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Verastem to Present Data at the 16th World Conference on Lung Cancer

On August 26, 2015 Verastem, Inc. (NASDAQ:VSTM), focused on discovering and developing drugs to treat cancer by the targeted killing of cancer stem cells, reported oral and poster data presentations at the 16th World Conference on Lung Cancer (WCLC) being held September 6-9, 2015 at the Colorado Convention Center in Denver, CO (Press release, Verastem, AUG 26, 2015, View Source;p=RssLanding&cat=news&id=2082044 [SID:1234507338]).

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The details for the data presentations at WCLC are as follows:

Oral Presentations

Title: Phase 2 study of defactinib, VS-6063, a focal adhesion kinase (FAK) inhibitor, in patients with KRAS mutant non-small cell lung cancer (NSCLC)
Date and time: Wednesday, September 9, 2015, 6:30 pm – 8:00 pm MT
Location: Four Seasons Ballroom F3 and F4
Session info: Mini oral 30: New Kinase Targets; Track: Treatment of Advanced Diseases – NSCLC

Title: FAK inhibitor VS-6063 targets mesothelioma cancer stem cells: Rationale for maintenance therapy after conventional chemotherapy
Date and time: Wednesday, September 9, 2015, 6:30 pm – 8:00 pm MT
Location: Rooms 702, 704 and 706
Session info: Mini oral 38: Biology and Prognosis; Track: Thymoma, Mesothelioma and Other Thoracic Malignancies

Title: The cancer stem cell inhibitors VS-6063 (defactinib) and VS-5584 exhibit synergistic anticancer activity in pre-clinical models of mesothelioma
Date and time: Wednesday, September 9, 2015, 4:45 pm – 6:15 pm MT
Location: Rooms 702, 704 and 706
Session info: Oral session 40: Biology 1; Track: Thymoma, Mesothelioma and Other Thoracic Malignancies

Title: Targeting cancer stem cells in small cell lung cancer
Date and time: Wednesday, September 9, 2015, 4:45 pm – 6:15 pm MT
Location: Rooms 605 and 607
Session info: Mini oral 27: Biology and other issues in SCLC; Track: Small Cell Lung Cancer
Poster Presentations

Title: Trials in progress: A Phase 1 dose escalation study of VS-5584, a PI3K/mTOR inhibitor, administered with VS-6063, a focal adhesion kinase inhibitor, in mesothelioma
Date and time: Tuesday, September 8, 2015, 9:45 am – 10:45 am and 3:45 pm – 4:45 pm MT
Location: Exhibit Hall (Hall B+C); Poster # P2.08.008
Session info: Thymoma, Mesothelioma and Other Thoracic Malignancies – Mesothelioma

Title: Trials in progress: COMMAND: A Phase 2 randomized, double-blind, study of defactinib (VS-6063) as maintenance therapy in malignant pleural mesothelioma
Date and time: Wednesday, September 9, 2015, 9:45 am – 10:45 am and 3:45 pm – 4:45 pm MT
Location: Exhibit Hall (Hall B+C); Poster # P3.08.014
Session info: Thymoma, Mesothelioma and Other Thoracic Malignancies – Mesothelioma

About VS-6063
VS-6063 (defactinib) is an orally available compound designed to target cancer stem cells through the potent inhibition of focal adhesion kinase (FAK). Cancer stem cells are an underlying cause of tumor resistance to chemotherapy, recurrence and ultimate disease progression. Research has demonstrated that FAK activity is critical for the growth and survival of cancer stem cells. VS-6063 is currently being studied in the registration-directed COMMAND trial in mesothelioma (www.COMMANDmeso.com), a "Window of Opportunity" study in patients with mesothelioma prior to surgery, a Phase 1/1b study in combination with paclitaxel in patients with ovarian cancer, a trial in patients with KRAS-mutated non-small cell lung cancer and a trial evaluating the combination of VS-6063 and VS-5584 in patients with relapsed mesothelioma. VS-6063 has been granted orphan drug designation for use in mesothelioma in the U.S. and EU.

About VS-5584
VS-5584 is an orally available compound that has demonstrated potent and highly selective activity against class 1 PI3K enzymes and dual inhibitory actions against mTORC1 and mTORC2. In preclinical studies, VS-5584 has been shown to reduce the percentage of cancer stem cells and induce tumor regression in chemotherapy-resistant models. Verastem is currently conducting a dose escalation trial of VS-5584 in patients with advanced solid tumors as a single agent and a combination trial of VS-5584 and VS-6063 in patients with relapsed mesothelioma. VS-5584 has been granted orphan drug designation for use in mesothelioma in the U.S. and EU.

Alliance Foundation Trials and Austrian Breast & Colorectal Cancer Study Group Open Largest Global Phase 3 Trial of Targeted Therapy, IBRANCE® (palbociclib), for Patients with Hormone Receptor–Positive Early Breast Cancer

On August 26, 2015 The Alliance Foundation Trials, LLC (AFT), the Austrian Breast & Colorectal Cancer Study Group (ABCSG) and Pfizer Inc. reported the launch of the Palbociclib Collaborative AdjuvantStudy, or PALLAS (Press release, Pfizer, AUG 26, 2015, http://www.pfizer.com/news/press-release/press-release-detail/alliance_foundation_trials_and_austrian_breast_colorectal_cancer_study_group_open_largest_global_phase_3_trial_of_targeted_therapy_ibrance_palbociclib_for_patients_with_hormone_receptor_positive_early_breast_cancer [SID:1234507337]). This global Phase 3 clinical trial for patients with early-stage breast cancer is being conducted in conjunction with Breast International Group (BIG), German Breast Group (GBG), National Surgical Adjuvant Breast and Bowel Project (NSABP) and PrECOG, LLC (PrECOG). The PALLAS trial will evaluate whether the addition of IBRANCE (palbociclib), developed by Pfizer, to standard therapy will improve disease-free survival and prevent the disease from recurring. Patients treated in this study will have cancers that are hormone receptor-positive (HR+), meaning their growth is fueled by the hormone estrogen, but are negative for human epidermal growth factor receptor 2 (HER2-), a different tumor-associated protein. About 60 to 65 percent of breast cancers in the United States fall into this category.i

"We are delighted that Alliance was chosen to co-lead the PALLAS trial along with our partners at ABCSG," said Monica M. Bertagnolli, MD, president and chief executive officer of AFT, and group chair and principal investigator of the Alliance for Clinical Trials in Oncology. "This exciting study examines a new CDK 4/6 inhibitor that has already demonstrated an impact for breast cancer patients with metastatic disease. The goal is to determine whether IBRANCE can also improve the disease-free survival rate in patients with surgically resectable disease."

"After intensively working together among trial leadership on the scientific conception, operational preparation and seamless transatlantic cooperation for this clinical trial, we are excited that this study, with the potential to revolutionize adjuvant therapy for the most common type of breast cancer, is now ready to start," said Professor Michael Gnant, MD, FACS, president of the ABCSG, and head of the Breast Health Center Vienna. "We are convinced that this global venture has potential to bring great benefit to our breast cancer patients."

A hallmark of cancer cell growth is loss of control of the cell cycle, leading to unregulated growth and spread of cancer. A promising strategy to overcome this process involves inhibition of enzymes called cyclin-dependent kinases (CDKs), which allows re-establishment of control of cell growth. iii,iv Recent research has shown that two related enzymes – CDK 4 and CDK 6 – are among the primary proteins that accelerate cancer cell growth, and may be particularly important in HR+ breast tumors. iii,iv Research also indicates that combining CDK 4/6 inhibitors with endocrine therapy is beneficial in patients with advanced breast cancer.iii,iv The new oral, anti-cancer drug IBRANCE blocks CDK 4/6.ii

IBRANCE was approved in February 2015 by the U.S. Food and Drug Administration (FDA) for the treatment of postmenopausal women with estrogen receptor-positive (ER+)/HER2- advanced breast cancer as initial endocrine-based therapy for their metastatic disease. This indication is approved under accelerated approval based on progression-free survival, the length of time during or after treatment a patient lives with a disease but does not get worse.ii Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. The confirmatory Phase 3 trial, PALOMA-2, is fully enrolled.

"We have seen exciting news about IBRANCE in 2015, not only from the accelerated approval based on PALOMA-1, but also from the results of the PALOMA-3 study, a Phase 3 trial showing the addition of IBRANCE to the hormone medicine fulvestrant in pre-treated patients with metastatic HR+/HER2- breast cancer improved clinical outcomes," said Erica L. Mayer, MD, MPH, co-principal investigator of the trial for AFT, Assistant Professor of Medicine at the Harvard Medical School and Senior Physician at the Susan F. Smith Center for Women’s Cancers and at the Dana-Farber Cancer Institute.

"The primary endpoint of the PALLAS trial is to look at the time to disease recurrence in patients who have stage 2 or stage 3 breast cancer," Dr. Mayer said. "The study is also enriched with an expansive correlative science program that includes analyses of patient tissue and blood samples, as well as an in depth analysis of patient adherence to oral medication and patients’ quality of life while on study."

The PALLAS trial is a prospective, two-arm, international, multicenter, randomized, open-label Phase 3 study. The trial is open to premenopausal and postmenopausal women or men with stage 2 or stage 3 HR+/HER2- early breast cancer. Participants will be randomized (selected by chance) to one of two treatment arms. One study arm will treat patients with IBRANCE (at a dose of 125 mg orally once daily, day 1 to day 21 followed by seven days off treatment in a 28-day cycle) for two years and standard endocrine adjuvant therapy for at least five years. The other study arm will treat patients with standard endocrine adjuvant therapy alone for at least five years. Participants will be recruited worldwide. Approximately 4,600 people are expected to enroll in the trial.

"We’re looking for ways that we can prevent recurrence of breast cancer in every patient. IBRANCE appears to be very promising in that regard because it boosted the effect of anti-estrogen treatments in women who already have recurrent, metastatic breast cancer," said Angela DeMichele, MD, MSCE, co-principal investigator for PrECOG, Miller Associate Professor of Breast Cancer Excellence in the Rowan Breast Center and Associate Professor of Medicine and Epidemiology at the Abramson Cancer Center of the University of Pennsylvania.

The scope of the PALLAS trial is global. AFT and the ABCSG have brought together a collaborative group of breast cancer specialists from around the world to team up with Pfizer to form a unique public-private cancer research partnership aimed at bringing more innovative therapies to patients in more efficient ways.

"Collaborations of this kind are crucial to advance the science and general understanding of how we can best treat breast cancer," said Maria Koehler, MD, PhD, vice president of Strategy, Innovation and Collaborations for Pfizer Oncology. "Working together, we will be able to efficiently answer important clinical questions in order to potentially bring IBRANCE to patients with early-stage breast cancer who need the treatment most."

"Pfizer is honored to partner with prominent breast cancer research groups to explore the use of IBRANCE for women and men with HR+/HER2- early-stage breast cancer, which affects millions of patients each year globally. This collaboration allows Pfizer to tap into many of the most respected scientific minds and well-established large global research networks to conduct a large, international Phase 3 trial," said Dr. Mace Rothenberg, senior vice president of Clinical Development and Medical Affairs and chief medical officer for Pfizer Oncology.

Availability

Currently, the new study is open to physicians and medical facilities throughout the U.S. if they are associated with Alliance, NSABP or PrECOG. The study will be available to non-U.S. sites beginning in October through an extended academic core network, including the ABCSG and BIG.

Funding and Sponsorship

Pfizer, the manufacturer of IBRANCE, is providing AFT and ABCSG with funding support for this trial. AFT is sponsoring the trial in the U.S. and ABCSG for all non-U.S. sites.

For questions about this trial, please contact [email protected] links icon.

Oncolytics Biotech® Inc. Announces Completion of Enrollment in Randomized Phase II Non-Small Cell Lung Cancer Study

On August 26, 2015 Oncolytics Biotech Inc. ("Oncolytics") (TSX:ONC, NASDAQ:ONCY) reported that enrollment has been completed in a randomized Phase II study of REOLYSIN in patients with previously treated advanced or metastatic non-small cell lung cancer ("NSCLC") (IND 211) (Press release, Oncolytics Biotech, AUG 26, 2015, View Source [SID:1234507336]). The trial is being sponsored and conducted by the NCIC Clinical Trials Group (NCIC CTG) at Queen’s University in Kingston, Ontario.

"Non-small cell lung cancer continues to present a significant health risk for patients," said Dr. Brad Thompson, President and CEO of Oncolytics. "We would like to thank our colleagues at the NCIC CTG for completing enrolment in this study."

The study is an open-label, randomized, non-blinded, Phase II clinical study of REOLYSIN as a treatment for advanced or metastatic non-small cell lung cancer patients who have received previous chemotherapy. A total of 166 patients were enrolled. Patients with squamous cell histology were randomized to receive either REOLYSIN given in combination with docetaxel (test arm) or docetaxel alone (control arm), while patients with non-squamous cell histology were randomized to receive either REOLYSIN given in combination with pemetrexed (test arm) or pemetrexed alone (control arm).

The primary objective of the trial is to evaluate the effect of REOLYSIN in combination with standard salvage chemotherapy on the progression free survival of patients with advanced or metastatic non-small cell lung cancer. The secondary objectives are to determine the tolerability and toxicity of the therapeutic combination; to investigate additional potential measures of efficacy, including progression rates at three months, objective response rate and overall survival; and to explore potential molecular factors predictive of response.

Although accrual is complete, patient follow-up will continue until planned analyses have been conducted.

About NSCLC
The Canadian Cancer Society estimates that 26,600 Canadians will be diagnosed with lung cancer and that 20,900 Canadians are expected to die from the disease in 2015. The American Cancer Society estimates that 221,200 new cases of lung cancer will be diagnosed in the United States and that 158,040 Americans are expected to die from the disease in 2015. Approximately 80% of all lung cancer cases are of the non-small cell type.

Advaxis Announces Licensing Agreement With Knight Therapeutics and Raises $25 Million Through Direct Investments From Knight and Sectoral Asset Management

On August 26, 2015 Advaxis, Inc. (NASDAQ:ADXS) ("Advaxis" or the "Company"), a clinical-stage biotechnology company developing cancer immunotherapies, reported that the Company has entered into a licensing agreement with Knight Therapeutics Inc. (TSX:GUD) ("Knight"), a Canadian-based specialty pharmaceutical company focused on acquiring, in-licensing, selling and marketing innovative prescription and over-the-counter pharmaceutical products, to commercialize in Canada Advaxis’s product portfolio including its three lead drug candidates: axalimogene filolisbac (ADXS-HPV) for human papilloma virus (HPV)-associated cancers, ADXS-PSA for prostate cancer and ADXS-HER2 for HER2 expressing solid tumors (Press release, Advaxis, AUG 26, 2015, View Source [SID:1234507339]).

In connection with the licensing agreement, Knight is purchasing directly from Advaxis 359,454 shares at $13.91 per share, which represents a 7 percent premium to the price of Advaxis’s common stock at market close on August 25, 2015. In addition, Sectoral Asset Management, a leading Canadian-based global healthcare investment advisor, is purchasing 1,437,815 shares at $13.91 per share directly from Advaxis on behalf of its clients. The combined gross proceeds to Advaxis from these direct investments is $25 million.

"We are extremely gratified to, in one transaction, monetize a non-core market with a well-established local partner, while simultaneously increasing our cash balance under very favorable terms," said Daniel J. O’Connor, President and Chief Executive Officer of Advaxis. "We have added both a key strategic partner in Knight and a top-tier healthcare institutional investor in Sectoral Asset Management. The license agreement with Knight is consistent with our strategy of focusing our resources in our core geographies."

Under the terms of the licensing agreement, Knight will be responsible for all commercial activities related to Advaxis current and future products, including axalimogene filolisbac, ADXS-PSA and ADXS-HER2, in Canada. Advaxis is eligible to receive double digit royalty as well as sales milestones.

"We believe Advaxis’s technology has significant potential to treat a multitude of cancers," said Jonathan Ross Goodman, President and Chief Executive Officer of Knight. "This agreement, as well as our investment in the Company, are representative of our confidence in Advaxis’s future prospects. Upon approval, Knight looks forward to leveraging our local market expertise to maximize the commercial value of axalimogene filolisbac, ADXS-PSA and ADXS-HER2 in Canada."

"Sectoral Asset Management is pleased to make this significant investment in Advaxis on behalf of our clients," said Stephan Patten, Deputy Chief Investment Officer of Sectoral Asset Management. "We believe the Company’s promising Lm Technology cancer immunotherapy platform, robust clinical pipeline and strong management team with a track record of execution combine to establish a compelling value proposition for Advaxis, and look forward to tracking the Company’s progress going forward."

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.

About ADXS-PSA

ADXS-PSA is an Lm Technology immunotherapy designed to target the prostate-specific antigen (PSA) associated with prostate cancer. ADXS-PSA is in clinical development both as a monotherapy and in combination with immune checkpoint inhibitors for the treatment of metastatic castration-resistant prostate cancer (mCRPC).

About ADXS-HER2

ADXS-HER2 is an Lm Technology immunotherapy being developed for the targeted treatment of HER2 expressing cancers. ADXS-HER2 has received orphan drug designation from the U.S. Food and Drug Administration (FDA) for the treatment of osteosarcoma. Advaxis is developing ADXS-HER2 for both human and animal-health, and has seen encouraging data in canine osteosarcoma, which is considered a model for human osteosarcoma. Advaxis licensed ADXS-HER2 and three other immunotherapy constructs to Aratana Therapeutics, Inc. for the development of pet therapeutics.

DelMar Pharmaceuticals to Present at the 17th Annual Rodman & Renshaw Global Investment Conference on September 9, 2015

On August 25, 2015 DelMar Pharmaceuticals, Inc. (OTCQX: DMPI) ("DelMar" and the "Company"), a biopharmaceutical company focused on the development and commercialization of new cancer therapies, reported that it will be presenting at the 17th Annual Rodman & Renshaw Global Investment Conference being held September 9-10, 2015, at the St. Regis Hotel in New York, New York (Press release, DelMar Pharmaceuticals, AUG 25, 2015, http://ir.delmarpharma.com/news/detail/775/delmar-pharmaceuticals-to-present-at-the-17th-annual-rodman-renshaw-global-investment-conference-on-september-9-2015 [SID:1234507331]).

Jeffrey Bacha, DelMar’s president and CEO, will present on Wednesday, September 9, 2015 at 3:50 p.m. Eastern Time. As part of his presentation, Mr. Bacha will present a corporate overview, including recent progress of DelMar’s Phase II clinical trial of VAL-083 (dianhydrogalactitol) for the treatment of refractory glioblastoma multiforme (GBM) and future plans to initiate clinical trials with VAL-083 as a potential treatment for non-small cell lung cancer (NSCLC) and other solid tumors in collaboration with Guangxi Wuzhou Pharmaceutical (Group) Co., Ltd.

The Company presented interim data from its ongoing study in GBM at the American Association of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual meeting confirming the completion of the Phase I dose-escalation portion of the VAL-083 trial and a promising dose-response trend in patients with recurrent GBM: Patients receiving a dose greater than or equal to 30mg/m2 had a median survival of 9.0 months vs. 4.4 months at doses less than 10mg/m2. DelMar also confirmed the initiation of a 14-patient Phase II expansion cohort at a dose of 40mg/m2. The purpose of the Phase II expansion cohort is to gain additional information about the safety and efficacy of VAL-083 at the 40mg/m2 dose prior to advancement into registration-directed Phase II/III clinical trials.

DelMar recently announced that the Company will present the next formal update of its clinical trial in GBM at the 2nd International Symposium on Clinical and Basic Research in Glioblastoma, being held September 9-12, 2015 in Toledo, Spain.

A live webcast of the presentation will be available by accessing the DelMar’s IR Calendar in the Investors section of the Company’s website (www.DelMarPharma.com). A webcast replay will be available approximately two hours after the presentation ends and will be accessible for one month.

About VAL-083
VAL-083 is a "first-in-class", small-molecule chemotherapeutic. In more than 40 Phase I and II clinical studies sponsored by the U.S. National Cancer Institute, VAL-083 demonstrated safety and efficacy in treating a number of cancers including lung, brain, cervical, ovarian tumors and leukemia. VAL-083 is approved in China for the treatment of chronic myelogenous leukemia and lung cancer and has received orphan drug designation in Europe and the U.S. for the treatment of gliomas.

DelMar is currently studying VAL-083 in a multi-center Phase I/II clinical trial for patients with refractory glioblastoma multiforme (GBM) in accordance with the protocol that has been filed with the U.S. Food and Drug Administration (FDA). As a potential treatment for glioblastoma, VAL-083’s mechanism of action appears to be unaffected by the expression of MGMT, a DNA repair enzyme that causes chemotherapy resistance to front-line treatment with Temodar (temozolomide).