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Oncolytics Biotech Inc. (ONCY)

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    April 2021 - Recent collaborations and financing deals involving small research companies and big pharmaceutical firms are focused on next-generation cancer therapies. This activity is exemplified by widespread efforts within the industry to develop antibody and T cell–based therapies in the fight to control and perhaps defeat cancer.

    Liberating the immune system
    In another growth move, Takeda has expanded into solid tumors with a concerted effort over the past four and a half years, under the leadership of drug hunter Loïc Vincent, PhD, head of the company’s oncology drug discovery and immunology units, to shift its cancer therapy work toward transformative immuno-oncology approaches. Takeda’s previous investments in cancer therapy included the 2008 acquisition of Millennium Pharmaceuticals (and its multiple myeloma drug Velcade) and the 2017 acquisition of Ariad Pharmaceuticals (and its lung cancer therapies).

    Takeda’s immuno-oncology R&D is focused on two pillars: a “cold to hot” pillar, which supports the goal of turning a non-immunogenic tumor microenvironment into an immunogenic state, and a “redirected immunity” pillar, which supports the direct killing of tumors by immune cells.

    T-cell engagement

    Another promising next-generation approach is the use of bispecific and multispecific antibodies to engage immune system elements, predominantly the T cell, at the site of cancer.

    [ Refer to ONCY's press releases regarding immuno-oncology, immune checkpoint inhibitors, CAR-T therapy, PARP inhibitors, CDK 4,6 inhibitors and bispecific antibody therapy - which I have indicated beforehand require an oncolytic agent like ONCY's pelareorep to preclude T-Cell exhaustion ]
  • d
    dreamer
    it's a new day and hopefully upward from here.
    There are a lot of positives going for the company and hopefully they can put it together in a timely manner. Yes I know that trials can only go so fast but don't spread yourself too thin and concentrate at this point on what needs to be done to get this to the endline.
    2. Amendment to the Employment Agreement
    The Employment Agreement Section 3 – Remuneration is amended as follows:
    (1) Commencing January 1, 2021, Oncolytics shall pay to the Employee a salary of SIX
    HUNDRED THIRTY-SEVEN THOUSAND TWO HUNDRED ($637,200.00) CANADIAN
    DOLLARS per annum, exclusive of bonuses, benefits and other compensation, payable in equal
    installments of TWENTY-SIX THOUSAND FIVE HUNDRED FIFTY DOLLARS ($26,550.00) on
    the 15th and last day of each month.
  • N
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    April 14, 2021 - Recent evidence describes the effect on how pelareorep exposure augments autophagy induction in human cancer cell lines with relationship to CDK 4,6 inhibitors and the upregulation of D-type cyclin AMBRA 1, which is a tumor suppressor enzyme.

    A recent paper "Oncolytic reovirus (pelareorep) induces autophagy in KRAS-mutated colorectal cancer"- (Jiffry et al. Albert Einstein College of Medicine, Bronx, NY) draws attention to how pelareorep administration facilitates a 4 fold upregulation of AMBRA 1 in the subject model used. Four genes (AMBRA1, ATG4, GB and SEC16A) were common between mouse model and human cell lines.

    Recent work at the University of Pennsylvania discovered that when human B-cell lymphoma cells were transplanted into mice, for instance, tumors without the AMBRA1 gene grew up to three times faster than those with the gene.

    This evidence further demonstrates that pelareorep's immune-based MOA, which includes the upregulating of AMBRA 1, has a broad capability of stimulating and thus enabling the adaptive immune system to turn cold tumors "HOT" by dialing up those genes that are needed, at the time when needed, to kill cancer.

    As a consequence ONCY's pelareorep is not only able to "prime" the adaptive immune system to trigger autophagy but also can "boost" the immune system to further this natural destructive process of cancer cells by overcoming the challenges of an otherwise immunosuppressive tumor microenvironment (TME) and relocate and enhance "new" T-cells to the tumor cell and facilitate T-cell infiltration into the tumor cell, which prepares the immune system for both immune checkpoint inhibitor and CAR-T therapy.

    https://www.biospace.com/article/releases/protein-found-to-control-drivers-of-normal-growth-and-cancer/
  • d
    dreamer
    Ok, even I am confused at this point, one usually expects the price to drop just because it is onc but this is actually some of the best news they have come out with. Big thing here is the kol talk and timeframe, If we are still looking 2-3 years out then one might expect this but this news is stellar and any other biotech and many others have gone way up on less results so why is this happening. Maybe confidence in the company going forward, maybe selling lots into the atm, who knows, there really is now logical explanation for this at this time imo other than people who have made the quick profit are selling expecting that we are still a long way out. Honestly, Roche must really like what they see as this could add huge to their bottom line but timelines can always hold a company back. We need some institutional backing for real and not just some analyst saying that we have a 15 dollar pt on the stock. Frustrated as hell, yes for sure, but actually more confident in the company than I have been in a long time although I do wish that once in awhile they would actually return an email or telephone call as they really do not have much for pr for the company. The kol talk could be key as it will lay out the future and timeframes for the company and of course they will and have always been in talks with big pharma but this might be different as someone just maybe might want to jump on board before a lot of other results come out. The company will survive as they have the ATM which they always seem to strategically use at the right time to keep the company going and at this time as hard as it is for me to say they actually need it. I am really hoping that Matt gives us something more in this talk than 6-18 months
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    Researchers at the Leiden University Medical Center (LUMC) in the Netherlands are exploring how to use oncolytic viruses to increase the effectiveness of immunotherapy cancer treatments.

    In the Journal for ImmunoTherapy of Cancer, the LUMC researchers used oncolytic reovirus in combination with T-cell-engaging CD3ε-bispecific antibodies to treat cancer in mouse models. The study – led by Thorbald van Hall, professor of tumor immunology, and Nadine van Montfoort, group leader of viro-immunotherapy of cancer.

    Both bispecific T-cell engagers and oncolytic viruses are promising cancer therapies, but the new research demonstrates that combining the two approaches could work even better. The researchers first administered oncolytic reovirus to both syngeneic murine and humanized tumor models, then injected the CD3ε-bispecific antibodies. The combined treatment induced strong tumor regression and prolonged survival compared to each treatment option individually.

    Preconditioning the tumor microenvironment with oncolytic reovirus resulted in the activation of immunologically cold tumors, explained the researchers. This in turn led to more successful engagement of bispecific antibodies, causing tumor cell death.

    ONCY's Mayo Clinic's CAR-T therapy + pelareorep's results proves out the above study.
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    April 13, 2021 - Inflammatory Markers in Cancer Immunotherapy

    Deepak Ravindranathan 1, Viraj A. Master 2 and Mehmet Asim Bilen 1,*

    1 Department of Hematology and Medical Oncology, Winship Cancer Institute of Emory University, Atlanta,
    GA 30322, USA; dravind@emory.edu
    2 Department of Urology, Emory University School of Medicine, Atlanta, GA 30322, USA;
    vmaster@emory.edu

    Conclusions

    ICIs have emerged as a modality of treatment for advanced malignancies. Discovery of inhibition of negative immune regulation led to American immunologist, Dr. James P. Allison and Dr. Tasuku Honjo, immunologist from Japan to receive the Nobel Prize in Physiology or Medicine in 2018. Current indications for immunotherapy are based on PDL‐1 percentage detected on tumor cells or based on combined positive score (CPS). FDA approval for immunotherapy has been primarily in the metastatic setting and there are clinical trials are studying its role in the neoadjuvant and adjuvant settings. Hence, identifying and developing biomarkers that can predict responses to cancer immunotherapy is vital.

    ----------

    [ONCY is meeting this vital need by developing and validating a predictive T-Cell clonality/diversity biomarker that is capable of identifying patients who will positively respond to ONCY's oncolytic virus pelareorep + immune checkpoint inhibitor - as described in yesterday's KOL presentation by Dr. Aleix Prat on SOLTI's AWARE-1 study and the CelTiL scores that pelareorep + the checkpoint inhibitor atezolizumab were able to achieve when used in combination.

    Dr. Richard Vile of the Mayo Clinic was able to further elaborate on the use of pelareorep in combination with CAR-T therapy in solid tumors and in particular the enhanced effectiveness of CAR-T when both "primed" and "boosted by ONCY's pelareoep.]

    https://www.oncolyticsbiotech.com/press-releases/detail/535/oncolytics-biotech-and-solti-achieve-primary-endpoint-in
  • U
    Uber
    Support/Resistance
    Type Value Conf.
    resist. 4.85 1
    resist. 4.66 2
    resist. 4.11 6
    resist. 3.88 3
    resist. 3.65 2
    resist. 3.51 4
    resist. 3.29 4
    resist. 2.95 4
    supp 2.68 6
    supp 2.30 10
    supp 2.05 4
    supp 1.97 2

    The 200 day moving average is $2.46 US and my trend line is now $2.65. If I didn't know Matt/Canaccord was selling shares with both fists right now, I might be tempted to start a position here and put a stop in at $2.60. Believe it or not, going back to October of 2019, ONCY is still in an uptrend.
  • K
    Kenny
    So I got no takers???? Dollar bet that it closes at 4 today! Chickens!!!!! You just watch .... boom surprise!
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    Tumor-tagging by oncolytic viruses: A novel strategy for CAR-T therapy against solid tumors - April 10, 2021

    Highlights

    The less satisfying efficacy of CAR-T cell therapy in solid tumors might at least due to antigen heterogeneity, suboptimal CAR-T cell trafficking and tumor immunosuppressive environment.


    Instead of hunting CAR-T cell targets, tagging tumor cells by oncolytic viruses (OV) provides more choices.


    Oncolytic viruses can deliver novel CAR-T targets specifically to tumor cells, redirecting single-target CAR-T cells to previously antigen-mismatched tumor cells.

    "We mainly focus on the combination with oncolytic viruses (OV), the born allies for CAR-T cells. "
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    The AWARE-1 study confirmed the results of ONCY's IND 213 study which demonstrated the clinical benefit in breast cancer patients who were given pelareorep in combination with chemotherapy. The pelareorep/chemotherapy combination result demonstrated a doubling of OS in breast cancer patients who were administered ONCY's pelareorep + paclitaxel (chemotherapy).

    In an effort to confirm the IND 213 results ( and show that the pelareorep + chemotherapy were "legitimate") the AWARE-1 study was conducted by SOLTI in Spain and as discussed in Dr. Prait's presentation, both the pelareorep + chemotherapy arm (Cohort 1) and the pelareorep + chemotherapy + immune checkpoint inhibitor arm(Cohort 2) demonstrated significant CelTils score increases (70%) along with a robust adaptive immune response in both cohorts, when pelareorep was administered intravenously.

    In effect the IND 213 study acted as a control arm/ study for the AWARE-1 breast cancer study since the iND 213 study compared pelareorep monotherapy against pelareorep + chemotherapy (paclitaxel) combination, and confirmed that pelareorep given as a monotherapy was less effective when given alone in comparison to when pelareorep was combined with a chemotherapy.

    The AWARE-1 study confirmed the IND 213 findings and went on to demonstrate that pelareorep + chemotherapy was able to increase the CelTils score and that the addition of an immune checkpoint inhibitor (atezolizumab) further enhanced the favorable immune responses (turning cold tumors 'hot') in both the tumor and the blood. This has already been discussed in earlier posts, along with the fact that ONCY has confirmed a predictive CelTils/T-Cell clonality/diversity biomarker that will positively identify patients who will respond to pelareorep + immune checkpoint blockade ( again discussed previously)

    These data confirm pelareorep's immune-based MOA and support the clinical rationale for the Phase 2 BRACELET -1 .

    Furthermore, and as discussed on this message board several times, IND 213, AWARE-1, and BRACELET-1 sets the stage for ONCY's Phase 3 study in breast cancer, particularly now that the results have demonstrated continuity in their findings of pelareorep in combination with other agents (chemotherapy and immune checkpoint inhibitors for example).

    Now ONCY's pelareorep is also able to be combined with CAR-T therapy in solid tumors and to enhance the applicability of CAR-T therapy in cancers beyond just liquid cancers.

    Also ONCY's pelareorep is demonstrating to be able to be combined with bispecifics along with PARP and CDK 4,6 inhibitors.
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    A combination of PD‑1/PD‑L1 inhibitors: The prospect of overcoming the weakness of tumor immunotherapy - March 2021

    Authors: Xianbin Kong Peng Lu Chuanxin Liu Yuzhu Guo Yuying Yang Yingying Peng Fangyuan Wang Zhichao Bo Xiaoxin Dou Haoyang Shi Jingyan Meng

    The present study reviews the synergistic effects of PD‑1/PD‑L1 inhibitor with oncolytic virus, tumor vaccine, molecular targeted drugs, immunotherapy, chemotherapy, radiotherapy, intestinal flora and traditional Chinese medicine, to provide information for development of effective combination therapies.
  • d
    dreamer
    My posts keep disappearing so will try again. It appears that onc/oncy was successful in the cohort 2 of the aware1 trial so should bode well for the company going forward. link copied from another forum.
    https://twitter.com/MansoLuigi/status/1380931773358555136
  • s
    stockparty
    The selling began on Friday, and today most biotech got creamed, price drop was going to happen even without the news. News for the most part didn't seem all that new anyway, holding, still not buying here. Typical ONCY price action. Though I would like to see the other cohorts, just looking at the design of the study alone:
    HR+ / HER2- (two cohorts)
    HR+ / HER2+
    HR- / HER2+
    TNBC (triple negative)
    only one biomarker set has two cohorts, the rest have 1, therefore doing both of those will signal relative comparative completeness. So for HR+ / HER2- things look sufficient (in other words excellent) for going forward with a phase 3 clinical trial.

    Therefore this Oncology has a pipeline with two phase 3 clinical trials in the works--that should be dynamite. Coffee is getting offers, no doubt about it. Maybe this less detailed operational view will help some investors.
    Bullish
  • c
    canadafan
    Today’s NR, & data is the best I have ever seen for oncy.
    The 2pm teleconferance will further enhance the price.
    Today?
    Huge volume & wild price swings.
    Short squeeze + above expectations Aware -1 & additional cAr-t results....price will go up, today & next 3 days.
    Enjoy
    Bullish
  • R
    R
    We need a partner. Period! Why after all these years do we not have a partner. We need a phase 3 trial running!
  • N
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    For the naysayers... yes IND 213 can be considered the control because this study determined pelareorep's immune based MOA in breast cancer, with and without chemotherapy, and then the AWARE-1 breast cancer study was able to compare pelareorep + chemotherapy against the triplet combination of pelareorep + chemotherapy + immune checkpoint inhibitor to demonstrate the synergistic effect of adding pelareorep to a checkpoint inhibitor.

    And in each arm pelareorep has been able to demonstrate enhanced effectiveness - from pelareorep monotherapy to pelareorep triple therapy with a checkpoint inhibitor.

    The design of the trials progressively demonstrated pelareorep's MOA and clinical benefit in the treatment of breast cancer while also discovering a predictive biomarker while progressing through this process.
  • R
    R
    Check out US Patents numbers
    10,668,119 Attenuated reovirus
    10,369,171 Attenuated reoviruses for selection of cell populations
    10,260,049 Attenuated reovirus

    patft.uspto.gov/netahtml/PTO/search-adv.htm
  • m
    m00nsh0t
    This recent data presentation may not have been new to some here but it was obviously new to the folks at AACR or they would not have allowed it as late breaking. Both doctors spoke of a wow factor so there is clearly exciting information here. Remember IMMU had the same kind of disparaging comments from their resident bashers as we have here from people like armed uber and some of the newer ones and where did that get them on that board, a $21 billion buyout.
  • a
    armedescapade
    Guys, don't get discouraged. The action of the last few days is 100% normal. Actually it is so normal for ONCY it can be scary. But all it so doing is following market pattern. ONCY and pundits pumped the stock with promises for uplifting , course changing news. As the interest lifted the PPS ATM opened its window and flooded the rise with paper. The players in this rise knew the pattern ,made their money, suckered nubees with 50% loss and left. The company withdrew from the newswire as usual by announcing continuation of action in the next 6 mo's and after. And the usual fluff 0f looking at partners. You are the commodity that's needed. Partners will be looking for you ,no, in this time cycle they should be looking at you. You can bet your life they already did, and just passed by the lemonade stand ,didn't even throw a quarter in the hat. The Market makers will be pushing the price ever lower and accumulate shares for the next April Fools Day. For ONCY that's twice a year, actually 2 and a 1/2 times. April/May , a whiff of one- pre Annual meeting , 1/2 at fall Sept with drop into October/Nov and rise on hope for the "by end of year for sure" thingy told by Mngmnt every year, as was this year. Nothing special, nothing to do with Company performance, it's a façade of show w/smoke and mirrors, daytraders know this stock by heart(wallet), its timing and milk it for all its worth( or not). From this point we can expect testing of the artificial lows (based on threshold of investor' pain) at $2.50US or so and then if there are enough suckers( interest) they will push lower to under $2 and scoop up as many shares as possible from that newly scammed crowd for the inevitable leg up in repetition. I TOLD YOU SO. It isn't on clairvoyance ability it is based solely on experience. If you are fed the same plate of borscht at the same time of day ,day after day, you will be getting sick at the same time of day in a pattern you can describe in your sleep.
    Our only hope is some fund manager had a bad night and skipped over details of ONCY prospectus and bought to fill a quota, the Market will think Christmas coming early, Pharma getting tricked into a love affair and we get a chance to escape with our skins intact. S##$ happens. Maybe we will be the lucky s#!*heads.
  • R
    Ronjohn
    Michael is criticizing management. I guess he finally checked his brokerage account. Prepare for the end of ONCY. 🤔😳