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News Article | February 23, 2017
Site: phys.org

A new risk model developed by a team of researchers from the University of Delaware's College of Agriculture and Natural Resources (CANR) and the Delaware Environmental Observing System (DEOS), will allow lima bean growers in the state to utilize a free on-line tool to help them assess the risk of having their fields hit with downy mildew, a fungal-like disease caused by Phytophthora phaseoli. The research was funded by a five-year, $1.5 million U.S. Department of Agriculture (USDA) Specialty Crop Research Initiative grant (SCRI). The team includes Nicole Donofrio and Tom Evans, professors of plant pathology in CANR's Department of Plant and Soil Sciences; Gordon Johnson, assistant professor of plant and soil sciences and a fruit and vegetable specialist for Cooperative Extension; and Kevin Brinson, director of DEOS, which is housed in UD's Department of Geography in the College of Earth, Ocean, and Environment (CEOE). Matthew Shatley, computer research specialist, and Chris Hughes, environmental applications developer, both in CEOE, helped develop the website. Donofrio said one of the goals of the grant was to create a risk model that growers and processors could easily access for lima bean downy mildew, adding that this new user-friendly website will be "an excellent tool that our cooperators can use that will inform them when and if they need to spray fungicides." Evans, who has been working on prediction models for downy mildew for 15 years with multiple students conducting research both in the field and in greenhouses, said that an older model predicted based strictly on temperature and rainfall. This newer model uses that predictor but adds dew point and temperature, which is helpful as the ideal conditions for downy mildew may also be found in September when growers encounter heavy dews but not much rain. "The month of September typically has a lot of dew because we have high humidity and low night temperatures. The one that uses dew point is the one that's been predicting the most because most of the occurrences were in September. We haven't had any major epidemics in July and August, which is kind of when we have rainfall driven disease," said Evans. The risk model utilizes a numeric scale from one to 10 and allows growers to assess how much risk they are willing to take on, before taking action. "Everybody has a different risk tolerance and their tolerance has to be taken into account. My recommendation is that you're in high risk when you're in somewhere between seven, eight or nine, but there's a lot of variation in that depending on the field and the conditions," said Evans. To use the website, users request an account via email to deos-info@udel.edu and an account is set up for them. Once the user has an account, they can log in to the website to add their lima bean fields or view risk values of their existing fields. New fields are added to the system by providing GPS coordinates or by using a map interface to select the field's location. Weather data from the nearest stations in the DEOS network are determined using the field's geographic location. Additional information required for each field includes information on the lima bean cultivar planted as well as the field's downy mildew disease history. The website allows growers to look at a set of data and graphs that show them their fields' daily risk value for the occurrence of downy mildew. Knowing their individual risk factor allows them to know whether or not they need to spray their crops, which helps their economic bottom line. "This might cut two or three protectant fungicide sprays out in a year and that might save them $100 an acre. And that adds up over time," said Evans. The less fungicides that growers use, the better it is for the environment and it also gives downy mildew less of an opportunity to develop resistance to the fungicides that are being used. Evans said this model is unique to the state of Delaware and the researchers are in the stages of validating it so that that they can feel more comfortable about setting a general range for growers. "I have not found a system that operates quite like this but that's because we're a small state and it's free data. It's public data and it's being done by people that are employed by the state or the University or both," said Evans. Brinson said that the website should be launched in time for the spring growing season and that to validate the model, the researchers used data from lima bean fields owned by vegetable production companies that have scouts who regularly check their fields for downy mildew. "We loaded that data into the system and then ran the model and did all the calculations and as the risk scores got higher, they would go out and try to confirm the presence of downy mildew," said Brinson, noting that Evans would do a lot of the scouting himself. "I know Tom was literally driving around with his iPad looking at our tool and saying, 'Looks like this score is an eight so I want to drive to this field and check it out.' The research team has put a lot of work into certainly this disease but this particular crop, too," said Brinson.


WOBURN, Mass.--(BUSINESS WIRE)--Sirtex Medical Limited (ASX: SRX) today announced that SIR-Spheres® Y-90 resin microspheres has been included as a Category 2A recommended treatment in the latest National Comprehensive Cancer Network® (NCCN®) Clinical Practice Guidelines in Oncology for colon cancer and rectal cancer. This designation denotes that there is uniform consensus among the NCCN panel that Selective Internal Radiation Therapy (SIRT) with yttrium-90 microspheres is an appropriate option in patients with liver dominant, chemotherapy resistant colorectal disease (mCRC). This recommendation places SIR-Spheres Y-90 resin microspheres at the same designation as the recommended mCRC systemic chemotherapeutic regimens. The new NCCN Guidelines are available online at https://www.nccn.org/professionals/physician_gls/f_guidelines.asp Nearly 140,000 Americans are diagnosed with colorectal cancer every year1, more than 50 percent of whom will see the cancer spread to their liver.2 “The NCCN Guidelines aim to assist medical teams, patients and their families in making informed treatment-related decisions with the goal of optimal cancer care,” said Kevin Richardson, chief executive officer for Sirtex Americas. “The 2A designation represents a very important milestone for SIR-Spheres resin microspheres and provides further validation for the role of our medical device as an important treatment option for unresectable, liver dominant metastatic colorectal cancer. We also have positive signals in the first-line setting through the results to date of the pivotal SIRFLOX study3 and eagerly anticipate the overall survival results in more than 1,100 patients from the SIRFLOX, FOXFIRE and FOXFIRE Global studies which we expect to be available in the first half of 2017.” These findings are also supported by the landmark MORE study4, a large retrospective analysis conducted in the United States with SIR-Spheres Y-90 resin microspheres in more than 600 mCRC patients. The MORE study helped to increase the understanding of SIRT as a treatment option for patients who have failed multiple lines of chemotherapy while highlighting the positive aspects of the safety and efficacy of the protocol for patients of all ages. “Clinical research has shown that SIRT brings patients with colorectal liver metastases improved and prolonged quality of life,” said lead investigator of the MORE study, Andrew S. Kennedy, M.D., F.A.C.R.O., director, Radiation Oncology Research at Sarah Cannon Research Institute, Nashville, Tenn. “We look forward to expanding access to this outpatient procedure, which has demonstrated minimal side effects, to improve outcomes for this population of patients and advance the standard of care.” SIR-Spheres Y-90 resin microspheres are the first and only microspheres with FDA premarket approval (PMA) for colorectal cancer that has metastasized to the liver.5 SIR-Spheres® Y-90 resin microspheres are a medical device used in an interventional radiology procedure known as selective internal radiation therapy (SIRT), or radioembolization, which targets high doses of radiation directly to liver tumors. The treatment consists of tens of millions of radioactive Y-90 coated resin particles, each no bigger in diameter than a human hair. Interventional radiologists inject these resin particles, or microspheres, into the hepatic artery via a catheter inserted into the femoral artery through an incision in the groin. The Y-90 resin microspheres become lodged in the capillaries that surround liver tumors, where they deliver a high dose of short-range (mean 2.5 mm; maximum 11 mm) beta radiation to the liver tumors, while sparing healthy liver tissue. The low specific gravity of the Y-90 resin microspheres allows the blood flow to distribute the radioactivity within and around the liver tumors. Available at more than 550 treatment centers in the U.S., more than 67,000 doses of SIR-Spheres Y-90 resin microspheres have been supplied worldwide. SIR-Spheres Y-90 resin microspheres have a Premarket Approval (PMA) by the FDA and are indicated for the treatment of non-resectable metastatic liver tumors from primary colorectal cancer in combination with intra-hepatic artery chemotherapy using floxuridine. SIR-Spheres Y-90 resin microspheres are approved for the treatment of inoperable liver tumors in Australia, the European Union, Argentina, Brazil, Canada and several countries in Asia, such as India and Singapore. The National Comprehensive Cancer Network® (NCCN®), a not-for-profit alliance of 27 of the world’s leading cancer centers devoted to patient care, research, and education, is dedicated to improving the quality, effectiveness, and efficiency of cancer care so that patients can live better lives. Through the leadership and expertise of clinical professionals at NCCN Member Institutions, NCCN develops resources that present valuable information to the numerous stakeholders in the health care delivery system. As the arbiter of high-quality cancer care, NCCN promotes the importance of continuous quality improvement and recognizes the significance of creating clinical practice guidelines appropriate for use by patients, clinicians, and other health care decision-makers. Sirtex Medical Limited (ASX:SRX) is an Australian-based global healthcare business working to improve outcomes in people with cancer. Our current lead product is a targeted radiation therapy for liver cancer called SIR-Spheres Y-90 resin microspheres. More than 67,000 doses have been supplied to treat patients with liver cancer at more than 1,000 medical centers in over 40 countries. SIR-Spheres® is a registered trademark of Sirtex SIR-Spheres Pty Ltd. Sarah Cannon Research Institute is the research arm of Hospital Corporation of America’s global cancer institute, Sarah Cannon. Focused on advancing therapies for patients, it is one of the world’s leading clinical research organizations conducting community-based clinical trials throughout the United States and United Kingdom. Sarah Cannon’s network of strategic sites includes more than 275 physicians who engage in research. The organization has led more than 250 first-in-man clinical trials since its inception in 1993, and has been a clinical trial leader in more than two-thirds of approved cancer therapies over the last 10 years. Additionally, Sarah Cannon offers management, regulatory, and other research support services for drug development and industry sponsors as well as strategic investigator sites through its contract research organization (CRO), Sarah Cannon Development Innovations (formerly known as SCRI Development Innovations). For more information, visit sarahcannon.com.


Bendell J.C.,Sarah Cannon Research Institute Tennessee Oncology PLLC | Jones S.F.,Sarah Cannon Research Institute | Hart L.,Florida Cancer Specialists SCRI | Pant S.,University of Oklahoma | And 8 more authors.
Cancer Investigation | Year: 2015

Background: This phase I study determined the maximum tolerated dose (MTD) of AUY922 with capecitabine in advanced solid tumors. Methods: Capecitabine 1000mg/m2 PO BID was administered with escalating doses of AUY922 IV; the MTD of AUY922 was combined with capecitabine 1250 mg/m2 (DL6). Results: 23 patients were treated at 5 dose levels (22 mg/m2-70 mg/m2). No DLTs were observed until DL6 (grade 3 diarrhea). Reversible vision darkening was seen in 26%. Four patients had partial response; 2 previously progressed on fluorouracil. Eight patients had stable disease (median 25.5 weeks). Conclusion: AUY922 plus capecitabine was well-tolerated up to 70mg/m2 with encouraging preliminary efficacy. Copyright © 2015 Taylor & Francis Group, LLC.


News Article | March 1, 2017
Site: www.businesswire.com

SEATTLE--(BUSINESS WIRE)--Juno Therapeutics, Inc. (NASDAQ: JUNO), a biopharmaceutical company developing innovative cellular immunotherapies for the treatment of cancer, today reported financial results and business highlights for the fourth quarter and year ended December 31, 2016. “2016 was a year of progress and learning for Juno and the cancer immunotherapy field. We continue to experience encouraging signs of clinical benefit in our trial addressing NHL, but we also recognize the unfortunate and unexpected toxicity we saw in our trial addressing ALL with JCAR015. We have decided not to move forward with the ROCKET trial or JCAR015 at this time, even though it generated important learnings for us and the immunotherapy field. We remain committed to developing better treatments for patients battling ALL and believe an approach using our defined cell technology is the best platform to pursue. We intend to begin a trial with a defined cell product candidate in adult ALL next year. We look forward to sharing detailed data supporting our learnings from the ROCKET trial at an upcoming scientific conference," said Hans Bishop, Juno’s President and Chief Executive Officer. "Looking forward into 2017, we continue to be optimistic about the progress we are making with JCAR017 and our pipeline more broadly. We expect 2017 will be a data-rich year of key insights, based on up to 20 ongoing trials by year end, and we plan to present data from these trials as appropriate throughout the year.” In March 2016, Celgene exercised its annual right to purchase additional shares of the Company’s common stock to “top-up” its ownership interest in the Company. Celgene purchased 1,137,593 shares at a price of $41.32 per share, for an aggregate cash purchase price of $47.0 million. Cash burn in the fourth quarter of 2016, excluding cash inflows and outflows from business development activities, was $106.6 million including $38.4 million for the purchase of property and equipment, of which $18.2 million was for the purchase of Juno's manufacturing facility. Cash burn in the fourth quarter of 2015 was $51.4 million, including $4.8 million for capital expenditures. The cash burn increase of $55.2 million was primarily due to cash outflows in connection with the overall growth of the business, including clinical, manufacturing, and research costs, the purchase of Juno's manufacturing facility, build out of its new headquarters facility, and purchase of manufacturing equipment. These increases were offset by $10.2 million received from Celgene for reimbursement of costs incurred by Juno in connection with the CD19 program. General and administrative expenses include $5.2 million and $21.0 million of non-cash stock-based compensation expense for the three and twelve months ended December 31, 2016, respectively, compared to $5.4 million and $14.9 million for the same periods in 2015. A reconciliation of GAAP net loss to non-GAAP net loss is presented below under “Non-GAAP Financial Measures.” Juno expects 2017 cash burn, excluding cash inflows or outflows from upfront payments related to business development activities, of between $270 million and $300 million. Juno will host a conference call today to review Juno’s financial results for the fourth quarter and year ended December 31, 2016 beginning at 2:00 p.m. Pacific Time (PT)/5:00 p.m. Eastern Time (ET). Analysts and investors can participate in the conference call by dialing (855) 780-7198 for domestic callers and (631) 485-4870 for international callers, using the conference ID# 60783648. The webcast can be accessed live on the Investor Relations page of Juno's website, www.JunoTherapeutics.com, and will be available for replay for 30 days following the call. Juno Therapeutics is building a fully integrated biopharmaceutical company focused on developing innovative cellular immunotherapies for the treatment of cancer. Founded on the vision that the use of human cells as therapeutic entities will drive one of the next important phases in medicine, Juno is developing cell-based cancer immunotherapies based on chimeric antigen receptor and high-affinity T cell receptor technologies to genetically engineer T cells to recognize and kill cancer. Juno is developing multiple cell-based product candidates to treat a variety of B-cell malignancies as well as solid tumors. Several product candidates have shown compelling clinical responses in clinical trials in refractory leukemia and lymphoma conducted to date. Juno's long-term aim is to leverage its cell-based platform to develop new product candidates that address a broader range of cancers and human diseases. Juno brings together innovative technologies from some of the world's leading research institutions, including the Fred Hutchinson Cancer Research Center, Memorial Sloan Kettering Cancer Center, Seattle Children's Research Institute, the University of California, San Francisco, and The National Cancer Institute. Juno Therapeutics has an exclusive license to the St. Jude Children’s Research Hospital patented technology for CD19-directed product candidates that use 4-1BB, which was developed by Dario Campana, Chihaya Imai, and St. Jude Children’s Research Hospital. Juno's product candidate JCAR017 was developed in collaboration with SCRI and others. Celgene Corporation and Juno Therapeutics formed a collaboration in June 2015 under which the two companies will leverage T cell therapeutic strategies to develop treatments for patients with cancer and autoimmune diseases with an initial focus on chimeric antigen receptor (CAR) and T cell receptor (TCR) technologies. In April 2016, Celgene exercised its option to develop and commercialize the Juno CD19 program outside North America and China. This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933, and Section 21E of the Securities Exchange Act of 1934, including statements regarding Juno’s mission, progress, and business plans; clinical benefits; clinical trial results and the implications thereof; clinical trial plans and regulatory approval timelines; timing of future clinical data; the potential of CD22/CD19 combinations, combinations of CAR T cells with checkpoint inhibitors, and CAR T constructs with fully human binding domains; the potential of acquired or licensed technology and capabilities; the potential of the Celgene collaboration; the potential of JW Therapeutics (Shanghai) Co., Ltd.; the timing or outcome of any dispute resolution proceedings; and 2017 cash burn forecast. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from such forward-looking statements, and reported results should not be considered as an indication of future performance. These risks and uncertainties include, but are not limited to, risks associated with: the success, cost, and timing of Juno's product development activities and clinical trials; Juno's ability to obtain regulatory approval for and to commercialize its product candidates; Juno's ability to establish a commercially-viable manufacturing process and manufacturing infrastructure; regulatory requirements and regulatory developments; success of Juno's competitors with respect to competing treatments and technologies; Juno's dependence on third-party collaborators and other contractors in Juno's research and development activities, including for the conduct of clinical trials and the manufacture of Juno's product candidates; Juno's dependence on Celgene for the development and commercialization outside of North America and China of Juno’s CD19 product candidates and any other product candidates for which Celgene exercises an option; Juno’s dependence on JW Therapeutics (Shanghai) Co., Ltd, over which Juno does not exercise complete control, for the development and commercialization of product candidates in China; Juno's ability to obtain, maintain, or protect intellectual property rights related to its product candidates; amongst others. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to Juno's business in general, see Juno's Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on November 9, 2016 and Juno’s other periodic reports filed with the Securities and Exchange Commission. These forward-looking statements speak only as of the date hereof. Juno disclaims any obligation to update these forward-looking statements. To supplement the financial results presented in accordance with generally accepted accounting principles in the United States (GAAP), Juno uses certain non-GAAP financial measures to evaluate its business. Juno’s management believes that these non-GAAP financial measures are helpful in understanding Juno’s financial performance and potential future results. These are not meant to be considered in isolation or as a substitute for comparable GAAP measures and should be read in conjunction with Juno’s financial statements prepared in accordance with GAAP. These non-GAAP measures differ from GAAP measures with the same captions, may be different from non-GAAP financial measures with the same or similar captions that are used by other companies, and do not reflect a comprehensive system of accounting. Juno’s management uses these supplemental non-GAAP financial measures internally to understand, manage, and evaluate Juno’s business and make operating decisions. In addition, Juno’s management believes that the presentation of these non-GAAP financial measures is useful to investors because they enhance the ability of investors to compare Juno’s results from period to period and allows for greater transparency with respect to key financial metrics Juno uses in making operating decisions. Juno endeavors to compensate for the limitation of the non-GAAP measures presented by also providing the most directly comparable GAAP measures and descriptions of the reconciling items and adjustments to derive the non-GAAP measures. The following is a reconciliation of GAAP to non-GAAP financial measures: (1) The success payment expense (gain) represents the change in the estimated fair value of the success payment obligations and the associated elapsed service period. As of December 31, 2016, the estimated fair values of the success payment liabilities to FHCRC and MSK on the consolidated balance sheets, after giving effect to the success payments achieved in December 2015, were approximately $13.3 million and $9.5 million, respectively. In December 2015, success payments of $75.0 million, less indirect costs of $3.3 million, and $10.0 million, less indirect costs of $1.0 million, were triggered to FHCRC and MSK, respectively. Juno elected to make the payments in shares of its common stock and thereby issued 1,601,085 shares to FHCRC in December 2015 and 240,381 shares to MSK in March 2016. In April 2016, Juno repurchased from MSK the 240,381 shares of common stock that had been issued to MSK. If success payment thresholds are met in the future, Juno may pay FHCRC and MSK the applicable success payment in cash or publicly-traded equity at Juno’s election. The success payment liabilities are subject to re-measurement each reporting period and may fluctuate from quarter-to-quarter and year-to-year, sometimes significantly, resulting in either an expense or a gain depending on the trading price of Juno common stock, estimated term, expected volatility, risk-free interest rate, estimated number and timing of valuation measurement dates, and estimated indirect costs that are creditable against the success payments to FHCRC and MSK. (2) This relates to a restricted stock grant in 2013 to a former co-founding director who became a consultant upon his departure from Juno’s board of directors in 2014. Unlike other outstanding awards to Juno’s employees, scientific founders, and continuing directors, the value of this restricted stock award is subject to re-measurement each reporting period as the award vests and may result in the associated expense fluctuating from quarter-to-quarter and year-to-year, sometimes significantly, based on changes in the trading price of Juno common stock through the end of the vesting period. (3) This is the change in the estimated fair value of the contingent consideration liabilities recorded in connection with the Stage and X-Body acquisitions after giving effect to a contingent consideration milestone of €6.0 million paid to the former shareholders of Stage in the fourth quarter of 2016. (4) The upfront payments related to the acquisition of technology in 2016 include payments made in connection with technology licensing and the acquisition of RedoxTherapies. The upfront payments related to the acquisition of technology in 2015 include payments in connection with the Editas and Fate Therapeutics collaborations.


News Article | February 28, 2017
Site: www.businesswire.com

SEATTLE--(BUSINESS WIRE)--Juno Therapeutics, Inc. (NASDAQ: JUNO) today announced that it will webcast its presentations at two investor conferences in March. The presentations will feature a business overview and update. The webcasts will be accessible on the Investor Relations page of Juno's website at www.JunoTherapeutics.com. A replay of each presentation will be available at the same location for 30 days following the corresponding conference. Juno Therapeutics is building a fully integrated biopharmaceutical company focused on developing innovative cellular immunotherapies for the treatment of cancer. Founded on the vision that the use of human cells as therapeutic entities will drive one of the next important phases in medicine, Juno is developing cell-based cancer immunotherapies based on chimeric antigen receptor and high-affinity T cell receptor technologies to genetically engineer T cells to recognize and kill cancer. Juno is developing multiple cell-based product candidates to treat a variety of B-cell malignancies as well as solid tumors. Several product candidates have shown compelling clinical responses in clinical trials in refractory leukemia and lymphoma conducted to date. Juno's long-term aim is to leverage its cell-based platform to develop new product candidates that address a broader range of cancers and human diseases. Juno brings together innovative technologies from some of the world's leading research institutions, including the Fred Hutchinson Cancer Research Center, Memorial Sloan Kettering Cancer Center, Seattle Children's Research Institute (SCRI), the University of California, San Francisco, and The National Cancer Institute. Juno Therapeutics has an exclusive license to the St. Jude Children’s Research Hospital patented technology for CD19-directed product candidates that use 4-1BB, which was developed by Dario Campana, Chihaya Imai, and St. Jude Children’s Research Hospital. Juno’s product candidate JCAR017 was developed in collaboration with SCRI and others. This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933, and Section 21E of the Securities Exchange Act of 1934, including statements regarding Juno’s mission, progress, and business plans, Juno’s participation in the Cowen and Company 37th Annual Health Care Conference and the 2017 Barclays Global Healthcare Conference, and the subject matter of Juno's presentations at the conferences. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from such forward-looking statements, and reported results should not be considered as an indication of future performance. These risks and uncertainties include, but are not limited to, risks associated with: the success, cost, and timing of Juno's product development activities and clinical trials; Juno's ability to obtain regulatory approval for and to commercialize its product candidates; Juno's ability to establish a commercially-viable manufacturing process and manufacturing infrastructure; regulatory requirements and regulatory developments; success of Juno's competitors with respect to competing treatments and technologies; Juno's dependence on third-party collaborators and other contractors in Juno's research and development activities, including for the conduct of clinical trials and the manufacture of Juno's product candidates; Juno's dependence on Celgene for the development and commercialization outside of North America and China of Juno’s CD19 product candidates and any other product candidates for which Celgene exercises an option; Juno’s dependence on JW Therapeutics (Shanghai) Co., Ltd, over which Juno does not exercise complete control, for the development and commercialization of product candidates in China; Juno's ability to obtain, maintain, or protect intellectual property rights related to its product candidates; amongst others. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to Juno's business in general, see Juno's Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on November 9, 2016 and Juno’s other periodic reports filed with the Securities and Exchange Commission. These forward-looking statements speak only as of the date hereof. Juno disclaims any obligation to update these forward-looking statements.


SEATTLE--(BUSINESS WIRE)--Juno Therapeutics, Inc. (NASDAQ:JUNO) will announce financial results for the fourth quarter and year ended December 31, 2016, on Wednesday, March 1, 2017, after the close of U.S.-based financial markets. Following the announcement, Juno management will host a conference call and live webcast to provide a business update and discuss financial results beginning at 2:00 p.m. Pacific Time (PT) / 5:00 p.m. Eastern Time (ET). Analysts and investors can participate in the conference call by dialing (855) 780-7198 for domestic callers and (631) 485-4870 for international callers, using the conference ID# 60783648. The webcast can be accessed live on the Investor Relations page of Juno's website, www.JunoTherapeutics.com, and will be available for replay for 30 days following the call. Juno Therapeutics is building a fully integrated biopharmaceutical company focused on developing innovative cellular immunotherapies for the treatment of cancer. Founded on the vision that the use of human cells as therapeutic entities will drive one of the next important phases in medicine, Juno is developing cell-based cancer immunotherapies based on chimeric antigen receptor and high-affinity T cell receptor technologies to genetically engineer T cells to recognize and kill cancer. Juno is developing multiple cell-based product candidates to treat a variety of B-cell malignancies as well as solid tumors. Several product candidates have shown compelling clinical responses in clinical trials in refractory leukemia and lymphoma conducted to date. Juno's long-term aim is to leverage its cell-based platform to develop new product candidates that address a broader range of cancers and human diseases. Juno brings together innovative technologies from some of the world's leading research institutions, including the Fred Hutchinson Cancer Research Center, Memorial Sloan Kettering Cancer Center, Seattle Children's Research Institute (SCRI), the University of California, San Francisco, and The National Cancer Institute. Juno Therapeutics has an exclusive license to the St. Jude Children’s Research Hospital patented technology for CD19-directed product candidates that use 4-1BB, which was developed by Dario Campana, Chihaya Imai, and St. Jude Children’s Research Hospital. Juno’s product candidate JCAR017 was developed in collaboration with SCRI and others. This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933, and Section 21E of the Securities Exchange Act of 1934, including statements regarding Juno’s mission, progress, and business plans, and the anticipated timing of the financial results release and business update. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from such forward-looking statements, and reported results should not be considered as an indication of future performance. These risks and uncertainties include, but are not limited to, risks associated with: the success, cost, and timing of Juno's product development activities and clinical trials; Juno's ability to obtain regulatory approval for and to commercialize its product candidates; Juno's ability to establish a commercially-viable manufacturing process and manufacturing infrastructure; regulatory requirements and regulatory developments; success of Juno's competitors with respect to competing treatments and technologies; Juno's dependence on third-party collaborators and other contractors in Juno's research and development activities, including for the conduct of clinical trials and the manufacture of Juno's product candidates; Juno's dependence on Celgene for the development and commercialization outside of North America and China of Juno’s CD19 product candidates and any other product candidates for which Celgene exercises an option; Juno’s dependence on JW Therapeutics (Shanghai) Co., Ltd, over which Juno does not exercise complete control, for the development and commercialization of product candidates in China; Juno's ability to obtain, maintain, or protect intellectual property rights related to its product candidates; amongst others. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to Juno's business in general, see Juno's Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on November 9, 2016 and Juno’s other periodic reports filed with the Securities and Exchange Commission. These forward-looking statements speak only as of the date hereof. Juno disclaims any obligation to update these forward-looking statements.


News Article | February 23, 2017
Site: www.eurekalert.org

One of the most important factors for lima bean growers in Delaware and throughout the world is the ability to accurately measure and forecast disease occurrence in their fields during the growing season. A new risk model developed by a team of researchers from the University of Delaware's College of Agriculture and Natural Resources (CANR) and the Delaware Environmental Observing System (DEOS), will allow lima bean growers in the state to utilize a free on-line tool to help them assess the risk of having their fields hit with downy mildew, a fungal-like disease caused by Phytophthora phaseoli. The research was funded by a five-year, $1.5 million U.S. Department of Agriculture (USDA) Specialty Crop Research Initiative grant (SCRI). The team includes Nicole Donofrio and Tom Evans, professors of plant pathology in CANR's Department of Plant and Soil Sciences; Gordon Johnson, assistant professor of plant and soil sciences and a fruit and vegetable specialist for Cooperative Extension; and Kevin Brinson, director of DEOS, which is housed in UD's Department of Geography in the College of Earth, Ocean, and Environment (CEOE). Matthew Shatley, computer research specialist, and Chris Hughes, environmental applications developer, both in CEOE, helped develop the website. Donofrio said one of the goals of the grant was to create a risk model that growers and processors could easily access for lima bean downy mildew, adding that this new user-friendly website will be "an excellent tool that our cooperators can use that will inform them when and if they need to spray fungicides." Evans, who has been working on prediction models for downy mildew for 15 years with multiple students conducting research both in the field and in greenhouses, said that an older model predicted based strictly on temperature and rainfall. This newer model uses that predictor but adds dew point and temperature, which is helpful as the ideal conditions for downy mildew may also be found in September when growers encounter heavy dews but not much rain. "The month of September typically has a lot of dew because we have high humidity and low night temperatures. The one that uses dew point is the one that's been predicting the most because most of the occurrences were in September. We haven't had any major epidemics in July and August, which is kind of when we have rainfall driven disease," said Evans. The risk model utilizes a numeric scale from one to 10 and allows growers to assess how much risk they are willing to take on, before taking action. "Everybody has a different risk tolerance and their tolerance has to be taken into account. My recommendation is that you're in high risk when you're in somewhere between seven, eight or nine, but there's a lot of variation in that depending on the field and the conditions," said Evans. To use the website, users request an account via email to deos-info@udel.edu and an account is set up for them. Once the user has an account, they can log in to the website to add their lima bean fields or view risk values of their existing fields. New fields are added to the system by providing GPS coordinates or by using a map interface to select the field's location. Weather data from the nearest stations in the DEOS network are determined using the field's geographic location. Additional information required for each field includes information on the lima bean cultivar planted as well as the field's downy mildew disease history. The website allows growers to look at a set of data and graphs that show them their fields' daily risk value for the occurrence of downy mildew. Knowing their individual risk factor allows them to know whether or not they need to spray their crops, which helps their economic bottom line. "This might cut two or three protectant fungicide sprays out in a year and that might save them $100 an acre. And that adds up over time," said Evans. The less fungicides that growers use, the better it is for the environment and it also gives downy mildew less of an opportunity to develop resistance to the fungicides that are being used. Evans said this model is unique to the state of Delaware and the researchers are in the stages of validating it so that that they can feel more comfortable about setting a general range for growers. "I have not found a system that operates quite like this but that's because we're a small state and it's free data. It's public data and it's being done by people that are employed by the state or the University or both," said Evans. Brinson said that the website should be launched in time for the spring growing season and that to validate the model, the researchers used data from lima bean fields owned by vegetable production companies that have scouts who regularly check their fields for downy mildew. "We loaded that data into the system and then ran the model and did all the calculations and as the risk scores got higher, they would go out and try to confirm the presence of downy mildew," said Brinson, noting that Evans would do a lot of the scouting himself. "I know Tom was literally driving around with his iPad looking at our tool and saying, 'Looks like this score is an eight so I want to drive to this field and check it out.' The research team has put a lot of work into certainly this disease but this particular crop, too," said Brinson.


PubMed | a Sarah Cannon Research Institute Tennessee Oncology PLLC, c Florida Cancer Specialists SCRI, b Sarah Cannon Research Institute, PLLC SCRI and University of Oklahoma
Type: Clinical Trial, Phase I | Journal: Cancer investigation | Year: 2015

This phase I study determined the maximum tolerated dose (MTD) of AUY922 with capecitabine in advanced solid tumors.Capecitabine 1000 mg/m(2) PO BID was administered with escalating doses of AUY922 IV; the MTD of AUY922 was combined with capecitabine 1250 mg/m(2) (DL6).23 patients were treated at 5 dose levels (22 mg/m(2)-70 mg/m(2)). No DLTs were observed until DL6 (grade 3 diarrhea). Reversible vision darkening was seen in 26%. Four patients had partial response; 2 previously progressed on fluorouracil. Eight patients had stable disease (median 25.5 weeks).AUY922 plus capecitabine was well-tolerated up to 70 mg/m(2) with encouraging preliminary efficacy.

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