On September 7, 2016 Exosome Diagnostics, Inc. reported the launch of its ExoDxProstate(IntelliScore) test (EPI) through the company’s CLIA certified laboratory in Cambridge, Massachusetts. EPI is a laboratory-developed test designed to provide clinicians and patients with information that will improve the prostate biopsy decision-making process. EPI is the first test using specific genetic information captured from a simple urine sample to provide physicians with a score to help evaluate their patient’s risk for high grade, potentially more aggressive prostate cancer.

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In the United States each year, approximately one million prostate biopsies are performed with up to 80 percent of the results indicating no cancer, or a low-grade cancer that could instead be monitored under a watchful waiting or active surveillance program. The EPI test was designed to reduce the number of unnecessary prostate biopsies and the associated overtreatment of low-grade disease. Complications associated with unnecessary prostate tissue biopsies range from discomfort and temporary incontinence or impotence, to hospitalization for serious infections in three to four percent of patients.

"Prostate cancer is really a spectrum of disease. Not all patients have the same type of tumor or the same grade of disease," stated Peter Carroll M.D., chair of urology at the University of California, San Francisco and an investigator in the EPI clinical validation trial. "Very few men need immediate treatment. Repeat PSA testing, PSA/protein based diagnostic tests, MRI scans and now molecular genetic testing with EPI will provide important data to help clinicians, patients and their families make better informed decisions about whether to proceed with an initial prostate biopsy. This test launch marks an important step forward in efforts to develop more sensitive markers for assessing the risk of aggressive prostate cancer and the ability to monitor disease progression in a completely non-invasive approach."

The scientists and clinicians at Exosome Diagnostics developed this innovative test with input from the Prostate Cancer Foundation, urologists, patients and insurance providers. The EPI test uses a simple urine catch without a digital rectal exam, making it completely non-invasive for the patient and easy to integrate into patient care. The EPI test utilizes a three-gene signature, in combination with a proprietary algorithm. The score generated is simple for physicians to understand and discuss with their patients. The EPI test is unique from other tests in this space because it is a stand-alone diagnostic, as it does not take into account other standard of care parameters in the score thus making it a powerful complement to the existing PSA test.

A final clinical evaluation study enrolled over 1,500 patients through collaborations with 26 leading urology centers across the United States. Results from the study demonstrated that the EPI test was highly accurate for ruling out the presence of high-grade cancer (Gleason score seven or higher) prior to an initial prostate biopsy. The data from this blinded, prospective U.S. clinical validation study were published in JAMA Oncology in March 2016.

"Molecular and genetic testing are improving the quality of cancer care and patient outcomes. We are excited to provide this first-of-its-kind test to men at risk for prostate cancer," said Tom McLain, Chief Operating Officer of Exosome Diagnostics. "Using our patented technology to analyze the RNA released by prostate cancer cells, we provide a simple score to help evaluate the patient’s risk for high-grade prostate cancer. This will better inform clinicians and patients and help to clarify the decision process surrounding prostate biopsy."

EPI is one test in a portfolio of diagnostic and companion diagnostic tests being developed and launched by the company. "Today’s announcement provides another demonstration of the value of Exosome Diagnostics’ platform combining patented, leading isolation methodologies, ancillary technologies to increase the signal over the noise, tissue specific exosome identification methodologies, and proprietary algorithms to develop sensitive diagnostic assays and accelerate the development of companion diagnostics," said John Boyce, President and CEO of Exosome Diagnostics. "Our tests are unique in the liquid biopsy space. By combining the information about disease from exosomes and cell-free DNA captured from any biofluid sample, we are able to achieve the clinical and analytical performance needed for liquid biopsy tests to provide clinicians with real-time, patient specific information that can be used to improve care, select the right therapy, avoid unnecessary procedures and lower overall healthcare costs."

About the EPI Test
The EPI test is a completely non-invasive, urine-based test designed to be used along with clinical assessment and other standard of care factors (including age, race and family history) to enable physicians to assess whether an individual patient presenting for an initial biopsy is at greater risk for high-grade prostate cancer. As a "rule out" test, it is designed to more accurately predict whether a patient presenting for an initial biopsy does not have high-grade prostate cancer and, thus, could potentially avoid the discomfort, complications and cost of an initial biopsy and, instead, continue to be monitored. EPI, which is intended for use in men 50 years or older with a prostate-specific antigen (PSA) result of 2-10ng/mL presenting for an initial biopsy, involves patients submitting a simple urine sample, without having to first undergo a digital rectal exam (DRE).

The EPI test analyzes the urine for three biomarkers on exosomal RNA (exoRNA) that are expressed in men with high-grade prostate cancer. Using a proprietary algorithm that combines the relative weighted expression of the three-gene signature, the test assigns an individual risk score for patients ranging from zero to 100. Scores above a pre-defined cut point are associated with an increased likelihood of high-grade prostate cancer on a subsequent biopsy.

This test was evaluated and its performance characteristics determined by Exosome Diagnostics Inc. It has not been cleared or approved by the U.S. Food and Drug Administration (FDA). The FDA has determined that such clearance or approval is not necessary. Exosome Diagnostics is certified under the Clinical Laboratory Improvement Amendments (CLIA) act of 1988 as qualified to perform high complexity clinical testing.

On September 7, 2016 Fate Therapeutics, Inc. (NASDAQ:FATE), a biopharmaceutical company dedicated to the development of programmed cellular immunotherapies for cancer and immune disorders, reported a partnership with Memorial Sloan Kettering Cancer Center for the development of off-the-shelf T-cell product candidates using engineered pluripotent cell lines (Press release, Fate Therapeutics, SEP 7, 2016, View Source [SID:1234515009]). Research and development activities under the multi-year collaboration will be led by Michel Sadelain, M.D., Ph.D., Director of the Center for Cell Engineering and the Stephen and Barbara Friedman Chair at Memorial Sloan Kettering Cancer Center.

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"This partnership brings together Memorial Sloan Kettering’s excellence in the manufacture and delivery of cell-based immunotherapies, and our established expertise in pluripotent cell generation, engineering and differentiation," said Scott Wolchko, President and Chief Executive Officer of Fate Therapeutics. "Together, we are at the forefront of an off-the-shelf paradigm shift, seeking to broaden patient access to revolutionary T-cell immunotherapies through a renewable, robust and standardized product approach."

"Engineering therapeutic attributes into pluripotent cell lines, such as antigen specificity, lack of alloreactivity, enhanced persistence and histocompatibility, is a breakthrough approach to renewably generate potent T-cell immunotherapies," said Dr. Sadelain. "This unique approach offers the prospect for off-the-shelf delivery of T-cell immunotherapies with enhanced safety and therapeutic potential at the scale necessary to serve significant numbers of patients."

The collaboration unites research, preclinical development and manufacturing work currently being conducted independently at Fate Therapeutics and Memorial Sloan Kettering to accelerate the clinical translation of T-cell product candidates derived from engineered pluripotent cells. Collectively, the groups have amassed significant and complementary expertise necessary to deliver off-the-shelf T-cell immunotherapies, including the engineering, maintenance and expansion of induced pluripotent cell lines and the scalable generation of T cells with enhanced safety profiles and effector functions.

In connection with the partnership, Fate Therapeutics has exclusively licensed from Memorial Sloan Kettering foundational intellectual property covering induced pluripotent cell-derived immune cells, including T cells and NK cells derived from pluripotent cells engineered with chimeric antigen receptors, for human therapeutic use. Additionally, Fate Therapeutics maintains an option to exclusively license intellectual property arising from all research and development activities under the collaboration.

Off-the-Shelf Immunotherapy Opportunity
Cellular immunotherapies are poised to transform the treatment of cancer and immunological conditions. However, cellular immunotherapies currently undergoing clinical investigation are patient-specific and their delivery requires the extraction, engineering, expansion and re-introduction of each individual patient’s T cells. This multi-step manufacturing process is logistically challenging and complex, and significant hurdles remain to ensure that patient-specific T-cell immunotherapies can be efficiently and consistently manufactured, and safely and reliably delivered, at the scale necessary to support broad patient access and wide-spread commercialization.

Induced pluripotent cells possess the unique dual properties of self-renewal and differentiation potential into all cell types of the body including T cells. Similar to master cell lines used for the manufacture of monoclonal antibodies, engineered pluripotent cell lines can repeatedly deliver clonal populations of T cells with broad histocompatibility and enhanced effector functions. These highly-stable pluripotent cell lines have the potential to serve as a renewable cell source for the consistent manufacture of homogeneous populations of effector cells for the treatment of many thousands of patients.

Exclusive License & Development Plan
Through the three-year collaboration, the group aims to leapfrog the field’s current patient-specific approach to T-cell immunotherapy. Over the last decade, Fate Therapeutics has developed a proprietary, patent-protected platform to efficiently generate, genetically engineer, isolate and bank pluripotent cell lines. Memorial Sloan Kettering is leading the field in generating pluripotent cell-derived, tumor-targeting T cells that are capable of profound tumor clearance in vivo. The scientific teams will combine forces to create pluripotent cell lines that have been engineered for enhanced antigen specificity and functionality, optimize T-cell differentiation protocols, and clinically translate off-the-shelf engineered T-cell product candidates.

New Subsidiary Formed
Fate Therapeutics has also launched a new venture company, Tfinity Therapeutics, Inc., which will focus exclusively on the advancement of off-the-shelf T-cell immunotherapies across a wide range of diseases using Fate’s proprietary, patent-protected pluripotent cell platform. Fate Therapeutics has an intellectual property portfolio consisting of over 60 issued patents and 90 pending patent applications, which are owned or exclusively licensed by Fate Therapeutics, that cover compositions and methods critical for deriving, engineering, maintaining and differentiating induced pluripotent cells. Tfinity Therapeutics is a majority-owned subsidiary of Fate Therapeutics, and holds an option to license from Fate Therapeutics intellectual property covering pluripotent cell-derived T-cell immunotherapies.

On September 6, 2016 Valeant Pharmaceuticals International, Inc. (NYSE: VRX and TSX: VRX) ("Valeant") and Progenics Pharmaceuticals, Inc. (Nasdaq: PGNX) ("Progenics") reported the U.S. commercial launch of RELISTOR (methylnaltrexone bromide) Tablets, which is now available for prescribing. RELISTOR Tablets (450 mg once daily) were approved by the U.S. Food and Drug Administration (FDA) for the treatment of opioid-induced constipation (OIC) in adults with chronic non-cancer pain on July 19, 2016.

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"We are very pleased to launch RELISTOR Tablets in the U.S. and provide an exceptional new treatment option for the millions of patients who suffer from extreme discomfort due to OIC," said Joseph C. Papa, Chief Executive Officer of Valeant. "This new method of delivery for RELISTOR offers healthcare professionals a novel alternative to address the treatment of OIC – a growing need in pain management – and demonstrates Valeant’s continued commitment to delivering innovative products that improve people’s lives."

In addition, RELISTOR Tablets will be highlighted during poster presentations at PAINWeek, the largest U.S. pain conference for frontline clinicians, in Las Vegas, Nevada, from September 6-10. The posters will include the following:
Webster LR, Harper JR, Israel RJ. "Oral methylnaltrexone is efficacious and well tolerated for the treatment of opioid-induced constipation in patients with chronic noncancer pain taking concomitant methadone." PAINWeek Poster, public viewing begins on
Thursday, September 8 at 12:30 p.m. PT.

Webster LR, Harper JR, Israel RJ. "Oral methylnaltrexone does not negatively impact analgesia in patients with opioid-induced constipation and chronic noncancer pain." PAINWeek Poster, public viewing begins on Thursday, September 8 at 12:30 p.m. PT.
The RELISTOR Tablets data will also be presented by Steven Simon, M.D., Professor of Pathology, University of Miami Health System, during a product theatre, "Opioid-Induced Constipation When Reliable and Rapid Relief Matters," on Friday, September 9 at 8 a.m. PT.

Important Safety Information about RELISTOR
RELISTOR (methylnaltrexone bromide) Tablets are contraindicated in patients with known or suspected gastrointestinal obstruction and patients at increased risk of recurrent obstruction, due to the potential for gastrointestinal perforation.
Cases of gastrointestinal perforation have been reported in adult patients with OIC and advanced illness with conditions that may be associated with localized or diffuse reduction of structural integrity in the wall of the gastrointestinal tract (e.g., peptic ulcer disease, Ogilvie’s syndrome, diverticular disease, infiltrative gastrointestinal tract malignancies or peritoneal metastases). Take into account the overall risk-benefit profile when using RELISTOR in patients with these conditions or other conditions which might result in impaired integrity of the gastrointestinal tract wall (e.g., Crohn’s disease). Monitor for the development of severe, persistent, or worsening abdominal pain; discontinue RELISTOR in patients who develop this symptom.

If severe or persistent diarrhea occurs during treatment, advise patients to discontinue therapy with RELISTOR and consult their healthcare provider.

Symptoms consistent with opioid withdrawal, including hyperhidrosis, chills, diarrhea, abdominal pain, anxiety, and yawning have occurred in patients treated with RELISTOR.

Patients having disruptions to the blood-brain barrier may be at increased risk for opioid withdrawal and/or reduced analgesia. Take into account the overall risk-benefit profile when using RELISTOR in such patients. Monitor for adequacy of analgesia and symptoms of opioid withdrawal in such patients.

Avoid concomitant use of RELISTOR with other opioid antagonists because of the potential for additive effects of opioid receptor antagonism and increased risk of opioid withdrawal.

The most common adverse reactions (≥ 12%) in adult patients with opioid-induced constipation and chronic non-cancer pain receiving RELISTOR tablets were abdominal pain, diarrhea, headaches, abdominal distention, hyperhidrosis, anxiety, muscle spasms, rhinorrhea, and chills. Adverse reactions of abdominal pain, diarrhea, hyperhidrosis, anxiety, rhinorrhea, and chills may reflect symptoms of opioid withdrawal.

Please see complete Prescribing Information for RELISTOR at www.valeant.com. For more information about RELISTOR, please visit www.relistor.com.

About RELISTOR
Progenics has exclusively licensed development and commercialization rights for its first commercial product, RELISTOR, to Valeant. RELISTOR Tablets (450 mg once daily) is approved in the United States for the treatment of OIC in patients with chronic non-cancer pain. RELISTOR Subcutaneous Injection (12 mg and 8 mg) is a treatment for opioid-induced constipation approved in the United States and worldwide for patients with advanced illness and chronic non-cancer pain.

On September 6, 2016 (GLOBE NEWSWIRE) Cyclacel Pharmaceuticals, Inc. (Nasdaq:CYCC) (Nasdaq:CYCCP) ("Cyclacel" or the "Company"), a biopharmaceutical company developing oral therapies that target various phases of cell cycle control for the treatment of cancer and other serious disorders, reported the presentation of preclinical data demonstrating that both Cyclacel’s CYC065, a clinical stage, second generation, cyclin-dependent kinase CDK2/9 inhibitor, and CCT68127, a preclinical stage CDK2/9 inhibitor, prolong survival in MYCN-addicted neuroblastoma models (Press release, Cyclacel, SEP 6, 2016, View Source [SID:1234514936]). The data were presented at the Childhood Cancer Meeting, September 5 — 7th in London, UK.

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"This study adds to the growing evidence of the value of CDK inhibition as an approach to treating cancer. MYCN is an important therapeutic target in oncology and a major oncogenic driver of neuroblastoma, a childhood cancer. There are no approved drugs that act against MYCN or MYC proteins," said Spiro Rombotis, President and Chief Executive Officer of Cyclacel. "We are encouraged by the preclinical data, which extend and support earlier findings, showing that CYC065 and CCT68127 reduce MYCN transcription and protein levels and have antitumor activity in neuroblastoma models. Additionally, we have demonstrated in other preclinical studies, that our transcriptional CDK2/9 inhibitors target key molecular features of cancers with poor prognosis, such as MLL-r leukemias or MYC-driven lymphomas. Furthermore, evidence from early clinical trials show that CDK2/9 inhibitors can have a synergistic effect with other anticancer agents. We look forward to reporting data from our ongoing Phase 1 study of CYC065 in patients with solid tumors."

In this preclinical study, an international group of researchers led by Prof. Louis Chesler from The Institute of Cancer Research, London, explored in vitro and in vivo the sensitivity of neuroblastoma cells to CYC065 and CCT68127. Neuroblastoma cells with MYCN amplification and overexpression were found to be particularly sensitive to both CDK2/9 inhibitors. The mechanism of action of CYC065 and CCT68127 included inhibition of MYCN transcription, downregulation of N-MYC protein, blocking neuroblastoma cell proliferation and induction of apoptosis. Treatment with either CYC065 or CCT68127 significantly reduced tumor burden and prolonged survival in several neuroblastoma models in vivo.

Citation

Poon E, Jamin Y, Walz S, Hakkert S, Kwok C, Hallsworth A, Thway K, Barker K, Sbirkov Y, Pickard L, Urban Z, Tardif N, Webber H, Box G, Valenti M, De Haven Brandon A, Petrie K, Ebus M, Molenaar J, Eccles S, Robinson SP, Zheleva D, Eilers M, Workman P, Chesler L. The small molecule CDK2 and CDK9 inhibitors CYC065 and CCT68127 are potent inhibitors of MYCN via transcriptional repression. Childhood Cancer Meeting 2016, September 5 — 7th, London, UK, Abs. 1-19.

About MYCN

The MYCN gene encodes a transcription factor that is expressed in fetal brain and neural crest and is critical for normal development of the brain and nerves. The MYCN oncogene is over-expressed in a number of different types of cancer, most notably neuroblastoma, and also rhabdomyosarcoma, medulloblastoma, astrocytoma, Wilms’ tumor and small cell lung cancer. Amplification of the MYCN oncogene is the most common genomic alteration in aggressive neuroblastomas and is associated with poor clinical outcome. There are no approved drugs that directly target MYCN prompting the investigation of indirect approaches such as exploitation of a synthetic lethal relationship between MYCN amplification/overexpression and inhibition of CDK2.

About Neuroblastoma

According to the American Cancer Society, neuroblastoma is the most common cancer in infants less than one year old and it accounts for about six percent of all pediatric cancers or about 700 cases per year. The disease has a fatal outcome in one out of every seven children diagnosed with it. Preclinical data from an international investigator group demonstrated that Cyclacel’s CYC065 and CCT68127 target MYCN gene expression and have potent in vitro and in vivo anti-tumor activities, suggesting therapeutic potential in neuroblastoma, including high-risk patients with MYCN amplification.

About CYC065

CYC065 is a highly-selective, orally- and intravenously-available, second generation inhibitor of CDK2 and CDK9 and causes apoptotic death of cancer cells at sub-micromolar concentrations. Antitumor efficacy has been achieved in vivo with once a day oral dosing at well tolerated doses. Evidence from published nonclinical studies show that CYC065 may benefit patients with adult and pediatric hematological malignancies, including certain Acute Myeloid Leukemias (AML), Acute Lymphocytic Leukemias (ALL), Chronic Lymphocytic Leukemias (CLL), B-cell lymphomas, multiple myelomas, and certain solid tumors, including breast and uterine cancers. Independent investigators published nonclinical evidence that CYC065 induced regression or tumor growth inhibition in a model of HER2-positive breast cancer addicted to cyclin E that is resistant to trastuzumab, reduced tumor growth in models of CCNE1-amplified uterine serous carcinoma and reduced tumor burden and prolonged survival in several neuroblastoma models in vivo.

CYC065 is mechanistically similar but has much higher dose potency, in vitro and in vivo, improved metabolic stability and longer patent protection than seliciclib, Cyclacel’s first generation CDK inhibitor. Translational biology data support development of CYC065 as a stratified medicine for solid and liquid cancers. CYC065 has been shown to reverse drug resistance associated with the addiction of cancer cells to cyclin E and may inhibit CDK9-dependent oncogenic and leukemogenic pathways, including malignancies driven by certain oncogenes and mixed lineage leukemia rearrangements (MLL-r). CYC065 causes prolonged down regulation of the Mcl-1-mediated pro-survival pathway in cancer cells.

On September 6, 2016 Peregrine Pharmaceuticals, Inc. (NASDAQ:PPHM) (NASDAQ:PPHMP), a biopharmaceutical company committed to improving patient lives by manufacturing high quality products for biotechnology and pharmaceutical companies and advancing its proprietary R&D pipeline, reported that the National Comprehensive Cancer Network (NCCN) Oncology Research Program (ORP) has awarded three grants to investigators to support research of bavituximab in combination with other therapeutics for the treatment of glioblastoma, head and neck cancer, and hepatocellular carcinoma (Press release, Peregrine Pharmaceuticals, SEP 6, 2016, View Source [SID:1234514951]).

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NCCN, a not-for-profit alliance of 27 of the world’s leading cancer centers devoted to patient care, research, and education, is dedicated to improving the quality, effectiveness, and efficiency of cancer care so that patients can live better lives. Funding for the three investigator-initiated clinical studies will take place through a $2 million research grant made by Peregrine to NCCN’s ORP. NCCN will be responsible for oversight and monitoring of the clinical studies through the research grant. It is expected that the selected trials will be initiated in early 2017.
"NCCN is excited to initiate three studies by accomplished investigators at NCCN Member Institutions that will explore the effect of this novel immunotherapy in three different cancers with significant unmet need," said Robert C. Young, MD, Interim Vice President, NCCN ORP.
The following NCCN-affiliated researchers were recipients of the grant awards:
Jessica Frakes, MD, Moffitt Cancer Center, "A Phase I Trial of Sorafenib and Bavituximab Plus Stereotactic Body Radiation Therapy (SBRT) for Unresectable Hepatitis C Associated Hepatocellular Carcinoma"

Elizabeth Gerstner, MD, Massachusetts General Hospital Cancer Center, "Phase I/II Clinical Trial of Bavituximab with Radiation and Temozolomide for Patients with Newly Diagnosed Glioblastoma"

Ranee Mehra, MD, The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, "Phase II Study of Pembrolizumab and Bavituximab for Progressive Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck"
"Our collaboration with NCCN provides the unique opportunity to support the group’s highly-regarded research institutions and advance our understanding of the potential role of bavituximab in the treatment of various cancers. With this in mind, we were very pleased by the level of interest shown in bavituximab from the NCCN community and are grateful to all those who submitted their projects for rigorous evaluation by the ORP scientific review committee," said Joseph Shan, MPH, vice president, clinical and regulatory affairs of Peregrine. "We’d like to extend our congratulations to the three investigators who were selected for their unique and innovative concepts. These studies align with our development strategy for bavituximab which is currently focused on small, early stage clinical trials evaluating the drug in combination with other cancer treatments. Collaborators such as NCCN play a central role in this strategy and we look forward to integrating the valuable clinical data generated by these investigators to expand our knowledge regarding bavituximab-focused cancer treatment combinations."
Bavituximab is an investigational chimeric monoclonal antibody that targets phosphatidylserine (PS). Signals from PS inhibit the ability of immune cells to recognize and fight tumors. Bavituximab is believed to override PS mediated immunosuppressive signaling by blocking the engagement of PS with its receptors as well as by sending an alternate immune activating signal. PS targeting antibodies have been shown to shift the functions of immune cells in tumors, resulting in multiple signs of immune activation and anti-tumor immune responses.