Oncolytics Biotech Inc ONCY

“Second mouse gets the cheese “

[Noteable]

”While work continues to find the next oncolytic virus therapy to make a clinical impact, several unanswered questions remain, including when the treatment should be deployed. Clinical trials of novel therapeutics typically focus on patients with advanced cancers for whom all other treatment avenues have been explored, and this has also been the case for oncolytic viruses. Kaufman, however, believes that their place may be earlier in the treatment journey, as a neoadjuvant therapy. He predicts that “getting to earlier stage cancers and neoadjuvant therapy for the more advanced disease is going to be the sweet spot for these agents because they get you that personalized immune response you need.”

https://www.insideprecisionmedicine.com/news-and-features/are-we-nearly-there-yet/

ONCY’s planned Phase 3 clinical trial involving pelareorep in combination with the PD-L1 checkpoint inhibitor atezolizumab (Tecentriq) as a first line therapy in advanced/metastatic pancreatic cancer, and following CG Oncology’s intended Phase 3 clinical trial results submission for an FDA Biologics License Application in bladder cancer, should make ONCY’s pelareorep in PDAC a hot item, as the 2nd CPI + OV combination on the market in a what is considered to be a very difficult cancer with an unmet treatment need. The FDA will have gained enough experience with OVs + CPIs by then to look at ONCY’s much more favorable light as an addition to this class of biological therapies.

[Noteable]

The FDA will have gained enough experience with OVs + CPIs by then to look at ONCY’s pelareorep in a much more favorable light, as an effective biological addition to this class of expanding biological therapies.

[Noteable]

‘.... the early bird gets the worm and the second mouse gets the cheese .... ’

[Noteable]

https://www.biospace.com/article/5-cancer-vaccines-to-watch-in-2024/

[Noteable]

just repeating what Matt already said.

[Noteable]

It is apparent that inthno keeps trying to obscure the fact that  ..... ONCY’s planned Phase 3 clinical trial involving pelareorep in combination with the PD-L1 checkpoint inhibitor atezolizumab (Tecentriq) as a first line therapy in advanced/metastatic pancreatic cancer, and following CG Oncology’s intended Phase 3 clinical trial results

[Noteable]

 An Accelerated Approval following the start of ONCY’s planned Phase 3 clinical trial involving pelareorep in combination with the PD-L1 checkpoint inhibitor atezolizumab (Tecentriq) as a first line therapy in advanced/metastatic pancreatic cancer, along with the increasing probability of a near-term M&A, is a fact that certain message

[Noteable]

 “ .... getting the cheese ... “ maybe sounds grating to trolls but definitely sounds like a good business decision to me.

[Noteable]

December 05, 2023 -  Results from a small phase 3 study presented at at the Society of Urologic Oncology conference conference last week suggest that cancer treatments, known as oncolytic viruses, bodes well for the dozens of other trials now underway. The data showed that an oncolytic virus developed by Irvine, California–based CG Oncology eliminated tumors in 64% of 66

[Noteable]

Obviously this requires reposting .....   >>>  Another problem was that researchers didn’t understand how oncolytic viruses worked. Now other candidate oncolytic viruses may soon get their chance.  An avenue to improve oncolytic viruses is pairing them with other immune therapies or with chemotherapy and radiation. Checkpoint inhibitors are obvious partners

[Noteable]

January 03, 2024 - CG Oncology plans to list on the Nasdaq under the symbol CGON. CG Oncology filed confidentially on October 27, 2023. Morgan Stanley, Goldman Sachs, and Cantor Fitzgerald are the joint bookrunners on the deal

[Noteable]

ONC.TO  MorningTrades January 03, 2024 -  Jan 3, 2024 11:39 AM 1.77 - - 100 TSX Anonymous Morgan Stanley Canada Limited Jan 3, 2024 11

[CMHarring218431]

Goldman, Morgan Stanley. Why are they showing up? Are we looking at signals?

[Buckhenry]

Hey canuckfan.... how are we looking for that "big news" this first week?   Good or bad of course......

[Azzak34]

Hey Bucky, how's the being a little Karen, passive aggressive doosh coming along? Sort of ongoing no? 

[Buckhenry]

Everything canuckfan just mentioned is old news. Just stick to things you know ... which is nothing... and quit rubbing your cracked crystal ball. All you pumpers  have done done is spew crape like this. The only thing you should have in your hand is a huge wad of toilet paper to wipe ur runny tush. You pumpers  are just continuing with your same garbage as last year as you have nothing

[inthno]

Well I guess we shall know soon enough is cf is right or not as if we are under an nda as he suggested then the next news from onc has to be about the buyout. I hope for once u r right cf as it would be a nice change and then everyone can finally put all this behind us.

[Buckhenry]

We are all tired of these pumpers and their gut feelings. They are no more privy to board info than the rest of us. If and when something ever happens they will all pat themselves on the back.  Well I guess even a blind squirrel finds a nut once in a while...

[Azzak34]

This post has been removed in accordance with Community Policy

[CaseyL]

I thothe you buckhenry. This is going to the moon and nothing short. My personal wish is to know how all the women in San Antonio in the breast cancer trials are doing? My heart especially goes out to them. Godspeed.

[Buckhenry]

If you dumb ace pumpers would not keep regurgitating the SOS I would not have to keep reminding yall. You folks just don't learn. 

[Azzak34]

Can you describe how you look for me? I have an image but I just want confirmation. 

[Azzak34]

This post has been removed in accordance with Community Policy

[venture009]

Here, here to that !

[Azzak34]

Why are you still here with your passive aggressive remarks on every site going? Why are still in this stock? 

[CaseyL]

I'm absolutely passive aggressive. I have a ton of money invested, and I've always been passive aggressive.  I don't need to be morally correct or sound to want the right thing here. And yes, I can say some pretty crappy things. But one thing is true. We will prevail! The day I see Oncolytics succeed is the day I'm internally smitten, forever and always. 

[Azzak34]

I wasn't talking about you Lee but we will absolutely prevail. My only point is always, believe then stay and keep your powder dry. We all know people are frustrated, posting about it everyday will only hurt. If you don't believe, go away and leave is who do alone!! 

[CaseyL]

You know nothing of the fight. I will remain here. Silly. You will struggle deluding the future of ONCY. Its Inevitable honestly. I'll see you on the other end azzak34. 

[Noteable]

Goldman, Morgan Stanley are contolling the trades in the stock with CIBC clearing foreign trades.

[13X2413]

Wow. A volume of 34,000 shares today. Those big companies are really sticking their necks out!  :)

[inthno]

Morgan Stanley is also on the sell side. 12:49:35 U 1.80 0.04 900 2 RBC 14 Virtu ITG K 12:49:35 U 1.80 0.04 300 2 RBC 2 RBC K 12:49:35 U 1.80 0.04 100 2 RBC 2 RBC K 12:44:40

[Noteable]

January 03, 2024 - Goldman Sachs is planning to make a splash in the life sciences sector, taking in $650 million for its first fund aimed at the drug development space. The size of the West Street Life Sciences I fund, which overshot its original target, makes it one of the largest first-time private life sciences growth funds, Goldman Sachs Asset Management claimed in a Jan. 3 release

[Noteable]

In June 2023 the US Food and Drug Administration (FDA) accepted Ipsen's supplemental new drug application (sNDA) for the Onivyde regimen as a first-line treatment for metastatic pancreatic ductal adenocarcinoma (mPDAC) patients. The review is based on positive results from the pivotal Phase III NAPOLI 3 trial, in which the Onivyde regimen demonstrated a statistically significant

[Noteable]

https://www.fiercebiotech.com/biotech/cg-oncology-plans-ipo-ahead-phase-3-bladder-cancer-drug-readout CG’s use of an oncolytic virus to treat BCG-unresponsive NMIBC has drawn comparisons with Ferring, which was granted approval for an adenovirus vector-based gene therapy in the tumor type in late 2022. The Ferring product, Adstiladrin, differs in that it encodes interferon alfa-2b, turning

[Noteable]

January 18, 2024 - Oncolytics virus company CG Oncology is looking to raise $209 million from its upcoming IPO. The company's OV is designed to infect and replicate in tumor cells, directly killing them while also causing the release of tumor-derived antigens and GM-CSF to stimulate an immune attack. CG has initially been developing the candidate as a treatment for non-muscle invasive

[13X2413]

Just another example of ONC left standing on the platform watching the train leave the station. 

[askretka]

CG oncology@s Oncolytic virus is very significant I think moving forward.@ Watched the Endpoints Webinar on Oncolytics viruses recently and the original work done on V-TEC by Howard Kaufman,@ he was pretty certain that CG Oncology would have next virus approval by FDA Howard Kaufman was involved early with OV and 1st FDA approval. TVEC. Currently CEO of ANKYRA Therapeutics.@ @

[Noteable]

January 25, 2024 - CG Oncology started trading on the Nasdaq this morning, after announcing its $380 million upsized initial public offering, putting 20 million shares of its common stock up for sale for $19 apiece. CG Oncology’s Upsized $380M IPO is First Biotech to Go Public in 2024 CG Oncology only has one asset: the late-stage cretostimogene grenadenorepvec. The candidate is a

[Noteable]

Now other candidate oncolytic viruses may soon get their chance.  An avenue to improve oncolytic viruses is pairing them with other immune therapies or with chemotherapy and radiation. Checkpoint inhibitors are obvious partners because they stymie tumors’ mechanisms for shutting down T cells. The company Oncolytics Biotech has performed two successful phase 2 trials of a tumor

[Noteable]

CG Oncology opens trading at stpomf US$31.00. The difference between CG Oncology (CGON) and ONCY is that CGON used Morgan Stanley, Goldman Sachs and Cantor as joint book-running managers for the offering, while LifeSci Capital is serving as its co-manager. ONCU used Canaccord and Cannacord has been the bain of ONCY ever since.

[Noteable]

Should read: CG Oncology opens trading at around US$31.00. The difference between CG Oncology (CGON) and ONCY is that CGON used Morgan Stanley, Goldman Sachs and Cantor as joint book-running managers for the offering, while LifeSci Capital is serving as its co-manager. ONCY used Canaccord and Cannacord has been the bain of ONCY ever since.

[Noteable]

What is also funny is that ONCY met with Morgan Stanley, Goldman Sachs, and Cantor prior to moving on the Anson Funds Management's US$ 15 Million deal. So ONCY must have naively handed over enough information to Morgan Stanley, Goldman Sachs, and Cantor for them to then become the lead book-runners in the CGON offering. And in so doing CGON became the "second mouse", in this

[Noteable]

CGON put up 20 million shares of its common stock up for sale. At the current trading price of $US31.70, CGON's market cap is US$634 million. I don't know how some came up with the market cap figure of $1.5 Billion, unless they are prescient, which I highly doubt given their post posts here. What CGON's trading shows is that an acquisition value for ONCY of between US $7.5 - 10

[lonc17]

Hey Notable, To calculate market cap you will need to account for the portion of the company held by the principal shareholders (original owners prior to IPO). So yes, at a trading price of $35 the market cap of CGON is greater than 1.5 Billion.

[lonc17]

Closer to $2 Billion now. https://stockanalysis.com/stocks/cgon/market-cap/

[Noteable]

Fair enough - On further inspection CG Oncology has 63.48 million shares outstanding -  which in comparison to ONCY's 73.4 million shares outstanding - demonstrates that ONCY's acquisition value is somewhere between US$7.5 - $10 Billion, as has been previously outlined.

[lonc17]

Too funny, Notable.  You have a great sense of humour. 

[Azzak34]

But you think our buyout will be $2 billion? So we're good then? 

[Noteable]

Biotech sector funds and players were deemed as "most likely" to acquire CGON stock. This development of the biotech sector acquiring CGON should have an overall benefit to the oncolytic virus sector as a whole since more "eyes-balls" will become focused on OV stocks like ONCY.

[Noteable]

Cancer biopharma IPOs build momentum of the heels of CG Oncology's offering Cancer-focused Arrivent Biopharma announced late Thursday that it is looking at around $175 million in gross proceeds from its upsized initial public offering. Goldman Sachs, Jefferies and Citigroup are joint book-running managers for ArriVent’s IPO, while LifeSci Capital is its lead manager. https://www

[Noteable]

Jan 30, 2024   IRVINE, Calif.--(BUSINESS WIRE)-- CG Oncology, Inc. (Nasdaq: CGON), a late-stage clinical biopharmaceutical company focused on developing and commercializing a potential backbone bladder-sparing therapeutic for patients afflicted with bladder cancer, today announced the closing of its upsized initial public offering of 23,000

[Noteable]

CG Oncology bladder cancer study shows that “when you do everything well, you can get good clinical outcomes,”  virologist Grant McFadden of Arizona State University says. The company chose a type of cancer that is easy to target. The modified virus powerfully stimulated the immune system. And the enrolled patients had not undergone previous chemotherapy that would prevent their

[Noteable]

With ONCY - being the second mouse and the only OV company that has a clinically proven and effective, systemically administered agent through intravenous (IV) injection able to address metastatic cancers. Sept. 09, 2024 (GLOBE NEWSWIRE) -- Replimune Group, Inc. (NASDAQ: REPL), a clinical stage biotechnology company pioneering the development of novel oncolytic immunotherapies, today announced it

[Noteable]

Sept. 9, 2024 /PRNewswire/ -- Roche announced today the expansion of its digital pathology open environment with the integration of more than 20 advanced artificial intelligence (AI) algorithms from eight new collaborators, ultimately to provide the diagnostic tools to help clinicians improve the lives of patients worldwide. ONCY has been contributing to the development of biomarkers to

[Noteable]

AstraZeneca is now partnering with Roche to co-develop and commercialize a new biomarker is called normalized membrane ratio of TROP2 by quantitative continuous scoring (NMR-QCS). The TROP2-QCS biomarker companion diagnostic and digital pathology algorithm, which will combine AZ’s proprietary computational pathology platform with Roche’s navify digital pathology image management

[Noteable]

Let's add the idiom of  "a blind squirrel finds a nut once in a while" into this mouse n cheese mix, ands see what happens.

[fasttrack5]

Any thoughts on upcoming fireside chats?

[CaseyL]

It's only gonna draw down the share price. These events do nothing. Absolutely nothing. 

[Noteable]

Could Matt Coffey have been referring to the BioNTech / Genentech mRNA + atezolizumab combination in the treatment of resectable pancreatic cancer as the first mouse? https://stockhouse.com/companies/bullboard/oncy/oncolytics-biotech-inc?postid=35977702

[Noteable]

Previous to BioNTech / Genentech's release of Phase 1 data with mRNA + atezolizumab combination Phase 1 data in the treatment of resectable pancreatic cancer at AACR24 this week, a Phase 2 study was initiated in combination with with mFOLFIRINOX, in October 2023.  An ongoing open-label, multicenter, randomized Phase 2 trial (NCT059668326), sponsored by Genentech in

[Noteable]

October 2023 was about the same time that a decision was made not to proceed with the ONCY/ PanCan Phase 3 pancreatic cancer study using pelareorep + atezolizumab + chemotherapy. Instead PanCan had sponsored a Phase 3 study involving pelareorep + atezolizumab + mFOLFIRINOX. These events happening at the same time that BioNTech/Genentech(Roche) initiated a Phase 2 with autogene cevumeran

[Noteable]

Correction: the PancCan sponsored pancreatic cancer study with mFOLIRINOX is a cohort extention of the Phase 1/2 Goblet-1 study. " ...  a new Phase 1/2 cohort evaluating pelareorep in combination with modified FOLFIRINOX (mFOLFIRINOX) with and without atezolizumab (Tecentriq®) in patients with newly diagnosed metastatic pancreatic ductal adenocarcinoma (PDAC)..." https:/

[Noteable]

Correction: " ..These events happening at the same time that BioNTech/Genentech(Roche) initiated a Phase 2 with autogene cevumeran + atezolizumab + chemotherapy compared to the standard of care mFOLFIRINOX in October 2023 ...."

[Noteable]

For those who can't see the larger picture BioNTech / Genentech's Phase 2 mRNA "vaccine" clinical trial involving adjuvant autogene cevumeran in combination with the anti-PD-L1 immune checkpoint inhibitor atezolizumab and chemotherapy compared with the current standard of care chemotherapy (mFOLFIRINOX)  in patients in resected PDAC, this BioNTech study

[Noteable]

Correction: BioNTech / Genentech's Phase 2 mRNA "vaccine" clinical trial involving adjuvant autogene cevumeran in combination with the anti-PD-L1 immune checkpoint inhibitor atezolizumab and chemotherapy is randomized to mFOLFIRINOX. Excuse my oversight, however everything else regarding DFS as the primary endpoint applies.

[Noteable]

March 21, 2024 - Swiss contract manufacturer Lonza has agreed to acquire the Genentech large-scale biologics manufacturing facility in Vacaville, California, US, from Roche in a $1.2bn deal. This move to shed this sort of large-scale biologics manufacturing appears to signal that Genentech is leaning-in on further partnering with specialized biologic "vaccine" manufacturing that