Oncolytics Biotech Inc ONCY

ONCY's pelareorep activates TiLs (CD8+ Dendritic Cells)

[Noteable]

Reovirus Activates Human Dendritic Cells to Promote Innate Antitumor Immunity

The attached link to research conducted in 2008 demonstrated that  [ONCY's] reovirus directly activates human DC and that reovirus-activated DC stimulate innate killing by not only NK cells, but also T cells, and suggested a novel potential role for T cells in oncolytic virus-induced local tumor cell death.

It has been subsequently shown that  reovirus recognition by DC triggers innate effector mechanisms to complement the virus’s direct cytotoxicity, potentially enhancing the efficacy of reovirus as a therapeutic agent.

For example, data from the pancreatic cohort in the Goblet Phase 1/2 cancer study showed a correlation between the expansion of TIL-specific clones and tumor response, which provides compelling support for the use of pelareorep-based therapies in immunologically “cold” tumors. In particular, these data, along with the impressive clinical results, support the ability of pelareorep-checkpoint inhibitor combination therapies to meaningfully improve treatment responses in diseases like pancreatic cancer that have resisted immune-based therapeutic approaches.

https://journals.aai.org/jimmunol/article/180/9/6018/78455/Reovirus-Activates-Human-Dendritic-Cells-to

https://oncolyticsbiotech.com/press_releases/oncolytics-presents-positive-updated-pancreatic-cancer-data-from-goblet-phase-1-2-study-at-esmo/

[Noteable]

In October 2023 ONCY data from the PDAC arm of the GOBLET study (pelareorep + immune checkpoint inhibitor - atezolizumab), was presented showing a 62% objective response rate (ORR), 7.2 months of median progression-free survival (mPFS), interim median overall survival (mOS) of 10.6 months, and expansion of both pre-existing and new T-cell clones.  Analysis of changes of T-cell clones and

[Noteable]

Reovirus (pelareorep) studies have also demonstrated that the PKR- and NF-κB-dependent induction of pro-inflammatory molecules (i.e cytokine  response molecules) that accompanies reovirus-mediated killing can recruit and activate innate and adaptive effector cells [such as macrophages like natural killer (NK) cells, dendritic cells (DC) and cytotoxic T cells (CTL))] thus altering the

[13X2413]

Good to see you're still around. Can you please change your tact and post things specific to ONC?

[Noteable]

It's increasingly obvious that numbersxnumbers doesn't understand what he reads, and just posts to be obstreperous, like his other operatives are doing.

[Azzak34]

Could be more subterfuge however whenever it comes to numbers, bucky, ionc17, quentin you must never rule out stupidity!!! 

[Noteable]

The FDA has increasingly used pooled efficacy analysis to grant an Accelerated Approval and ONCY appears to have such analysis of meta-data in over 120 pancreatic patients to include in a submission for an Accelerated Approval, since the company has been presenting translational data at multiple international conferences and meetings, such as SABCS in December 2023. “Translational data presented

[Buckhenry]

I have never ruled out the stupidity of the pumpers here. It's at the top of my list for them. 

[Peladawn]

Coming from you, thats a compliment.

[Noteable]

Big Pharma companies with ADCs have seen ONCY data's from the PDAC arm of the GOBLET study (pelareorep + chemotherapy + immune checkpoint inhibitor - atezolizumab), that was presented on October 2023 showed a 62% objective response rate (ORR), 7.2 months of median progression-free survival (mPFS), interim median overall survival (mOS) of 10.6 months, and expansion of both pre-existing and

[Noteable]

Reovirus type 3 Dearing (pelareorep), is shown to enhance the efficacy of immunotherapy by recruiting CD8+ T cells to the TME. https://jitc.bmj.com/content/jitc/8/2/e001191.full.pdf

[Noteable]

https://stockhouse.com/companies/bullboard/oncy/oncolytics-biotech-ord-shs?postid=35897324 Since pelareorep has been proven to activate TiLs, specifically CD8+ dendritic cells, and has shown it capability to remodels the tumor microenvironment, which both facilitates and synergizes the addition of an immune checkpoint inhibitor, the combination of pelareorep + immune checkpoint inhibitor is ready

[Noteable]

Overall survival data has  continued to mature  from the BRACELET-1 metastatic breast cancer  Phase 2 study. 12 month data from this sstudyhas already validated the results of IND-213, a prior phase 2 trial that showed a statistically significant which demonstrated a near doubling of median overall survival in HR+/HER2- metastatic breast cancer patients treated with pelareorep

[Noteable]

Should read: Bracelet-1 -  12 month Phase 2 mOS  data" ...  showed a statistically significant near doubling of median overall survival in HR+/HER2- metastatic breast cancer patients treated with pelareorep combined with paclitaxel " compared to paclitaxel alone.

[Peladawn]

Isn't it amazing how there are never any posts that praise the virtues of Queen Kamala that are removed from this thread....and yet the posts praising Trump are regularly removed.....that is all you need to know about the dark road down which this country is headed.

[Peladawn]

This post has been removed in accordance with Community Policy

[venture009]

Noteable, two questions: 1. How does this compare to other treatments available? Are there better options available? 2. If pela is the superior treatment why is there no coverage by infleuential analysts and the interest in the stock is anemic to say the least? As a shareholder for 25 years I have seen all kinds of promises and screw ups by this company and very little enthusiasm shown by the

[Noteable]

With two Phase 2 clinical trials completed, in metastatic breast cancer, namely IND-213 and Bracelet-1, and a PFS, ORR and mOS reported in Bracelet-1 of 38.2%, 37.5% and a near doubling in median overall survival, respectively, ONCY is the closest to an Accelerated Approval than any other agent in this category of immunomodulators. Mature overall survival (OS) from the Bracelet-1 study is

[CMHarring218431]

There's something out there mucking up the water. That's the point. With all these positives, what/who in the world is holding this stock back? Every stock has spurts. Here, it's as if there has been no news for a year. Frustrating 

[13X2413]

The price action speaks volumes. Nobody cares about the positives being spun on this chat. 

[Azzak34]

Good point. It's almost as if the big players don't go on to chat rooms to hear what's going on with the company.  It's a new-ish approach to oncology. We're front row when the MOA proves out. Google it and make sure you read a variety of sources. Getting your info from 1 or 2 places can be detrimental to your IQ. 

[Noteable]

ONCY should be able to eadily enroll 180-200 patients for its Phase2b -> Phase3 -> Confirmatory metastatic breast cancer patients since there is a significant unmet need for patients who will progress from Enhertu 2nd line therapy. Presently overall survival data has continued to mature from the BRACELET-1 metastatic breast cancer Phase 2 study suggesting overall survival (OS) 2+ year data

[Noteable]

Should read: ONCY should be able to easily enroll 180-200 global patients given the unmet medical need in 3rd line mBC that pelareorep + paclitaxel is seeking to address. ONCY is looking to enroll study patients in the United States and EU - so there should be plenty of available clinical trial  participants.

[inthno]

I am not sure how easily it will be able to enroll that many patients as there are a lot of trials out there but with the help of a hopeful partner it will be much easier as it will be promoted much more rather than onc taking the chance of going it alone. That is why even though this is not officially a phase 3 registration trial that it is important that onc has help going forward. Also one must

[Noteable]

As I've already stated It should be easy to enroll 180-200 patients because (1) patients who have progressed from Enhertu will already have been identified as those who are eligible for 3rd line pelareorep + paclitaxel treatment making it a seamless transition from the ADC treatment to pelareorep, and (2) patients will be recruited from the United States and the EU, where patients populations

[Noteable]

And no ... ONCY will NOT be dealing with a different patient population. ONCY will be dealing with the same patient population who have failed a 2nd line breast cancer therapy, whether it was CDK4,6 inhibitors or ADC Enhertu, whose active payload is a chemotherapy - the same therapies that pelareorep was up against in various other completed ONCY trials in which pelareorep had successfully

[Noteable]

Don't lose sight of the fact that 55,000 3rd line mBC patients at a cost of approximately $US 100k per patient treatment equals to $US 5.5 Billion of pelareorep sales annually.

[Noteable]

The long view is eventually moving pelareorep into first line therapy in combination with a variation of immune checkpoint inhibitors +/- bispecifics +/- ADCs +/-   small molecule inhibitors. +/- CAR-T therapy., for example.

[Noteable]

The long view is eventually moving pelareorep into first line therapy in combination with a variation of immune checkpoint inhibitors +/- bispecifics +/- ADCs +/- small molecule inhibitors +/- CAR-T therapy, for example.

[inthno]

I certainly hope that you are right Note as I do not consider 3rd line patients with a compromised immune system the same patient population that was in the mbc 213 trial. As for the 55k patients, whether it will be easy to enrol or not depends upon how well we are promoted as it is still a trial and there might be a lot of companies trying for the same patients. Market has great potential but