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Oncolytics Biotech Inc. (ONC.TO)

Toronto - Toronto Delayed Price. Currency in CAD
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0.51-0.05 (-8.93%)
At close: 3:56PM EDT
  • Oncolytics Biotech (ONCYf / ONC.to) Announces end-of-phase 2 meeting with the U.S. Food and Drug Administration

    CALGARY and SAN DIEGO, July 26, 2017 /CNW/ - Oncolytics Biotech® Inc. (Oncolytics or the Company) (TSX:ONC) (OTCQX:ONCYF) today announced that two abstracts describing both pooled safety and tolerability data and the mechanism of REOLYSIN®, also known as pelareorep®, have been selected for poster presentation (display) at the European Society for Medical Oncology (ESMO) 2017 Congress. The abstracts will be published online on the ESMO website at 3:05 ET on Wednesday, August 30. The conference is taking place from September 8-12, 2017, in Madrid, Spain.

    "The pooled analysis of patients treated with intravenous pelareorep is the largest safety database available for this class of agents in combination with chemotherapy," said Dr. Andres Gutierrez, Chief Medical Officer at Oncolytics Biotech. "While our efficacy in metastatic breast cancer announced earlier this year at AACR was captivating, the safety component of pelareorep increases the benefit-risk ratio of the therapy and supports its further development. We are particularly excited to present these results as other immuno-oncology agents in the same class have had limited or no experience with systemic administration."

    Publication number:
    1193P
    Title:
    Pooled data analysis of the safety and tolerability of intravenous Pelareorep in combination with chemotherapy in 500 + cancer patients
    Lead Author:
    Dr. Andres Gutierrez, Oncolytics Biotech

    Publication number:
    523P
    Title:
    Mechanism of Pelareorep (Pel)-mediated cell death in a Phase I study in combination with irinotecan/ fluorouracil/ leucovorin/ bevacizumab (FOLFIRI/B) in patients with KRAS mutant metastatic colorectal cancer (mCRC)
    Lead Author:
    Dr. Sanjay Goel, Montefiore Medical Center, NY

    The Company also announced that it has been granted an End-of-Phase 2 meeting with the United States Food and Drug Administration (FDA), taking place in August 2017. The meeting will address registration pathways for REOLYSIN® for the treatment of metastatic breast cancer, the indication for which the FDA has granted Fast Track designation. The Company expects to announce the outcome of this meeting in the fourth quarter of 2017.
  • july 27, 2017 - AstraZeneca cancer drug fails progression free survival (PFS) endpoint.

    "AstraZeneca said human trials of the drug Imfinzi failed to meet the goal of improving progression-free survival rates in patients with non-small cell lung cancer. Investors saw the results as a major setback because the company had hoped the study, known as Mystic, would show Imfinzi to be more effective than standard chemotherapy."
  • Senator John McCain - glioblastoma diagnosis - potential treatment using the herpes virus according to Dr. David Agus, "who is one of the country's top oncologists and director of the USC Norris Westside Cancer Center."

    "When asked about the possibility of finding a cure for the deadly form of cancer, Agus referred to a recent study from Duke University that used a genetically re-engineered polio virus to prompt the immune system to attack glioblastoma. Some of the patients who were involved in the study "have survived many years with this form of treatment," he said. "

    "
  • July 20, 2017 "Since the biotechnology bubble burst in 2015, resulting in a 40% bear market, something has been building that I've been waiting several quarters for -- a resumption of the great, long-term bull market."

    http://www.nasdaq.com/article/biotech-bull-is-back-4-keys-to-play-it-cm819626

    Biotech Bull is Back: 4 Keys to Play It
    Since the biotechnology bubble burst in 2015, resulting in a 40% bear market, something has been building that I've been waiting several quarters for.
    www.nasdaq.com
  • .38 sucks... buy holding
  • Oncolytics Biotech's Reolysin is a biological agent and the company plans on a BLA (registraton) pathway.

    The following clinicaltrials.gov site identifies Reolysin as a biological agent in the UK multiple myeloma (MM) study.

    https://clinicaltrials.gov/ct2/show/NCT03015922

  • Oncolytics Biotech seeks to obtain FDA approval in p53 mutated/metatstic breast cancer patients. This group of Reolysin treated mBC patients have demonstrated statistical significance in Overall Survival (OS) of p=0.03

    CALGARY, April 5, 2017 /CNW/ - Oncolytics Biotech® Inc. (Oncolytics or the Company) (TSX:ONC) (OTCQX:ONCYF) today announced data demonstrating a statistically significant (p=0.03) overall survival (OS) benefit for patients with mutated p53 metastatic breast cancer, when treated with REOLYSIN®, an immuno-oncology viral agent, in combination with paclitaxel. Results from IND 213, an open-label, randomized, phase 2 study were presented at the Annual Meeting of the American Association of Cancer Research (AACR), April 1-5, 2017 in Washington, D.C.
  • FDA "Fast Track" Drug Approval allowed after single small patient size Phase II clinical study.

    "Fast track: The FDA’s “fast track” approval designation of 1988 allows drugs that treat life-threatening or debilitating diseases to be approved after a single phase II clinical study."
  • Amgen Submits Regulatory Applications In US And Europe To Include Overall Survival (OS) Data In KYPROLIS® (Carfilzomib) Label

    Data Showed KYPROLIS and Dexamethasone Reduced the Risk of Death by 21 Percent and Increased Overall Survival by 7.6 Months Compared to Velcade® (Bortezomib) and Dexamethasone in Relapsed or Refractory Multiple Myeloma Patients

    THOUSAND OAKS, Calif., July 14, 2017 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) and a variation to the marketing application to the European Medicines Agency (EMA) to include overall survival (OS) data from the Phase 3 head-to-head ENDEAVOR trial in the product information for KYPROLIS® (carfilzomib).

    Data submitted to regulatory authorities showed that KYPROLIS, administered at the 56 mg/m2 dose as a 30-minute infusion twice weekly with dexamethasone (Kd56), reduced the risk of death by 21 percent over Velcade® (bortezomib) and dexamethasone (Vd), resulting in a 7.6 month OS benefit (median OS 47.6 months for Kd56 versus 40.0 months for Vd, HR=0.79; p=0.01). The OS benefit was consistent regardless of prior bortezomib therapy (HR 0.75 for no prior Velcade; HR 0.84 for prior Velcade). These results were presented earlier this year at the 16th International Myeloma Workshop and the 22nd Congress of the European Hematology Association.
  • Did anyone else see $ONCYF report from http://jcharlesassets.com/opiant-pharmaceuticals/?s=ONCYF ? It had some interesting information. "rht" Investing day trading.

    Best MicroCap, Small Cap and Emerging Stocks to Buy - J Charles Assets
    We search for the smart new growing companies to invest in with stock deals to watch in pharmacuetical and digital verticals.
    jcharlesassets.com
  • Celegene acquires pre-clinical anti-PD-1 agent from newly created partnership with Chinese company

    July 06, 2017

    "The prolific dealmaker is paying $263 million upfront to get its mitts on the ex-Asia rights to Beigene’s PD-1 inhibitor BGB-A317 in solid tumors.

    BGB-A317 has yet to enter global pivotal trials and has already given up a big head start to rival checkpoint inhibitors from Bristol-Myers Squibb, Merck and the rest of the PD-1/PD-L1 pack. But, while BGB-A317 may arrive too late to make a dent on the monotherapy market, it could still be a useful tool for Celgene as it puts together combinations of cancer drugs to hit solid tumors. "
  • FDA is transforming the drug approval process. FDA's new drug approval process - is coming out of the 21st Century Cures Act, signed into law last year, which gave the agency $500 million over the next 9 years.

    "In the words of the FDA, Cures is designed to speed up the regulatory process while also taking on board the views of patients when it comes to drug development. It also wants to modernize clinical trial designs as well as clinical outcome assessments, which it hopes will help speed up the development and review of new meds."
  • The board is awfully quiet! Any one have anything to add to the latest news and SP activity?
  • " .....at ASCO we saw more and more oncolytic virus research coming through the pipeline and more and more data suggesting that oncolytic viruses will be part of the future cocktail of solid tumour treatments."

    https://labiotech.eu/targovax-interview-immuno-oncology-vaccines/

    Interview: Targovax is Bringing Cancer Vaccines & Oncolytic Viruses Back
    We talked to CEO Øystein Soug and CMO Magnus Jäderberg of Targovax about why the company’s technologies may succeed where others have failed.
    labiotech.eu
  • Zack's Research Update on Oncolytics Biotech June 23, 2017

    Shares Undervalued

    "Since the capital raise, shares on the TSE have declined from the issue price by approximately 34%, despite the
    company exercising its full allotment option and raising sufficient capital to support clinical trials and operations
    through the end of 2018 and perhaps slightly longer. Oncolytics is also coming up on its end-of-Phase II meeting
    with the FDA, which is expected to take place in the first half of August, depending upon scheduling. Following the
    meeting, the FDA may approve Oncolytics submission of a biologics license application (BLA) or grant
    breakthrough status, which will allow for priority review and closer collaboration with the FDA. Generally, the FDA
    takes 60 days to respond to the submission and Oncolytics anticipates making an announcement on the path
    forward regarding REOLYSIN for metastatic breast cancer in the fourth quarter of 2017.
    Our estimates take a conservative stance and assume that no special status will be granted and yield a target price
    of US$2.00. If special status is granted, there is upside to our estimates due to lower costs incurred and faster time
    to market. We also note that even under our base case scenario, where the Phase III trial is required, our target
    price will increase upon the start of the trial based on a higher probability of success for candidates that reach
    Phase III. There has been positive news so far for the company and we note several upcoming potentially positive
    catalysts as well. "
  • .32 sucks--- but buy
  • Market Analysis : The New Biotech Boom Begins NOW

    Biotech is blowing every other sector out of the water this week.

    https://dailyreckoning.com/new-biotech-boom-begins-now/

    The New Biotech Boom Begins NOW - Daily Reckoning
    Not all investments are created equal...
    dailyreckoning.com
  • http://www.fiercepharma.com/vaccines/trump-administration-picks-pro-vaccine-cdc-director

    Trump administration picks pro-vaccine CDC director | FiercePharma
    After fears that President Trump may push for a change in vaccine policy on autism concerns, Brenda Fitzgerald's appointment will likely be a relief to medical professionals.
    www.fiercepharma.com
  • Several of the reasons that Oncolytics Biotech is establishing a US office in San Diego is because (1) the OV Reolysin is being manufactured and validated by SAFC Carlsbad (Sigma-Aldrich) now Millipore Sigma( a subsidiary of Merck KGaA) located in Carlsbad, California - north of San Diego, CA. AND; (2) both ONCY's VP of Business Development and VP of Investor Relations currently reside in San Diego AND; (3) ONCY CEO Matt Coffey spends considerable time in San Diego and at the Millipore Sigma facilities in Carlsbad completing the FDA's product manufacturing requirements, as ONCY readies itself for a BLA and registration of Reolysin for FDA approval in the treatment of metastatic breast cancer (mBC).
  • p53 as a molecular marker / biomarker for the detection of cancer.

    The p53 gene is the most frequently mutated gene in cancer and accordingly has been the subject of intensive investigation for almost 30 years. Loss of p53 function due to mutations has been unequivocally demonstrated to promote cancer in both humans and in model systems. As a consequence, there exists an enormous body of information regarding the function of normal p53 in biology and the pathobiological consequences of p53 mutation. It has long been recognised that analysis of p53 has considerable potential as a tool for use in both diagnostic and, to a greater extent, prognostic settings and some significant progress has been made in both of these arenas."

    "Research in specific cancers indicates that the uses of increasingly well informed p53 mutational analysis are likely to expand to other cancers."

    https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5019193/