1stOncology™: Cancer Intelligence Service – Page 17361 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

Dynavax Announces Presentation of Clinical Data at ASH Annual Meeting

On November 30, 2015 Dynavax Technologies Corporation (NASDAQ: DVAX) reported that it will present clinical data at the 57th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting this weekend in Orlando, Florida (Press release, Dynavax Technologies, NOV 30, 2015, View Source [SID:1234508366]). The details for the poster presentation are as follows:

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

Schedule Your 30 min Free Demo!

Date and Time: Saturday, December 5, 2015, 5:30pm – 7:30pm EST
Abstract Title: Regulatory T Cells Are Depleted in Low-Grade Lymphoma By the Combination of Local Low-Dose Radiation Followed By Intratumoral CpG-ODN.
Session Number: 616
Session Name: Lymphoma: Therapy with Biologic Agents, excluding Pre-Clinical Models: Poster I
Abstract Number: 1539
Location: Hall A, Level 2 (Orange County Convention Center)

Please click here for the full abstract. The poster presentation with updated data will be made available on or after December 5, 2015.

About SD-101

SD-101, the subject of ASH (Free ASH Whitepaper) abstract 1539, is Dynavax’s proprietary, second-generation, TLR 9 agonist CpG-C class oligodeoxynucleotide. SD-101 activates multiple anti-tumor activities of innate immune cells and activates plasmacytoid dendritic cells to stimulate T cells specific for antigens released from dying tumor cells. TLR9 agonists such as SD-101 enhance T and B cell responses and provide potent Type 1 interferon induction and maturation of plasmacytoid dendritic cells to antigen-presenting cells. SD-101 is being evaluated in several Phase 1/2 oncology studies to assess its preliminary safety and activity.

Juno Therapeutics Announces Data Presentations at the American Society of Hematology Annual Meeting

On November 30, 2015 Juno Therapeutics, Inc. (NASDAQ:JUNO), a biopharmaceutical company focused on re-engaging the body’s immune system to revolutionize the treatment of cancer, reported the Company, in partnership with its collaborators, will present data from its product candidates and process development activities with six oral and poster presentations at the upcoming 57th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting (Press release, Juno, NOV 30, 2015, View Source;p=RssLanding&cat=news&id=2118842 [SID:1234508362]). Senior management will also review the data and provide an update on Juno’s ongoing clinical development strategy during an analyst and investor event and webcast.

The first of two oral presentations will report updated data from the ongoing trial of JCAR014 in adults with relapsed or refractory non-Hodgkin lymphoma (NHL) and chronic lymphocytic leukemia (CLL). This translational clinical research trial focuses on how optimization of the pharmacokinetics or exposure of JCAR014 relates to clinical outcomes. The second presentation will discuss the implications of prior allogeneic stem cell transplant and achievement of minimal residual disease negative complete remission in patients with relapsed or refractory B-cell acute lymphoblastic leukemia (ALL) treated with JCAR015. Additionally, initial data from the anti-CD22 chimeric-antigen receptor (CAR) product candidate in pediatric and young adult relapsed or refractory ALL will be highlighted in one of four poster presentations.

"The clinical data in ALL, NHL, and CLL continue to be encouraging. The response rates and durability of responses across a range of B cell malignancies provide important insights on how persistence and depth of response translate into improved clinical outcomes, and are applicable to our portfolio broadly," said Hans Bishop, Juno’s President and Chief Executive Officer. "We are also looking forward to the first presentation of early results from the anti-CD22 CAR study in pediatric ALL patients, a study which appears to be of increasing relevance with the ongoing emergence, particularly in pediatric patients, of CD19 epitope loss with treatment."

The following data will be presented at ASH (Free ASH Whitepaper):

Oral Presentations

Anti-CD19 Chimeric Antigen Receptor-Modified T Cell Therapy for B Cell Non-Hodgkin Lymphoma and Chronic Lymphocytic Leukemia: Fludarabine and Cyclophosphamide Lymphodepletion Improves In Vivo Expansion and Persistence of CAR-T Cells and Clinical Outcomes (Abstract #184)

Presenter: Cameron J. Turtle, M.B.B.S., Ph.D., Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, WA, and Department of Medicine, University of Washington, Seattle, WA

Date: Sunday, December 6, 2015: 8:15 a.m. Eastern Time

Implications of Minimal Residual Disease Negative Complete Remission (MRD-CR) and Allogeneic Stem Cell Transplant on Safety and Clinical Outcome of CD19-Targeted 19-28z CAR Modified T Cells in Adult Patients with Relapsed, Refractory B-Cell ALL (Abstract #682)

Presenter: Jae H. Park, M.D., Leukemia Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY
Date: Monday, December 7, 2015: 3:30 p.m. Eastern Time

Poster Presentations

Clinical Activity and Persistence of Anti-CD22 Chimeric Antigen Receptor in Children and Young Adults with Relapsed/Refractory Acute Lymphoblastic Leukemia (ALL) (Abstract #1324)

Presenter: Terry J. Fry, M.D., Pediatric Oncology Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD

Date: Saturday, December 5, 2015: 5:30 p.m. – 7:30 p.m. Eastern Time

Functional Characterization of a T Cell Stimulation Reagent for the Production of Therapeutic Chimeric Antigen Receptor T Cells (Abstract #1901)

Presenter: Keenan T. Bashour, Ph.D., Department of Process & Analytical Development, Juno Therapeutics, Inc., Seattle, WA; Ryan P. Larson, Ph.D., Department of Translational Sciences, Juno Therapeutics, Inc., Seattle, WA

Date: Saturday, December 5, 2015: 5:30 p.m. – 7:30 p.m. Eastern Time

Multi-center Clinical Trial of CAR T Cells in Pediatric/Young Adult Patients with Relapsed B Cell ALL (#2533)

Presenter: Kevin J. Curran, M.D., Department of Pediatrics and Center for Cell Engineering, Memorial Sloan Kettering Cancer Center, New York, NY

Date: Sunday, December 6, 2015: 6:00 p.m. – 8:00 p.m. Eastern Time

Addition of Fludarabine to Cyclophosphamide Lymphodepletion Improves In Vivo Expansion of CD19 Chimeric Antigen Receptor-Modified T Cells and Clinical Outcome in Adults with B Cell Acute Lymphoblastic Leukemia (Abstract #3773)

Presenter: Cameron J. Turtle, M.B.B.S., Ph.D., Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, WA, and Department of Medicine, University of Washington, Seattle, WA

Date: Monday, December 7, 2015: 6:00 p.m. – 8:00 p.m. Eastern Time

ASH Investor and Analyst Event and Webcast
The Juno ASH (Free ASH Whitepaper) Investor and Analyst Event and webcast will be held Monday, December 7, 2015, at 8:30 p.m. Eastern Time. 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 event.

Leading Cancer Center Adopts Varian Tumor Tracking System as Standard for Prostate Treatments

On November 30, 2015 Varian Medical Systems reported that clinicians in Melbourne have commenced advanced radiotherapy treatments for prostate cancer using a real-time tumor tracking system from Varian Medical Systems (NYSE: VAR) (Press release, InfiMed, NOV 30, 2015, View Source [SID:1234508361]). Epworth HealthCare, the largest not-for-profit private hospital group in Victoria, has become the first care provider in Australia to utilize Varian’s Calypso transponders to enhance precision during image-guided radiotherapy treatments as standard of care.

"The Calypso system gives us information about internal movement of the prostate during treatment that we’ve never had before," says Anne Perkins, senior medical physicist at Epworth HealthCare. "Reviewing the data for the first five patients we treated shows that the prostate moved outside the limits specified by the radiation oncologist on 20 percent of the treatment visits. The Calypso system can automatically turn off the radiation beam until the prostate returns to its planned position and if necessary radiation therapists can move the treatment couch to reposition the patient before resuming treatment. More than 25 patients have now been treated with Calypso at Epworth."

"Calypso is a user-friendly system that gives us precise real-time information about the location of the prostate during treatment. Before we had Calypso, we relied on x-ray imaging to determine that our patients were in the correct position for treatment. Calypso is proving to be at least as accurate as x-ray imaging and has the advantage of providing continuous information during treatment, rather than just a snapshot in time."

Dr. Pat Bowden, Epworth HealthCare’s director of radiation oncology, adds, "The Calypso system enables us to reduce margins for our prostate cancer patients, with an expectation this will reduce long-term toxicity. With Calypso, we feel we are providing our patients with the most advanced radiotherapy treatment techniques available."

Calypso continuously pinpoints the location of a tumor similar to the way that GPS works in navigation system for cars. The prostate is not a stationary target. It can shift by as much as several millimeters during a radiotherapy treatment session.

Epworth HealthCare provides advanced radiotherapy and radiosurgery treatments using four Varian linear accelerators, including a state-of-the-art TrueBeam STx system installed in February this year. Doctors at the center are planning to introduce Calypso-guided treatments for patients with lung and gastro-intestinal cancers, as well as surface tracking beacons for DIBH (deep inspiration breath hold) breast treatments. It is estimated there will be 128,000 new cancer cases diagnosed in Australia this year and this number is expected to rise to 150,000 by 2020.

Sunesis Pharmaceuticals Announces European Patent Covering Vosaroxin Combination Use in AML and Other Hematologic Malignancies

On November 30, 2015 Sunesis Pharmaceuticals, Inc. (Nasdaq:SNSS) reported that the European Patent Office (EPO) has granted European Patent No. 2 049 109 B1, claiming certain combined uses of vosaroxin and cytarabine, at doses of 10-120 mg/m2 and 5-1500 mg/m2, respectively, for the treatment of acute myelogenous leukemia and acute myeloblastic leukemia (Press release, Sunesis, NOV 30, 2015, View Source;p=RssLanding&cat=news&id=2118591 [SID:1234508360]). The patent further provides for combinations of vosaroxin and cytarabine with other therapies, such as radiation, or other chemotherapeutics, including anti-cancer agents, in hematologic disorders, whether administered simultaneously or sequentially. Sunesis is proceeding to validate this patent in multiple EPO member states. The resulting national patents would expire in the third quarter of 2027, but could be eligible for supplementary patent term in EPO member states beyond this date. Related patent applications are pending in several countries, including the United States and Japan.

"This patent adds important value to a European commercial opportunity for vosaroxin, as it covers a wide range of its contemplated commercial use with cytarabine out to 2027," said Eric Bjerkholt, Executive Vice President, Corporate Development and Finance of Sunesis. "Granting of this European patent is particularly timely, as we prepare to file a European Marketing Authorization Application for vosaroxin in combination with cytarabine in AML by year end. It also provides us with greater certainty in pursuing the full clinical and commercial potential of vosaroxin using various therapeutic combinations in AML and other hematologic malignancies."

About QINPREZO (vosaroxin)

QINPREZO (vosaroxin) is an anti-cancer quinolone derivative (AQD), a class of compounds that has not been used previously for the treatment of cancer. Preclinical data demonstrate that vosaroxin both intercalates DNA and inhibits topoisomerase II, resulting in replication-dependent, site-selective DNA damage, G2 arrest and apoptosis. Both the U.S. Food and Drug Administration (FDA) and European Commission have granted orphan drug designation to vosaroxin for the treatment of AML. Additionally, vosaroxin has been granted fast track designation by the FDA for the potential treatment of relapsed or refractory AML in combination with cytarabine. Vosaroxin is an investigational drug that has not been approved for use in any jurisdiction.

The trademark name QINPREZO is conditionally accepted by the FDA and the EMA as the proprietary name for the vosaroxin drug product candidate.

Incyte’s Jakafi® (ruxolitinib) to be Featured in over 60 Abstracts at ASH Annual Meeting

On November 30, 2015 Incyte Corporation (Nasdaq:INCY) reported that more than 60 abstracts featuring data from its ongoing clinical development program for Jakafi (ruxolitinib) will be presented at the upcoming American Society of Hematology (ASH) (Free ASH Whitepaper) 57th Annual Meeting December 5-8, 2015 in Orlando, FL (Press release, Incyte, NOV 30, 2015, View Source;p=RssLanding&cat=news&id=2118588 [SID:1234508359]).

"We are very pleased to have a substantial amount of ruxolitinib data selected for presentation at the upcoming ASH (Free ASH Whitepaper) Annual Meeting," stated Rich Levy, MD, Chief Drug Development Officer, Incyte. "Not only will long-term data for COMFORT-II, one of ruxolitinib’s pivotal registration studies be shared, but also new data exploring its potential in combination with other compounds for myeloproliferative neoplasms and other hematologic cancers. Continuing to identify and research combinatorial synergies with our medicines and others in development is a critical part of our continued commitment to discovering new treatment options for patients with cancer."

Key abstract presentations, inclusive of studies sponsored by Incyte and Novartis as well as independent investigator studies, include:

Myelofibrosis

Long-Term Efficacy and Safety in COMFORT-II, a Phase 3 Study Comparing Ruxolitinib with Best Available Therapy for the Treatment of Myelofibrosis: 5-Year Final Study Results (Abstract #59)

Saturday, December 5, 2015, 9:30-11:30 AM EST, Room W224
The Impact of Anemia on Overall Survival in Patients with Myelofibrosis Treated with Ruxolitinib: an Exploratory Analysis of the COMFORT Studies (Abstract #1604)

Saturday, December 5, 2015, 5:30-7:30 PM EST, Hall A
Safety and Efficacy of Ruxolitinib in an 1869-Patient Cohort of Jump: An Open-Label, Multicenter, Single-Arm, Expanded-Access Study in Patients with Myelofibrosis (Abstract #2799)

Sunday, December 6, 2015, 6:00-8:00 PM EST, Hall A
Phase 1b/2 Study of the Efficacy and Safety of Sonidegib (LDE225) in Combination with Ruxolitinib (INC424) in Patients with Myelofibrosis (Abstract #825)

Monday, December 7, 2015, 4:30-6:00 PM EST, Room W315
An Open-Label, Multicenter, 2-Arm, Dose-Finding, Phase 1b Study of the Combination of Ruxolitinib and Buparlisib (BKM120) in Patients with Myelofibrosis: Results from HARMONY Study (Abstract #827)

Monday, December 7, 2015, 4:30-6:00 PM EST, Room W315
A Phase 1B/2 Study of Ruxolitinib plus Pomalidomide in Myelofibrosis: Data from the MPNSG-0212 Trial (NCT01644110) (Abstract #826)

Monday, December 7, 2015, 4:30-6:00 PM EST, Room W315
Efficacy, Safety, and Confirmation of the Recommended Phase 2 Starting Dose of the Combination of Ruxolitinib (RUX) and Panobinostat (PAN) in Patients (Pts) with Myelofibrosis (MF) (Abstract #4060)

Monday, December 7, 2015, 6:00-8:00 PM EST, Hall A
Polycythemia Vera

Continued Treatment with Ruxolitinib Provides Additional Hematocrit Control and Spleen Volume Responses in Patients with PV Treated in the RESPONSE Study (Abstract #2804)

Sunday, December 6, 2015, 6:00-8:00 PM EST, Hall A
The Effect of Ruxolitinib on White Blood Cell Counts in Patients with Polycythemia Vera: Results From the RESPONSE Trial (Abstract #4070)

Monday, December 7, 2015, 6:00-8:00 PM EST, Hall A
Myeloproliferative Neoplasms

Safety and Efficacy of Combination Therapy of Interferon-Alpha 2 + JAK1-2 Inhibitor in the Philadelphia-Negative Chronic Myeloproliferative Neoplasms. Preliminary Results from the Danish COMBI-Trial – An Open Label, Single Arm, Non-Randomized Multicenter Phase II Study (Abstract #824)

Monday, December 7, 2015, 4:30-6:00 PM EST, Room W315
Other Hematologic Cancers

5-Azacytidine (AZA) in combination with ruxolitinib (rux) as therapy for patients (pts) with myelodysplastic/myeloproliferative neoplasms (Abstract #823)

Monday, December 7, 2015, 4:30-6:00 PM EST, Room W315
Full session details and data presentations at ASH (Free ASH Whitepaper) 2015 can be found at: View Source

About Jakafi (ruxolitinib)

Ruxolitinib is a first-in-class JAK1/JAK2 inhibitor approved by the U.S. Food and Drug Administration, as Jakafi (ruxolitinib), for treatment of people with polycythemia vera (PV) who have had an inadequate response to or are intolerant of hydroxyurea.

Jakafi is also indicated for treatment of people with intermediate or high-risk myelofibrosis (MF), including primary MF, post–polycythemia vera MF, and post–essential thrombocythemia MF.

Jakafi is marketed by Incyte in the United States and by Novartis as Jakavi (ruxolitinib) outside the United States.

Important Safety Information

Jakafi can cause serious side effects, including:

Low blood counts: Jakafi may cause your platelet, red blood cell, or white blood cell counts to be lowered. If you develop bleeding, stop taking Jakafi and call your healthcare provider. Your healthcare provider will perform blood tests to check your blood counts before you start Jakafi and regularly during your treatment. Your healthcare provider may change your dose of Jakafi or stop your treatment based on the results of your blood tests. Tell your healthcare provider right away if you experience unusual bleeding, bruising, fatigue, shortness of breath, or a fever.

Infection: You may be at risk for developing a serious infection during treatment with Jakafi. Tell your healthcare provider if you develop any of the following symptoms of infection: chills, nausea, vomiting, aches, weakness, fever, painful skin rash or blisters.

Skin cancers: Some people who take Jakafi have developed certain types of non-melanoma skin cancers. Tell your healthcare provider if you develop any new or changing skin lesions.

The most common side effects of Jakafi include: anemia, low platelet count, bruising, dizziness, headache.

These are not all the possible side effects of Jakafi. Ask your pharmacist or healthcare provider for more information. Tell your healthcare provider about any side effect that bothers you or that does not go away.

Before taking Jakafi, tell your healthcare provider about all the medications, vitamins, and herbal supplements you are taking and all your medical conditions, including if you have an infection, have or had tuberculosis (TB), or have been in close contact with someone who has TB, have or had liver or kidney problems, are on dialysis, had skin cancer or have any other medical condition. Take Jakafi exactly as your healthcare provider tells you. Do not change or stop taking Jakafi without first talking to your healthcare provider. Do not drink grapefruit juice while on Jakafi.

Women should not take Jakafi while pregnant or planning to become pregnant, or if breast-feeding.

Full Prescribing Information, including a more complete discussion of the risks associated with Jakafi, is available at www.jakafi.com.