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.

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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.

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:

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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.

On November 30, 2015 Novartis reported that it will demonstrate the strength of its research program and portfolio at the 57th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting (Press release, Novartis, NOV 29, 2015, View Source [SID:1234508354]). Presentations will highlight data across leukemias, lymphomas and myelomas as well as supportive care, including key findings in rare and difficult-to-treat patient populations, in addition to personalized cell therapies. The ASH (Free ASH Whitepaper) Annual Meeting will be held December 5-8 in Orlando, Florida.

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

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"We pride ourselves in our drive for new science and innovation, and look forward to bringing this promise to life at ASH (Free ASH Whitepaper) through the results of our latest hematology research," said Bruno Strigini, President, Novartis Oncology. "We will be presenting encouraging overall survival data for both investigational and approved products, underscoring our commitment to improve and extend people’s lives."

A key focus in hematology for Novartis is developing therapies for rare and difficult-to-treat patient populations. The acute myeloid leukemia (AML) community in particular is in need of new treatment options as the general therapeutic strategy has remained unchanged for more than 25 years[1],[2]. Further, about one-third of AML patients harbor a FLT3 mutation, which is associated with poorer prognoses than in those without the mutation[3],[4]. To this end, key data on PKC412 (midostaurin) from the following two studies will be presented:

The Multi-Kinase Inhibitor Midostaurin (M) Prolongs Survival Compared with Placebo (P) in Combination with Daunorubicin (D)/Cytarabine (C) Induction (ind), High-Dose C Consolidation (consol), and As Maintenance (maint) Therapy in Newly Diagnosed Acute Myeloid Leukemia (AML) Patients (pts) Age 18-60 with FLT3 Mutations (muts): An International Prospective Randomized (rand) P-Controlled Double-Blind Trial (CALGB 10603/RATIFY [Alliance]) (Abstract #6, Plenary Session, Sunday, December 6, 2:00 – 4:00 pm EST)

Midostaurin in Combination with Intensive Induction and As Single Agent Maintenance Therapy after Consolidation Therapy with Allogeneic Hematopoietic Stem Cell Transplantation or High-Dose Cytarabine (NCT01477606) (Abstract #322, Oral Presentation, Sunday, December 6, 5:15 pm EST)

Novartis and the University of Pennsylvania’s Perelman School of Medicine (Penn) have an exclusive global collaboration to research, develop and commercialize chimeric antigen receptor (CAR) T cell therapies for the investigational treatment of cancers. New data on investigational CART therapy CTL019, as well as cell processing technology will be presented at ASH (Free ASH Whitepaper) including:

Durable Remissions in Children with Relapsed/Refractory ALL Treated with T Cells Engineered with a CD19-Targeted Chimeric Antigen Receptor (CTL019) (Abstract #681, Oral Presentation, Monday, December 7, 3:15 pm EST)

Sustained Remissions Following Chimeric Antigen Receptor Modified T Cells Directed Against CD19 (CTL019) in Patients with Relapsed or Refractory CD19+ Lymphomas (Abstract #183, Oral Presentation, Sunday, December 6, 8:00 am EST)

Successful Translation of Chimeric Antigen Receptor (CAR) Targeting CD19 (CTL019) Cell Processing Technology from Academia to Industry (Abstract #3100, Poster Presentation, Sunday, December 6, 6:00 – 8:00 pm EST)

Novartis will share new research for pipeline compound ABL001, a small molecule designed to inhibit BCR-ABL. ABL001 is different from Glivec (imatinib)* and Tasigna (nilotinib) as it binds to a unique region of BCR-ABL, forcing a conformational change that disables the protein’s active site. As part of Novartis’ ongoing commitment to chronic myeloid leukemia (CML) research, ABL001 represents the company’s evolving science and is being investigated in Phase I trials:

ABL001, a Potent, Allosteric Inhibitor of BCR-ABL, Exhibits Safety and Promising Single- Agent Activity in a Phase I Study of Patients with CML with Failure of Prior TKI Therapy (Abstract #138, Oral Presentation, Saturday, December 5, 5:15 pm EST)
Novartis will also be presenting safety and efficacy data, including long-term studies, at ASH (Free ASH Whitepaper) from its approved hematological treatments:

Jakavi (ruxolitinib)**

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, Oral Presentation, Saturday, December 5, 10:30 am EST)
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, Poster Presentation, Sunday, December 6, 6:00 – 8:00 pm EST)
Demographics, Baseline (BL) Characteristics, and Disease Symptom Burden in RESPONSE-2: A Randomized, Phase 3 Study of Ruxolitinib in Polycythemia Vera Patients (pts) Who Are Resistant to or Intolerant of Hydroxyurea (HU) (Abstract #2807, Poster Presentation, Sunday, December 6, 6:00 – 8:00 pm EST)

Continued Treatment With Ruxolitinib Provides Additional Hematocrit Control and Spleen Volume Responses in Patients with PV Treated in the RESPONSE Study (Abstract #2804, Poster Presentation, Sunday, December 6, 6:00 – 8:00 pm EST)

Tasigna (nilotinib)

Dose-Optimized Nilotinib (NIL) in Patients (pts) with Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase (CML-CP): Final results from ENESTxtnd study (Abstract #344, Oral Presentation, Sunday, December 6, 4:45 pm EST)

Impact of Age on Efficacy and Toxicity of Nilotinib in Patients with Chronic Myeloid Leukemia in Chronic Phase (CML-CP): ENEST1st Sub-Analysis (Abstract #479, Oral Presentation, Monday, December 7, 8:00 am EST)

International Scale (IS)-Standardized BCR-ABL1 Digital Polymerase Chain Reaction (dPCR) Assays Using ABL1, BCR, and GUS Control Genes for Measuring Deep Molecular Response (MR) in Chronic Myeloid Leukemia (CML) (Abstract #136, Oral Presentation, Saturday, December 5, 4:45 pm EST)

Quantification of BCR-ABL with Digital PCR Results in a Significantly Lower Rate of Deep Molecular Response when Compared to RT-qPCR in CML Patients Treated in the ENEST1st Trial (Abstract #135, Oral Presentation, Saturday, December 5, 4:30 pm EST)
Farydak (panobinostat)

Final Analysis of Overall Survival from the Phase 3 Panorama 1 Trial of Panobinostat Plus Bortezomib and Dexamethasone Versus Placebo Plus Bortezomib and Dexamethasone in Patients with Relapsed or Relapsed and Refractory Multiple Myeloma (Abstract #3026, Poster Presentation, Sunday, December 6, 6:00 – 8:00 pm EST)
Analysis of Outcomes Based on Response in Patients with Relapsed or Relapsed and Refractory Multiple Myeloma Treated with Panobinostat or Placebo in Combination with Bortezomib and Dexamethasone in the Panorama 1 Trial: Updated Analysis Based on Prior Treatment (Abstract #4230, Poster Presentation, Monday, December 7, 6:00 – 8:00 pm EST)
In addition, Sandoz, a Novartis company and the global leader in biosimilars, will present data from PROTECT 2, one of their pivotal Phase III trials investigating use of their proposed pegfilgrastim biosimilar in patients with chemotherapy-induced neutropenia.

Proposed Biosimilar Pegfilgrastim (LA-EP2006) and Reference Pegfilgrastim for the Prevention of Neutropenia in Patients with Breast Cancer: A Randomized, Double-Blind Trial. PROTECT 2: Pegfilgrastim Randomized Oncology (supportive care) Trial to Evaluate Comparative Treatment Results (Abstract #632, Oral Presentation, Monday, December 7, 10:45 am EST)
Throughout ASH (Free ASH Whitepaper) 2015, Novartis Oncology will host dedicated content on the company website (View Source) that will feature unique insights and perspectives on emerging areas of cancer care and research.

Product Information
Approved indications for products vary by country and not all indications are available in every country. The product safety and efficacy profiles have not yet been established outside the approved indications. Because of the uncertainty of clinical trials, there is no guarantee that compounds will become commercially available with additional indications.

For full prescribing information, including approved indications and important safety information about marketed products, please visit
View Source

Because PKC412 (midostaurin), CTL019 and ABL001 are investigational compounds, the safety and efficacy profiles have not yet been fully established. Access to these investigational compounds is available only through carefully controlled and monitored clinical trials. These trials are designed to better understand the potential benefits and risks of the compound. Because of the uncertainty of clinical trials, there is no guarantee that PKC412 (midostaurin), CTL019 and ABL001 will ever be commercially available anywhere in the world.

On November 30, 2015 Boehringer Ingelheim reported insights from experts working on-the-ground in lung cancer, compiled by Boehringer Ingelheim, shed light on challenges faced by patients with advanced stage adenocarcinoma, a type of non-small cell lung cancer (NSCLC), in being tested for EGFR mutations, leaving some without access to the most appropriate treatment for them (Press release, Boehringer Ingelheim, NOV 29, 2015, View Source [SID:1234508356]).

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A new insights report sees healthcare professionals and patient group representatives reflect on existing gaps in nationwide EGFR testing, which should be conducted for eligible patients upon diagnosis according to guidelines.1

Dr Matthew Peters, Professor of Respiratory Medicine, Macquarie University Australia and Chair, Global Lung Cancer Coalition commented, "Whilst country-level insights within this report do vary, common barriers to achieving EGFR testing and personalised treatment for all eligible patients are clear. Education is key: for patients, healthcare professionals and the wider community. More is needed to bring us closer to helping each and every NSCLC patient receive the right treatment for them."

Country-level themes identified by experts from Western Europe and North America include:

Germany: insufficient reimbursement for mutation tests impacts EGFR testing rates for inpatients (majority of patients are diagnosed in an inpatient setting)

Italy: high number of patients are tested for EGFR mutations, but some patients and caregivers ask to start first-line treatment before receiving test results

Spain: many cancer centres are currently achieving high EGFR testing rates, but disparity exists as some centres are increasingly impacted by the growing economic crisis

UK: despite high levels of EGFR testing, some patients start treatment before results of this testing are available, so treatment is not personalised for their mutation

Canada: a healthcare system which is publically funded through each province and territory brings forth challenges in ensuring all eligible patients across the country are EGFR tested at diagnosis

USA: a substantial percentage of treatment decisions are not based on EGFR mutation subtype resulting in patients not receiving the most appropriate personalised treatment plans

Experts unite with a shared vision where all eligible NSCLC patients have the most appropriate diagnostic tests and access to personalised treatment. Common barriers holding back the realisation of this vision include difficulties in obtaining adequate tumour tissue samples to test, and delays in receiving test results. This is important as data have shown that EGFR targeted treatments significantly delay disease progression when compared to chemotherapy. For a specific targeted therapy, extended overall survival of patients with the most common type of mutation (del19) when compared to chemotherapy has also been observed.2

Dr Mehdi Shahidi, Medical Head, Solid Tumour Oncology, Boehringer Ingelheim added, "EGFR testing rates have improved dramatically over recent years, but there is still work to be done. Targeted therapies can benefit patients with EGFR mutation-positive lung cancer by delaying disease progression and for some, offering survival advantages compared to chemotherapy. This is why EGFR mutation testing and acting on the results of these tests is so important. Healthcare teams need to optimise the tools, resources and tests available to improve access to personalised treatment, for the ultimate benefit of patients."

On April 28, 2015 Co-D Therapeutics, Inc., a pre-clinical stage pharmaceutical company developing agents for the treatment of cancer, reported that the U.S. Food and Drug Administration (FDA) has granted Co-D’s request for orphan drug designation of Triolimus for the treatment of the highly lethal malignancy, angiosarcoma (Press release, Co-D Therapeutics, 28 11, 2015, View Source [SID1234516124]).

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"We are pleased that Triolimus has been designated an orphan drug for the treatment of angiosarcoma," commented Dr. Kevin Kozak, co-founder and Chief Medical Officer of Co-D Therapeutics. "With few effective options, new agents for angiosarcoma treatment are urgently required. The orphan designation reflects both the FDA’s and Co-D’s commitment to addressing the unmet clinical needs of patients with rare diseases like angiosarcoma."

The Orphan Drug Act provides for economic incentives to encourage the development of drugs for diseases affecting fewer than 200,000 people in the United States. Orphan drug designation will entitle Co-D to seven years of market exclusivity for Triolimus as a treatment for angiosarcoma following marketing approval by the FDA. Additional benefits include tax credits related to clinical trial expenses, potential exemption from the FDA-user fee, assistance in clinical trial design, and smaller trials required for new drug applications.

"The designation of Triolimus as an orphan-drug for angiosarcoma treatment is an early and critical milestone and will facilitate progress through the clinical and regulatory development process," said Abdalla Saad, co-founder and Chief Executive Officer of Co-D Therapeutics. "We find our preclinical data compelling and are thrilled the FDA judged Triolimus meritorious of orphan-drug designation."

Triolimus technology was developed by Prof. Glen Kwon at the University of Wisconsin-Madison. "We are excited to continue the enormously rewarding process of advancing Triolimus to the clinic," said co-founder and Chief Scientific Officer Prof. Kwon.

Triolimus’ intellectual property portfolio will be licensed from the Wisconsin Alumni Research Foundation (WARF). Funding from WARF’s Accelerator Program supported pre-clinical development of Triolimus.

About Angiosarcoma

Angiosarcoma is a rare, aggressive malignancy of endothelial cell differentiation that has a propensity for both local recurrence as well as regional and distant metastases. Long-term disease-free survival is achieved in only half of patients who present with apparently localized disease. Average survival in patients who present with distant disease is less than one year. This poor survival is, in large part, attributable to a dearth of currently available, effective treatment options.

About Triolimus

Triolimus is a novel "3-in-1" nanoparticle that contains three proven anti-cancer agents in a non-toxic carrier. Triolimus is designed to be superior to currently available chemotherapies through both the elimination of toxic excipients often required for intravenous use and through the delivery of three, complementary drugs to maximize anti-cancer effects.