297]). This milestone further supports Sanofi’s belief that the all cash acquisition proposal, which is not subject to any financing condition, would provide the highest level of transaction certainty to Medivation shareholders .

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As announced on April 28, 2016, Sanofi proposed to acquire Medivation for $52.50 per share, representing an all-cash transaction valued at approximately $9.4 billion.

On June 14, 2016 Transgenomic, Inc. (TBIO), (NASDAQ: TBIO), reported plans to expand its ICE COLD-PCR (ICP)-powered cancer assays ten-fold over the next 18 months, targeting a portfolio of more than 200 exons/mutations expected to be available to partners, cancer researchers, drug developers and clinicians by 2018 (Press release, Transgenomic, JUN 14, 2016, View Source [SID:1234513324]). Multiplexed ICP technology’s ultra-high sensitivity down to 0.01% makes it possible to run ICP assays using either tissue, blood or serum samples on any sequencing platform. Recently-released studies indicate high concordance between ICP detection tests and assays produced using conventional technology, with the added benefit that the ICP tests detected mutations in both plasma and tissue samples that were missed by conventional methods.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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The expanded ICP cancer test menu will be released over the course of the next 18 months, with about 10 new exons/mutations expected to be issued every 6-8 weeks. The new tests will available in several formats–for use by TBIO’s partners and licensees, through TBIO’s Biomarker Discovery Services group and Oncology CLIA laboratory, as well as through its ICEme kits, which customers can run on Sanger, NGS and other platforms in their own laboratories. The focus, as with TBIO’s current menu of detection tests and panels, will be on actionable mutations relevant to cancer treatment decisions, with priority given to mutations requested by customers along with those newly validated by cancer researchers. The company also intends to incorporate some of the added mutations into panels for use with specific cancers and tumor types.

TBIO President and CEO Paul Kinnon commented, "The rapidly growing use of genomic testing as an essential part of cancer treatment makes this a good time to build on the foundation we have created over the past year and to exponentially expand the menu of tumor exons/mutations that can be tested using our ICP technology. We have refined and industrialized the development of new tests, as we demonstrated with the recent rapid development and release of our EGFR C797S ICP assay. We therefore believe that our ambitious goal of offering more than 200 exons/mutations by 2018 is achievable. We are optimistic that the accuracy, versatility, ease of use and rapid turnaround of ICP cancer testing, along with its availability in multiple formats and on a variety of platforms, will generate strong demand as we expand the test menu. We look forward to working with a range of customers and diagnostic laboratory partners to apply the power of TBIO’s expanded ICP product line to accelerate cancer research and improve patient outcomes."

ICE COLD-PCR achieves its ultra-high sensitivity through selective amplification of mutant DNA. The result is up to a 500-fold increase in sensitivity in identifying mutations with the most precise sequence alteration detection rates available. ICP was originally developed by the laboratory of Dr. Mike Makrigiorgos at the Dana-Farber Cancer Institute, which has exclusively licensed rights to the technology to Transgenomic.

On June 14, 2016 Lytix Biopharma In collaboration with Adaptive Biotechnologies (Seattle, USA), reported that they have investigated changes in T cell clonality before and after treatment of murine B16 melanomas with LTX-315 (Press release, Lytix Biopharma, JUN 14, 2016, View Source [SID:1234514841]). At the World Preclinical Congress to be held in Boston this week, Sharon Benzeno from Adaptive Biotechnologies will present data showing that LTX-315 significantly enhances T cell infiltration and T cell clonality in B16 melanomas. The results indicate that LTX-315 has the potential to convert non-T cell inflamed tumors into T-cell inflamed tumors. Since immunotherapy normally is more effective in subsets of patients with a T cell inflamed tissue, LTX-315 may increase the number of patients responding to immunotherapy. In collaboration with Oncodesign (Dijon, France) Lytix has shown promising results by combining LTX-315 and the immune checkpoint blockade inhibitor anti-PD-L1. Phillippe Slos from Oncodesign will present data demonstrating that LTX-315 in combination anti-PD-L1 enhance the delay of tumor growth compared to each compound alone in the murine mammary carcinoma model EMT-6.

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World Preclinical Congress (WPC) is a key networking event for those involved in preclinical research and features conferences, training seminars and short courses that cover the very latest in preclinical strategies and technologies, to enable better and faster decisions in drug discovery.

On June 13, 2016 Sanofi reported that it has filed definitive consent solicitation materials with the U.S. Securities and Exchange Commission ("SEC") seeking to remove and replace each member of Medivation, Inc.’s (NASDAQ: MDVN) Board of Directors with eight independent and highly-qualified candidates (Press release, Sanofi, JUN 13, 2016, View Source [SID:1234513296]). Sanofi’s nominees are committed to fully and fairly evaluating all of Medivation’s strategic options, including Sanofi’s acquisition offer, in accordance with their fiduciary duties to Medivation and its shareholders.

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Sanofi is mailing a letter to Medivation’s shareholders along with the definitive consent solicitation statement, which includes a WHITE consent card, providing Medivation shareholders the ability to demonstrate support for a transaction.

"We have had extensive conversations with Medivation shareholders and believe that there is overwhelming support for Medivation to undertake a sale process that includes Sanofi," said Olivier Brandicourt, M.D., Chief Executive Officer, Sanofi. "We have been clear that if Medivation were to engage and provide information, we would be in a position to increase our offer and are confident that we would be able to offer significant additional value. Medivation’s continued refusal to substantively engage beyond its continued rejection underscores that the current Board is not acting, and will not act, in the best interests of Medivation shareholders. We urge all Medivation shareholders to support Sanofi’s efforts to elect directors that are committed to maximizing value."

The letter being mailed to Medivation shareholders with Sanofi’s definitive solicitation statement reads as follows:
MEDIVATION’S CONTINUED REFUSAL TO SUBSTANTIVELY ENGAGE WITH SANOFI, BEYOND ITS CONTINUED REJECTION, IS DENYING SHAREHOLDERS THE OPPORTUNITY TO REALIZE SIGNIFICANT, IMMEDIATE AND CERTAIN VALUE

ELECT DIRECTORS COMMITTED TO MAXIMIZING VALUE FOR MEDIVATION SHAREHOLDERS

SIGN, DATE AND RETURN THE "WHITE" CONSENT CARD TODAY

Dear Medivation Shareholder:
We are sending you the enclosed Consent Statement and accompanying WHITE consent card to enable you, Medivation’s shareholders, to act in your best financial interests by removing and replacing the current Medivation board of directors with eight independent and highly-qualified candidates.

We believe that the current Medivation board of directors is not acting, and will not act, in your best interests. Our belief is supported by the current Medivation board of directors’ consistent refusal to substantively engage, beyond its continued rejection, with Sanofi on our all-cash offer to acquire Medivation for $52.50 per share of Common Stock. This is all the more concerning given that we have been very clear that Sanofi would be in a position to increase our offer and we are confident that we will be able to offer significant additional value if Medivation were to engage and provide information.

SANOFI’S COMPELLING OFFER demaNDs SUBSTANTIVE ENGAGEMENT BEYOND CONTINUED REJECTION FROM THE MEDIVATION BOARD

On March 25, 2016 and April 3, 2016, Sanofi privately approached Medivation expressing our interest in negotiating a mutually beneficial transaction. In both instances, Medivation informed us that it was not interested in discussing a potential transaction. On April 15, 2016, Sanofi submitted a private proposal to Medivation to acquire all of the outstanding shares of Medivation for $52.50 per share in cash, representing over a 50 percent premium to Medivation’s two-month volume weighted average price prior to there being takeover rumors.

On April 28, 2016, Sanofi made its proposal public as a result of the Medivation Board’s refusal to engage, beyond its rejection. Then, without any significant discussions with Sanofi, the Medivation board of directors rejected Sanofi’s proposal and has consistently refused to substantively engage in any discussions or negotiations, beyond its continued rejection. Sanofi also advised Medivation, and disclosed publicly, that we were – and remain – willing to enter into a confidentiality agreement with Medivation, which would include a reasonable standstill for Medivation to conduct a sale process. As a testament to our good faith efforts to advance discussions with Medivation, Sanofi sent a proposed Confidentially Agreement to Medivation on May 30, 2016, which included a reasonable standstill to give time for Medivation to conduct a sale process. Despite these efforts, Medivation remains unwilling to substantively engage, beyond its continued rejection, and has only offered information already known to the market to justify its refusal to enter negotiations.

Medivation SHAREholders Deserve to Be Heard

Since Sanofi publicly disclosed our proposal to acquire Medivation, we have had extensive conversations with many of you and other Medivation shareholders. Based on our conversations, we believe that you overwhelmingly support the sale of Medivation and want the Medivation board to undertake a sale process and substantively engage with Sanofi, beyond its continued rejection.

We believe Medivation’s refusal to announce a sale process or substantively engage with Sanofi, beyond its continued rejection, underscores that the current Medivation Board is not listening to shareholders and not acting in your best interests.

VOTE TO ELECT DIRECTORS WHO ARE COMMITTED TO MAXIMIZING VALUE FOR MEDIVATION SHAREHOLDERS

Accordingly, we believe that the only way to protect Medivation shareholders is to replace Medivation’s directors with eight independent, well-experienced candidates who are willing to fully and fairly evaluate all of Medivation’s strategic options, in accordance with their fiduciary duties to you and Medivation. Sanofi is seeking your support for the election of eight independent and highly-qualified candidates. If the Nominees are elected, we intend to continue to pursue our acquisition proposal and hope that the new Medivation Board will fully and fairly evaluate all of Medivation’s strategic options, including Sanofi’s acquisition offer, in accordance with their fiduciary responsibilities.

We believe that our candidates are highly-qualified to serve as directors of Medivation and are
well-respected members of the business community with extensive business, public company and/or healthcare experience. Importantly, these individuals are committed to acting in the best interests of Medivation and its shareholders and have the necessary track-record, strategic vision and experience to maximize shareholder value. We believe that, if elected, each of our candidates would be considered an independent director of Medivation and will exercise his or her independent judgment in all matters that come before the Medivation board of directors.

Protect Your Investment and act promptly to sign
and return the white consent card TODAY

We urge you to demonstrate your support for a transaction and consent to the proposals set forth in this consent statement, including electing each of the independent candidates nominated by Sanofi. Please sign, date and return the enclosed WHITE consent card in the postage-paid envelope provided as soon as possible.

We also urge you not to revoke your consent by signing any consent revocation card sent to you by Medivation. You have every right to revoke any consent revocation you may have already submitted to Medivation. To revoke an earlier revocation and change your vote, simply consent to the proposals set forth in this consent statement by following the instructions on the WHITE consent card.

Remember, if your shares of Medivation common stock are held through a brokerage firm, bank or other nominee, only this entity can execute a consent representing your shares and only upon receipt of your specific instructions. Accordingly, it is critical that you promptly follow the instructions included in the materials that you have received or contact the person responsible for your account and give instructions to consent to the proposals, including the election of the independent and highly qualified candidates nominated by us, on your behalf.

If you have any questions about executing or delivering your WHITE consent card or require assistance, please contact our consent solicitor, Innisfree M&A Incorporated, toll-free at (877) 750-5837.

Very truly yours,
Olivier Brandicourt
Chief Executive Officer
Sanofi

For Sanofi’s proposals in the consent solicitation to become effective, written consents would need to be properly completed by the holders of a majority of Medivation shares outstanding as of the close of business on June 1, 2016. In order to ensure that your consent is delivered to Medivation in a timely manner, we have set July 25, 2016 as the deadline for submission of written consents, but Sanofi reserves the right, in its sole discretion, to extend such deadline.

About Sanofi’s Nominees
On May 25, 2016, Sanofi named its slate of highly qualified directors, which includes Michael E. Campbell, Barbara Deptula, Wendy E. Lane, Ronald S. Rolfe, Steven J. Shulman, Charles P. Slacik, James L. Tyree and David A. Wilson.
Additional information regarding the nominees is available on the Investor Relations section of Sanofi’s website at View Source or Sanofi Files Consent Solicitation to Remove and Replace Medivation’s Board.