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Kite Pharma Augments Commercial Leadership Team

On February 24, 2016 Kite Pharma, Inc. (Nasdaq:KITE), a clinical-stage biopharmaceutical company focused on developing engineered autologous cell therapy (eACT) products for the treatment of cancer, reported the formation of the company’s integrated commercial leadership team with the appointment of three senior-level industry executives (Press release, Kite Pharma, FEB 24, 2016, View Source [SID:1234509179]). The team will be responsible for all aspects of commercial and medical affairs strategy, planning, and analysis for the potential launch of KTE-C19, an investigational engineered T cell therapy for patients with relapsed and/or refractory B cell malignancies.

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The new commercial and medical affairs leadership team includes Diane L. Parks, Senior Vice President, Marketing, Sales & Market Research; Elizabeth A. Faust, Ph.D., Vice President, Medical Affairs; and Kimberly A. Metcalf, Vice President, Customer Engagement, Training & Development. The group will report to Shawn Tomasello, Kite’s Chief Commercial Officer. Dr. Faust will also report to Jeff Wiezorek, M.D., M.S., Senior Vice President of Clinical Development.

"Commercial readiness is a top priority for Kite as we prepare for pivotal data from the ZUMA-1 study and potential U.S. regulatory filing for KTE-C19 this year," said Arie Belldegrun, M.D., FACS, Chairman, President, and Chief Executive Officer. "Such a potentially transformative therapy as KTE-C19 will require a creative and strategic commercialization model to optimize access and impact for patients. We believe this proven and accomplished team, under the direction of Shawn Tomasello, can deliver on this promise."

"It is a privilege to welcome Diane, Elizabeth, and Kimberly to Kite," said Shawn Tomasello, Chief Commercial Officer. "As a group, they bring the range of critical skills and proven capabilities needed to prepare for commercialization. They have been closely involved in the launch of several major oncology therapies, and they understand how markets are reshaped by therapeutic innovations that improve patient outcomes. Our team is already fully engaged in market analysis and strategy development activities."

Diane L. Parks, Senior Vice President, Marketing, Sales & Market Research

Ms. Parks joins Kite from Pharmacyclics, where she was Vice President of Marketing. During her tenure at Pharmacyclics, Ms. Parks led the development and execution of all global marketing strategies for IMBRUVICA. Previously, she held senior leadership roles as Vice President of Sales for Amgen, representing oncology and nephrology products, and Senior Vice President of Specialty Biotherapeutics and Managed Care at Genentech, where she led the launches of multiple products as well as commercial development of LUCENTIS and RITUXAN. Ms. Parks began her career at Marion Merrell Dow. She holds a BS from Kansas State University and an MBA from Georgia State University.

Elizabeth A. Faust, Ph.D., Vice President, Medical Affairs

Prior to joining Kite, Dr. Faust was Vice President of Medical Affairs at Pharmacyclics, during which time she planned and successfully executed four IMBRUVICA launches for various indications. Before Pharmacyclics, Dr. Faust was Vice President of Clinical Sciences Research at Celgene Corporation, serving as the national lead for oncology Regional Medical Liaisons in the US, and as Senior Director of Medical Affairs at Gloucester Pharmaceuticals, which was acquired by Celgene in 2010. From 1995 to 2007, Dr. Faust held roles of increasing responsibility in research, development, and medical affairs at Amgen, including Executive Director, Oncology Regional Medical Liaisons. Dr. Faust has co-authored numerous publications and was the former President-Elect for the Pacific Southwest Chapter of the American Medical Writers Association. She holds a BS in microbiology from Auburn University, a MA in biology from University of California Riverside, and a PhD in microbiology and molecular genetics from University of California Los Angeles.

Kimberly A. Metcalf, Vice President, Customer Engagement, Training & Development

Ms. Metcalf most recently served as Vice President of Commercial Training and Administration at Pharmacyclics, where she was responsible for developing and executing commercial and medical affairs training including launch plans for IMBRUVICA. Previously, she spent eight years at Celgene Corporation where she contributed significantly to building the commercial training department and assumed roles of increasing responsibility in commercial training, market access, and sales and marketing operations, including Executive Director, US National and Regional Accounts. During her tenure at Celgene, she launched POMALYST, ISTODAX and OTEZLA. Ms. Metcalf began her career in biopharma at Pfizer. She holds a BS from Northwestern University, an MBA from West Chester University, and a Master of Health Systems from The University of Medicine & Dentistry of New Jersey.

About KTE-C19

KTE-C19 is an investigational therapy in which a patient’s T cells are genetically modified to express a CAR designed to target the antigen CD19, a protein expressed on the cell surface of B cell lymphomas and leukemias. Kite is currently enrolling four pivotal studies (also known as ZUMA studies) for KTE-C19 in patients with various B cell malignancies. The U.S. Food and Drug Administration has granted Breakthrough Therapy Designation status to KTE-C19, for the treatment of patients with refractory diffuse large B cell lymphoma, primary mediastinal B cell lymphoma, and transformed follicular lymphoma. KTE-C19 has also secured Orphan Drug Designation in the U.S. for DLBCL and in the EU for various hematological indications.

bluebird bio Reports Fourth Quarter and Full Year 2015 Financial Results and Recent Operational Progress

On February 24, 2016 bluebird bio, Inc. (Nasdaq: BLUE) a clinical-stage company committed to developing potentially transformative gene therapies for severe genetic diseases and T cell-based immunotherapies for cancer, reported business highlights and financial results for the fourth quarter and full year ended December 31, 2015 (Press release, bluebird bio, FEB 24, 2016, View Source;p=RssLanding&cat=news&id=2142878 [SID:1234509175]).

"In 2015 bluebird bio defined an accelerated regulatory path for LentiGlobin in ß-thalassemia and established a powerful reason to believe in LentiGlobin in sickle cell disease, though there is still more to learn as we treat additional patients. We also fully enrolled our Starbeam study of Lenti-D in cerebral adrenoleukodystrophy and made significant advances in building a competitive T cell oncology franchise," said Nick Leschly, chief bluebird. "In 2016 we are excited to learn even more across all of our programs and continue to innovate and improve. We are particularly looking forward to sharing data from the Starbeam study for the first time and presenting more data with longer follow-up from all three of our LentiGlobin clinical studies."

Recent Highlights

ADVANCED FIRST ONCOLOGY PROGRAM INTO THE CLINIC – Earlier in February, the first patient was infused in the CRB-401 study of bb2121 in relapsed/refractory multiple myeloma. Additionally, Celgene has exercised its option to exclusively license bb2121, under the terms of the collaboration agreement between the two companies. bluebird bio will receive a $10.0 million option exercise payment from Celgene and is also eligible to receive specified development and regulatory milestone payments and royalty payments on net sales.

PRESENTED UPDATED CLINICAL DATA IN ß-THALASSEMIA FROM HGB-204 AND HGB-205 CLINICAL STUDIES OF LENTIGLOBIN AT ASH (Free ASH Whitepaper) – In December 2015, investigators presented data from bluebird bio’s ongoing clinical studies in transfusion-dependent ß-thalassemia (TDT) and severe sickle cell disease (SCD). Data in patients with TDT from the HGB-204 and HGB-205 studies showed that 100% of patients with non-ß0/ß0 genotypes achieved sustained transfusion independence as of the data cut-off, ranging from 7.1 months to 23.4 months. Patients with the ß0/ß0 genotype all saw reductions in their transfusion needs, ranging from a 33% to 100% reduction.

PRESENTED CLINICAL DATA IN SICKLE CELL DISEASE FROM HGB-205 AND HGB-206 CLINICAL STUDIES OF LENTIGLOBIN AT ASH (Free ASH Whitepaper) –Marina Cavazzana, M.D., Ph.D., of Hospital Necker, University Paris Descartes, presented updated data on one patient with SCD from the HGB-205 study, who remained free of transfusions, hospitalizations and acute SCD-related events for more than nine months as of the data cut-off. At the 12-month post-drug infusion follow-up, the proportion of anti-sickling hemoglobin in this patient accounted for 49% (47% HbAT87Q + 2% HbF) of all hemoglobin production – well above the 30% threshold anticipated to achieve a disease-modifying effect. John Tisdale, M.D., of the National Institutes of Health presented early data from the HGB-206 study, in which two patients had at least three months of post-infusion follow-up. At the three-month post-infusion follow-up for Subject 1301, anti-sickling hemoglobin accounted for 17% of all hemoglobin production (4% HbAT87Q + 13% HbF). At the six-month post-infusion follow-up for subject 1303, anti-sickling hemoglobin accounted for 16 percent of all hemoglobin production (12% HbAT87Q + 4% HbF).

PRESENTED PRE-CLINICAL AND MANUFACTURING DATA FROM CAR T ONCOLOGY PROGRAMS AT ASH (Free ASH Whitepaper) – bluebird bio scientists presented three posters at ASH (Free ASH Whitepaper), covering critical basic research, translational and manufacturing aspects of the Company’s T cell oncology programs. One poster discussed an important observation made by bluebird bio scientists: culturing anti-BCMA CAR T cells with a PI3K inhibitor generated a product with many of the properties of younger, less differentiated T cells. Consistent with a younger T cell phenotype, this product showed improved in vivo efficacy and persistence in multiple model systems.
SHARED DATA ON PLATFORM IMPROVEMENTS – In an investor event at ASH (Free ASH Whitepaper), bluebird bio chief scientific officer Philip Gregory, D.Phil., presented data from ongoing research to improve the cell transduction process for LentiGlobin. The presentation showed that in preclinical experiments, adding selected compounds to the transduction process resulted in substantially increased vector copy number and transduction efficiency (i.e. percentage of corrected cells). Importantly, the new process was shown to be robust with similar improvements seen across multiple donors and vector lots.

ENTERED INTO CAR T LICENSE WITH VIROMED – Signed exclusive license agreement with Viromed Co., Ltd., to research, develop and commercialize CAR T therapies using Viromed’s proprietary humanized antibody to an undisclosed cancer target in solid tumors.

Upcoming Anticipated Milestones

Presentation of interim data from the Starbeam study of Lenti-D in patients with cerebral adrenoleukodystrophy (CALD) at the American Academy of Neurology annual meeting in April 2016

Update on LentiGlobin process improvements in the second half of 2016

Initiation of the HGB-207 study in patients with TDT with the non-ß0/ß0 genotype in the second half of 2016

Presentation of updated data from the HGB-204, HGB-205 and HGB-206 studies at the ASH (Free ASH Whitepaper) annual meeting in December 2016
Fourth Quarter and Full Year 2015 Financial Results and Financial Guidance

Cash Position: Cash, cash equivalents and marketable securities as of December 31, 2015 were $865.8 million, compared to $492.0 million as of December 31, 2014, an increase of $373.8 million, which was primarily driven by the June 2015 equity financing partially offset by cash used to fund operations.

Revenues: Collaboration revenue was $1.5 million for the fourth quarter of 2015 and $14.1 million for the year ended December 31, 2015, compared to $6.3 million and $25.0 million in the comparable periods in 2014. The decrease is a result of an amendment to our collaboration agreement with Celgene in the second quarter of 2015.

R&D Expenses: Research and development expenses were $35.7 million for the fourth quarter of 2015 and $134.0 million for the year ended December 31, 2015, compared to $20.5 million and $62.6 million for the comparable periods in 2014. The increase in research and development expenses was primarily attributable to increased employee compensation expense due to increased headcount, in-licensing milestones and fees, and manufacturing and clinical trial-related costs to support our advancing pipeline.

G&A Expenses: General and administrative expenses were $14.4 million for the fourth quarter of 2015 and $46.2 million for the year ended December 31, 2015, compared to $5.3 million and $23.2 million for the comparable periods in 2014. The increase in general and administrative expenses was primarily attributable to increased employee compensation expense due to increased headcount, and consulting and facilities-related costs to support our overall growth.

Net Loss: Net loss was $47.3 million for the fourth quarter of 2015 and $166.8 million for the year ended December 31, 2015, compared to net loss of $19.5 million and $48.7 million for the comparable periods in 2014.

Financial guidance: bluebird bio expects that its cash, cash equivalents and marketable securities of $865.8 million as of December 31, 2015 will be sufficient to fund its current operations through 2018.

NIH uses photon-counting CT scanner in patients for the first time

On February 24, 2016 The Clinical Center at the National Institutes of Health reported that they are investigating the potential use of a new generation of a computerized tomography (CT) scanner, called a photon-counting detector CT scanner, in a clinical setting (Press release, NIH, FEB 24, 2016, View Source [SID:1234509173]). The prototype technology is expected to replicate the image quality of conventional CT scanning, but may also provide health care specialists with an enhanced look inside the body through multi-energy imaging. Patients could receive a minimum amount of radiation, while the maximal amount of information needed would be delivered to health care providers.

Over the next five years, David Bluemke, M.D., Ph.D., chief of the Department of Radiology and Imaging Sciences, and his team will continue to develop scan protocols and image processing algorithms, which could improve screening, imaging, and treatment planning for health conditions like cancer and cardiovascular disease.

"The NIH Clinical Center has helped shape and share research advances and health care for decades. Now is an exciting time for us and for our study participants here in the Clinical Center as we help test and develop this CT technology so that it may one day help patients around the world and impact the health care they receive," said Dr. Bluemke.

As the world’s largest hospital solely dedicated to research, the NIH Clinical Center sees thousands of patients every year, many of whom have rare and complicated illnesses. In the treatment and study of disease, surgery is often viewed as the last option. CT scanning is one way that doctors can examine the body’s internal features in a non-surgical way. In collaboration and through a partnership known as a cooperative research and development agreement with the manufacturer, Siemens Healthcare, and researchers in the CT technology field, the Clinical Center is testing this technology to help the health care field optimize the scanner for clinical use across the U.S. and around the globe.

Image of photon-counting CT scan
Photon CT scan image of a research subject at the NIH. Greater amounts of iodine contrast are shown in brighter, yellow colors.
The Clinical Center is one of three sites in the world to use this technology and is the first hospital-based research setting of the device. More than 45 volunteers enrolled in a research protocol have benefited from this cutting edge equipment. Initial findings have been reported in Radiology (link is external).

By advancing this technology, researchers aim to improve the diagnosis that doctors can offer by increasing the resolution and contrasts available for analysis. Areas of research investigation with the new technology include:

Doctors can identify materials in the body with anatomic precision. A dye, or contrast, is often given to a patient so that researchers can see a selected area in more detail. Different materials in the body can be displayed in different colors for faster diagnosis and precision.
The new technology may be used to help identify and characterize tumors, plaques or vessels that are smaller than half a millimeter. For many patients, finding a tumor that size may make a difference in identifying if it is benign or could be cancerous.
The technology may help to more accurately identify soft tissues such as proteins, tendons or collagen which are hard to differentiate with current equipment.

Bayer proposes increased dividend for 2015 of EUR 2.50 per share

On February 24, 2016, At its meeting today, the Supervisory Board of Bayer AG announced that they have approved the Board of Management’s recommendation that a dividend payment of EUR 2.50 (2014: EUR 2.25) per share be proposed to the Annual Stockholders’ Meeting on April 29, 2016 (Press release, Bayer, FEB 24, 2016, View Source [SID:1234509168]). "2015 was a very good year for Bayer. We would like our stockholders to share appropriately in this success," explained Bayer CEO Dr. Marijn Dekkers. With 826,947,808 shares entitled to the dividend, the total dividend payment would amount to EUR 2,067 million (2014: EUR 1,861 million), an increase of 11.1 percent.

The Bayer Group’s consolidated financial statements for 2015 will be presented and discussed at the Financial News Conference on February 25, 2016.

8-K – Current report

On February 24, 2016 Provectus Biopharmaceuticals, Inc. (NYSE MKT: PVCT, www.pvct.com), a clinical-stage oncology and dermatology biopharmaceutical company ("Provectus" or "The Company"), reported that data on intralesional PV-10 and co-inhibitory blockade in a melanoma model will be presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper)’s ("AACR") Annual Meeting 2016 on Wednesday, April 20, 2016, from 8 am to 12 Noon Central Standard Time (Filing, 8-K, Provectus Pharmaceuticals, FEB 24, 2016, View Source [SID:1234509165]).

The poster presentation is titled "T Cell Mediated Immunity after Combination Therapy with Intralesional PV-10 and Co-Inhibitory Blockade in a Melanoma Model." Scheduled for presentation at Section 26 of the exhibition area, the data are from a team of researchers at the H. Lee Moffitt Cancer Center in Tampa, led by Dr. Shari Pilon-Thomas.

The AACR (Free AACR Whitepaper) Annual Meeting 2016 is being held at the Ernest N. Morial Convention Center in New Orleans, Louisiana, from April 16-20, 2016.