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Nektar Reports on Advancements with Pain and Oncology Clinical Pipeline at Investor and Analyst R&D Day

On October 8, 2015 Nektar Therapeutics (Nasdaq: NKTR) reported that it will present an overview of the Company’s pain and oncology portfolio during an Investor and Analyst R&D Day being hosted today from 12:30 – 3:30 p.m. Eastern Time in New York City (Press release, Nektar Therapeutics, OCT 8, 2015, View Source [SID:1234507672]).

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Leading experts in immuno-oncology will provide an overview of the current landscape in immuno-oncology and the need for new T-cell stimulatory agents, such as NKTR-214 and NKTR-255. For the first time, Nektar will announce new data for single-agent NKTR-214, including data in a preclinical model of Lewis Lung carcinoma. Details of the NKTR-214 Phase 1/2 clinical program and biomarker strategy will be presented. NKTR-214 is a CD122-biased immune-stimulatory cytokine designed to preferentially stimulate the production of CD8-positive T-cells. The Company will present new preclinical data for its next immuno-oncology candidate, NKTR-255, a new immune-stimulatory cytokine designed to improve T-cell memory by targeting the IL-15 pathway. The company will also discuss its new IDO inhibitor program, NKTR-218, which could increase IDO inhibition activity within the tumor micro-environment.

Pain management specialists will discuss opioid-induced constipation and new first-in-class medicine MOVANTIK, as well as review the regulatory landscape for abuse-deterrent analgesics. New in vitro manipulation and extraction data will be presented for NKTR-181, a first-in-class, mu-opioid analgesic investigational drug candidate with a novel molecular structure designed to reduce abuse liability.

The experts will also participate in two separate panel discussions on current treatment practices and share their perspectives on the medical need for new treatment options.

"Today’s presentations will highlight the significant promise of our internally discovered programs, particularly in immuno-oncology, which have the potential to drive the next stage of growth for Nektar," stated Howard W. Robin, President and Chief Executive Officer of Nektar. "We are leveraging our technology to create compelling new immuno-oncology drug candidates that access new cytokine biology to expand T-cell populations and improve T-cell memory in order to train the immune system to fight cancer. In the area of pain, NKTR-181 is a new opioid molecule that represents a completely new class of pain medicine which could allow us to maintain the efficacy of traditional opioids, while potentially reducing the serious risks of misuse, abuse and diversion."

Dynavax Initiates Immuno-Oncology Clinical Trial Evaluating SD-101 in Combination With Merck’s Anti-PD-1 Therapy, KEYTRUDA(R) (pembrolizumab)

On October 08, 2015 Dynavax Technologies Corporation (NASDAQ: DVAX) reported that it has initiated patient dosing in the company’s trial evaluating the combination of two immunotherapies: Dynavax’s SD-101 and Merck’s (NYSE: MRK) KEYTRUDA (pembrolizumab) (Press release, Dynavax Technologies, OCT 8, 2015, View Source [SID:1234507670]). The multicenter, open-label trial is enrolling patients with advanced or metastatic melanoma and will investigate the safety and potential efficacy of Dynavax’s investigational toll-like receptor 9 (TLR9) agonist, SD-101, in combination with Merck’s anti-PD-1 therapy, KEYTRUDA.

SD-101 and KEYTRUDA are immunotherapies designed to modulate the patient’s own immune response to fight cancer. SD-101 is designed to mediate anti-tumor effects by triggering both innate and adaptive immune responses, including inducing high levels of Type 1 interferon. KEYTRUDA is a humanized monoclonal antibody that blocks the interaction between PD-1 (programmed death receptor-1) and its ligands, PD-L1 and PD-L2. Preclinical data suggest that combining SD-101 and antibodies targeting PD-1 may lead to a stronger anti-tumor immune response compared to either agent alone.

The Phase 1b dose-escalation portion of the study is enrolling up to 12 patients with advanced or metastatic melanoma. Patients will receive intratumoral administrations of SD-101 at pre-specified dose levels and intravenous doses of KEYTRUDA. Patients will be monitored for safety and tolerability while an optimal dose of SD-101 is determined. Upon completion of dose escalation, the study will be expanded into a Phase 2 study that will enroll up to 85 patients. The patients enrolled in the expansion study will either have disease that is progressing while receiving an anti-PD-1 therapy or will have baseline characteristics associated with lower rates of response to anti-PD-1 therapy.

Antoni Ribas, M.D., Ph.D., of the Jonsson Comprehensive Cancer Center at the University of California, Los Angeles, is the primary investigator on this clinical trial. More information on this clinical trial can be found at View Source

Dynavax expects to complete the Phase 1b dose escalation and expand into the Phase 2 portion of the clinical trial with the selected dose of SD-101 by mid-year 2016.

About SD-101

SD-101 is a 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.

Lilly Receives FDA Breakthrough Therapy Designation for Abemaciclib – a CDK 4 and 6 Inhibitor – in Advanced Breast Cancer

On October 8, 2015 Eli Lilly and Company (NYSE: LLY) reported that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to abemaciclib, a cyclin-dependent kinase (CDK) 4 and 6 inhibitor, for patients with refractory hormone-receptor-positive (HR+) advanced or metastatic breast cancer (Press release, Eli Lilly, OCT 8, 2015, View Source [SID:1234507665]).

This designation is based on data from the breast cancer cohort expansion of the company’s Phase I trial, JPBA, which studied the efficacy and safety of abemaciclib in women with advanced or metastatic breast cancer. Patients in this cohort had received a median of seven prior systemic treatments. These data were presented at the San Antonio Breast Cancer Symposium in 2014.

According to the FDA, Breakthrough Therapy Designation is a process designed to expedite the development and review of drugs that are intended to treat a serious condition, and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint.

"If caught before it spreads, patients can survive breast cancer. However, for the nearly 10 percent of patients who are initially diagnosed at stage IV,1 and the nearly 30 percent of patients whose early-stage cancer will re-occur as metastatic disease,1 there remains an urgent need for effective therapy options," said Richard Gaynor, M.D., senior vice president of product development and medical affairs for Lilly Oncology. "We are pleased that the FDA has designated abemaciclib as a breakthrough therapy for patients with advanced breast cancer and Lilly will work closely with the FDA in this process to expedite its development and review."

Lilly has an active clinical development program studying abemaciclib in breast cancer. MONARCH 1 is a Phase II trial evaluating the use of abemaciclib as monotherapy in women with hormone-receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) metastatic breast cancer. In addition, Lilly is evaluating abemaciclib in two Phase III clinical trials: MONARCH 2 to evaluate the combination of abemaciclib and fulvestrant in postmenopausal patients with HR+, HER2- advanced or metastatic breast cancer, and MONARCH 3 to evaluate the combination of abemaciclib and a nonsteroidal aromatase inhibitor in patients with HR+, HER2- locoregionally recurrent or metastatic breast cancer.

About Metastatic Breast Cancer
Breast cancer is the most common cancer in women worldwide with nearly 1.7 million new cases diagnosed in 2012.2 In the U.S. each year, nearly 232,000 new cases of invasive breast cancer will be diagnosed and about 40,000 women will die from breast cancer.3 Of all diagnosed breast cancer cases in the U.S., approximately 30 percent will become metastatic, spreading to other parts of the body, with an estimated six to 10 percent of all new breast cancer cases initially being stage IV, or metastatic.1 Metastatic breast cancer is considered incurable, but is generally treatable.

About Abemaciclib
Cyclin-dependent kinases play a key role in regulating cell cycle progression. In many cancers, uncontrolled cell growth arises from a loss of control in regulating the cell cycle due to increased signaling from CDK 4 and 6. Lilly’s abemaciclib (LY2835219) is a cell cycle inhibitor, designed to block the growth of cancer cells by specifically inhibiting CDK 4 and 6. Although abemaciclib inhibits both CDK 4 and CDK 6, the results from the cell-free enzymatic assays have shown that it was most active against Cyclin D 1 and CDK 4. Results from preclinical and early-stage clinical studies support the further evaluation of abemaciclib for the treatment of human cancers – including breast cancer and lung cancer – in which aberrant CDK 4 and 6 pathways enhance cancer cell growth. Abemaciclib has now entered into Phase III development with two trials in HR+ breast cancer patients, as well as a Phase III trial in lung cancer.

Sunesis Announces Anticipated Submission of European Marketing Authorization Application for Vosaroxin in AML Before Year End

On October 7, 2015 Sunesis Pharmaceuticals, Inc. (Nasdaq:SNSS) reported that the company intends to submit a Marketing Authorization Application (MAA) for vosaroxin as a treatment for acute myeloid leukemia (AML) with the European Medicines Agency (EMA) by the end of 2015 (Press release, Sunesis, OCT 7, 2015, View Source;p=RssLanding&cat=news&id=2095135 [SID:1234507667]).

The company recently announced that it met separately with the Rapporteur (United Kingdom) and Co-Rapporteur (Netherlands) assigned to provide advice and guidance to the company through the MAA process. Based on these discussions, the company is proceeding with an MAA filing for the indication of relapsed/refractory AML in patients age 60 years and older, a population with the greatest medical need and for whom the greatest benefit was observed in the vosaroxin/cytarabine treatment arm of VALOR, the company’s pivotal Phase 3 study of vosaroxin and cytarabine in adult patients with relapsed or refractory AML.

"The filing of an MAA for vosaroxin in Europe by year end is our top corporate priority. As for the U.S., we are refining a plan to find a timely path towards market," said Daniel Swisher, Chief Executive Officer of Sunesis. "With these efforts underway, we also expect to achieve meaningful progress in our kinase inhibitor pipeline, including data presentations at the upcoming November AACR (Free AACR Whitepaper)-NCI-EORTC Conference in Boston. Among those being highlighted at the conference is our second generation, differentiated BTK program, SNS-062."

Sunesis also announced today changes to the executive management team. Chief Medical Officer, Adam R. Craig will step down from his role at the end of the year to pursue other opportunities. Dr. Craig will remain available to the company on an advisory basis throughout the regulatory process with the EMA. Also within the Development group, Jennifer A. Smith has been appointed Vice President of Biometrics, where her responsibilities include the statistical design of the company’s clinical trials as well as clinical data analyses and presentations, including those supporting ongoing regulatory filings. Dr. Smith joined Sunesis in 2012 from BiPar Sciences where she was Senior Director of Biometrics. Prior to BiPar, she served in similar roles at Geron, Pharmacyclics and Aviron.
Mr. Swisher added: "We thank Adam for his leadership and significant contributions at Sunesis as Chief Medical Officer and look forward to continuing to work with him as a valued advisor in 2016. We have begun a search to complement our experienced internal team with additional clinical development expertise."

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.

About AML
AML is a rapidly progressing cancer of the blood characterized by the uncontrolled proliferation of immature blast cells in the bone marrow. The American Cancer Society estimates that there will be approximately 20,830 new cases of AML and approximately 10,460 deaths from AML in the U.S. in 2015. Additionally, it is estimated that the prevalence of AML across major global markets (U.S., France, Germany, Italy, Spain, United Kingdom and Japan) is over 75,000. AML is generally a disease of older adults, and the median age of a patient diagnosed with AML is about 67 years. AML patients with relapsed or refractory disease and newly diagnosed AML patients over 60 years of age with poor prognostic risk factors typically die within one year, resulting in an acute need for new treatment options for these patients.

8-K – Current report

On October 7, 2015 BioTime, Inc. (NYSE MKT and TASE: BTX), a clinical-stage regenerative medicine company with a focus on pluripotent stem cell technology, and its subsidiary OncoCyte Corporation ("OncoCyte"), reported that OncoCyte has filed a Form 10 Registration Statement with the Securities and Exchange Commission ("SEC") in connection with BioTime’s planned distribution OncoCyte common stock to holders of BioTime common shares, on a pro rata basis (Filing, 8-K, BioTime, OCT 7, 2015, View Source [SID:1234507666]).

The filing represents an important milestone in separating BioTime’s therapeutics and cancer diagnostics businesses. BioTime expects that the distribution will provide OncoCyte with greater access to capital markets in order to obtain its own financing for its operations, separately from BioTime financings. The distribution will also allow BioTime and OncoCyte to each focus on its own strategic priorities relating to its own management, capital structure, business model, and financial goals. The distribution may also provide enhanced liquidity to holders of BioTime common shares, who after the distribution will hold two separate publicly traded securities that they may choose to monetize or retain.

BioTime continues to believe in the opportunity for cancer diagnostics and expects to continue to own a majority of the outstanding common stock in OncoCyte immediately after the distribution. The "record date" for determining BioTime shareholders entitled to receive OncoCyte common stock in the planned distribution, and the date on which the distribution will occur, have not yet been determined. However, BioTime’s plan is to effect the distribution to BioTime shareholders in late 2015, subject to certain conditions.

OncoCyte is engaged in the development of new "liquid biopsy" diagnostic tests for cancer based on analyzing patient blood or urine samples for specific gene or protein markers indicative of the presence of particular types of cancer. OncoCyte is presently developing diagnostic tests for lung cancer, breast cancer and bladder cancer.

More information about OncoCyte and the planned shared distribution can be found in the Information Statement filed as an exhibit to OncoCyte’s Form 10 Registration Statement, which is available on the "Latest News" page of OncoCyte’s website: www.oncocyte.com and the website maintained by the SEC at www.sec.gov.

This press release does not constitute an offer to sell or a solicitation of an offer to buy any OncoCyte securities. The distribution of OncoCyte common stock by BioTime will be made only in those states and other jurisdictions where permitted or not prohibited by law.