On October 18, 2016 Athenex reported that its development partner for KX-02, Xiangxue Pharmaceuticals Company Limited, has publicized that the Guangdong Province Food and Drug Administration (FDA) declared completion of the Investigational New Drug (IND) application for KX-02 active pharmaceutical ingredient and KX-02 Tablet and referred the IND to the Center of Drug Evaluation (CDE) of China FDA for review (Press release, Athenex, OCT 18, 2016, View Source [SID1234525097]). The IND application to the Chinese FDA was submitted jointly by Xiangxue New Drug Development Company Limited, Xiangxue Pharmaceuticals Limited, and Hangzhou Converd Co., Ltd.

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The Guangdong Province FDA has determined, after their inspection of the factory and initial review of the IND submission, that it is complete and was referred to the Center of Drug Evaluation (CDE) of China FDA for review. This IND application has been assigned the application number CXHL1600187.

In 2012, Athenex and Xiangxue Pharmaceuticals announced the execution of a license agreement granting Xiangxue Pharmaceuticals exclusive rights to KX-02, for all oncology indications, in the greater China territory (China, Hong Kong, Taiwan) and Singapore.

KX-02, a novel lipophilic dual Src/pretubulin inhibitor, was discovered and developed by Athenex through their internal research and development efforts. It is a small molecule that has shown potent inhibitory activity against a broad panel of brain tumor cell lines, including cells (T98G) that are resistant to Temodar, the most widely used chemotherapy for the treatment of malignant glioma. In a well-established brain tumor animal model, KX-02 has been shown to consistently clear brain tumors after 4 weeks of therapy in 30-60% of treated animals. Pharmacokinetic studies showed that KX-02 is absorbed orally and has 76% penetration to brain tissue from plasma.

KX-02 is already in Phase 1 study in the US and has been assigned "Orphan Drug" status by the US FDA. Preclinical studies have shown that KX-02 showed excellent brain penetration and promising anti-tumor activities in mouse brain tumor models. A proportion of rodents cleared the tumor after 6 weeks of oral KX-02 treatment.

On October 18, 2016 Celgene Corporation (NASDAQ: CELG) and Sage Bionetworks reported a collaboration to develop an iPhone application utilizing the Apple ResearchKit framework to improve the understanding of the burden of disease for patients living with chronic anemia due to myelodysplastic syndromes (MDS) or beta-thalassemia (Press release, Celgene, OCT 18, 2016, View Source [SID1234515895]).

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Smartphone-based apps like Sage Bionetworks’ mPower for Parkinson’s disease are increasingly being utilized as a tool by clinical study researchers to collect and analyze increasing volumes of patient-reported data in order to better capture and understand disease burden better and to improve therapeutic developments. Smartphone clinical study apps also enable the return communication of important study information to the patient participants.

"We stand at a point where technology is unlocking the ability to capture patient reported outcomes," said Michael Pehl, President, Hematology & Oncology for Celgene. "Through our collaboration with Sage Bionetworks and the evolving capability of smartphones and wearables as robust data collection devices, we believe we will be able to provide important new insights for patients with MDS and beta-thalassemia. We are pleased to be working alongside Sage Bionetworks and the patient community on this important project."

Celgene and Sage Bionetworks have chosen to address chronic anemia caused by myelodysplastic syndromes and beta-thalassemia. These diseases impose a great burden on affected individuals that is difficult to understand and quantify, and typically have clinical endpoints outside traditional measures. The collaboration seeks to move to a paradigm where this and other information like physiological testing are collected on a multi-dimensional and regular basis.

Already a leader in MDS, Celgene is currently developing three assets in the clinic across myelodysplastic syndromes and beta-thalassemia (CC-486, luspatercept, and enasidenib (AG-221/CC-90007)).

In addition to helping collect difficult to quantify data, the new mobile study will collect neurological assessments of patients using cognitive testing software from BrainBaseline, a leading technology for the self-assessment of cognitive performance. The app will also be an important channel for two-way communication and support for patients living with their disease – allowing them to understand their physical functioning and other symptoms of anemia.

Dr. Lara Mangravite, President of Sage Bionetworks stated, "We are thrilled to partner with Celgene to explore the use of sensor-based technologies to quantify the daily burden of disease in patients with chronic anemia. This is a first of its kind exploration from which we hope to gain insights that can be used to understand the impact of chronic anemia."

Celgene and Sage Bionetworks are working closely with the MDS Foundation (www.mds-foundation.org) and Cooleys Anemia Foundation (www.thalassemai.org) in defining the right elements for capture in the application to ensure patient relevance and applicability.

On October 18, 2016 NanoString Technologies, Inc. (NASDAQ:NSTG), a provider of life science tools for translational research and molecular diagnostic products, reported the commercial launch of two new translational research assays in the company’s Vantage 3D product line at the American Society of Human Genetics (ASHG) Annual Meeting in Vancouver Canada:

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nCounter Vantage 3D DNA (SNV) Solid Tumor Panel
nCounter Vantage 3D Protein Solid Tumor Signaling Pathways Panel

The two new panels can be combined with one another as well as with the nCounter Vantage RNA Panels to enable more comprehensive profiling of formalin-fixed, paraffin-embedded (FFPE) tumor tissue (Press release, NanoString Technologies, OCT 18, 2016, View Source [SID1234515900]). The nCounter Vantage 3D Solid Tumor portfolio provides a deeper understanding of genotype and phenotype in various solid tumor cancers by enabling multiplexed, digital analysis of combinations of DNA, RNA, fusion genes, proteins and phospho-proteins simultaneously in a single experiment. Researchers now have the ability to extract more biological information from the limited tissue available from each sample using just two FFPE slides. Designed for flexibility, the nCounter Vantage 3D Solid Tumor portfolio provides new ways for cancer researchers to apply 3D Biology technology.

The nCounter Vantage 3D Protein Solid Tumor Signaling Pathways Panel enables the identification of activation state through the measurement of total proteins and phospho-proteins from a single slice of FFPE tissue or from as little as 250 ng of protein from cell or tissue lysate. The protein solid tumor panel can be used in combination with nCounter Vantage 3D DNA Panels and nCounter Vantage 3D RNA Panels, or in combination with the 770 gene PanCancer Pathways Panel to provide comprehensive solid tumor profiling.

"Simultaneous measurement of DNA, RNA and proteins could change how we assess and treat cancer," said Gordon B. Mills M.D. Ph.D., Professor and Chair of Systems Biology at MD Anderson Cancer Center. "This new 3D Biology platform allows for an efficient approach to overcome this hurdle, and the identification of new biomarkers and signatures from a single platform could provide key clinical insights that can lead to a more personalized approach to medicine. Importantly, this platform could rapidly move to the clinic, directly benefitting patients."

"Identifying clinically actionable mutations that can be correlated with unique signatures and cell response is key to our biomarker discovery and signature development," said E. Aubrey Thompson, Ph.D., Professor of Cancer Biology, Mayo Clinic. "In the past we would have had to run multiple assays to answer our research question. Now we can run a single analysis, saving time and precious FFPE samples."

Many experiments involve measurements of DNA, RNA, and protein to determine the biological impact and correlation of genotypic and phenotypic changes. Traditionally, the analysis of all three biomolecules typically requires three separate platforms. This traditional approach has two important limitations: inefficient use of small samples and data compatibility challenges from using multiple platforms which creates uncertainty in determining whether discrepancies are due to biological factors or errors in measurement. The nCounter Vantage 3D Solid Tumor portfolio enables the simultaneous measurement of DNA, RNA and protein, addressing previous limitations.

The new products expand the portfolio of 3D Biology panels for analyzing solid tumors and FFPE tissue. The nCounter Vantage 3D DNA (SNV) Solid Tumor Panel is designed for highly multiplexed profiling of known cancer mutations, as well as insertions and deletions (INDELs) from as little as 5 nanograms of DNA.

NanoString will host a workshop at ASH (Free ASH Whitepaper)G where collaborators from MD Anderson Cancer Center and Fred Hutchinson Cancer Research Center will present data that demonstrate the robustness and sensitivity of the assay across a wide range of FFPE samples. The presentation, "3D Biology: Simultaneous Single-Molecule Quantification of DNA (SNVs), mRNA, Fusion Genes and Proteins Using Molecular Barcodes," will be held in Room 10 of the East Building, on Wednesday, October 19th from 1:00-2:30pm Pacific Time.

These new product launches demonstrate NanoString’s continued commitment to expanding the boundaries of biological research through 3D Biology. At the 2016 ASH (Free ASH Whitepaper)G Annual Meeting in Vancouver, British Columbia, NanoString will showcase nCounter Vantage 3D Solid Tumor capabilities at booth #512.

On October 17, 2016 Spherix Incorporated (Nasdaq: SPEX) an intellectual property development company committed to the fostering of technology and monetization of intellectual property, reported an update on its active patent infringement lawsuits, new lawsuits filed, and spending reduction initiatives (Press release, Spherix, OCT 17, 2016, View Source [SID1234538994]).

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Anthony Hayes, Chief Executive Officer of Spherix, stated, "Spherix is now in the best position to deliver shareholder value from its patent portfolio than at any time in the past. In the last six months, we’ve effectuated ten new patent infringement lawsuits against defendants with a combined market capitalization of approximately $48 billion. There are more suits on file now than at any time in the last four years. And while most of these suits are recently filed, we are working with our partner Equitable IP to reach fair and equitable settlements with any licensee. Copies of all ten complaints can be viewed on our website, (www.spherix.com). We anticipate additional suits will be filed before year end. I am increasingly encouraged with our strategic position and confident in our ability to create sustainable shareholder value, even as our stock continues to be valued at less than the Company’s net tangible book value."

The following is a list of our key initiatives:

Through our relationship with Equitable IP, we have commenced litigation against:
ATN International, Inc. Commnet Wireless, LLC Choice Communications LLC, and Choice Communications, LLC ("Choice Wireless"), case number: 1:16-cv-00718-RGA, in the U.S. District Court for the District of Delaware, related to alleged infringement of the ‘999 patent.
Cincinnati Bell, Inc., case number 1:16-cv-00715-RGA, in the U.S. District Court for the District of Delaware, related to alleged infringement of the ‘999 patent, ‘461 patent, and the ‘167 patent.
Echostar Corporation, case number 1:16-cv-00716-RGA, in the U.S. District Court for the District of Delaware, related to alleged infringement of the ‘999 patent.
Frontier Communications Corporation, case number 1:16-cv-00714-RGA, in the U.S. District Court for the District of Delaware, related to alleged infringement of the ‘999 patent.
Sprint Corporation and Clearwire Corporation case number 1:16-cv-00719-RGA, in the U.S. District Court for the District of Delaware, related to alleged infringement of the ‘999 patent.
Fortinet Inc., case number 1:16-cv-00795-RGA, in the U.S. District Court for the District of Delaware, related to alleged infringement of the ‘999 patent.
ViaSat, Inc., case number 1:16-cv-00720-RGA, in the U.S. District Court for the District of Delaware, related to alleged infringement of the ‘999 patent.
DragonWave Inc. and DragonWave Corp, case number 1:16-cv-00797-RGA, in the U.S. District Court for the District of Delaware, related to alleged infringement of the ‘999 patent.
Fortinet, Inc, case number 1:16-cv-00795-RGA, in the U.S. District Court for the District of Delaware, related to alleged infringement of the ‘999 patent.
GTT Communications, Inc., case number 1:16-cv-00796-RGA, in the U.S. District Court for the District of Delaware, related to alleged infringement of the ‘999 patent.
The Company’s Federal Circuit appeal against Uniden continues to proceed. The Uniden case has now been fully briefed and oral argument is expected to be calendared in the next several weeks. Oral argument in such appeals is usually calendared within two months of the submission of the Joint Appendix of the record, which was completed on October 5, 2016. The oral argument hearing usually occurs within five to six months of the submission of the Joint Appendix.
Spherix management is confident in its position that the Patent Trial and Appeals Board erred and that the Board’s Decision invalidating Spherix’s patent-in-suit should be reversed. As stated in the briefing, the Board failed to comply with the Administrative Procedure Act and its conclusion is not supported by the evidence. The Board also applied the wrong patent claim construction, requiring a reversal of its obviousness finding. Management looks forward to discussing its position with the Court during the upcoming oral argument and setting the record straight so that this case can move forward.
Mr. Hayes continued, "In addition to the strong progress we have made towards generating revenue, we have taken meaningful steps to reduce overhead and decrease our monthly cash burn. We have delivered sequential reductions in our overhead expenses in each of our last two quarters and expect this trend to continue as we work to refine our cost structure to an appropriate level consistent with providing the company with ample runway to achieving success. With costs on the decline and more than $7 million in unencumbered cash, we have the staying power to drive shareholder value."

"We understand that each of our cases may widely vary with respect to its size, scope and complexity," concluded Mr. Hayes. "However, there is one feature that tends to remain consistent. The patent enforcement process is often long and requires tremendous patience. To that end we want to thank our committed shareholders for their patience and long term focus. Our multimillion dollar settlement with RPX this past May is emblematic of the rewards that we can enjoy from our hard work and dedication simply by staying the course. As we move forward, we are constantly looking for ways to further creating value."

On October 17, 2016 Accurexa Inc. ("Accurexa") (ACXA), a biotechnology company focused on the development of novel neurological therapies to be directly delivered into the brain reported a collaboration with StemImmune Inc. ("StemImmune") to develop its stem cell-mediated immunotherapy for the treatment of cancer, such as brain cancer (Press release, Accurexa, OCT 17, 2016, View Source [SID1234516525]). StemImmune’s immunotherapy uses the stealth anti-cancer payload carrying and tumor seeking capacities of a patient’s own readily available (adult) stem cells to target cancer. The patient’s immune system cannot recognize and react to the "Trojan Horse" stem cells, because they are the patient’s own. To date, StemImmune has treated 25 cancer patients with its proprietary technology in a Phase 1 clinical trial that showed that its stem cell-mediated immunotherapy was safe and well-tolerated with no adverse events reported, and demonstrated potential anti-tumor activity which supports further investigation in clinical trials. All patients received treatment through a minimally invasive outpatient procedure.

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"We are excited to collaborate with StemImmune and to use stem cells for the delivery of immunotherapies. Stem cells have the capacity to home to tumors, and efficiently carry proprietary anti-cancer payloads directly to cancer cells, while mobilizing the patient’s immune system to recognize and fight the cancer. This approach is in line with the mission of Accurexa to directly deliver therapies to targeted areas in the treatment of cancer and other disorders, and adds a clinical-stage oncology program to our pipeline," said George Yu, MD, President & CEO of Accurexa.

"Eradicating cancer and giving patients the ability to undergo lifesaving treatment with no debilitating side effects is what drives our research. Combining our patented technology with Accurexa’s proprietary methods of delivering targeted therapies to specific areas of the brain makes Accurexa a valuable partner for us as we pursue the eradication of cancer," said Aladar Szalay, PhD, Founder, CEO and Chairman of StemImmune. "We look forward to a long and productive relationship with Accurexa."