Oncolytics Biotech Inc ONCY

Breast cancer treatment: perspectives on the oncolytic virus

[Noteable]

Here is a new review appearing in "Frontiers" on oncolytic virus, including reovirus, in the treatment of breast cancer suggesting that multi-approach strategies - combining OVs and chemotherapy, radiotherapy, or immunotherapy - provide better therapeutic effects and show great potential in future approaches to breast cancer treatment.

March 20, 2024 - "Reovirus is a double-stranded RNA virus. Its replication is promoted in cells with an activated RAS pathway. The gain-of-function mutations, activating RAS signalling, are prevalent in cancers. Therefore, reovirus is a natural candidate for a therapeutic agent (45). Reovirus has oncolytic activity in vitro against multiple solid tumour types, including breast cancer (46). Reolysin is an unmodified wild- type oncolytic reovirus. In 2017, it received FDA approval for the treatment of metastatic breast cancer (46). Data from the Phase II trial for the treatment of advanced metastatic breast cancer showed that the combination of Reolysin and Paclitaxel significantly increased overall survival for about seven months (47). Clinical studies have demonstrated its effectiveness in combination with systemic anti-programmed cell death protein 1 (PD-1). In a murine breast cancer model, intratumoral reovirus increased PD-L1 expression on tumour cells, and combination reovirus/anti-PD-1 treatment improved survival by reducing Treg numbers and ameliorating tumour-specific cytotoxic T lymphocyte responses (48). Reovirus has also been used in combination with CD3-bispecific antibodies. Reovirus-induced IFN stimulated the recruitment of NK cells and reovirus-specific CD8+ T cells to the tumour site, while reovirus-specific effector T cells acted synergistically with CD3- bispecific antibodies, reducing the in vivo growth of several tumour types, including breast (46). Interestingly, this combination treatment was also effective against distant lesions that were not previously injected with reovirus. It suggests the possibility of using this therapy in case of metastatic disease (45). The advances in reovirus engineering have enabled the creation of oncolytic reoviruses that can antagonize inhibitory mechanisms within the TME. In particular, mutations in viral cell attachment protein σ1 gene, have been incorporated to prevent proteolytic cleavage and inactivation of σ1 by breast cancer-associated proteases". 

The advent of precision medicine calls for tailoring OVs to individual patient profiles. Developing personalised viral platforms could involve genetic modifications or viral engineering to enhance tumour specificity, replication efficiency, and immune activation while mitigating adverse effects. Advancements in identifying predictive biomarkers for treatment response remain also urgent. Identifying biomarkers associated with the efficacy of OVs can aid in patient stratification, ensuring targeted therapies for individuals most likely to benefit. 

An exciting frontier remains the synergy between OVs and conventional treatments like chemotherapy, radiotherapy, and immunotherapy. Exploring combination therapies can capitalize on their complementary mechanisms, potentially amplifying therapeutic efficacy and overcoming resistance. 

It is also crucial to find strategies that restore the tumour microenvironment and bolster anti- tumour immune responses. This includes interventions that regulate immune checkpoints, modulate cytokine profiles, or stimulate adaptive immune cells within the tumour milieu.

 

https://www.frontiersin.org/journals/immunology/articles/10.3389/fimmu.2024.1375433/full

[Noteable]

Will oncolytic viruses potentially replace or complement monoclonal antibodies (‘mabs’) like Bevacizumab in the future?  Oncolytic viruses have the potential to complement monoclonal antibodies (mAbs) like Bevacizumab in the future. Oncolytic viruses are a novel regimen in cancer therapy that can mediate antitumor effects by infecting cancer cells and presenting tumor-associated antigens to

[Noteable]

Immunotherapy has been successful in stopping the recurrence of cancer and improving overall survival rates [4]. The combination of immune checkpoint inhibitors with chemotherapy has been approved for the first-line treatment of advanced gastroesophageal junction cancer, esophageal cancer, and gastric cancer [5]. The role of immunosuppressive cells within the tumor microenvironment in

[Noteable]

In the event you missed it because you were caught up in your conspiracy "bot" stuff ... An exciting frontier remains the synergy between OVs and conventional treatments like chemotherapy, radiotherapy, and immunotherapy. Exploring combination therapies can capitalize on their complementary mechanisms, potentially amplifying therapeutic efficacy and overcoming resistance.  It

[Noteable]

April 02, 2024 - Study reveals immune cell levels as prognostic marker in early-stage triple-negative breast cancer (TNBC)  Immune cells, also known as tumor-infiltrating lymphocytes, or TILs, are naturally existing immune system cells that can move from the bloodstream into a tumor and can recognize and destroy cancer cells.   " This is an important finding because it

[Noteable]

On April 12, 2024 ONCY announced that the company would be requesting a “Type C” meeting with the FDA , based on data from the Bracelet-1 breast cancer study.   “The data from the randomized BRACELET-1 trial showcased compelling results for the pelareorep/paclitaxel combination therapy in [patients with] HR-positive/HER2-negative metastatic breast cancer, with a nearly tripled confirmed ORR,

[Noteable]

(European Journal of Pharmaceutics and Biopharmaceutics June 2024) ".. Importantly, squential administration of the investigational agents (priming with the vector) further enhanced the anti-cancer efficacy in 3D culture over other groups tested. Taken together, these results support further evaluation of the virus in combination with anti-PD-1 and PTX for the treatment of triple-negative

[Noteable]

March 19, 2024 - Clinical evidence involving the checkpoint inhibitor pembrolizumab + chemotherapy demonstrates effectiveness in triple negative breast cancer (TNBC) pointing towards the benefit of adding an oncolytic virus, like ONCY's pelareorep, to further enhance the above effective doublet in both TNBC and ER+/HER2 negative breast cancer. "Patients were either treated with

[Noteable]

"TNBCs have the highest levels of TILs, expression of immune evasion molecules in a tumor microenvironment such as PD-L1, and the most genomic instability compared with other breast cancer subtypes, which consequently makes it an immunogenic disease. Recently, results from several clinical studies showed that immune checkpoint inhibitors alone or in combination with a backbone (chemotherapy

[Noteable]

https://stockhouse.com/companies/bullboard/t.onc/oncolytics-biotech-inc?postid=36092881

[Noteable]

Patholgists have recently made recommendations to include TILs in the pathology reports of early-stage TNBC worldwide, as it has the potential to inform clinicians and patients when they discuss treatment options. This biomarker would only require a visual evaluation by a pathologist looking through a microscope, meaning there are no additional costs associated with identifying the presence of

[Noteable]

In 2022, there were 2.3 million women diagnosed with breast cancer and 670 000 deaths globally. https://www.who.int/news-room/fact-sheets/detail/breast-cancer In 2024 approximately 310,720 women and 2,800 men will be diagnosed with invasive breast cancer in the United States. There are currently more than 4 million women with a history of breast canacer in the United States. This

[Noteable]

April 2024 -   Oncolytic virus-based combination therapy in breast cancer Highlights • - Breast cancer's heterogeneity makes single treatments less effective. • - Oncolytic viruses can work in synergy with other therapies to boost the immune system's ability to target and destroy breast cancer cells. • - Combination therapy

[Noteable]

https://stockhouse.com/companies/bullboard/t.onc/oncolytics-biotech-inc?postid=36005001

[Noteable]

Advancements in identifying predictive biomarkers for treatment response remain also urgent. Identifying biomarkers associated with the efficacy of OVs can aid in patient stratification, ensuring targeted therapies for individuals most likely to benefit.  An exciting frontier remains the synergy between OVs and conventional treatments like chemotherapy, radiotherapy, and immunotherapy

[Noteable]

Employing biomarkers and surrogate endpoints in Orphan/Rare diseases, like in metatstatic breast cancer, result in smaller registration studies and more particularly opens the door for "Accelerated Approval" and smaller/quicker post approval confirmation studies.  Consequently it would appear that ONCY has asked for a meeting with the FDA to have them confirm the biomarkers

[Noteable]

April 02, 2024 - Paper appearing in JAMA concludes that:  "In patients with early-stage TNBC who did not undergo adjuvant or neoadjuvant chemotherapy, breast cancer tissue with a higher abundance of TIL levels was associated with significantly better survival. These results suggest that breast tissue TIL abundance is a prognostic factor for patients with early-stage TNBC." https

[Noteable]

A new multicenter, international study suggests that people who have early-stage triple-negative breast cancer (TNBC) and high levels of immune cells within their tumors may have a lower risk of recurrence and better survival rates even when not treated with chemotherapy. The study was published today in the Journal of American Medical Association (JAMA). - Mayo Clinic review https://cancerblog

[Noteable]

https://stockhouse.com/companies/bullboard/oncy/oncolytics-biotech-inc?postid=36009698

[Noteable]

https://www.tiktok.com/@drteplinsky/video/7354838139112000814

[Noteable]

Some ask whether oncolytic viruses have been making progress in their offerings in the treatment of cancer and the conclusive answer is YES, particularly now that Big Pharma is beginning to embrace their need to combine cancer therapies to have a durable effect in the treatment of cancer. The same fundamental understanding of the need to combine various immune directed therapies came in the

[JohnnyYeg]

Thanks for that great overview Noteable. Concise and informative as always! 

[Noteable]

Cheers JohnnyYEG.

[Noteable]

Consequently ONCY will likely be acquired before it has to commence enrolling any patients in its planned Phase 2 180-200 patient HR+/HER2- metastatic breadt cancer study, or shortly after the enrollment process starts. So while Kirk Look has speculated that it would take 3-5 years to receive both PDAC and mBC FDA approval. That timeline is for 2 approvals in 2 different indications that ONCY is

[Noteable]

Also, because Kirk Look is a Chartered Public Accountant (CPA), which he made intentionally known at the Cantor's Global Healthcare Conference, Kirk Look has no acquired knowledge of how the Accelerated Approval process works or for that matter, how long a registrational study would take to complete if an Accelerated Approval isn't granted very much sooner than he extemporaneously

[13X2413]

Now you're really scrambling. It's hilarious that you're actually saying that Look doesn't know what he's talking about because he's only the CFO of the company??!! He's been involved since 2003, so don't you think he may have some idea or may have actually talked to people before releasing information to the public? When you're not cut and pasting, you make

[Noteable]

Exactly! He's a CPA and inappropriate as a spokeperson for a biotech. His knowledge and temperment is best suited for a small regional bank.

[13X2413]

He's a reflection of the operation. If he's inappropriate, don't you think a legit company would have someone on staff who is appropriate?

[Noteable]

What is further disturbing about Kirk Look is that he's been granting private conversations with investors and providing them with personal opinions that have little basis in an  overall knowledge of the pharma industry's practices and procedures. Whatever his knowledge happens to be it comes through a narrow and restricted lens that serves only a few.

[Noteable]

ONCY has sufficient positive data for an early Accelerated Approval in HR+HER2- mBC, with further positive data from ONCY's Phase 2 PDAC clinical trial being released sometime in Q4 2024, that will be entering into a CGAR adaptive Phase 2 clinical trial that also will be headed towards an Acclerated Approval. Nothing inept in that. So ONCY should be focused on both getting the HER2- mBC

[Noteable]

Clearly Kirk Look lacks an understanding of the global HR+/HER- mBC markets, since he only cited the US market and left out the ROW, notwihstanding that it is presently being reported that the demand is hot for big results in key markets like mBC with an unmet treatment need. Hot demand for biotech assets that can effectively address key cancer markets with unmet treatment needs, like HR+/HER2

[Noteable]

ONCY's prospective multi-billion dollar valuation is in breast, pancreatic, anal, GI and colorectal cancers, for example.

[Noteable]

Kirk Look has a history of down-playing the positives much too llong.

[Noteable]

Cancer immunotherapy research is following a fairly typical pattern, though. Generally, drug development occurs in 10-year cycles, said Caroline Loew, formerly Bristol Myers’ R&D strategy and planning chief and now CEO of Mural Oncology., and in immunotherapy, “we’re about to see another evolution, another step change.”  “It really does start with harnessing your own immune system

[Noteable]

The first decade in immunotherapy started in 2014 when Merck beat Bristol Myers to market, gaining an accelerated approval in melanoma for pembrolizumab, or Keytruda, on Sept. 4, 2014, more than three months ahead of Opdivo. While the two companies worked to shore up those first approvals in melanoma, a second prize awaited in a common form lung cancer. Once again, Merck got there first, winning

[Noteable]

What is beginning to be better understood is that PD1 drugs alone  are not a panaceas to an effective canxer treatment since approximately only 20-30% of the patients treated respond. What has been identified as a significant issue can be simply described as an immunosuppressed tumor microenvironment (TME) and insufficient level of TiLs and CD+8 cells that leads to T-cell exhaustion which are

[13X2413]

Note..... is this some sort of secret information that's being kept from potential investors? Price and volume indicates that nobody cares about ONC. A nearby 3 year low speaks volumes. 

[Noteable]

The advent of precision medicine calls for advancements in identifying predictive biomarkers for treatment response remain also urgent. Identifying biomarkers associated with the efficacy of OVs can aid in patient stratification, ensuring targeted therapies for individuals most likely to benefit.  https://stockhouse.com/companies/bullboard/t.onc/oncolytics-biotech-inc?postid=36118147

[Peladawn]

Isn't it funny how the leftwing mainstream media is now, suddenly, unanimously, "shocked" by our babbler-in-chief's disastrous debate performance.....when for 3 1/2 years they've been indoctrinating all the brainwashed as to how Biden is "sharp as a tack", and "runs circles around everyone around him"...5 .....the never-ending drumbeat of blatant lies

[Azzak34]

It was a horrific performance by JB no question and may well be indicative of a downward trend in competency for the job.  I imagine the guys are just busy reading the alleged newly released Epshtein documents where the orange man appears to be implicated in engaging in the worst kind of behavior possible. Have a read and let us know what you think. 

[Peladawn]

Not sure what you're reading, but one thing I can tell you for certain, is that there was even one iota, one tiny molecule, of misbehavior by "the most evil man in history" in any Epstein document, it would be front page and centre on every leftwing hack rag in the entire world.....the fact that Trump knew him as a fellow billionaire does not make him guilty of "the worst kind

[Peladawn]

Oh, and btw, Azzak, just out of curiosity, why exactly is it you like 20% inflation, thousands of unvetted illegal immigrants criminals walking freely across the southern border and some of them raping and murdering young girls, Mexican cartels making billions on sex trafficking young immigrant girls and boys, and smuggling deadly fentanyl pills that are killing thousands, Iran now building

[Azzak34]

For me I would like everyone would be even handed and consistent in everything they do/say.  I agree that the media would be picking on DT if there were hard evidence on this particular case..... however time will tell if there's any veracity to it. 

[Angler101]

If you would like everyone to be even-handed, then try being even remotely that way yourself....there's plenty of dirt to go after Biden about, but you and the rest of the kool-aiders always give him a free pass....sad.

[Azzak34]

I am not disagreeing with that. But again, you want a "cleanest dirty shirt in the hamper" debate. If your guy is dirty and their guy is dirty then maybe you have more in common than you think. 

[Angler101]

Azzak.....here are some facts for you to ponder....if you can actually wrap yoir head around them, then perhaps we can actually have a serious debate ....90% of journalists, by their own admission, are liberals (look up the polls) ....left leaning newspapers like the NYT and WSJ, and networks like CNN, MSNBC, etc. haven't endorsed a Republican candidate since the 80s .....they all started

[Azzak34]

The time it took you to write that could have been spent educating yourself.  I 100% agree the mainstream media is highlighting DTs alleged criminal activity and minimizing JBs, for me that is unequivocally true. But please stop putting your guy up as the savior of anything nevermind a country. He had 4 years to "drain the swamp" and he didn't. I will concede he did some good

[Peladawn]

Azzak....."If your guy can't survive the scrutiny".....oh you mean scrutiny from the blatantly obviously biased 90% leftwing corrupt media?.....well, my sadly uneducated friend, in spite of these relentless attacks, Trump is leading by a substantial margin in every poll out there including every one of the battleground states, and by a wide margin amongst young voters between 18 and

[Azzak34]

Man you're all the in on the Kool aid eh?! And again..... I agree the media is 100% highlighting his alleged crimes while minimizing JBs, although I suspect that'll change soon if he doesn't drop out. I'm no fan of either one of them so maybe loosen the maga hat, let the blood flow back to your brain and do some of your own thinking.  I'm not saying he did any of this but

[Peladawn]

This post has been removed in accordance with Community Policy

[Peladawn]

And what the heck are you talking about with the Epstein files?!....Trump has no say on whether or not the Epstein files are released!...That is simply more lies from the corrupt media attacking Trump....he has nothing to hide, because as I tried(with apparently no success) to tell you before, if there was one tiny molecule of criminality by Trump in the Epstein files, it would be pasted front and

[Peladawn]

Hey Azzak...I just watched an interview with the president of Finland, the lastest member of NATO...........he said there were only 3 members of NATO that were actually paying the required 2% of their gdp....since Trump came in a stirred things up, now there are 23.....NATO has received over $100 million dollars in payments since the Trump administration basically shamed members to finally start

[Azzak34]

It's a bit disingenuous to cherry pick information and I can't keep saying this if you're not reading it.... I think he did plenty of good things in office, that's not in question.  You didn't address the list of accusations you said I couldn't produce.  He did an interview where he said he wouldn't release the Epshtein files, go look that up. I suspect

[Peladawn]

Once again, I ask you, what makes you think Trump has anything to do with whether or not the Epstein files are released?.....whatever the h you're talking about was highly likely taken completely out of context, just like when Trump said he'd be a dictator on his first day of office, and since I've heard dozens of Democrats and just as many left wing hack pundits proclaim that "

[Azzak34]

Just stick Epshtein/ Trump release files in to YouTube amd you'll see what he said. Just have a look and tell me what you think. Yeah they definitely do take that out of context about the dictator and some of the left wing media are absolutely milking that for their own purposes. He still said he'd be a dictator on his first day though so that's still not great in a free society. 

[Peladawn]

You have got to be kidding me!....you think dictatorships last one day?....lmfao......you're not very good at picking up on sarcasm, are you....geez!.... but, not to change the subject, I just wanted to take this  chance to offer my deepest condolences to all the Democrats who are in mourning this evening because of the death of their last chance to take out their political opponent.....

[Angler101]

This post has been removed in accordance with Community Policy

[m00nsh0ts]

And on July 8, the divider in chief said "It's time to put Trump in the Bullseye".

[itntdf]

so, after the supreme court ruling, are you saying that only don is entitled to do things which might be considered to be in the outer perimeter of a president's official duties?  seems if one has taken an oath to defend against enemies both foreign and domestic and you want to blame joe that someone who wants to suspend the constitution and be a dictator would reasonably be considered a

[Angler101]

Moonshot....It wouldn't surprise me if this thing was orchestrated by the people around Biden, who are running things(certainly not President Mr. Mumbles!).....but what I know for certain is that a report just came out that the Trump campaign has asked and been refused upgraded levels of Secret Service protection numerous times. He basically has the same coverage as Hunter Biden.

[Peladawn]

The Dems think it's just fine to spend over 600 Billion tax-payer dollars buying themselves votes by "forgiving" student loans, but god forbid they spend a couple million on secret service protection for a political opponent......this from the party gaslighting the country that Trump is a "danger to democracy"...what a joke!....whenever I hear somebody say, I'm a

[Buckhenry]

Ole unnoteable has been touting those patent cliffs for years. Does not mean they are lined up trying to buy this pos stock. But keep up the rhetoric postings. 

[13X2413]

Up to over 900 shares today. The demand is overwhelming. Hang onto your hats. :)  I think the big players are playing possum just to annoy us. Come to think of it, not much from Azz and Not either. Is that an omen?

[Buckhenry]

The only cliff looming is the one this stock is going off of...

[Peladawn]

 Oh, and here is a list of Trump's accomplishments....about 99% of it was never covered by the corrupt mainstream media.....if you have an extra four or five hours, go ahead and educate yourself....cheers. https://trumpwhitehouse.archives.gov/trump-administration-accomplishments/

[Azzak34]

Yeah but that's coming from his administration? Go back and find us an impartial, bipartisan source. I think I said previously that he had quite a few wins in his presidency. I don't even think he did a bad job legislatively for the US. It's who he his and what he's being accused of that concerns me!!!! 

[Peladawn]

Yes it is coming from his administration.....but everyone knows that there was 1.4% inflation....gas was about half the price it is now....the border was under the best control it had been in decades.....no wars were erupting around the world...wages were rising at a rate far outpacing inflation....interest rates weren't exploding....jobs and industries were coming back to the US..... AZZAK.