Oncolytics Biotech Inc ONCY

CD8+ TiLs and T-cell exhaustion

[Noteable]

CD8+ TiL cells are critical mediators of cytotoxic effector function in cancer, however, in cancer, CD8+ TiL cells undergo a progressive loss of cytokine production and cytotoxicity, a state termed T-cell exhaustion as well as T-cell dysfuntion, resulting in a failure of T-cells to eradicate tumor cells in the tumor microenvironment (TME).

Also, high levels of PD-1 expression contribute to the characteristic dysfunction seen in exhausted CD8+ TiL cells. Correspondingly, in human tumors, a higher proportion of progenitor exhausted cells was associated with a greater likelihood of response to checkpoint blockade. While PD-1 blockade therapies have been successful in multiple tumor types, their effectiveness has been limited to between 10-20% of the patients treated. 

Results from ONCY's AWARE-1 study showed that pelareorep treatment upregulated tumor PD-L1 expression, induced the generation and expansion of T cell clones, promoted tumor infiltration of CD8+ TiL cells, and increased the CelTIL score, a measure of tumor cellularity and inflammation associated with favorable clinical outcomes. Besides being able to overcome an immunosuppressive TME, pelareorp is a critical 'facilitator' in 'priming' the adaptive immune system in advance of PD-1 blockade, thus turning a 'cold' tumor into a 'hot' tumor that is more much conducive for PD-1 blockade, and a more effective I/O therapy than either agent alone.

https://www.newswire.ca/news-releases/oncolytics-biotech-r-and-solti-achieve-primary-endpoint-in-aware-1-study-871181269.html

[Noteable]

According the the following linked review ... 'Clinical use of various forms of immunotherapeutic drugs in glioblastoma (GBM), has highlighted severe T cell dysfunction such as exhaustion in GBM patients. However, reversing T cell exhaustion using immune checkpoint inhibitors in GBM clinical trials has not shown significant overall survival benefit. Phenotypically, CD8+ T cells with

[canadafan]

All we need is an announcement of a Car-t development / deal. with some up front & some future bio bucks & the price will recover quite well. IMHO, we will hear about a CAR-t deal, before end of this year. previously I said " soon".... well in relative terms of a 20 yr company, a few months is soon. thinking out loud..... quickest path to the deal? request for information

[Noteable]

September 2023 - The FDA has extended the priority review period for the biologics license application (BLA) seeking the approval of the tumor infiltrating lymphocyte (TIL) therapy lifileucel (LN-144) for the treatment of patients with advanced melanoma who progressed on or after anti–PD-1/PD-L1 therapy and targeted therapy. the updated PDUFA date is February 24, 2024. The BLA was supported

[Noteable]

Repost - CD8+ TiL cells are critical mediators of cytotoxic effector function in cancer, however, in cancer, CD8+ TiL cells undergo a progressive loss of cytokine production and cytotoxicity, a state termed T-cell exhaustion as well as T-cell dysfuntion, resulting in a failure of T-cells to eradicate tumor cells in the tumor microenvironment (TME). Also, high levels of PD-1

[Noteable]

https://stockhouse.com/companies/bullboard/oncy/oncolytics-biotech-inc?postid=35969330 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

[Noteable]

Repost - CD8+ TiL cells are critical mediators of cytotoxic effector function in cancer, however, in cancer, CD8+ TiL cells undergo a progressive loss of cytokine production and cytotoxicity, a state termed T-cell exhaustion as well as T-cell dysfuntion, resulting in a failure of T-cells to eradicate tumor cells in the tumor microenvironment (TME).   Also, high levels of PD-1 expression

[Noteable]

https://stockhouse.com/companies/bullboard/t.onc/oncolytics-biotech-inc?postid=36006537

[Noteable]

ONCY's drug platform pelareorep is part of that promising future referenced in the previous post. In particular,  ONCY's AWARE-1 study showed that pelareorep treatment upregulated tumor PD-L1 expression, induced the generation and expansion of T cell clones, promoted tumor infiltration of CD8+ TiL cells, and increased the CelTIL score, a measure of tumor cellularity and

[Noteable]

March 24, 2024 -  Tumor-Infiltrating Lymphocytes (TILs) in Breast Cancer: Prognostic and Predictive Significance across Molecular Subtypes  " Tumor-infiltrating lymphocytes (TILs) are pivotal in the immune response against breast cancer (BC), with their prognostic and predictive significance varying across BC subtypes. In triple-negative BC (TNBC), higher TIL levels correlate with

[Noteable]

April 24, 2024 -  " TILs and their subtypes can be used in gastric cancers (GC) for predictive and prognostic purposes. The complex interplay of TILs with factors like MMR, HER2, and H. pylori infection demonstrates that they form an integral part of the immune response to the tumor cells." "In conclusion, TILs represent a promising avenue in the battle against GC. It is

[Noteable]

December 07, 2023 - - Pelareorep induced prominent expansion of pre-existing Tumor Infiltrating Lymphocytes (TILs) in the blood and new TILs in the tumor - Data highlights the association between the expansion of existing TILs in the blood and decreased tumor size - Results affirm pelareorep's role as an immunotherapy https://www.newswire.ca/news-releases/oncolytics-biotech-r-and-solti

[Noteable]

On the Prognostic Power of Tumor-Infiltrating Lymphocytes – A Critical Commentary The prognostic value of tumor-infiltrating lymphocytes (TILs) in pediatric cancer is significant. Studies have shown that higher counts of CD8+ TILs in pediatric tumors are associated with better clinical outcomes, including lower tumor recurrence rates and improved disease-free survival. https://typeset.io/papers

[Noteable]

https://southfloridahospitalnews.com/new-study-finds-triple-negative-breast-cancer-tumors-with-an-increase-in-immune-cells-have-lower-risk-of-recurrence-after-surgery/

[Noteable]

April 02, 2024 - Mayo Clinic -  "Five years after surgery, 95% of participants with small tumors, stage 1 TNBC, and whose tumors had high TILs were alive, compared to 82% of patients whose tumors had low TILs. Importantly, the breast cancer recurrence rate was significantly lower among patients whose tumors had high TILs," says co-senior author, Stefan Michiels, Ph.D., head of

[Noteable]

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

[Noteable]

https://stockhouse.com/companies/bullboard/t.onc/oncolytics-biotech-inc?postid=36068453

[Noteable]

  Meeting Abstract: 2024 ASCO Annual Meeting I F Developmental Therapeutics—Immunotherapy  - May 29, 2024 Volume 42 Issue 16_suppl June 1, 2024 2024 ASCO Annual Meeting I Pelareorep driven blood TIL expansion in patients with pancreatic, breast and colon cancer. https://ascopubs.org/doi/10.1200/JCO.2024.42.16_suppl.e14625

[Noteable]

Tumor-infiltrating lymphocytes (TILs), frontline soldiers of the adaptive immune system, are recruited into the tumor site to fight against tumors. Recent advances in how ONCY's pelareorep remodels the TME and precludes T cell immune exhaustion, while bestowing its synergistic benefits to immune checkpoints have paved the way for the understanding of how pelareorep is able to enhance the

[Noteable]

ASCO 2024 poster conclusions support the previous post's observations that external TiLs therapy is not required with ONCY's pelareorep in order to gain the same advantages of T cell expansion and tumor killing effect.. To quote:   "These findings, while preliminary, suggest that the clinical benefits observed following pela immunotherapy may be mechanistically analogous to

[Noteable]

The tumor microenvironment (TME)  primarily comprises cancer cells, cancer-infiltrating immune cells, and stromal cells. And while tumor cells alter the TME by secreting signaling molecules to induce immune tolerance, ONCY's pelareorep is able to enhance the propagation of new and existing TiLs, thus remodeling the TME, and these immune cell infiltrating and remodeling the TME positively

[Noteable]

The tumor microenvironment (TME)  primarily comprises cancer cells, cancer-infiltrating immune cells, and stromal cells. And while tumor cells alter the TME by secreting signaling molecules to induce immune tolerance, ONCY's pelareorep is able to enhance the propagation of new and existing TiLs, thus remodeling the TME, and these immune cell infiltrating and remodeling the TME positively

[Noteable]

June 2024 - 'Proteomic analysis of CD8+ T lymphocytes in peripheral blood across different breast cancer subtypes provides a comprehensive view of the molecular mechanisms of the systemic immune response that can significantly contribute to advancements in the diagnosis, treatment, and prognosis of this disease." https://www.mdpi.com/1422-0067/25/12/6423 2024 ASCO Annual Meeting

[Noteable]

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

[Noteable]

CD8+ TiL cells are critical mediators of cytotoxic effector function in cancer, however, in cancer, CD8+ TiL cells undergo a progressive loss of cytokine production and cytotoxicity, a state termed T-cell exhaustion as well as T-cell dysfuntion, resulting in a failure of T-cells to eradicate tumor cells in the tumor microenvironment (TME). Also, high levels of PD-1 expression contribute

[Noteable]

ESMO 2022 - Poster - Results from Aware-1  https://oncolyticsbiotech.com/wp-content/uploads/2022/04/AWARE-1-ESMO-BC-poster.pdf Conclusion: Previously we showed that Cohort 2 met the study’s success criterion of ≥30% increase in CelTIL score in at least 50% of the patients   The additional translational research results presented here show that pelareorep and atezolizumab act

[Noteable]

December 2023 - Poster at SABCS T Cell Receptor Sequencing to Monitor Pelareorep-Induced Expansion of Tumor Infiltrating Lymphocytes (TiLs) Conclusions  • These results confirm the previously reported CelTIL results from AWARE-1 demonstrating pelainduced increases in TILs post-treatment • Clonal expansion of TILs was also observed in the blood • Newly detected TIL clones were more

[13X2413]

Not sure why you're citing old news that has resulted in the share price languishing at $1.36.  Can you please bring up fresh and exciting info that will get some sort of buying by smart money. 

[Noteable]

The information that I post is related, like ONCY's planned mBC registration study design being similar to Pfizer's Paloma and Daiichi's Destiny study designs, which lead to both drugs being approved through the FDA Accelerated Approval pathway. 

[Noteable]

  March 5, 2024 , by Carmen Phillips   FDA has approved the first treatment for cancer that uses tumor-infiltrating lymphocytes, or TILs. Credit: National Cancer Institute In an event more than three decades in the making, the Food and Drug Administration (FDA) has approved lifileucel (Amtagvi), the first treatment for cancer that

[Noteable]

Iovance is pricing their TiLs treatment at a wholesale acquisition cost of $515,000 per patient, the company’s interim CEO Frederick Vogt, Ph.D. Iovance's TiLs product, Amtagvi is manufactured using immune cells from individual patients. To make the final product, a patient’s TIL cells are collected from a portion of their resected tumor and then expanded outside the body before being

[Peladawn]

If you as a voter want tax cuts, and conservative, common sense spending, vote Trump.....if you want 3 to 5 trillion (by her own admission) in tax increases, and out of control spending and bigger government, vote for Kacklin Kamala. For a person with even limited intelligence, the choice should be obvious.....historically, unfortunately, that excludes about 75 million Liberals.

[Noteable]

I wonder if "he" knew that Celine's song 'My Heart Will Go On" featured a sinking ship in the movie The Titanic.

[Azzak34]

Taxes have to go up and spending has to go down. No matter who is in charge.  Am I detecting a realization that the orange convict can't win this race anymore? It's all over baby. Cackling Kamala is the next President!!! 

[venture009]

Azzaro, have you forgotten that Trumps administration lowered the tax rate  which resulted in an increase in tax revenue. It's nieve to think corporations will absorb any tax increases and not pass it onto the consumer.  Won't happen.  Hence more inflation. On the ONC front an increase in volume on the NASDQ and sp down may suggest the ATM is at work. With one year cash

[itntdf]

?????Azzaro, have you forgotten that Trumps administration lowered the tax rate  which resulted in an increase in tax revenue.????? tax cuts initially enacted during the republican trifectas in the past 25 years slashed taxes disproportionately for the wealthy and profitable corporations, severely reducing federal revenues. if not for the bush tax cuts and their extensions as well as the

[Peladawn]

Itntdf....so you've got it all figured out do ya?.....is that why inflation during the Trump admin averaged 1.7% and averaged 6% during the Biden-Harris disaster?.....and you people are cheering for another 4 or even 8 years of that?.....God help us!....If Kacklin Kamala gets elected, it will be cataclysmic for this Nation and the World.....I'll be fine out here on my sailboat, but

[venture009]

Did tax revenues increase or decrease? 

[Peladawn]

Tax revenues increased....because Trump had the country running on all 8 cylinders....any honest economist will tell you that we had the strongest economy in decades....the tax breaks had companies repatriating trillions of dollars back into the country that had previously been taken out, exactly because of excessive tax pressure.

[venture009]

Did tax revenues increase or decrease?

[Azzak34]

What are you looking at Venture because I'm seeing answers for both potential outcomes here? Tough to find an impartial answer.  It's skewed no matter which agenda the writer ascribes to.  Post a link and I'll have a read. 

[venture009]

Anzac, the tax rules are far more complicated since globalization.  Countries now compete with each other to attract corporations. Therefore   increasing taxes stands a very strong possibility that the lower tax destination will attract companies.  Before Trumps tax cut the US had some of the highest corporate taxes. They are currently in middle of the pack. Countries have

[Azzak34]

I actually like you Venture so please don't think I'm being a doosh here.  You are so close on every thing you just said. But you're actually making an argument for more migration which helps expand economies. Thats the whole reason for it!! That's what the right never acknowledges. To continue expansion requires more of everything, people, money, resources etc.  You

[Angler101]

Azzak....you haven't got a clue.....socialism! Really?....Name one country where socialism did NOT end in total disaster!....You're an advocate of smaller government!?....and yet you're pulling for the Demautocrat machine!?....Lol....oh, you mean smaller govt. like the 87000 new IRS agents the Biden/Harris regime hired to go after anyone with an extra few dollars to spare?...that's

[Azzak34]

Socialism is all around you!!!! When the banks failed in '08, who bailed them out? When they fail again, who will bail them out? Read about Dodd Frank and please God begin to educate yourself. Didn't you read what I wrote? The major institutions are all socialist. Banks use a fractional reserve lending system, what does that rely on? Insurance companies pay out claims on the basis that the

[Peladawn]

Listen to yourself!.....you keep telling me to educate myself, but I, at least, am educated enough to know who bailed out the banks.....hint....it wasn't the Republicans....the reason we see socialism all around us is because millions of useful idiots keep cheering for the Demautocrats that are doing everything they possibly can to turn our country into one party rule......you're like an

[Azzak34]

Hahahaha it was!!!!  Senate voted on it and Bush signed it!!!! That's good Ole Dubya, a republican who invaded Iraq on falsified evidence!!!!  I want the big banks out!!! If you're going to privatize gains and socialize losses what is the point of a profit driven, privately owned corporation??  The Senate approved the plan Wednesday night by 74 to 25, after adding a

[Peladawn]

See, there you go again....anything good that happens, according to you, it's because of the Dems, anything bad?.....oh, that had to be the Republicans!.....was the bill that passed through the senate signed only by Republicans, Azzak?......oh, and you still haven't revealed all the countries where this wonderful communism (aka "socialism") worked out to anything but total

[Azzak34]

Haha Peladawn.... Listen to yourself!.....you keep telling me to educate myself, but I, at least, am educated enough to know who bailed out the banks.....hint....it wasn't the Republicans Are we moving past the fact that it was the Republicans that signed that bailout in to law? Have you conceded that ground? Are you educated enough to realize you were hilariously wrong?  Yes the

[Peladawn]

Yes, I admit I was wrong....it was Bush that signed the Bill....now, you tell me, was it only Republicans that passed the bill, or did just as many and possibly even more Dems have a hand in it?...or have you moved past that....as you have with numerous other topics you still haven't had answers for.

[Azzak34]

That wasn't your argument. You said it wasn't the Republicans who bailed out the banks. It was. A republican president signed it in to law. And yes, democrats also voted for that bill.  List your questions you believe I haven't answered and I shall do my best. 

[venture009]

Of course it is . You missed the point.  It creates more and more debt and eventually you can't pay even the carrying costs . The US is a few years away from this occurrence. In the mean time everyone's standard of living declines and dopes keeping wanting the government to do more. If you're one of those then like so many you haven't learned much. Freedom is being erased by

[Azzak34]

I think you and I are on exactly the same team, we're just coming at it from opposite sides. The Scandinavians have a hybrid socialist/ capitalist system and they're doing great.  The government won't save the people, no matter who is in charge. It's oppression both ways. You may be more ok with the freedoms Republicans take versus what the Democrats take but they're

[Peladawn]

Of course they have....it's called something that totally illudes you...common sense. -Democrats have made the stupid people believe that requiring a citizen to have proof of citizenship is "restricting voting rights" -so-called "protesters" who burn down innocent people's businesses and attack people, SHOULD be given HARSH penalties....if it was YOUR business burned

[Azzak34]

I actually don't disagree with much there. I do find it funny that a debate about education starts with what is ***eluding*** me!!  Ok now what have the Republicans done that have impinged on peoples freedoms? There's quite a bit so let's see your scientific approach to data. Very difficult argument for to make about public disorder when it was your guys who "stormed"

[Peladawn]

Speaking about education, when you say "peoples freedoms", shouldn't that be ***peoples' *** freedoms? 'my guys stormed the capital" was a fabricated lie from the beginning....my guys held a peaceful protest of the capital (which you just advocated for in your last post)....it was the Soros-backed paid malicious protesters that did the storming....it was Nancy Pelosi

[Azzak34]

I think I said that the "Insurrectionists" were coerced in to assaulting the building no? Your team took the bait and got yourselves in to trouble no? Twas the right wingers strolling through the capital building was it not?  He's already been found guilty of fraud no? 

[Peladawn]

Sure, some Republican protesters strolled through the capital building, ...they followed once the doors were thrown wide open by the Dem- run capital police, but it was the paid Soros-backed rioters that have been photographed in riots all over the country, that perpetrated all the violence.   and yes, Trump was found guilty of "fraud", but the only fraud was the sham trial and

[Buckhenry]

Let's stick to bashing this stock. Take your politics somewhere else. 

[Peladawn]

Bucky.....take a very long walk on a short peer.

[Peladawn]

It's fascinating how Kamacameleon is now promising, on day one, when she is in the White House to fix the problems at the border (you know, the problems that the Biden/Harris administration purposely caused by reversing Trump's policies, the problems that she totally denied for 3 1/2 years even existed).......but seeing as how she is already in the White House, and has been there for over

[m00nsh0ts]

You're right they're the ones who pushed the tax on tips wanted 87,000 new IRS agents to enforce. Thie latest hypocrisy you'll need photo ID to get into DNC Convention   no ID needed to vote.

[Buckhenry]

I reported u girls.. STAY ON TOPIC... 

[Peladawn]

You reported us?....Oh NO!.....The Humanity!

[Azzak34]

Haha Bucky. You don't even have shares here, your presence isn't required. 

[Buckhenry]

Hopefully Trump gets elected and half ..or more...of the liberals move to Canada.......

[Azzak34]

Not a surprise Buckster is on that team.  Well said Canadafan. 

[Buckhenry]

Not forTrump but sure don't want kamikaze in there. And Canada needs more woke liberals. 

[Noteable]

Should read " ...led to both drugs being approved through the FDA's Accelerated Approval process/pathway. "

[Noteable]

As posted beforehand in this thread while immune checkpoint inhibition (ICI) therapy can be approximately 20-30% effective in a broad variety of tumors, resistance to ICIs arises from immune suppressive tumor microenvironments (TME). This nothwithstanding,  pelareorp has demonstrated that it can generate a highly immune-infiltrated, inflammatory TME, that restores ICI responsiveness via

[Noteable]

Pelareorep's ability to remodel the tumor microenvironment, enhance TiLs, and "prime" the innate and adaptive immune systems, results in a significant and synergistic improvement in the effectiveness of immune checkpoint inhibitors when added in combination with ONCY's pelareorep.

[Noteable]

CD8+ TiL cells are critical mediators of cytotoxic effector function in cancer, however, in cancer, CD8+ TiL cells undergo a progressive loss of cytokine production and cytotoxicity, a state termed T-cell exhaustion as well as T-cell dysfuntion, resulting in a failure of T-cells to eradicate tumor cells in the tumor microenvironment (TME).   Also, high levels of PD-1 expression contribute

[Noteable]

As a reminder -  CD8+ TiL cells are critical mediators of cytotoxic effector function in cancer, however, in cancer, CD8+ TiL cells undergo a progressive loss of cytokine production and cytotoxicity, a state termed T-cell exhaustion as well as T-cell dysfuntion, resulting in a failure of T-cells to eradicate tumor cells in the tumor microenvironment (TME). Also, high levels of

[Noteable]

Iovance Biotherapeutics' PDUFA date of February 24, 2024 determining the approval of its tumor infiltrating lymphocyte (TIL) therapy will serve to confirm ONCY's pelareorep critical effect on the increase of CD8+ TiLs cells as significant mediators of cytotoxic effector function in the treatment of cancer, As posted earlier, high levels of PD-1 expression contribute to

[Noteable]

ONCY-s pelareorep is able to expand on new and existing T-cell clones and in the process overcome T-cell exhaustion while setting up the tumor microenvironment  (TME) for the addition of immune checkpoint inhibitors.

[Noteable]

The facts also show the expansion of T-cells in the TME and a reduction in T-cell exhaustion, following pelareorep administration.

[Noteable]

January 31, 2024 - Novartis’ anti-TIM-3 antibody has flunked a phase 3 blood cancer trial, failing to prevent T-cell exhaustion, as one significant deficiency. https://www.fiercebiotech.com/biotech/novartis-calls-time-tim-3-axing-cancer-candidate-after-phase-3-flop

[Noteable]

Novartis’ anti-TIM-3 antibody (MBG453/sabatolimab) failed to simultaneously activate the immune system and suppress the proliferation of cancer cells. The TIM-3 canadidate was intended to be combined with an immune checkpoint inhibitor. Roche removed their PD-1xTIM-3 bispecific from its pipeline in 2022

[Noteable]

April 21, 2024 - "It took more than 35 years for tumor-infiltrating lymphocytes, which Steven A. Rosenberg, MD, PhD, and colleagues first reported on in 1988 for the treatment of advanced melanoma, to progress enough to gain FDA approval."  As physicians, researchers and patients celebrated the FDA approval for lifileucel (Amtagvi, Iovance Biotherapeutics) in February

[Noteable]

“When it comes to immunotherapy, one of the most important findings that we’ve made in the last several years is an understanding of the targets of the immune system on the cancer,” Rosenberg said. “The fact that we can now, today, identify T cells that recognize a cancer in 70% to 80% of all patients with metastatic cancer holds substantial optimism for the ability to take advantage of that in

[Noteable]

According to rearchers like James J. Mul, PhD, immunologist and associate center director of translational science at Moffitt Cancer Center, an I/O strategy under investigation involves inducing TILs in tumors that do not produce them through the use of oncolytic viruses, which turn cold tumors into hot tumors to generate TILs, by stimulating the innate and adaptive immune system while remodeling

[Noteable]

Should read: "According to researchers like James J. Mule..." (should have an accent grave over the"e" in the surname  Mule - which Stockhouse formatting does not recognize).

[Noteable]

April 02, 2024 - New 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."

[Noteable]

Iovance Biotherapeutics is tied up in the proposed Biosecure Act. Iovance Bio received FDA approval in February 2024 for its TiLs therapy. The Biosecure Act would prohibit U.S. companies from working with “a biotechnology company of concern” and extending any contracts, but specifically seeks to limit ties with Chinese biotechs. The proposed bill calls out a handful of companies, including

[Noteable]

Like WuXi AppTec, I-Mab is headquartered in Shanghai, China. https://www.globaldata.com/company-profile/i-mab-biopharma-co-ltd/

[Noteable]

In February 2024 the FDA approved Iovance Biotreherapeutics' TiLs therapy, via the FDA's Accelerated Approval process, for the treatment of advanced melanoma cancer which bodes well for ONCY's drug platform pelareorep, in the treatment of multiple cancers that currently are Orphan/Rare cancers or those cancers with "unmet treatment needs" such as advanced/metastatic breast

[inthno]

It is nice to see companies being accepted for AA.... From the Iovance PR The FDA approval is based on safety and efficacy results from the C-144-01 clinical trial. C-144-01 is a global, multicenter trial investigating AMTAGVI in patients with advanced melanoma previously treated with anti-PD-1 therapy and targeted therapy, where applicable. AMTAGVI demonstrated deep and durable responses. The

[Noteable]

itntdf - you haven't answered my question about what you think I don't know, about force majeure, since you are so very good at "creative writing" and "spreading sheet" .  See attached link. Or will you again just try to deflect away from what you obviously don't know - AGAIN. https://stockhouse.com/companies/bullboard/oncy/oncolytics-biotech-inc?postid

[Noteable]

Iovance Biotherapeutics' Febrursy 2024 approval of its tumor infiltrating lymphocyte (TIL) therapy serves to confirm ONCY's pelareorep critical effect on the increase of CD8+ TiLs cells as significant mediators of cytotoxic effector function in the treatment of cancer,  

[Noteable]

Should read : Iovance Biotherapeutics' February 16, 2024 FDA TiLs therapy accelerated approval confirms ONCY's pelareorep TiLs advantage in the treatment of multiple solid tumors including pancreatic and breast cancer, without the need for an external intervention to achieve the TiL cells needed for an effective tumor killing approach.

[Noteable]

The Scientist - regarding CAR-T cells on TiLs - TCR complex Dr. Michel Sadelian, originally from Alberta Canads, and now an immunologist at Memorial Sloan Kettering Cancer Center (MSKCC), is the original developer of CAR-T therapy and received the 2024 Breakthrough Prize in Life Sciences with Carl June who is a Richard W. Vague Professor in Immunotherspy in the Perelman School of Medicine at the

[Noteable]

The road ahead Cancer immunotherapy represents a new paradigm in cancer care. The approach is already transforming the lives of some patients – and holds immense promise for the future.   https://www.technologynetworks.com/cancer-research/articles/harnessing-the-power-of-the-immune-system-advances-in-cancer-immunotherapy-380857

[Noteable]

And ONCY's drug platform pelareorep is part of that promising future referenced in the previous posts.

[Noteable]

ONCY's drug platform pelareorep is part of that promising future referenced in the previous post. In particular,  ONCY's AWARE-1 study showed that pelareorep treatment upregulated tumor PD-L1 expression, induced the generation and expansion of T cell clones, promoted tumor infiltration of CD8+ TiL cells, and increased the CelTIL score, a measure of tumor cellularity and

[Noteable]

With respect to ONCY partnerships it is important to know that while BioNTech is involved with Genentech (Roche) in the development of mRNA vaccine in the treatment of resected pancreatic cancer in combination with Roche's checkpoint inhibitor atezolizumab (Tecentrq) - BioNTech is also partnered with Pfizer in the development and distribution of Pfizer's Covid-19 vaccine (Comirnaty) . 

[Noteable]

March 10, 2024 - "  Pfizer is ready to move on from Covid.  Now, the company is betting on cancer drugs to help it regain its footing after a rocky year marked by the rapid decline of its Covid business. It just might take a while before that bet pays off.  Pfizer pitched its deeper push into oncology during a four-hour investor event 

[Noteable]

Neither BioNTech or Pfizer will allow their mRNA vaccine knowledge & manufacturing capacity languish into oblivion. Instead both companies will be transitioning into therapeutic technologies like oncolytic virus that complement their RNA vaccine knowledge and manufacturing/distribution superiority. More specifically Pfizer/BioNTech will seek to acquire late stage development cancer companies

[CaseyL]

"Drug Platform" Love it Noteable. ONCY has a great SALE aspects if results trun out. Just so happenes those results are turning out.... : )

[Noteable]

Related to the activation of T-cells within the TME is the Phase 1 company Janus Therapeutics which is developing a bispecific and is currently trading at approximately US$50 and a market cap of US$2.5 Billiion. "Janux’s initial development programs are designed to activate T cells within the tumor microenvironment. The company leverages its proprietary tumor activated T cell engager (TRACTr

[Noteable]

Phase 1 data released in February 2024 from JANX007’s first-in-human Engager-PSMA-01 study, in metastatic castration-resistant prostate cancer patients as a median fifth-line therapy, used a stepwise dose escalation that focused on 18 of the 23 evaluable patients; these subjects had received a first JANX007 dose of at least 0.1mg, and Janux claimed a 56% rate of ≥50% PSA reduction. On

[canadafan]

Yet another week has passed.  The Q1 update, did make some things clear. 1. FDA meeting & MBc trial phase 3 and/ or registration will be updated in this quarter. They in context talk about Q2 , as if it was a distant time frame. Probably the speaking notes written in Q1. 2. Further updates on anal cancer. Pelarerrp if advanced is only thing on the market. There is no existing

[ENEMENEMYNEMO]

An eating disorder is a tragic diagnosis primarily for teens and younger women. To say you are blessed is horrible. 

[Azzak34]

No, no, no.... the moral high ground is lost to you. You're actively campaigning against cancer treatment which is currently helping people stay alive longer. Don't pretend you care about people to suit you're own agenda. Shameful!!!! 

[ENEMENEMYNEMO]

Oh where is your proof.  I've been waiting 20 years...surely that's long enough???? 

[Noteable]

The below post in March 2024 by "Mo" of the 3 Stooges - said he hadn't been in ONCY for at least 4 years.  yet now he's back saying he's been "waiting for 20 Years"? So "Mo" likes to exaggerate just a bit, don't you think? post by ENEMENEMYNEMOon Mar 03, 2024 5:59pm 150 Views  Post# 35912305 Thanks

[ENEMENEMYNEMO]

You don't know me! Sell the peak buy the lows. 

[Noteable]

So "Mo" - truth and trust aren't really big in the 3 Stooges repetoire? Now I know you.

[ENEMENEMYNEMO]

And come on Azz.  Wipe.  You know Canfan comments are dorked out!

[Noteable]

Should read : Phase 1 company Janus Therapeutics  ...trading at approximately US$50 per share ... 

[Noteable]

2023 - Janux Therapeutics is betting that its pipeline of biomarker-driven T-cell engagers will overcome limitations typically seen in this class of immunotherapies, such as cytokine release syndrome and a short duration of response. Bispecific T-cell engager (BiTE) immunotherapies comprise two epitopes: one that binds a tumor-associated antigen expressed on the tumor cell and one that binds a T

[Noteable]

April 29, 2024 - CD8+ T cell-based cancer immunotherapy https://translational-medicine.biomedcentral.com/articles/10.1186/s12967-024-05134-6

[Noteable]

CD8 T cells play a pivotal role in the antitumor immune response by directly targeting and eliminating tumor cells expressing tumor antigens.However, tumor suppression by tumor-reactive CD8 T cells can be hindered by T cell exhaustion or dysfunction, in which continuous antigen stimulation along with the signals from immune checkpoint molecules, gradually impairs T cell

[Noteable]

October 2023 -  Unveiling the Immune Microenvironment’s Role in Breast Cancer: A Glimpse into Promising Frontiers Quote: "TILs encompass a range of lymphocytes, including B cells, T cells, and plasma cells, contributing to the intricate immune modulation in the TME [42,43,44]. TILs can be further categorized into various cell types, including CD8+ cytotoxic T lymphocytes, CD8+ tissue

[Noteable]

For tthose traders who are trying to exploit the BRACELET-1 cohort 3 results by implying something that is not .. cohort 3 involved the immune checkpoint inhibitor avelumab which is the only PD-(L)1 inhibitor with an intact Fc component, thus precluding this ICI's effectiveness. Other ICIs like atezolizumab or pembrolizumab, foe example, have the Fc component inactived, and more effective than

[Noteable]

" Unlike other approved anti-PD-L1 antibodies, avelumab has a native Fc region that retains FcγR binding capability." Avelumab is cleared faster and has a shorter half-life than other anti-PD-L1 antibodies, such as atezolizumab and durvalumab, which appears to negatively impact T cell clones expansion. Consequently the addition of the PD-L1 inhibitor avelumab, unlike atezolizumab

[Noteable]

Results from ONCY's AWARE-1 study showed that pelareorep treatment upregulated tumor PD-L1 expression, induced the generation and expansion of T cell clones, promoted tumor infiltration of CD8+ TiL cells, and increased the CelTIL score, a measure of tumor cellularity and inflammation associated with favorable clinical outcomes. Besides being able to overcome an immunosuppressive TME

[Noteable]

Bracelet-1 demonstrated that pelareorep is an effective immunotherapy agent without an immune checkpoint inhibitor AND that pelareorep is more effective than chemotherapy (I.e. paclitaxel).  Consequently ONCY is now able to report that pelareorep is an effective immunotherapy by itself but is synergistically more effective when combined with another I/O agent and/or a chemotherapy agent in a

[Noteable]

CD8+ TiL cells are critical mediators of cytotoxic effector function in cancer, however, in cancer, CD8+ TiL cells undergo a progressive loss of cytokine production and cytotoxicity, a state termed T-cell exhaustion as well as T-cell dysfuntion, resulting in a failure of T-cells to eradicate tumor cells in the tumor microenvironment (TME). Also, high levels of PD-1 expression contribute

[Noteable]

https://www.nature.com/articles/d41591-024-00040-2

[Noteable]

The unpasteurized milk drinkers' disinformation strategy here is more than obvious.

[Noteable]

It's remarkable how those like Quentin30, who doesn't own any shares on ONCY, keep trying to post unfactual information about Bracelet-1 when we know that the PD-1 checkpoint inhibitor avelumab is unlike other CPIs given its active Fc region. ONCY's CMO Thomas Heineman has made this known in multiple presentations he has given. " Unlike other approved anti-PD-L1 antibodies

[m00nsh0ts]

Why did we steak so much on its synergy with Pella??? I felt bad for Tom trying to explain that failure in yesterday's interview.

[Noteable]

For those who don't understand these distinctions and differences, ONCY's September 2024 Corporation Presentation addresses the molecular differences that one PD-L1 has over the other. https://oncolyticsbiotech.com/investor-overview/

[Noteable]

The synergy of pelareorep + checkpoint inhibitors is with CPIs that have an inactived Fc region that was demonstrated with pelareorep with both Keytruda and Tecentriq. ONCY has posted this synergy in its PDAC and GOBLET-1 Phase 2 clinical trials. ONCY's BRACELET-1 Phase 2 mBC has demonstrated pelareorep's ability to be significantly statistic in clinically meaningful median overall

[m00nsh0ts]

Are you saying that we ran that arm of bracelet to demonstrate that there is one CI that Pella doesn't work with when it seems to work with all the others.

[Noteable]

Bracelet-1 demonstrated 2 major findings: (1) PD-L1 with an activated Fc region result in T-cell exhaustion and (2) pelareorep is effective as a single agent monotherapy + paclitaxel vs paclitaxel alone. AND pelareorep promotes the upregulation of T-cell immune lymphocytes (TiLs) thus overcoming T-cell exhaustion, which ONC's GOBLET-1 Phase 2 cohort studies are showing when pelareorep is

[Noteable]

What Bracelet-1 has demonstrated was that pelareorep is effective as a single agent (monotherapy) that can be putatively combined with multiple I/O agents like PD-L1 checkpoint inhibitors with unactivated Fc regions, or with small molecules (like CDK4 and CDK-pan inhibitors), or with bispecific antibodies (BsMAB, BsAB), or with cell therapies (like CAR-T therapies), or multiple combinations with

[Noteable]

Should read : ONCY's BRACELET-1 Phase 2 mBC has demonstrated pelareorep's statistical significant in a clinically meaningful endpoints of progression free survival (PFS) and median overall survival (mOS) as a single agent (monotherapy I/O agent) + paclitaxel in 3rd line metastatic breast cancer that has an unmet treatment need 

[Noteable]

October 14, 2024 - Transgene’s therapeutic oncolytic virus / vaccine candidate TG4001when combined with the activated/native Fc checkpoint inhibitor Bavencio (avelumab) failed in their Phase 2 clinical trial recurrent or metastatic HPV16-positive cervical and anogenital cancers - in much the same way that ONCY's pelareorep did in their Phase 2 Bracelet-1 study. Transgene's

[Noteable]

Unlike atezolizumab, pela’s clinical activity was lost when combined with avelumab, a PD-LI inhibitor with a native Fc region that is capable of binding Fc receptors and inducing ADCC. The addition of avelumab eliminated pre-existing TIL expansion in the blood highlighting the importance of TIL expansion following pela therapy. The same elimination of pre-existing TILs and TILs expansion in the

[Noteable]

Transgene's failure with Bavencio (avelumab) serves to confirm ONCY's findings in ONCY's Phase 2 Bracelet-1 clinical study in metastatic breast cancer.

[Noteable]

From ONCY's October 2024 slide deck: Slide #37 Why Did Avelumab Eliminate the Benefit of Pelareorep? - Avelumab is the only licensed anti- PD-L1 Ab with a native Fc region that retains FcγR binding   - Hypothesis:   Binding of avelumab to Fc receptors impairs the expansion of T cell clones thereby diminishing the generation of potentially beneficial pelareorep

[Noteable]

"CD8+ T cell exhaustion is a stable dysfunctional state driven by chronic antigen stimulation in the tumor microenvironment (TME). " https://pubmed.ncbi.nlm.nih.gov/37398660/ CD8+ TiL cells are critical mediators of cytotoxic effector function in cancer, however, in cancer, CD8+ TiL cells undergo a progressive loss of cytokine production and cytotoxicity, a state termed

[Noteable]

Mechanisms of CD8+ T cell exclusion and dysfunction in cancer resistance to anti-PD-(L)1 -  July 2023  CD8+ T cells in tumor microenvironment CD8+ T cells are the key defensive cells within TME. Here, CD8+ T cells form functional circuity with dendritic cells (DCs) and natural killer (NK) cells. There is a positive cross-talk between CD8+ T cells with

[Noteable]

May 22, 2024 - New research has discovered an important breakthrough that may further attribute to cancer treatment resistance. The immune system has a naturally occurring 'brake' that tells the body to silence key killer immune cells called CD8+ T-cells as a safeguard to restrain excessive immune responses. Cancer cells are known to exploit this process, called exhaustion, by hijacking

[Noteable]

With the exception of PD-L1 and TMB, there are no predictive biomarkers to guide immune checkpoint inhibitor treatment decisions in advanced or metastatic breast cancer, according to a paper that was pressented at ESMO 2024. This may have been the case UP UNTIL NOW with clinical evidence that shows ONCY's pelareorep is able to drive biomarkers that enhance exisiting and new CD8+ -TiLs complex

[Noteable]

ONCY's ASCO 2024 abstract provides additional support for pelareorep’s immunotherapeutic mechanism of action by describing its ability to stimulate the expansion of pre-existing and new TIL clones in the blood, which correlate with treatment response. These results build upon previously reported data from the AWARE-1 study in breast cancer to expand our understanding of pelareorep’s

[13X2413]

Why is it when a company like MDNA releases news about an upcoming presentation, the share price leaps forward.  When ONC provides information about upcoming presentations, the market looks at it as a non event?  

[Noteable]

March 16, 2024 -  Further to ONCY's ASCO 2024 poster presentation ... " there has been a growing emphasis on the development of “liquid biopsy” derived biomarkers, which offer a minimally invasive means to dynamically monitor the immune status of [cancer] patients either before and/or during the course of treatment." " ... compelling correlations between the

[Noteable]

ONCY's CD8+-TiLs biomarkers are determined through a minimally invasive "liquid biopsy" accomplished with a simple "blood draw" and is significantly easier to administer as a blood-based predictive diagnostic to determine biomarker levels in contrast to the present use of "tissue biopsies" that requires the invasive removal of a peice of tissue or cells to

[CMHarring218431]

Respect your , in what seems incredible understanding of all biological processes which relate to the incredibly complex cancer stuff. Yes, I said stuff, because it is fascinating and confusing and I'm sure most here say.... what does that mean. Your files and library are apparently at a fingers touch and is beyond any organizational attempt I might try. My point..... to this extreme and

[Noteable]

Do you remember when Matt Coffey said that pelareorep was the "Swiss Army Knife" of immunotherapy? Well I have taken the time to explain the fundamentals of what this Swiss Army knife can do and how it can do it with other immuno-oncology agents such as immune checkpoint inhibitors, bispecifics, ADCs, CAR-T therapies and small molecules such as CDK4/6, P13KCA and PARP inhibitors, for

[Noteable]

And do you remember how pelareorep's effectiveness could serve as a predictive diagnostic to the synergistic addition immune checkpoint inhibitors for an effective immuno-oncology combination therapy ? Well I have tried to explain how and why ONCY has an advantage that few other oncology companies have and to educate the naysayers on this novel, innovative and effective therapy.

[Noteable]

" Patients with early-stage triple-negative breast cancer (TNBC) who had breast tissue with more tumor-infiltrating lymphocytes (TIL) and did not receive adjuvant or neoadjuvant chemotherapy had significantly better survival, according to findings from a study published in JAMA."  https://www.cancernetwork.com/view/survival-outcomes-improve-with-til-presence-in-tnbc

[Noteable]

Pelareorep driven blood TIL expansion in patients with pancreatic, breast and colon cancer. Richard Trauger, Houra Loghmani, Amy Kupic, Thomas Charles Heineman; Oncolytics Biotech, San Diego, CA; Oncolytics Biotech, Calgary, AB, Canada Background: Tumor infiltrating lymphocytes (TILs) represent a major immunological tumor control mechanism that is associated with better prognosis in cancer. One

[Noteable]

What is of particular matter is pelareorep ability to expand new and existing TiLs in the blood and tumor cell, resulting in enhanced T cell killing of the pelareorep infected cancer cells, resulting from pelareorep's stimulation of the innate and adaptive immune system, and the overcoming of T cell exhaustion, that T cell expanders (I.e.BiTes) are seeking to achieve. Clonal T cell expansion

[Noteable]

Pelareorep driven blood TIL expansion in patients with pancreatic, breast and colon cancer. Identification of TIL clones was performed by immunosequencing of the CDR3 regions of human T-cell receptor-b (TCRb) chains (ImmunoSEQ Assay, Adaptive Biotechnologies). DNA was isolated from tissue and blood at baseline and from blood collected posttreatment. TCRb CDR3 regions were amplified by a multiplex

[Noteable]

Many tumors prevent stem-like T cells from generating cytotoxic T cells in the tumor that could attack the cancer. Current immunotherapies aim to prevent the cancer from switching off immune responses at a later phase that cause T cell exhaustion. Checkpoint inhibitor therapies, for example, aim to release the blockade of fully differentiated cytotoxic T cells and "switch them back on"

[Noteable]

https://stockhouse.com/companies/bullboard/t.onc/oncolytics-biotech-inc?postid=36101843

[Noteable]

" Tumor-infiltrating lymphocytes (TILs): These lymphocytes primarily comprise cytotoxic (CD8+) and helper (CD4+) T cells and a smaller proportion of B and NK cells. Their functions can dynamically change throughout tumor progression and in response to anticancer therapy. The presence of lymphocytes in tumors is often associated with a better clinical outcome " - ( Luigi

[Noteable]

"CD8+ T cell exhaustion is a stable dysfunctional state driven by chronic antigen stimulation in the tumor microenvironment (TME). " https://pubmed.ncbi.nlm.nih.gov/37398660/ CD8+ TiL cells are critical mediators of cytotoxic effector function in cancer, however, in cancer, CD8+ TiL cells undergo a progressive loss of cytokine production and cytotoxicity, a state termed

[Peladawn]

Biden campaign now passing out and posting flyers at the border,  instructing illegals "to make sure they vote for President Biden to make sure the border stays open"......this is being done through a so-called "NGO, or a "Non Government Organization", and I know it's a real shocker, but both the NGO and the Biden campaign deny any involvement with posting the

[Noteable]

June 26, 2024 - New clinical study demonstrates that TILs correlate positively with overall survival (OS) and are an independent prognostic/predictive indicator for the overall survival (OS) in patients. https://journal.waocp.org/article_91171_eb892dd6bd1ad57cd9fcb12d7562086d.pdf Correspondingly, ONCY has recently found that pelareorep therapy may offer a means to directly expand TILs

[Noteable]

June 26, 2024 - New clinical study demonstrates that TILs correlate positively with overall survival (OS) and are an independent prognostic/predictive indicator for the overall survival (OS) in patients. https://journal.waocp.org/article_91171_eb892dd6bd1ad57cd9fcb12d7562086d.pdf Correspondingly, ONCY has recently found that pelareorep therapy may offer a means to directly expand TILs

[Noteable]

https://www.cancerhealth.com/article/fda-oks-two-novel-immunotherapies

[Angler101]

This post has been removed in accordance with Community Policy

[Azzak34]

https://www.fiercepharma.com/pharma/firepower-aplenty-and-patent-cliffs-ahead-time-right-ma-activity-report

[Noteable]

July 15, 2024 - "While patent cliffs are looming for many of biopharma’s top-selling products, the industry has enormous capacity to respond as “conditions for M&A are favorable,” according to a research note from Morgan Stanley.  We continue to see the conditions as generally favorable for bolt-on M&A as large-cap pharma companies have balance sheet capacity and a need to

[Noteable]

August 29, 2024 - Combo immunotherapy produces distinct waves of cancer-fighting T cells with each dose Immune checkpoint inhibitors work by unleashing T cells to find and kill cancer cells. It was thought that this type of combination immunotherapy works by equipping an army of T cells to recognize and fight cancer throughout the course of treatment. In a sense, the idea was that if this

[Noteable]

" We found that after every infusion, you have a new immune response, with a new group of T cells coming in to fight the cancer,” explained senior author Alexander Huang, MD, an assistant professor of Hematology-Oncology and a research investigator with the Tara Miller Melanoma Center at the ACC. “Think about these T cells like an army: for many cancer patients, even when they have tumors

[Noteable]

https://stockhouse.com/companies/bullboard?symbol=t.onc&postid=36245960

[Noteable]

"Accordingly, pela therapy may offer a means to directly expand TILs without the need for tumor resection, ex vivo TIL expansion, T cell ablation and IL-2 therapy." Comment by Noteableon Aug 10, 2024 6:39pm 95 Views  Post# 36173068 RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:CD8+ TiLs and T-cell exhaustion Iovance is pricing their TiLs

[Noteable]

Once again we see that Buckeroo and his clan can't understand the face-value meaning of my posts. 

[Noteable]

ONCY has $500 million in R&D write-offs and the potential of $US 2.4 Billion in peak annual sales, according to ONCY's presentation but much higher by an estimated 2x+ more from global reports, for the 3rd line HR+/HER2- breast cancer alone that pelareorep is expectedto address, and with 13 years of FDA market exclusivity from the approval date of pelareorep.   And then there are

[Noteable]

ONCY's Bracelet-1 Phase 2 clinical study demonstrated 2 major findings: (1) PD-(L)1 checkpoint inhibitors with an activated Fc region result in T-cell exhaustion and (2) ONCY's pelareorep is effective as a single agent monotherapy + paclitaxel vs paclitaxel alone. AND (3) pelareorep promotes the upregulation of T-cell immune lymphocytes (TiLs) thus overcoming T-cell exhaustion, which ONC

[Noteable]

Correction: ONCY's Bracelet-1 Phase 2 clinical study demonstrated 3 major findings: ( see previous post )

[Noteable]

CD8+ TiL cells are critical mediators of cytotoxic effector function in cancer, however, in cancer, CD8+ TiL cells undergo a progressive loss of cytokine production and cytotoxicity, a state termed T-cell exhaustion as well as T-cell dysfuntion, resulting in a failure of T-cells to eradicate tumor cells in the tumor microenvironment (TME).   Also, high levels of PD-1 expression contribute

[Noteable]

The immunosuppressive tumor microenvironment (TME) plays an important role by interfering with intratumoral T-cell infiltration, promoting effector T-cell exhaustion, upregulating inhibitory molecules, inducing hypoxia, and so on.   Oncolytic virotherapy (OV) contributes to the reprogramming of the TME, thus synergizing the functional effects of current ICIs and CAR T-cell therapy to