On June 29, 2016 Foundation Medicine, Inc. (NASDAQ:FMI) reported that the company will release approximately 18,000 genomic profiles of adult cancers from its FoundationCORE knowledgebase to the National Cancer Institute’s (NCI) Genomic Data Commons portal (GDC) (Press release, Foundation Medicine, JUN 29, 2016, View Source [SID:1234513616]). This contribution of de-identified and HIPPA-compliant genomics information represents the largest public data release of its kind to the NCI, more than doubling the size of the NCI’s GDC database. The genomics information is being contributed in an effort to facilitate increased collaboration and accelerate research in precision medicine with the goal of advancing patient care. The announcement was made today to coincide with Cancer Moonshot summits being held across the country.

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"This major infusion of data in the GDC will greatly enhance our ability to use this tool to explore genetic abnormalities in cancer," said Douglas Lowy, M.D., NCI Acting Director. "Through TCGA and TARGET, we had already established a strong cancer genomic foundation for the GDC at its launch, but with the addition of the genomic data from Foundation Medicine, we believe that the GDC will be an even more useful resource for researchers worldwide to help us unravel the complexities of many forms of cancer."

Run by the NCI, a part of the National Institute of Health (NIH), the GDC is a new unified data system to facilitate sharing of genomic and clinical data among researchers. It was launched earlier this month as a core component of the National Cancer Moonshot and the Precision Medicine Initiative. FoundationCORE is one of the largest and most robust knowledgebases, containing comprehensive genomic information and insights from more than 80,000 real-world clinical cases. FoundationCORE continuously evolves over time, informed by every new tumor profiled with the company’s clinical assays, FoundationOne, FoundationOne Heme and FoundationACT.

"We’re honored to participate in this important global effort to transform patient care and to be the first commercial entity to contribute data to the NCI’s GDC, which we believe underscores the quality, integrity and richness of the genomics information contained in FoundationCORE," said Vincent Miller, M.D., chief medical officer, Foundation Medicine. "The amount of genomics information within FoundationCORE has reached unparalleled scale. The insights gleaned from this data release will be instrumental in accelerating research and development efforts for targeted agents and immunotherapies."

This collaboration with the NCI marks the second public release of information from FoundationCORE this year. In February, Foundation Medicine announced the first ever public release of its pediatric data to stimulate research and development of precision therapies to fight cancer in children. The data set has received a substantial number of inquiries from around the world since the information was made available for research use.

Foundation Medicine is participating in local Cancer Moonshot summits being held across the country today, including at Fox Chase Cancer Center in Philadelphia, PA and Tufts Medical Center, in Boston, MA.

On June29, 2016 BioMarker Strategies reported that the National Cancer Institute (NCI) has awarded the Company a Phase I/II Fast Track Small Business Innovative Research (SBIR) grant to develop PathMAP NSCLC, a pathway-based companion diagnostic test to facilitate the selection of optimal therapy for individual patients with non-small cell lung cancer (Press release, BioMarker Strategies, JUN 29, 2016, View Source [SID:1234513621]). The two-year $2 million Phase II grant will begin after predetermined milestones are achieved under a 6-month $300,000 Phase I grant that is now underway.

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"Targeted therapies now exist, including the EGFR inhibitor erlotinib, that can help patients with non-small cell lung cancer keep their cancer in check"

"Targeted therapies now exist, including the EGFR inhibitor erlotinib, that can help patients with non-small cell lung cancer keep their cancer in check," said Jerry Parrott, President and CEO of BioMarker Strategies. "The challenge is to determine which individual patients are most likely to benefit from which therapy or combination of therapies. PathMAP is a pathway-based companion diagnostic assay that uses a patient’s live tumor cells to provide better information, including patient resistance to therapy, to support targeted therapy selection for individual patients with solid tumor cancers."

Lung cancer is the leading cause of cancer death in the United States, with an estimated 158,040 deaths in 2015. Non-small cell lung cancer (NSCLC) is responsible for 83% of these deaths.

On June 29, 2016 Oncolytics Biotech Inc. ("Oncolytics" or the "Company") (TSX: ONC) (OTCQX: ONCYF) (FRA: ONY) reported that, following submission to the U.S. Food and Drug Administration ("FDA") for review, the Investigational New Drug Application containing the protocol titled "Phase 2 study of REOLYSIN (pelareorep) in combination with FOLFOX6, bevacizumab and pembrolizumab in female patients with KRAS-mutant colorectal cancer metastatic to the liver" is now active (Filing, 6-K, Oncolytics Biotech, JUN 29, 2016, View Source [SID:1234513714]).

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"This study is intended to confirm the encouraging objective overall and liver metastases response rates in female patients that we saw in a sponsored randomized Phase II study conducted in Canada," said Dr. Brad Thompson, President and CEO of Oncolytics. "We are adding a checkpoint inhibitor to the treatment regimen based on our evolving understanding of how REOLYSIN upregulates immune responses and how the combination may make cancer cells more susceptible to attack by the immune system."

This is a multicenter, single arm safety and efficacy study of REOLYSIN in combination with chemotherapy (FOLFOX6), bevacizumab (Avastin) and pembrolizumab (KEYTRUDA) in female patients with KRAS-mutant metastatic colorectal cancer (CRC) in the liver. The primary objective is to evaluate the overall response rate (ORR) according to Immune-related Response Evaluation Criteria in Solid Tumors ("irRECIST"). Secondary objectives include evaluating disease response in liver metastases and overall survival. The Company also intends to examine the effect of study treatment on immune-related cells and biomarkers associated with immune response; and genetic biomarkers associated with positive response to study treatment. Study enrollment will be approximately 30 patients.

Oncolytics recently announced data from a sponsored Phase 2 study of REOLYSIN, in combination with FOLFOX6 and bevacizumab in patients with advanced or metastatic CRC (IND 210). In that study, the overall test arm had an objective response rate of 52.9% (n=51) versus 34.6% (n=52) in the control arm (p=0.06). The Company conducted a pre-planned analysis of patient responses by gender, as specified in the study protocol. The female patients in the test arm had an objective response rate of 63.2% (n=19) versus 23.8% (n=21) in the control arm (p=0.0054), and in the test arm had a median overall survival of 19.3 months (n=19) versus 14.5 months (n=21) in the control arm. The overall survival was an interim analysis, as 62 of 103 patients overall were alive at the time of data cut off. The male patients in the test arm had an objective response rate of 46.9% (n=32) versus 41.9% (n=31) in the control arm (p=0.6747). For patients (both male and female) who had metastases to the liver, those treated with REOLYSIN had objective tumour response rates of 55% (n=40), versus 28.6% (n=42) for those who did not receive REOLYSIN (p=0.0077).

About Colorectal Cancer
The American Cancer Society estimates that 134,490 Americans (63,670 women) will be diagnosed with colorectal cancer and an estimated 49,190 Americans (23,170 women) will die from the disease in 2016. The five- and ten-year survival rates are 65% and 58%, respectively, however five-year survival drops to 13% in cases where the cancer spreads to other parts of the body, away from the primary tumour.

On June 28, 2016 OncoSec Medical Incorporated ("OncoSec") (NASDAQ: ONCS), a company developing DNA-based intratumoral cancer immunotherapies, reported recent advancements in electroporation (gene electro-transfer) for immunotherapy in two poster presentations at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Special Conference on Engineering and Physical Sciences in Oncology in Boston (Press release, OncoSec Medical, JUN 28, 2016, View Source [SID:1234513598])1. New data related to OncoSec’s Tissue-based Real-time Adaptive Controlled Electroporation (TRACE) technology and helical integrated applicator (Helix) showed that these technologies have the potential to reduce procedural frequency as well as enhance usability by physicians. Together, these novel technologies may improve a patient’s experience to gene electro-transfer and improve therapeutic outcomes, which will help broaden the adoption of gene-electro transfer technologies in immunotherapy.

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The TRACE and Helix technologies are central to OncoSec’s next-generation device development and represent a significant advancement in electroporation technology. Existing electroporation systems apply fixed pulses, independent of tissue conditions, that are typically optimized by heuristics. The new TRACE technology brings together OncoSec’s research and engineering efforts to adapt the pulses to tissue conditions in real time and detect when optimal conditions have been achieved to complete electroporation treatment. The new Helix applicator integrates engineering advancements to function synergistically with the TRACE technology. The TRACE and Helix technologies have the potential to improve delivery of new therapeutic agents and access a variety of new tumor types and locations.

"The new TRACE and Helix technologies are a testament to the expertise of OncoSec’s engineering and research teams," said Punit Dhillon, President and CEO. "Electroporation is a powerful gene delivery tool, and we believe that these novel technologies are a breakthrough in the field of electroporation therapy. As we look beyond the proof-of-concept stage for our intratumoral immunotherapy programs, these advancements are a major step forward in being able to consistently deliver more advanced therapeutic agents with the potential to target multiple facets of tumor immune subversion."

TRACE Technology
The poster presentation entitled "Feedback Optimized Gene Electro-Transfer for Immunotherapy" highlights the efficacy of modulating pulse durations in real-time for the intratumoral delivery of plasmid DNA in mouse tumor models. OncoSec’s generator incorporating TRACE technology was used to perform electroporation with electrochemical impedance spectroscopy feedback operating in a closed-loop configuration to optimize each pulse duration in real-time.

Preclinical studies demonstrated electroporation integrating TRACE technology is capable of achieving maximum expression of reporter genes with minimal energy delivered. Based on these findings, it is hypothesized that this technology will minimize collateral cell death and reduce treatment variability observed in patients. These findings represent a significant advancement in gene electro-transfer, because retaining the viability of transfected cells is critical for treatment success.

Helix Technology
The poster presentation entitled "A Novel Applicator for Endoscopic Gene Electro-Transfer" discusses the role of DNA dispersion during intratumoral gene delivery and its impact on gene electro-transfer efficiency. OncoSec researchers developed a single-helical injection needle that anchors the target tissue and delivers plasmid DNA. This achieves delivery of the plasmid to an area three times larger than that of a standard injection needle. Helix combines the helical needle with electroporation electrodes on a single applicator, which may enhance gene delivery by increasing surface area for tissue-DNA-electroporation interaction.

The Helix technology showed enhanced efficacy of IL-12 plasmid electroporation in an aggressive B16.F10 mouse melanoma model, significantly reducing tumor growth rate and increasing survival after a single treatment. The anchoring associated with the helical needle and the close proximity of the electrodes ensures co-localization of the electric field with the injected plasmid DNA as well as repeatable treatment of malleable tumors. In addition, the compact design of the electrodes and helical needle could make the applicator compatible with standard medical devices, including trocars, endoscopes, and other catheter based devices, thus enabling the application of intratumoral gene immunotherapy to a broad range of deep tissue cancers.

The poster presentations are available in the Publications section of OncoSec’s website.

On June 28, 2016 STORM Therapeutics, a spin-out company from the University of Cambridge’s Gurdon Institute focused on the identification and development of small molecule drugs that target RNA-modifying enzymes, reported that it has received £12 million in Series ‘A’ funding from Cambridge Innovation Capital, Merck Ventures, Pfizer Venture Investments and Touchstone Innovations (Press release, STORM Therapeutics, JUN 28, 2016, View Source [SID1234561051]). STORM Therapeutics is based upon the ground-breaking work of its co-founders, Professor Tony Kouzarides and Professor Eric Miska, in the field of RNA epigenetics.

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RNA (ribonucleic acid) is the only direct product of the human genome and acts as the template for the synthesis of all proteins, the molecular machines of the cell. RNA is also known to be a key player in cellular decision-making. There are several large families of RNA-modifying enzymes which catalyse a diverse range of epigenetic modifications of RNA, changing RNA activity and thereby key processes within the cell. There is a growing understanding of the importance of RNA modification in the development of cancer, opening up novel therapeutic targets in cancer treatment.

Professors Kouzarides and Miska and their research groups have identified certain of these RNA-modifying enzymes against which STORM Therapeutics intends to develop potential therapeutics using intellectual property licensed from the University of Cambridge and Cancer Research UK. The company will use the proceeds of the funding to identify small molecule modulators of these novel targets in RNA modification pathways and develop them into new classes of anti-cancer treatments.

Professors Tony Kouzarides and Eric Miska commented: "The work that our research groups are undertaking on non-coding RNA and the enzymes that modify this RNA is giving us incredibly interesting insights into how gene expression can be modified at a cellular level. The funding and support that STORM Therapeutics has received from its investors will allow the development of these insights into a new class of therapeutics ready to be taken into clinical trials."