Oncolytics Biotech Inc T.ONC

MBC phase 3

[inthno]

Hopefully Panc should be settled soon and favorably.... It will be interesting to see if we try it alone or partner.
Just curious if anyone has concern with the new guidance for the mbc phase 3 trial which is now 550 patients as compared to the original 400 patients with a spa in the original December 5th 2017 press release from onc.
One would think that with all they learned from the aware1 , bracelet and new biomarkers that I thought it was supposed to reduce trial time, derisk the trial and lower the patient numbers especially with the use of the biomarkers...
Just curious on thoughts as I do find it confusing that we will now basically be running the same trial but with a much larger number of patients.
Thanks for the thoughts

[Noteable]

Where did you find that 550  number of patients required for a Phase3 mBC trial? Are just pulling this number out of your hat and hope it sticks? Adlai Nortye's US$85 million payment to ONCY will be triggered on the enrollment of the 50th patient into the pelareorep + paclitaxel Phase 3 mBC trial. ONCY has close to that number with inclusion of patients from the IND-213,  BRACELET-1

[inthno]

Hello Noteable, you are good but not always up to date on everything. And I do appreciate what you have to offer to the boards. From the August sedar report which you can look up to find the prospectus in regards to the proceeds fromt the recent financing. Breast Cancer Commence the regulatory and planning process for a Phase 3 clinical study investigating the combination of pelareorep and

[inthno]

Also form the AN agreement One common share purchase warrant of USD $2 million whereby, upon exercise, Adlai may purchase Oncolytics' common shares priced at a 120% premium of the five-day weighted average closing price immediately preceding the exercise date. Oncolytics has the right to call this warrant when the first patient is enrolled in the phase 3 mBC study or six months after execution

[Noteable]

November 16, 2017 -  Oncolytics Biotech® Inc. and Adlai Nortye Enter into USD $86.6 Million Regional Licensing Agreement for REOLYSIN® Terms of The Agreement Oncolytics will receive an upfront licensing fee and milestone payments to support the phase 3 registration study in metastatic breast cancer (mBC) of USD $21.2 million, and is eligible to receive up to an

[Buckhenry]

I would not expect a Christmas card from unnoteable after that remark. 

[Noteable]

August 13, 2023 - SEDAR - (ONC.TO) MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS  No mention of an increase to 550 patients for a P3 mBC trial from previously announced number of 400

[inthno]

 I gave you a direct quote from the prospectus from sedar...You obviously did not look at the prospectus for August which has a supplement. www.sedarplus.ca USE OF PROCEEDS The Corporation estimates that its net proceeds from the Offering will be approximately US$13,650,000 after deduction of the Underwriter’s Fee of approximately US$1,050,000 and the estimated expenses of the Offering of

[Noteable]

ONC.TO Condensed Interim Consolidated Financial Statements (unaudited) Oncolytics Biotech® Inc. For the three and six months ended June 30, 2023 - NADA  Nothng 

[Noteable]

  inthno - I cannot find anything that you stated appearing in August 2023 SEDAR - no 550 patients, no FDA feedback in Q1 2024, no anticipated cost of $0.5 million - nothing inthnointhno

[inthno]

So I am guessing you did not find the supplement and that the direct quote is wrong. Did you narrow the search peramiters and check all of the August filings.

[Noteable]

I have checked all of the July and August SEDAR filings - NADA.

[Noteable]

I have also checked all of the August SEC filings - NADA. So you must be seeing something that the rest of us dont OR it doesnt exist in the public domain.

[inthno]

I will do my best to help as I am on the sedar website as I write this and this is the filings. Maybe you can access the filings from this   Oncolytics Biotech Inc. / Oncolytics

[Noteable]

Result : Profile type Profile Filing Submissions Principal jurisdiction from profile Reporting issuer   Company Oncolytics Biotech Inc. / Oncolytics Biotech Inc. (000013081) News releases (06002270)

[inthno]

Hello Note and from my previous post where I copied and pasted, you should just be able to click on the prospectus supplement to get the filing...I just went to my post and clicked on it and it took me directly to the prospectus. Hope this works

[Noteable]

Tried. No luck. Menu Go to Dashboard     Franais   Login       The page you have requested can not be found. Ensure you are logged in if required, else contact your system administrator

[inthno]

Hello Note and I went to sedar again and found it so lets give it another go. 1) open browser and typer sedar.ca 2) Hit search at top of page 3) type in oncolytics biotech- the name should auto come up and just click it to auto fill 4) Do not fill any other boxes in 5) Go to date range at the bottom of the search 6) click start date Aug 1sth 2023 7) End date  Aug 18th 8) 12 results should

[Noteable]

Got it now. On page 2.

[Normandt]

550 patients is an estimated not an official guidance received from the fda.... for a normal phase 3 trial.   400 patients in 2017 was for a fast track phase 3 trial.   Then I don't see where is the problem here.

[inthno]

hello Normandt According to onc we still have a fast track for our phase 3 mbc indication and if they could run the trial back in 2017 with 400 patients , it is diffiucult to comprehend that with all the work done to bring us where we are that the company is saying they will run the exact same 2 arm trial with 550 patients...The trial will most likely not start unil 2025 as they said they are

[Noteable]

Remember that Accelerated Approval provides that pelareorep can be approved in HR+/HER2- while the Phase 3 is running so ONCY should be going after this developing option during its iterative meetings with the FDA.

[Noteable]

AWARE-1 demonstrated that in HR+/HER2- early-stage breast cancer:  Treatment with pelareorep alone or in combination with atezolizumab increased tumor PD-L1 expression and led to the conversion of PD-L1 negative tumors into PD-L1 positive tumors So Roche and other Big Pharma companies with checkpoint inhibitors will be coming into the picture at 

[Noteable]

Aware-1 identified pelareorep biomarkers in HR+/HER2- early-stage breast cancer that satisfy the FDAs use of surrogate endpoints/biomarkers in its Accelerated Approval pathway and pelareoreps early approval filing in mBC. - Pelareorep alone and with checkpoint blockade converts tumors to PD-L1 positive classification - Oncolytics validates that pelareorep

[Noteable]

With CelTIL as one biomarker : 70% of all cohort 1 and 2 patients (n=20) saw an increase in CelTIL from baseline to surgery 60% of cohort 2 patients (n=10) saw a CelTIL increase of at least 30% from baseline (pre-pelareorep administration) to surgery (21-days post-administration), exceeding the study's pre-specified success criteria

[Noteable]

As previously posted - A surrogate endpoint used for accelerated approval is a marker - a laboratory measurement, radiographic image, physical sign or other measure that is thought to predict clinical benefit, but is not itself a measure of clinical benefit.  The FDA instituted its Accelerated Approval Program to allow for earlier approval of drugs that treat serious conditions, and

[Noteable]

Biomarkers are used to identify the best treatment for a patient, to monitor the safety of a therapy, or to find out if a treatment is having the desired effect on the body. Many biomarkers used today have been developed to be used in a specific disease or as part of the development program for a specific medical product. Under the FDA’s recently established Biomarkers Qualification Program

[Noteable]

Should read: This view appears to place pelareorep in a favorable position for an early Accelerated Approval in mBC .... and reinforces the need for ONCY to pursue the FDAs actions in relaxing regulations involving early drug approval in diseases with unmet medical treatment needs, such as Her2- mBC, where ADCs are not indicated.

[Normandt]

No , you don't understand the process.   It's not hard to understand and we don't have to worry about that.    550 patients  is estimated for a normal ph3 trial.    They can not claim something that they should have when even the mbc ph3 is not yet announced.

[inthno]

Hello Note and hope you were able to access the docs and nice when everyone works together for the common goal without confrontation....We must understand that everyone has different pov's especially depending upon how long they have been invested with the company and that most but not necessarily all concerns can be deemed valid. Onc history has not generally been kind especially to any long