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Oncolytics Biotech Inc. (ONC.TO)

Toronto - Toronto Delayed Price. Currency in CAD
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0.65+0.01 (+1.56%)
At close: 3:54PM EDT
  • M
    Michael
    Michael
    Interesting that the market hasn't substantially rewarded this stock for the continued encouraging news around the therapy.
  • L
    Lefty
    Lefty
    Oncolytics Biotech® Announces Successful End-of-Phase 2 Meeting with FDA for REOLYSIN® in Metastatic Breast Cancer
    Well, this has to be one of the most frustrating stocks that I have ever owned, but this does sound promising.
  • b
    bailey201306
    bailey201306
    Zack's research - Sept 20th - ONCYF preparing request to ask FDA for Breakthrough Therapy Designation for Reolysin
  • b
    bailey201306
    bailey201306

    September 20, 2017 - Zack's Research - John Vandermosten - Oncolytics Biotech preparing request for FDA Breakthrough Status for Reolysin

    https://finance.yahoo.com/news/oncolytics-oncyf-end-phase-ii-140000413.html

    Oncolytics’ (ONCYF) End of Phase II Meeting
    By John Vandermosten, CFA OTC:ONCYF TSX:ONC.V Oncolytics Biotech (OTC:ONCYF) (TSX:ONC.TO) announced a successful end of Phase II meeting with the FDA in a September 18 press release. The purpose of the ...
    finance.yahoo.com
  • S
    Steve
    Steve
    Steady climb from here. IMHO
  • b
    bailey201306
    bailey201306

    Congress and FDA nominee heap love on ‘adaptive trials’

    The 21st Century Cures Act, signed into law this past December, Congress required that FDA issue guidance and hold a public meeting to clarify how drug sponsors can use adaptive trials in their submissions for drug and device approvals.

    Why all this love for adaptive trials? “You have the ability to learn so much more about response to a drug or a device by being more flexible,” says William Barsan, an emergency physician at the University of Michigan in Ann Arbor who runs such trials for neurological conditions.

    http://www.sciencemag.org/news/2017/04/congress-and-fda-nominee-heap-love-adaptive-trials

    Congress and FDA nominee heap love on ‘adaptive trials’
    Push for faster approval brings attention to long-heralded but tricky study design
    www.sciencemag.org
  • b
    bailey201306
    bailey201306

    ESMO 2017 - Tumor Mutation and I/O drug combination

    "Research presented at Europe’s biggest oncology congress in Madrid adds to evidence that patients with an above average number of genetic mutations in their tumors have a better chance of responding to the new treatments, and drugmakers are racing to confirm the idea."

    "https://www.geo.tv/latest/157270-cancer-mutation-gains-ground-as-test-for-immunotherapy-drugs

    Cancer mutation gains ground as test for immunotherapy drugs
    Such analysis to measure what is known as tumor mutation burden should lead to better targeting of medicines
    www.geo.tv
  • b
    bailey201306
    bailey201306

    September 13, 2017 - Scientists discover that high levels of VEGF-C in the blood correlated with positive responses to checkpoint blockade - and in combination with oncolytic virus

    "Checkpoint inhibitors have transformed the treatment of some cancers, most notably melanoma. But only 20% of patients are cured by the drugs, and many patients who do respond eventually become resistant to them. Several methods for solving this problem are under investigation, including combining the drugs with cancer-killing viruses and using a drug that improves blood flow to boost the population of beneficial immune cells."

    http://www.fiercebiotech.com/research/can-culprit-for-cancer-spreading-also-boost-immuno-oncology-treatments

    Can the culprit for cancer spreading also boost immuno-oncology treatments? | FierceBiotech
    Lymphatic vessels are tiny structures that drain fluid from the body—but they are also blamed for carrying cancer cells from the primary tumor to other locations in the body. Now a research team led by the University of Chicago has discovered that th
    www.fiercebiotech.com
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    bailey201306
    bailey201306
    Immuno-Oncology (IO) looks set to become the fifth pillar of cancer treatment

    "Immuno-Oncology (IO) looks set to become the fifth pillar of cancer treatment alongside surgery, radiotherapy, chemotherapy, and other targeted treatments according to GlobalData, a recognized leader in providing business information and analytics."

    "A large selection of treatments within immune-oncology focus on utilizing the immune system to induce an anti-tumor response, leading to tumor stabilization and potential remission from the disease. These treatments achieve their effects through the inhibition, or blockade, of immune checkpoint proteins (ICPs) such as CTLA-4 and PD-1. PD-(L)1 inhibitors are rapidly adopted in indications receiving approval due to significant survival benefit and relatively good safety profiles in comparison with other Standard Of Care (SOC) treatments."

    "Of the big advances in cancer care over recent years, excitement around the clinical and market potential of IO has been driven by IO’s ability to harness the natural processes of the body’s immune system to search for, examine and eradicate foreign particles. IO teaches the immune system to recognise and destroy cancer cells and thereby enable the body to regain control. The future of IO looks brighter than ever, and IO drugs are now in a position to compete as monotherapies against traditional SOC chemotherapy regimens in the first line of the metastatic setting. In addition, these treatments have shown efficacy in a wide variety of indications offering a less toxic treatment alternative.

    Bourgognon continued: ‘‘Despite all the initial setbacks and challenges in IO, researchers and drug developers have now found innovative ways to successfully augment the immune response against cancer. In the near future, it is hoped that the combination of IO agents with other IO agents, targeted therapies, or chemotherapy regimens will lead to improved long-term survival outcomes for even more cancer patients.'’

    The field of immuno-oncology (IO) involves the development of therapies that can harness the body’s ability to generate and sustain, naturally or artificially, an effective immune response against cancer. The majority of these mechanisms revolve around priming and boosting the immune system via antigen-presenting cell (APC), T-cell, or innate cell stimulation, reducing immunosuppression in the tumor environment by regulating inhibitory pathways, and enhancing adaptive or innate immunity.
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    bailey201306
    bailey201306
    Orphan Drug Designation

    "Orphan Drug Designation is granted by the FDA to drugs and biologics which are defined as those intended for the safe and effective treatment, diagnosis or prevention of rare diseases / disorders that affect fewer than 200,000 people in the U.S. Orphan Drug Designation provides certain incentives that may include tax credits toward the cost of clinical trials and prescription drug user fee waivers. If a product holding Orphan Drug Designation receives the first FDA approval for the disease in which it has such designation, the product is entitled to seven years of market exclusivity, which is independent from intellectual property protection."
  • A
    Alfredo
    Alfredo
    The BIOPHARM MARKET is a scam!!!!
  • b
    bailey201306
    bailey201306
    Biological Products Exclusivity

    "The Biologics Price Competition and Innovation Act, which was broadly supported by both sides of the aisle in both the House and Senate, ..........provided a 12-year period of data protection for innovator biologics "
  • b
    bailey201306
    bailey201306
    ESMO 2017 - Presentation today - Reolysin + FOLFIRI/B in KRAS mutant metastatic colorectal cancer in (mCRC) demonstrated a median PFS of 63 weeks - up from the previously reported 49 weeks

    "Conclusions: At the highest dose, the combination was safe, well tolerated, with a PFS of 63 (range 27-101) wk, superior to historic data (18-27 wk). Electron Microscopic and immune changes seen consistently among patients."
  • b
    bailey201306
    bailey201306

    Bavarian Nordic’s delayed phase 3 cancer vaccine prostate trial flops.

    "The failure of Prostvac to improve overall survival in patients with metastatic castration-resistant prostate cancer has crushed hopes that Bavarian Nordic will see much of the close to $1 billion in milestones tied to the Bristol-Myers deal.

    Copenhagen, Denmark-based Bavarian Nordic’s hopes of salvaging Prostvac now rest on whether it can boost the effect of other immuno-oncology agents,"

    http://www.fiercebiotech.com/biotech/bavarian-nordic-tanks-after-bristol-myers-partnered-vaccine-flunks-phase-3-prostate-cancer

    Bavarian Nordic tanks after Bristol-Myers-partnered vaccine flunks phase 3 prostate cancer trial | FierceBiotech
    Bavarian Nordic’s repeatedly delayed phase 3 cancer vaccine trial has come crashing to a halt. The data monitoring committee ended the six-year odyssey after ruling it would be futile to keep treating patients with the Bristol-Myers Squibb-partnered
    www.fiercebiotech.com
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    bailey201306
    bailey201306
    ESMO 2017 - Data Presented in Phase 2 mBC study demonstrated that the test arm of REOLYSIN/paclitaxel more than doubled median overall survival (OS) with a p-value = 0.003.

    " In the IND 213 randomized phase 2 study in metastatic breast cancer, conducted by the Canadian Cancer Trials Group, HR+ (ER+/PR+) / HER2- patients (n=47) demonstrated that the test arm of REOLYSIN/paclitaxel more than doubled median overall survival (OS) from 10.8 months on the control arm (paclitaxel alone) to 21.8 months. The hazard ratio was 0.36 and p-value was 0.003. The ITT (intent-to-treat) group (n=74, all genetic subtypes) improved median OS from 10.4 months on the control arm to 17.4 months on the test arm. "
  • b
    bailey201306
    bailey201306

    September 13, 2017 - Bank of Nova Scotia raised its stake in shares of Celgene Corporation (NASDAQ:CELG) by 340.0% during the 1st quarter, according to the company in its most recent 13F filing with the Securities and Exchange Commission. The firm owned 192,020 shares of the biopharmaceutical company’s stock after buying an additional 148,375 shares during the period. Bank of Nova Scotia’s holdings in Celgene Corporation were worth $23,893,000 as of its most recent SEC filing.

    https://ledgergazette.com/2017/09/13/celgene-corporation-celg-shares-bought-by-bank-of-nova-scotia.html

    Celgene Corporation (CELG) Shares Bought by Bank of Nova Scotia
    Bank of Nova Scotia raised its stake in shares of Celgene Corporation (NASDAQ:CELG) by 340.0% during the 1st quarter, according to the company in its most recent 13F filing with the Securities and Exchange Commission. The firm owned 192,020 shares of
    ledgergazette.com
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    bailey201306
    bailey201306

    September 12, 2017 - New FDA Commissioner Scott Gottlieb wants to target drug development costs as yet another study asks how much it really costs to make a medicine.

    "He said one way of cutting down on costs and time is the use of combined-phase studies, or what’s referred to as seamless trials, which are increasingly being used in cancer tests.

    “Instead of conducting the usual three phases of study, seamless trials encompass one adaptive study where the phases are separated by interim looks. By using one large, continuous trial, it saves time and reduces costs. It also reduces the number of patients that have to be enrolled in a trial.”

    http://www.fiercebiotech.com/biotech/fda-commish-we-need-to-talk-about-drug-development-costs

    FDA commissioner: We need to talk about drug development costs | FierceBiotech
    New FDA Commissioner Scott Gottlieb wants to target drug development costs as yet another study asks how much it really costs to make a medicine.
    www.fiercebiotech.com
  • b
    bailey201306
    bailey201306
    Oncolytic virus + checkpoint inhibitors continue to prove effective

    Inactivated Vaccinia Virus Safe and Effective Against Advanced Cancers Alone or in Combination with Immune Checkpoint Inhibitors

    9/5/2017

    MAINZ/FRANKFURT, GERMANY — Modified vaccinia virus Ankara (MVA), a poxvirus, was found to be safe when administered in an inactivated form in mice, and delivering it into the tumor in addition to systemic delivery of an immune checkpoint inhibitor yielded synergistic antitumor effects in mice with large tumors and those with multiple tumors, according to data presented at the Third CRI-CIMT-EATI-AACR International Cancer Immunotherapy Conference: Translating Science into Survival, held Sept. 6-9.
  • b
    bailey201306
    bailey201306
    Embracing the Promise of Oncolytic Virus Immunotherapy

    Tue, 09/05/2017 - 10:56am
    by Andres A. Gutierrez, M.D., Ph.D.

    "The mechanism of action of the systemically-administered, oncolytic viral immunotherapy, Reolysin, has allowed Oncolytics Biotech to shape the therapy’s clinical development path to now potentially treat patients with metastatic breast cancer (mBC). In combination with the current standard-of-care for mBC (paclitaxel), Reolysin demonstrated a statistically significant increase in overall survival and a clinically meaningful increase of seven months, compared to the patients treated via paclitaxel alone. The combination therapy was also safe and well tolerated which supports a positive benefit/risk ratio for further development."
  • K
    Kenny
    Kenny
    oh my, it seems like Yahoo is having more trouble ... sigh. hayoo haha you? laugh at your???? what ever represents the sham that Yahoo has become, that aside. ((( oh no what proof??? just look at the history of this message board. There was a time when it was actually viable, now Yahoo has ground that into the ground. Oh well.... Hmmm can I say something intelligent without it being eliminated? Well I will try. Alfredo is a sauce and that is all she will ever be. She is full of rotten cheese and wilted herbs from her own garden of lustful short sales. Ok here comes one intelligent post, sorry of I confuse people here, like the sauce queen, Miss Alfredo... but here goes. We are a couple of months out from gaining some actual realistic perspective on where REO and ONCY will go from here. There is an extremely important FDA meeting going on at the moment and the outcome will determine the fate of ONCY both in short term and long term. No one here knows poopoo. Not poopoo white sauce, (Miss Alfredo) not Bailey, not basher nor pumper, Everyone here is full of nothing.... so ahhhh that felt GREAT! No comment on your totally irrelevant lives. If you actually think you are influencing the SP of this biotech, you are as delusional as the backass side of the moon is. (yea that is redundant) Peace out