Oncolytics Biotech Inc ONCY

FDA guides on how AA can be converted to full approval.

[Noteable]

March 24, 2023 "While Congress recently passed legislation (IRA) that will allow FDA to require confirmatory trials to be recruiting and ongoing prior to granting an accelerated approval, the agency is now making clear that the initial trial used to win the AA, if designed appropriately, can also serve as the trial for converting the accelerated approval into a full approval."

But the design of that trial must be precise as FDA says in today’s draft guidance that it must be “powered for the longer-term clinical endpoint with follow-up in the same trial to verify clinical benefit,” and should ensure that the accelerated nod doesn’t inadvertently introduce bias.

As far as logistics, the draft notes, “The trial sample size should be chosen so that it has adequate power to detect a clinically meaningful and statistically significant improvement in both the endpoints for accelerated approval (e.g., response rate) and verification of clinical benefit (e.g., PFS or OS).”

[ONCY is likely in talks with the FDA and Big Pharm potential acquirers on how to design 2 Phase 3 clinical trials to obtain both an accelerated aprroval AND a FULL approval - in both breast and pancreatic cancers]

https://endpts.com/fda-spells-out-how-cancer-drug-developers-can-use-one-trial-for-both-accelerated-and-full-approvals/

[Noteable]

So when Matt stated that the trial design for the breast cancer Phase 3 clinical trial would include 200-300 patients - he would seem to have been informing us that  ..the trial sample size would be large enough to adequately power the detection of a clinically meaningful and statistically significant improvement in both the endpoints for accelerated approval (e.g., response rate) and

[Noteable]

Here is the FDA's draft guidance on this matter released this morning ... https://www.fda.gov/media/166431/download

[Noteable]

Furthermore, patient trial sizes may be smaller for those patients who have been identified by a biomarker .... ( so the Phase 3 breast cancer study may be much smaller than 200-300 patients as recently stated)- and as outlined in the FDA's draft guidance. "In cases wherein historical trials did not specifically evaluate the response rate for the standard of care treatment in a biomarker

[Noteable]

March 24, 2023 "While Congress recently passed legislation (IRA) that will allow FDA to require confirmatory trials to be recruiting and ongoing prior to granting an accelerated approval, the agency is now making clear that the initial trial used to win the AA, if designed appropriately, can also serve as the trial for converting the accelerated approval into a full approval."&

[Noteable]

ONCY's potential Big Pharma acquirer would be the one to decide on the design of the Phase 3 registration study so that an accelerated approval request could be submitted at around the same time as the Phase 3 is filed.

[Noteable]

Read this and learn Quentin30

[Noteable]

"Stuff" is happening around ONCY - and its being regulated by the FDA's timeline. Now that Big Pharma has a clear understanding on how they can take ONCY's 2 Phase 3 clinical trials through to FULL APPROVAL using the FDA's new "one-trial" approach ... "stuff" should really be ramping-up on the acquisition front for ONCY  - which could well be 

[Kswdelux]

Interesting, I wonder if this is something that needed to be out in place based on ONC science and something BP wanted or needed in place prior to and final agreements or bids. The timing of this just seems interesting...

[Kswdelux]

Further to this, a typical Phase III registration study is 800-850 patitients. When ONC receieved the FDA's letter of Special Protocal back around 2016, that letter cut the mBC Phase III required patients to 400-450 patients. At that time, ONC recieved aditional advise on Phase II reported data from the FDA. Basically stating, there appears to be a pattern in the data that may suggest a

[inthno]

2-300 patients would be fantastic but if you listen to the latest podcast ,Links on the stocktwits board you will have just heard that Matt is predicting  the trial size to be somewhere between 4-500 patients so just need to keep this in perspective and also Matt has never mentioned the use of the bio-markers in his talks in regards to running the phase 3 trials but to clarify it does state

[Noteable]

The latest podcast happened BEFORE today.. Today the FDA handed down DEFINITIVE GUIDANCE on biomarker driven patient trials with specfic reference to surrogate endpoints and the reduced trial size for biomarker identified patients.

[inthno]

I guess we shall see soon enough on the trial size as we can guess all we want but not up to us. Personally I would just like to see one or both of our phase 3 trials up and running this year. Now that would be a welcome early Xmas gift for all.

[Buckhenry]

can the pumping dreamers stop the bleeding with their worthless posts or is it time to put it out of its misery??

[Noteable]

Trial size is of no issue should the FDA grant an accelerated approval (AA) and as ONCY's acquirer taking on the responsibility of a "one-trial approach" to FULL APPROVAL. All this means is that ONCY has 2 Phase 3 ready clinical trials "in the hopper" ready for Big Pharma to take through to FULL APPROVAL by means of today's guidance by the FDA.

[Noteable]

With the FDA's guidance today, any focus on the size of a "one-trial" biomarker driven Phase 3/Accelerated Approval/Full Approval clinical trial is only relevant to powering the trial so that it can reach statitical significance, and the FDA seems now prepared to grant an Accelerated Approval allowing any product to be marketed, if all the parameters of a biomarker dirven "one

[Noteable]

In 2022, pre-Phase 3 targets made up 50% of M&A deal volume for the very first time as Big Pharma companies  are increasingly moving toward earlier-stage assets to gain access to innovative and novel drug therapies in light of Big Pharma's looming patent cliff. With Pfizer's proposed take-over of  Seagen for US$43 Billion, Big Pharma leaders are acknowledging that they

[fox7mf]

Coffey needs to get the SP up exponentially before acquisition if we are to get anywhere near $5-$15b. He needs to get on this at once.

[inthno]

If If's and but's were candies and nuts we would all have a very merry Xmas. So we can extrapolate all we want and hope for the best but at this time the latest comment by Matt Coffey is 4-500 patients and that is a fact and until we hear different it is what it is. Am hoping for less and of course AA would solve all the problems but until we hear the news telling us so, the latest

[Noteable]

Aside of any candies and nuts, the fact is that any of the Phase 3s/AAs will be sized and powered to the degree that is sufficient to achieve statistical significance for the FDA's approval. Whether that size is a 200 patient biomarker driven size or some other plus or minus number,  what matters is that the FDA will be involved in agreeing to the patient size of this "one-trial"

[Quentin30]

Why do you think Matt would state in his most recent podcast. that the mBC trial would require 400-500 patients... THIS is exactly the number that was posited to investors 5 years ago, when ONCY recieved a SPA from FDA... Matt was then telling us that with biomarkers, they could get the population down to 250, and thus save time.. SO.. 5 years on, we have the same trial size... still no partner

[Noteable]

By achieving an accelerated approval to allow for the immediate sale of the product neither the trial size nor the time it will take to complete the "one-trial" for full approval will matter whatsoever.

[inthno]

Hey Note, agree completely with you on this on, BUT that is if we get AA and if onc has applied for AA , neither of which we know for sure at this time. Hopefully it will come to pass and end all speculation. As for the timing of a possible AA, that is the big question also. Did onc apply and when did they apply and how long does it take for this process and possible approval. With fast track in

[Noteable]

Under the new FDA guidance and the "one-trial approach, an accelerated approval would be sought alongside the registration of what would be considered a Phase 3/4 clinical study AND I would think that ONCY's potential Big Pharma would want to be responsible for such registration action as they would want to be responsible for the design, implemention and control of such a critical late

[Kswdelux]

I don't know the answer to this... In an AA scenario where the product is then sale-able, is the product sold throughout the trial at the actual product sales end point price? Or, is it sold at a discounted price throughout the trial? My thought is, with AA will we only know the discounted sale price, or will we know the actual final endpoint sale price? Knowing the actual final

[Noteable]

Kswdelux - you're unfortunately wrong in your thoughts and my trying to further explain the process would still just end up going over your head. Best.

[Noteable]

The fact that the FDA's biomarker driven "one-trial" approach leads to FULL APPROVAL appears to have been lost on many here. Full approval means fully "de-risked" which is much easier to achieve particularly when this final "one-trial" is comprised of biomarker defined cohort of patients. As the FDA has stated: "In cases wherein historical trials did not

[Noteable]

Sounds to me as though inthno has an opposing dog in this race. 

[Noteable]

It seems that I have to repeat this one example of the pre-clinical company Trillium Therapeutics that was acquired by Pfizer for US$2.3 Billion. And as an anthesis to inthno's analogy in this deal there were No birds, No hands, No defined product or cancer indication, and No nothing other a hypothesis and James Parsons, who now sits on ONCY's BOD. https://www.oncolyticsbiotech.com

[Noteable]

May I also remind those on the attack that Takeda aquired Nimbus Lakshimi (a subsidiary of Nimbus LLC.) for US$6 Billion for one drug in one indication ..... psoriasis .....

[Lesalpes29]

No phase 3 yet, no guarantee that a phase 3 would be successfull, market cap less than 80 millions not 800 ... 80! Almost no interest by the market... And we can't say that a 3 billions buyout could be good! Barking doggy yourself Noteable... Have a great week,

[Noteable]

The pre-clinical biotech company Trillium Therapeutics had a market cap of $600 million on Friday August 20, 2021 and then on the morning of Monday August 23, 2021 TRIL opened for trading with a market cap of US$2.3 Billion with the announcement of Pfizer's acquistion over the weekend. Woof Woof. In ONCY's case this company has multiple cancer indications which represent multiples of

[westcoast1000]

ksw, That is a good question. My GUESS is that it would be the ballpark market price. However, your point would have even more weight if the number of indications were very limited, like just panc or Mbc. It seems there may be more indications as well as CAR-T and other combos. So we are not just multiplying price times quantity. Plus there is the precision medicine side coming from a biomarker.&

[Kswdelux]

All I was getting at was a potential for a ballpark price. Google the cost of cancer patient treatment costs, and it will tell you the avergage monthly cost of cancer treatment for a patient ranges from $1000/mo to $12,000/mo. That is a seriously big range. Products like Roche's Tecentriq was turned down overseas due to it is costly and efficacy is only 1 or 2 in 5. So there is information

[Noteable]

Reportedly the cost for a course of intravenous checkpoint inhibitor therapy is around $US150,000 to $250,000 while the rate of effectiveness is between 10 - 20 %. With ONCY's pelareoep continuing to prove synergistic effectiveness in combination with PD-(L)1 immune checkpoint inhibitors, the increased degree of efficacy would result in an increased number of patients who could be placed

[Noteable]

With the FDA's guidance this March, any focus on the size of a "one-trial" biomarker driven Phase 3/Accelerated Approval/Full Approval clinical trial is only relevant to powering the trial so that it can reach statitical significance, and the FDA seems now prepared to grant an Accelerated Approval allowing any product to be marketed, if all the parameters of a biomarker dirven "

[Noteable]

Recent ONCY developments pursuant to the  following March 2023 FDA guidance has moved the goal posts closer to ONCY's acquisition, given that Big Pharma is now more inclined to want to take a product from an accelerated approval through to a full approval to assure that the trial is appropriately designed and executed. March 24, 2023 "While Congress recently passed legislation (IRA)

[Noteable]

July 18, 2024 - The FDA turns down Agenus’ plans to seek accelerated approval for a colorectal cancer combination. Agenus is using a combination of its CTLA-4 blocking antibody botensilimab and PD-1 candidate balstilimab. Agenus said the FDA discouraged a filing for accelerated approval because of its belief objective response rates may fail to translate into survival benefit.  

[fasttrack5]

What about our ONC:)

[Noteable]

Amgen secured approval on May 16, 2024 for its first-in-class bi-specific T-cell engager, Imdelltra, for extensive-stage small cell lung cancer (SCLC). With the FDA nod, Imdelltra becomes the first bispecific T-cell engager therapy for advanced SCLC.   The accelerated approval was based on a Phase II study of 99 patients in the target population, where Imdelltra led to an overall

[Noteable]

The previous post on Amgen's bispecific Accelerated Approval that of those patients with objective response to Imdelltra, 59% sustained the response for a median duration of at least six months and the median progression-free survival (PFS) was 4.9 months in the 10-mg group, while overall survival was 14.3 months. By Comparison : In May 2023 ONCY's announced the pelareorep + paclitaxel

[Noteable]

Should read : " ....The FDA's granting of an Accelerated Approval to Amgen's bispecific Imdelltra was based on those patients with an objective response (ORR) to Imdelltra ...."

[Noteable]

https://www.biospace.com/amgen-wins-fda-approval-for-difficult-to-treat-lung-cancer