1stOncology™: Cancer Intelligence Service – Page 16335 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

Bristol-Myers Squibb Employees Cycle Nearly 2,900 Miles Across the Country to Raise Money for Cancer Research

On September 10, 2015 Bristol-Myers Squibb (NYSE:BMY) reported that their oncology team set off on the first leg of the Coast 2 Coast 4 Cancer Ride, a 19-day bike relay that will involve over 80 employees riding a combined total of nearly 2,900 miles, from today’s start on the Oregon Coast to the Jersey Shore, to show their support for the cancer community while raising funds for cancer research (Press release, Bristol-Myers Squibb, SEP 10, 2015, View Source [SID:1234507440]). Bristol-Myers Squibb will match donations raised by the riders, dollar-for-dollar up to $500,000, to support Stand Up To Cancer, whose collaborative "Dream Teams" of scientific researchers are working together to accelerate cancer research and to provide innovative treatment to patients faster.

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!

"This is the second consecutive year that Bristol-Myers Squibb employees are making this remarkable effort for Coast 2 Coast 4 Cancer. Most of our cyclists are riding for people they know whose lives have been touched by this disease, and the teams’ dedication reflects our commitment to helping cancer patients across the country," said Teresa Bitetti, senior vice president, U.S. Oncology, Bristol-Myers Squibb. "The strength and passion of our employees make it possible for us to strive toward changing the way cancer is treated, and those same qualities inspire us to reach the Coast 2 Coast 4 Cancer finish line on behalf of the cancer community."

In addition to the Coast 2 Coast 4 Cancer Ride, Bristol-Myers Squibb has a significant history of providing support to Stand Up To Cancer to advance cancer research, awareness and patient care. "We are very impressed by the Bristol-Myers Squibb employees who are cycling this year and are grateful for their support of the Stand Up To Cancer movement," said Stand Up To Cancer Co-Founder Katie Couric. "Their commitment to our dream of making every person diagnosed with cancer a survivor is inspiring for all of us, and we are proud to be a part of the larger Coast 2 Coast 4 Cancer team."

Last year, Coast 2 Coast 4 Cancer riders raised $359,000 for Stand Up To Cancer research and this year’s ride is even more ambitious, with six teams of 11-14 riders each, covering approximately 450 miles per team. "I am riding for my mom who battled cancer. She was my best friend and if I have achieved anything in this life, it is because of her. This race is about the patients we serve, their families, their doctors and their nurses who fight every day for them," said E. G. "Bubba" Klugh, Bristol-Myers Squibb, Little Rock, AR. "The training leading up to our ride has been strenuous, but the discipline required is part of what makes Coast 2 Coast 4 Cancer so meaningful to the riders because we are riding for patients. We would all ride as far as it takes – for them."

For more information on how you can show your support for Coast 2 Coast 4 Cancer, visit www.cancerbikeride.org.

Stemline Therapeutics Announces SL-401 Receives EU Orphan Drug Designation for Treatment of Acute Myeloid Leukemia (AML)

On September 10, 2015 Stemline Therapeutics, Inc. (Nasdaq:STML) reported that the European Medicines Agency (EMA) has granted Orphan Drug designation to SL-401 for the treatment of acute myeloid leukemia (AML). SL-401 previously received Orphan Drug designation from the U.S. Food and Drug Administration (FDA) for the treatment of AML and blastic plasmacytoid dendritic cell neoplasm (BPDCN) (Press release, Stemline Therapeutics, SEP 10, 2015, View Source [SID:1234507443]).

SL-401 is a targeted therapy directed to the interleukin-3 receptor (IL-3R) present on cancer stem cells (CSCs) and tumor bulk of BPDCN, AML, and other hematologic cancers. Stemline is evaluating SL-401 in three trials across 7 different indications. The clinical programs include an ongoing pivotal trial in BPDCN, as well as trials in early and late stage AML and several high-risk myeloproliferative neoplasms.

"We are pleased with the EMA’s decision to grant Orphan Drug designation to SL-401 as it underscores the continued unmet need in AML," noted Eric K. Rowinsky, M.D., Stemline’s Chief Medical Officer and Head of Research and Development. "Additionally, SL-401’s orphan designation from regulators in both the U.S. and Europe provides Stemline with several potential avenues to accelerate clinical development in AML and other orphan indications."

About Orphan Drug Designation

Orphan Drug designation by the European Commission provides regulatory and financial incentives for companies to develop and market therapies that treat a life-threatening or chronically debilitating condition affecting no more than five in 10,000 persons in the European Union (EU), and where no satisfactory treatment is available. In addition to a 10-year period of marketing exclusivity in the EU after product approval, orphan drug designation provides incentives for companies seeking protocol assistance from the EMA during the product development phase, and direct access to the centralized authorization procedure.

BioLineRx Announces Regulatory Submission for Phase 2 Trial of BL-8040 as Novel Treatment for Hypoplastic Myelodysplastic Syndrome and Aplastic Anemia

On September 10, 2015 BioLineRx Ltd. (NASDAQ: BLRX; TASE: BLRX), a clinical-stage biopharmaceutical company dedicated to identifying, in-licensing and developing promising therapeutic candidates, reported that it has filed the regulatory submissions required to commence a Phase 2 trial for BL-8040, in combination with standard-of-care immunosuppressive therapy, as a novel treatment for two bone marrow failure conditions: hypoplastic myelodysplastic syndrome (hMDS) and aplastic anemia (AA) (Press release, BioLineRx, SEP 10, 2015, View Source [SID:1234507442]). The trial is expected to commence shortly after receipt of regulatory approval, anticipated in the next few months.

The open-label Phase 2 trial will be conducted in collaboration with MD Anderson Cancer Center in Houston and is expected to enroll up to 25 patients. The study will examine BL-8040’s ability to improve bone marrow cellularity and peripheral blood counts in patients suffering from these bone marrow failure conditions.

Both hMDS and AA are characterized by a T cell-driven autoimmune attack on the bone marrow that results in depletion of hematopoietic precursors, leading to anemia and low white blood cell counts. In this regard, high CXCR4 expression on pathogenic T cells has been suggested to facilitate infiltration of the bone marrow. BL-8040, a CXCR4 antagonist, is expected to inhibit migration of pathogenic T cells to the bone marrow, thereby mitigating the severe depletion of hematopoietic stem and progenitor cells.

In addition, BL-8040 can directly affect the number of hematopoietic precursors. Preclinical studies in mice showed that multiple doses of BL-8040 led to a marked increase in the number of hematopoietic progenitor cells and hematopoietic stem cells in both the bone marrow and peripheral blood. BL-8040 also promoted production of megakaryocytes in the bone marrow, leading to a prolonged increased platelet production. These direct effects of BL-8040, along with the exclusion of the pathogenic T cells from the bone marrow, may improve bone marrow cellularity and peripheral blood counts.

Dr. Kinneret Savitsky, CEO of BioLineRx, stated, “We are very pleased to have filed the necessary regulatory submissions for an additional Phase 2 trial of BL-8040, our unique oncology platform, in these novel and non-malignant indications. We are honored to collaborate yet again with the prestigious MD Anderson Cancer Center, expanding upon our current collaboration on the Phase 2 trial for treating relapsed/refractory acute myeloid leukemia (AML), as well as our planned Phase 2 trial for treating AML patients with the FLT3-ITD mutation. The hMDS/AA trial will assess BL-8040 in combination with standard of care immunosuppressive therapy, with interim results expected by the end of 2016. Both hMDS and AA represent significant unmet medical needs and we are very hopeful that BL-8040, as part of a novel treatment regimen, will significantly improve bone marrow cellularity and peripheral blood counts in patients suffering from these difficult bone marrow failure conditions.”

About BL-8040
BL-8040 is a clinical-stage drug candidate for the treatment of acute myeloid leukemia, as well as other hematological indications. It is a short peptide that functions as a high-affinity antagonist for CXCR4, a chemokine receptor that is directly involved in tumor progression, angiogenesis (growth of new blood vessels in the tumor), metastasis (spread of the disease to other organs or organ parts) and cell survival. CXCR4 is over-expressed in more than 70% of human cancers and its expression often correlates with disease severity. In a Phase 1/2, open-label, dose escalation, safety and efficacy clinical trial in 18 multiple myeloma patients, BL-8040, when combined with G-CSF, demonstrated an excellent safety profile at all doses tested and was highly effective in the mobilization of hematopoietic stem cells and white blood cells from the bone marrow to the peripheral blood. Additionally, in a Phase 1 stem-cell mobilization study in healthy volunteers, BL-8040 as a single agent was safe and well tolerated at all doses tested and resulted in efficient stem-cell mobilization and collection in all study participants. Importantly, the results of this study support the use of BL-8040 as one-day, single-dose collection regimen, which is a significant improvement upon the current standard of care.

BL-8040 also mobilizes cancer cells from the bone marrow and may therefore sensitize these cells to chemo- and bio-based anti-cancer therapy. Importantly, BL-8040 has also demonstrated a direct anti-cancer effect by inducing apoptosis. Pre-clinical studies show that BL-8040 inhibits the growth of various tumor types including multiple myeloma, non-Hodgkin’s lymphoma, leukemia, non-small cell lung carcinoma, neuroblastoma and melanoma. BL-8040 also significantly and preferentially stimulated apoptotic cell death of malignant cells (multiple myeloma, non-Hodgkin’s lymphoma and leukemia). Significant synergistic and/or additive tumor cell killing activity has been observed in-vitro and in-vivo when tumor cells were treated with BL-8040 together with Rituximab, Bortezomib, Imatinib, Cytarabine and the FLT-3 inhibitor AC-220 (in NHL, MM, CML, AML, and AML-FLT3-ITD models, respectively). In addition, the current Phase 2 clinical trial in AML patients has demonstrated robust mobilization and apoptosis of cancer cells. BL-8040 was licensed by BioLineRx from Biokine Therapeutics and was previously developed under the name BKT-140.

About AA and hMDS
Aplastic anemia (AA) and hypoplastic myelodysplastic syndrome (hMDS) are hematological conditions caused by progressive bone marrow failure, and characterized by ineffective production of all blood cells, leading to severe anemia and cytopenias (low blood counts). AA and hMDS result from disorders of the hematopoietic stem cells in the bone marrow. Hematopoiesis is disrupted and the number and quality of blood-forming cells decline irreversibly, further impairing blood production. Treatment may include immunosuppressive therapy, chemotherapy or hematopoietic stem cell transplant.

10-Q – Quarterly report [Sections 13 or 15(d)]

(Filing, 10-Q, Peregrine Pharmaceuticals, SEP 9, 2015, View Source [SID:1234507438])

Aduro Biotech Announces Clinical Trial Agreement to Evaluate Combination of Two Novel Cancer Immunotherapies for the Treatment of Ovarian Cancer

On September 9, 2015 Aduro Biotech, Inc. (Nasdaq:ADRO) reported that it has entered into a clinical trial agreement with Incyte Corporation (Nasdaq:INCY) to evaluate the safety, tolerability and preliminary efficacy of Aduro’s lead LADD immunotherapy, CRS-207, in combination with Incyte’s oral indoleamine dioxygenase 1 (IDO1) inhibitor, epacadostat (INCB24360), in patients with ovarian cancer (Press release, Aduro BioTech, SEP 9, 2015, View Source;p=RssLanding&cat=news&id=2086398 [SID:1234507459]).

The combination of both investigational immunotherapeutic agents, which have different but complementary mechanisms directed at enhancing the body’s own immune defenses, may provide unique synergies in fighting cancer. Incyte’s epacadostat has been shown in vitro and in preclinical tumor models to enhance activities of multiple types of immune cells by reducing the immune suppression characteristic of the tumor microenvironment. Aduro’s CRS-207 has been shown to stimulate immune cell activity, with particular targeting mechanisms that seek and attack tumor cells that express mesothelin like those found in ovarian cancer.

"There’s a growing body of evidence and enthusiasm in the field of oncology to combine therapeutic agents with different mechanisms that may result in very powerful approaches to treating tough cancers," said Stephen T. Isaacs, chairman, president and chief executive officer of Aduro. "Incyte is a leader in the field of cancer immunotherapy and we’re pleased to join forces with them to study a novel approach to treating ovarian cancer."

Rich Levy, M.D., chief drug development officer of Incyte added, "This clinical trial collaboration with Aduro is an important opportunity to further investigate the therapeutic value of epacadostat in advanced ovarian cancer. Research partnerships like this one help us deliver on our goal of advancing innovative science to improve patients’ lives."

The Phase 1/2 trial, which is being funded equally between the two companies, is designed to test combinations of CRS-207 with two dose levels of epacadostat in dose escalation and then will expand to a Phase 2 evaluating the combination at the optimal dose level compared to CRS-207 alone based on safety and tumor biomarkers. The study plans to enroll up to 40 patients in Phase 1 and up to 86 patients in Phase 2 with platinum-resistant ovarian, fallopian or peritoneal cancers. The trial is expected to begin enrolling patients in early 2016.

Under the terms of the collaboration, Aduro and Incyte will collaborate on a non-exclusive basis to evaluate the combination. Aduro will be responsible for conducting the study and the results will be used to determine whether further clinical development of this combination is warranted.

About Epacadostat

Indoleamine 2,3-dioxygenase 1 (IDO1) is an immunosuppressive enzyme that has been shown to induce regulatory T cell generation and activation, and allow tumors to escape immune surveillance. Epacadostat is an orally bioavailable small molecule inhibitor of IDO1 that has nanomolar potency in both biochemical and cellular assays and has demonstrated potent activity in enhancing T lymphocyte, dendritic cell and natural killer cell responses in vitro, with a high degree of selectivity. Epacadostat has shown proof-of-concept clinical data in patients with unresectable or metastatic melanoma in combination with the CTLA-4 inhibitor ipilimumab, and is currently in four proof-of-concept clinical trials with PD-1 and PD-L1 immune checkpoint inhibitors in a variety of cancer types.

About CRS-207

CRS-207 is one of a family of product candidates based on Aduro’s live-attenuated, double-deleted (LADD) Listeria monocytogenes immuno-oncology platform that are designed to induce potent innate and adaptive immune responses. CRS-207 has been engineered to express the tumor-associated antigen mesothelin, which is over-expressed in many cancers including mesothelioma and pancreatic, non-small cell lung, ovarian and gastric cancers.