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 FUJIFILM Corporation (President: Kenji Sukeno) reported the progress in a Phase I clinical trial of radioimmunotherapeutic anti-cancer agent FF-21101 in the United States in patients with advanced solid cancers (Press release, Fujifilm, JUN 28, 2016, View Source [SID:1234513609]). In imaging, tumor uptake of antibody FF-21101 was demonstrated in administered patients. Taking these results, it is expected to treat diseases with emission from the radiolabeled antibody. Fujifilm will proceed with the clinical trial and evaluate FF-21101 as an anti-cancer agent.

FF-21101 is an anti-cancer agent consisting of a radioisotope labeled antibody (armed antibody*1), and uses radiation emitted by the radioisotope to directly attack cancer cells. This is why it is expected to have a higher level of efficacy, regardless of the state of patient’s immune system. In addition, its accumulation in cancer tissue can be confirmed by imaging with an administration of antibodies labeled with a radioisotope. To date, tumor uptake of antibody was demonstrated in 3 of 4 patients who have undergone imaging with an administration of radiolabeled FF-21101.
These results were presented on June 27th at the World Innovative Networking in Personalized Cancer Medicine Symposium 2016 (Paris, France) by principal investigator, Vivek Subbiah MD, of The University of Texas MD Anderson Cancer Center*2 (MD Anderson Cancer Center, hereafter), Houston, TX, USA.

Fujifilm has organized the technologies of its Group companies to develop FF-21101. The bio-venture, Perseus Proteomics, has contributed to antibody drug discovery, while the biopharmaceutical contract manufacturer, FUJIFILM Diosynth Biotechnologies, has taken charge of antibody production. The radiopharmaceutical company, FUJIFILM RI Pharma, utilized its technology for developing the diagnostic and therapeutic radiopharmaceuticals.

Fujifilm initiated the Phase I clinical trial of radiolabeled FF-21101 in patients with advanced solid cancers at MD Anderson Cancer Center in the United States, one of the world’s most distinguished facilities for cancer research and treatment, in January 2016. In this trial, FF-21101(111In), antibodies labeled with Indium-111*3, were administered prior to therapy and its biodistribution to normal and cancerous tissues were visualized and quantified by imaging procedures. In addition, for safety estimation in advance, radiation absorbed doses of Yttrium-90*4 in organs were calculated from these data, after which, patients were moved on to the therapeutic dosing of FF-21101(90Y), antibodies labeled with Yttrium-90.

Although the trial is still underway, preliminary observations include:
Imaging revealed tumor uptake in 3 of 4 patients administered FF-21101(111In).
FF-21101 was well tolerated in all patients who went on to receive the therapeutic dose of FF-21101(90Y).

Fujifilm will continue the study to further evaluate tolerability and efficacy in multiple advanced solid tumors at MD Anderson Cancer Center, and will move on to the phase IIa study.

Fujifilm is working on the R&D of innovative pharmaceutical products and creation of their production processes by combining the technologies and know-how accumulated in the photographic film business including analysis technology, nanotechnology, and production technology, with the technological expertise of its core pharmaceutical affiliates such as Toyama Chemical. Defining "oncology", a field with numerous unmet medical needs as its focal area, the company will actively promote R&D to expand business deployment and supply innovative pharmaceutical products so as to contribute to resolving challenges social issues.

*1： Armed antibody: Antibody conjugated with toxin or radioisotope via a chemical linker. It is expected to have a potent anti-tumor effect.
*2：One of the world’s largest cancer centers based in Houston. Texas (USA), specializing in cancer treatment, research, education and prevention. It was established in 1941 with a mission to eliminate cancer. Under the core values of "Caring", "Integrity" and "Discovery", the Center has developed numerous new cancer treatments and is as an international leader in oncology.
*3：A radioisotope which emits gamma rays appropriate for imaging. Its physical half-life is, approximately 67 hours.
*4：A radioisotope which emits beta particle radiation with a range of 5 mm in human body, appropriate for treatment. Its physical half-life is, approximately 64 hours.
　　
About anti-cancer agent FF-21101:
FF-21101 uses antibodies that target P-cadherin*5, which is overexpressed on the surface of solid cancer cells, including lung, pancreatic and colon cancers, and is implicated in tumor growth and cancer metastasis. For the clinical application of FF-21101, tumor uptake will be confirmed in patients administered antibodies radiolabeled with emitter, such as Indium-111 or other radioisotopes. Antibodies labeled with Yttrium-90 namely FF-21101(90Y), will be subsequently administered and directly attacks cancer cells by radiation emitted from the 90Y radioisotope. FF-21101 is expected to be more effective than therapy using the P-cadherin targeted antibody without the 90Y. In animal testing, it has already demonstrated a high efficacy in shrinking human tumors implanted in mice.

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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."

On June 28, 2016 Bio-Path Holdings, Inc., (NASDAQ: BPTH), a biotechnology company leveraging its proprietary DNAbilize liposomal delivery and antisense technology to develop a portfolio of targeted nucleic acid drugs, reported that it has entered into a sponsored research agreement with Thomas Jefferson University to investigate DNAbilize antisense DNA technology for the development of a brain cancer immunotherapy that works by activating the patient’s own immune system to fight their cancer (Press release, Bio-Path Holdings, JUN 28, 2016, View Source [SID:1234513645]).

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D. Craig Hooper, Ph.D., Department of Cancer Biology, Sidney Kimmel Cancer Center at Thomas Jefferson University and the Principal Investigator of the study, previously evaluated Bio-Path’s DNAbilize liposomal delivery and antisense technology in preclinical studies that demonstrated efficacy, suggesting the potential for a systemic antisense immunotherapy for brain cancers. The objective of the collaboration is to demonstrate that DNAbilize delivered systemically would have an effect in redirecting the immune system to fight a patient’s own cancer.

"Brain cancers, such as glioblastoma, are very aggressive and with median survival of about 15 months, novel treatments are urgently needed," said Peter Nielsen, President and Chief Executive Officer of Bio-Path. "We are excited to continue our work with Dr. Hooper to further demonstrate the potential of DNAbilize to safely and systemically deliver a brain cancer immunotherapy. We are entering the immunotherapy market with a unique approach to triggering the immune system to fight a patient’s cancer. This collaboration offers a significant development opportunity for Bio-Path that has the potential to create a second technology platform of immunotherapy products."