On September 14, 2016 Ipsen (Euronext:IPN; ADR:IPSEY), a global specialty-driven pharmaceutical group, reported that the European Commission has approved Cabometyx (cabozantinib) 20, 40, 60 mg tablets for the treatment of advanced renal cell carcinoma (RCC) in adults following prior vascular endothelial growth factor (VEGF)-targeted therapy (Press release, Ipsen, SEP 14, 2016, View Source [SID:SID1234515138]). Cabometyx (cabozantinib) is the only single agent to demonstrate significant clinical benefits across all three efficacy endpoints (OS, PFS, ORR) in a phase 3 study in previously treated patients with RCC. This approval allows for the marketing of Cabometyx (cabozantinib) in previously treated advanced RCC in all 28 member states of the European Union, Norway and Iceland.

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David Meek, Chief Executive Officer, Ipsen stated: "The approval of Cabometyx (cabozantinib) in Europe provides a breakthrough treatment to physicians and their patients suffering from renal cancer who failed on initial therapy. This oral drug has the potential to become a new standard of care in the second line setting of advanced renal cell carcinoma as it prolongs survival, slows disease progression, and shrinks tumors, with a clinically-acceptable safety and tolerability profile."

Dr. Bernard Escudier, oncologist, kidney cancer and immunotherapy specialist at Institut Gustave Roussy, Villejuif (France) added: "The approval of Cabometyx (cabozantinib) by the European Commission brings a new treatment option offering survival benefit for patients with renal cancer who failed a prior treatment with a VEGFR-targeted therapy. This oral drug, in addition to targeting VEGF, has a unique mechanism of action targeting MET and AXL which are common pathways of resistance in renal cell carcinoma. Cabometyx also offers a convenient oral schedule for patients and flexibility of dosing for individualized treatment. "

The approval is based on the results of a large, randomized phase 3 trial METEOR.

About CABOMETYX (cabozantinib)

Cabometyx (cabozantinib) targets include MET, AXL and VEGFR-1, -2 and -3. In preclinical models, cabozantinib has been shown to inhibit the tyrosine kinase activity of these receptors, which are involved in normal cellular function and pathologic processes such as tumor angiogenesis, invasiveness, metastasis and drug resistance.

On April 25, 2016, the U.S. Food and Drug Administration (FDA) approved Cabometyx (cabozantinib) for the treatment of patients with advanced RCC who have received prior anti-angiogenic therapy.

On September 9, 2016, the European Commission approved Cabometyx (cabozantinib) for the treatment of advanced renal cell carcinoma in adults who have received prior vascular endothelial growth factor (VEGF)-targeted therapy in the European Union, Norway and Iceland.

February 29, 2016, Exelixis and Ipsen jointly announced an exclusive licensing agreement for the commercialization and further development of cabozantinib indications outside of the United States, Canada and Japan.

About the METEOR Phase 3 Pivotal Trial

METEOR was an open-label, event-driven trial of 658 patients with advanced renal cell carcinoma who had failed at least one prior VEGFR TKI therapy. The primary endpoint was PFS in the first 375 patients randomized. Secondary endpoints included OS and objective response rate in all enrolled patients. The trial was conducted at approximately 200 sites in 26 countries, and enrollment was weighted toward Western Europe, North America, and Australia. Patients were randomized 1:1 to receive 60 mg of Cabometyx (cabozantinib) daily or 10 mg of everolimus daily and were stratified based on the number of prior VEGFR TKI therapies received and on MSKCC risk criteria. No cross-over was allowed between the study arms.

METEOR met its primary endpoint by significantly improving PFS. Compared with everolimus, Cabometyx (cabozantinib) was associated with a 42 percent reduction in the rate of disease progression or death. Median PFS for Cabometyx (cabozantinib) was 7.4 months versus 3.8 months for everolimus (HR=0.58, 95% CI 0.45-0.74, P<0.0001). Cabometyx (cabozantinib) also significantly improved the objective response rate compared with everolimus, be it through investigator assessment (24% versus 4%, p<0.0001) or through central review (17% versus 3%, p < 0.0001). These data were presented at the European Cancer Congress in September 2015 and published in The New England Journal of Medicine.1

Cabometyx (cabozantinib) also demonstrated a statistically significant and clinically meaningful increase in OS in the METEOR trial. Compared with everolimus, Cabometyx (cabozantinib) was associated with a 34 percent reduction in the rate of death. Median OS was 21.4 months for patients receiving Cabometyx (cabozantinib) versus 16.5 months for those receiving everolimus (HR=0.66, 95% CI 0.53-0.83, P=0.0003).

Cabometyx (cabozantinib) benefit in OS was robust and consistent across all pre-specified subgroups. In particular, benefit was observed regardless of risk category, location and extent of tumor metastases, and tumor MET expression level. These results were presented on June 5, 2016 at the ASCO (Free ASCO Whitepaper) Annual Meeting and concurrently published in The Lancet Oncology.2

At the time of the analysis, the median duration of treatment in the trial was 8.3 months with Cabometyx (cabozantinib) versus 4.4 months with everolimus. The most frequent adverse events regardless of causality were diarrhea, fatigue, decreased appetite and hypertension for Cabometyx and fatigue, anemia, decreased appetite and cough for everolimus. Dose reductions occurred for 62 percent and 25 percent of patients, respectively. Discontinuation rate due to an adverse event not related to disease progression was 12 percent with Cabometyx (cabozantinib) and 11 percent with everolimus.

About Advanced Renal Cell Carcinoma

Renal cell carcinoma (RCC) represents 2-3% of all cancers3, with the highest incidence occurring in Western countries. Generally, during the last two decades until recently, there has been an annual increase of about 2% in incidence both worldwide and in Europe, though in Denmark and Sweden a continuing decrease has been observed4. In 2012, there were approximately 84,400 new cases of RCC and 34,700 kidney cancer related deaths within the European Union5. In Europe, overall mortality rates for RCC have increased up until the early 1990s, with rates generally stabilizing or declining thereafter6. There has been a decrease in mortality since the 1980s in Scandinavian countries and since the early 1990s in France, Germany, Austria, the Netherlands, and Italy. However, in some European countries (Croatia, Estonia, Greece, Ireland, Slovakia), mortality rates still show an upward trend with increasing rates6.

The majority of clear cell RCC tumors have lower than normal levels of a protein called von Hippel-Lindau, which leads to higher levels of MET, AXL and VEGF.7,8 These proteins promote tumor angiogenesis (blood vessel growth), growth, invasiveness and metastasis.9-12 MET and AXL may provide escape pathways that drive resistance to VEGFR inhibitors.8,9

On September 14, 2016 Varian Medical Systems (NYSE: VAR), reported it has been selected by Proton Therapy Pte., Ltd. (View Source) to install and service a Varian ProBeam Compact single-room proton therapy system for a new oncology center in Singapore. Construction of the new center is expected to begin by the end of 2016 (Press release, InfiMed, SEP 14, 2016, View Source [SID:SID1234515137]). In addition to a 10 year service agreement, Varian will also provide its Eclipse treatment planning system training environment for use by Proton Therapy Pte., Ltd. at its new Advanced Medicine Training Centre. Varian booked the order for the equipment in the fourth quarter of its fiscal year 2016.

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The Varian ProBeam Compact system is the only single room system capable of fully rotational intensity modulated proton therapy (IMPT). Treatments can be delivered with an unmatched combination of speed, flexibility and cost efficiency. The full-featured ProBeam Compact includes a cyclotron, Varian’s unique Dynamic Peak scanning technology for IMPT, a fully rotational gantry, robotic patient positioning tools, and a comprehensive suite of motion management tools. It incorporates cone beam CT imaging for positioning the patient based on high quality anatomical images with excellent soft tissue resolution, and Varian’s world-class Eclipse and ARIA software systems for the planning and managing of treatments.

"We selected the Varian ProBeam Compact system because it is the only system suitable to fit within the existing building constraints and for its many technical advantages, the full system integration with ARIA and Eclipse, and Varian’s history of innovation and providing its customers access to new technology for the life of the platform," said Dr. Djeng Shih Kien, chairman, Proton Therapy Pte., Ltd. "We look forward to working closely with the Varian team on this important cancer-fighting technology in Singapore."

"We have given our Compact system all the technical capabilities of our multi-room ProBeam systems so that clinics can offer the best possible treatment without having to make any sacrifices in performance," said Dr. Moataz Karmalawy, general manager of Varian’s Particle Therapy division. "By working closely with Proton Therapy Pte., Ltd. on the adoption of precision proton treatments, we are providing the opportunity for increased access to this technology for cancer patients across Southeast Asia and Australasia."

On September 14, 2016 – Third Rock Ventures, LLC reported the formation
of Relay Therapeutics with $57 million in Series A financing, including participation from an affiliate of
D. E. Shaw Research, LLC (Press release, Relay Therapeutics, SEP 14, 2016, View Source [SID1234520734]).

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Relay Therapeutics is building the world’s first dedicated drug discovery
platform centered on protein motion, with the aim of designing and developing new medicines that will
make a transformative difference for patients. Relay’s novel approach will build on recent scientific and
technological advances in structural biology, biophysics, computation, chemistry and biology to create
an integrated drug discovery engine fueled by a detailed understanding of the dynamic structural
changes undergone by protein molecules within the body. The company’s groundbreaking activities are
being spearheaded by a team that includes some of the world’s leaders in these emerging areas.
"Our integration of protein motion into the heart of the drug discovery process represents both a
philosophical and technological once-in-a-generation paradigm shift," said Alexis Borisy, Executive
Chairman and interim CEO of Relay Therapeutics, and Partner at Third Rock Ventures. "At Relay, we
have assembled the team and tools to build the first company with a dedicated drug discovery pipeline
centered around protein motion. This advancement in drug discovery – from static to dynamic – creates
opportunities to develop more effective therapies that we believe will improve and extend the lives of
millions of patients."

Scientific Approach
While much of biology is controlled by the three-dimensional motion of proteins, this reality is not
reflected in today’s drug discovery process. Relay Therapeutics is using emerging technologies and
insights to move from a static perspective to a moving one, allowing for the rational discovery and
design of medicines for diseases where effective therapies do not currently exist. The company’s drug
discovery engine illuminates the full mobility of a protein and the ways in which protein motion
regulates function. By applying these technologies as an integrated team focused on disease-causing
targets, Relay Therapeutics aims to develop breakthrough medicines for patients in need. The
company’s initial programs are focused on oncology.
"Relay’s novel approach enables us to observe large-scale and subtle protein motions, identifying new
opportunities for the drug design process," said Mark Murcko, Ph.D., Chief Scientific Officer of Relay
Therapeutics. "This innovative and integrated approach allows us to pursue novel medicines against a
wide array of compelling drug targets that, until now, have been challenging or even inaccessible."
History of Protein Motion in Drug Discovery
Sixty years ago, scientists acquired the ability to generate detailed static images of the molecular
machines that operate within our bodies, yielding an improved understanding of the molecular
underpinnings of certain diseases. By the late 1980s, after a generation of technological improvements,
the adoption of these stationary molecular snapshots into the drug discovery process marked a turning
point in the history of the pharmaceutical industry, accelerating the design of more effective drugs. In
recent years, however, it has become clear that such static images tell only part of the story, and that the
emerging ability to observe how these machines move, function, and interact has the potential to once
again transform the process of drug design. Today – two generations after the first static pictures of
molecular structures, and one generation after they were first incorporated into drug discovery – Relay
Therapeutics is drawing on new computational and experimental advances to move beyond the era of
static snapshots into one in which movies of the body’s molecular machines become central to drug
discovery.
Founders
Relay Therapeutics was founded by a group of experts in structural biology, biophysics and
biomolecular simulation who have played a pioneering role in the development of technologies that are
central to the company’s approach. The founding team is applying this expertise to Relay’s drug
discovery efforts, focusing on achieving a deeper understanding of the relationship between protein
motion and drug action. The company founders are:
• Matthew Jacobson, Ph.D., Professor and Pharmaceutical Chemistry Department Chair,
University of California, San Francisco (UCSF)
• Dorothee Kern, Ph.D., Professor, Brandeis University; Investigator, Howard Hughes Medical
Institute
• Mark Murcko, Ph.D., Chief Scientific Officer and Co-Founder, Relay Therapeutics; Senior
Lecturer, Massachusetts Institute of Technology (MIT)
• D. E. Shaw Research (David E. Shaw, Ph.D., Chief Scientist)
About Relay Therapeutics
Relay Therapeutics is committed to discovering and developing medicines that will make a
transformative difference for patients by building the first dedicated drug discovery pipeline centered on
protein motion. Bringing together the latest scientific advances in structural biology, biophysics,
computation, chemistry and biology, Relay’s drug discovery engine illuminates the full mobility of a
protein and the ways in which protein motion regulates function. By applying this approach as an
integrated team focused on disease-causing targets, Relay aims to develop breakthrough medicines for
patients in need. The company’s initial programs are focused on developing therapeutics in oncology.
Headquartered in Cambridge, Massachusetts, Relay Therapeutics is a private company launched in 2016
with $57 million in Series A financing from Third Rock Ventures and an affiliate of D. E. Shaw
Research.

On September 14, 2016 Immune Design Corp. (Nasdaq:IMDZ) reported that it plans to offer and sell shares of its common stock in an underwritten public offering. All of the shares in the proposed offering are to be sold by Immune Design (Press release, Immune Design, SEP 14, 2016, View Source [SID:SID1234515147]). The offering is subject to market conditions, and there can be no assurance as to whether or when the offering may be completed, or the actual size or terms of the offering.

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Jefferies LLC, Leerink Partners LLC and Wells Fargo Securities, LLC are acting as joint book-running managers for the offering. In connection with the offering, Immune Design intends to grant the underwriters a 30-day option to purchase up to an additional 15% of the shares of its common stock offered in the public offering.

Immune Design plans to use the net proceeds of the offering to fund further clinical development of its Antigen Specific and Antigen Agnostic approaches, including CMB305, G100, ZVexNeo and ZVex2.0, continue developing the manufacturing process and scale up of its product candidates, and for working capital and general corporate purposes.

The securities described above are being offered pursuant to a "shelf" registration statement previously filed and declared effective by the Securities and Exchange Commission (SEC). The offering is being made only by means of a prospectus supplement and accompanying prospectus. A preliminary prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and will be available on the website of the SEC at www.sec.gov. When available, copies of the preliminary prospectus supplement and accompanying prospectus relating to the offering may be obtained from: Jefferies LLC Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 12th Floor, New York, NY 10022, telephone: (877) 547-6340, e-mail: Prospectus_Department@Jefferies.com; Leerink Partners LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, telephone: (800) 808-7525, ext. 6142, email: syndicate@Leerink.com; or Wells Fargo Securities, LLC, Attention: Equity Syndicate Department, 375 Park Avenue, New York, New York 10152, telephone: (800) 326-5897, email: cmclientsupport@wellsfargo.com.

This press release shall not constitute an offer to sell, or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.