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Advaxis Accepts Medical Visionary Award From the Farrah Fawcett Foundation for Collaborative Research in HPV-Associated Anal Cancer

On September 10, 2015 Advaxis, Inc. (NASDAQ:ADXS), a clinical-stage biotechnology company developing cancer immunotherapies,reported that the Farrah Fawcett Foundation honored Advaxis with the Foundation’s inaugural "Medical Visionary Angel Award" on September 9, 2015, at the Wallis Annenberg Center for the Performing Arts in Beverly Hills, Calif (Press release, Advaxis, SEP 10, 2015, View Source [SID:1234507441]). The event benefitted the Farrah Fawcett Foundation / Stand Up To Cancer (SU2C) research team on HPV-related cancers and celebrated the life and legacy of actress Farrah Fawcett and her commitment to fund research for a cure for anal cancer, which took her life in 2009.

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Advaxis also announced plans to commence enrollment this fall of a Phase 2 clinical study of Advaxis’s lead investigational Lm Technology immunotherapy, axalimogene filolisbac (ADXS-HPV), in metastatic anal cancer. The study is to be called FAWCETT (Fighting Anal-Cancer with CTL Enhancing Tumor Therapy), in honor of Farrah Fawcett, and will be the company’s second Phase 2 study of axalimogene filolisbac in anal cancer. The two-part, single-arm, open-label study is designed to evaluate the efficacy and safety of axalimogene filolisbac as monotherapy in patients with human papillomavirus (HPV)-associated metastatic anal cancer who have received at least one prior treatment regimen for advanced disease.

"We would like to thank the Farrah Fawcett Foundation for this honor," said Daniel J. O’Connor, President and Chief Executive Officer of Advaxis. "While there is still so much work to be done in this space, we are unwavering in our commitment to bring new treatments to market in anal cancer and other underserved HPV-associated cancers."

The FAWCETT study will enroll approximately 31 patients in Part A and approximately 24 patients in Part B. The primary efficacy endpoints include overall response rate and progression-free survival, and the secondary endpoints include evaluation of overall response rate and the safety/tolerability of the dose. Further information about the Phase 2 study can be found on ClinicalTrials.gov, using Identifier NCT02399813.

The Farrah Fawcett Foundation’s "Medical Visionary Angel Award" is intended for companies that have demonstrated an outstanding commitment to innovative research in anal cancer and HPV-related cancers. Advaxis was selected for the award due to the company’s collaboration with Brown University Oncology Group on a Phase 1/2 clinical study conducted by Howard Safran, M.D., investigating axalimogene filolisbac in HPV-associated locally advanced anal cancer. The preliminary data showed treatment with axalimogene filolisbac indicated a clinical complete response and no recurrence in all 10 patients who completed the treatment regimen.

"When the Farrah Fawcett Foundation first invested in the cancer research at Brown University, we did so with great enthusiasm, knowing the work of Dr. Safran and appreciating the collaboration with Advaxis," said Alana Stewart, President and CEO of the Farrah Fawcett Foundation. "Now we are proud to honor Advaxis for their continued research on underserved cancers and breakthrough discoveries in the treatment of anal cancer and other HPV-associated cancers."

The Brown University Oncology Group study has the potential to transition into a pivotal Phase 2/3 clinical trial in collaboration with the Radiation Therapy Oncology Group (RTOG) Foundation and NRG Oncology to evaluate the safety and efficacy of axalimogene filolisbac with or without chemotherapy and radiation as adjuvant treatment in high-risk, locally advanced anal cancer.

About the Farrah Fawcett Foundation

The mission of the Farrah Fawcett Foundation is to provide funding for cutting edge cancer research, to support prevention and awareness, and to help those struggling with cancer today. Farrah Fawcett was diagnosed with anal cancer in 2006 and established the Foundation before her death in 2009. For more information, visit www.thefarrahfawcettfoundation.org and follow them on Facebook.

About Anal Cancer

Anal cancer is a fairly rare form of cancer in the United States, but the number of new anal cancer cases has been rising for years. The risk of being diagnosed with anal cancer in one’s lifetime is about 1 in 500. According to the American Cancer Society, approximately 7,270 new cases of anal cancer were diagnosed and about 1,010 people died of the disease in 2014.

About Axalimogene Filolisbac

Axalimogene filolisbac (ADXS-HPV) is Advaxis’s lead Lm Technology immunotherapy candidate for the treatment of HPV-associated cancers and is in clinical trials for three potential indications: invasive cervical cancer, head and neck cancer, and anal cancer. In a completed randomized Phase 2 study in recurrent/refractory cervical cancer, axalimogene filolisbac showed apparent prolonged survival, objective tumor responses, and a manageable safety profile alone or in combination with chemotherapy, supporting further development of the company’s Lm Technology.

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.

"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])