Oncolytics Biotech Inc T.ONC

Adlai Nortye

[lonc17]

Pelareorep has been removed from Adlai Nortye's website (sometime during the past three weeks).

I have no idea what this means, but it is surprising. 

https://www.adlainortye.com/index.php/products

[inthno]

good catch on this one as I do find it more than intersting especially at this time. We are still listed as a business partner but that is all as we are no longer listed in their pipeline. My guess is that they will no longer be doing the trial which was originally scheduled to start this year ( with the approval of ONC according to docs ) but it was just an extention of the original trial and

[jimsenior]

I have had to come out of retirement from the yahoo board to try and settle this AN situation. At the AN website look under patients, pela is there AKA AN 1004. AN can be found at clinicaltrials.gov, and are active, not recruiting. As always, if I am wrong, I am happy to stand corrected.

[inthno]

Yes it makes sense as the bridging trial was already in progress and some patients had been treated with pela but now no mention of the bridging trial results which should have been done a long time ago and onc is no longer listed in their pipeline of drugs going forward as this is how it used to be mentioned so am still thinking that something has changed. I now no longer see them going forward

[jimsenior]

Yes. I see your point about a change. Perhaps when they stopped recruiting or any number of other things. It seems to me (and I could be wrong) that AN and  ONC/ONCY are if anything closer than say a few months ago. This is the time for those at the corporate level to be circumspect. The recent hires are there to facilitate. To me, if there is a deal in the works, it is complex, and all the

[Noteable]

Agreed jimsenior. Also note that Oncolytics Biotech is still listed as one of Adalai Nortye's current partners, along with Novartis, MSD, Roche and Eisai. AND the licensing deal with ONCY for Reolysin still appears in their Business Development list of accomplishments. https://www.adlainortye.com/index.php/partner_cooperation https://www.adlainortye.com/index.php/partner_business

[Noteable]

This could also suggest that ONCY (or acquirer) may be looking to file for an accelerated marketing approval for pelareorep with the FDA based on the collective results the IND-213, AWARE-1, Bracelet-1 and Goblet Phase 2 clinical trials which investigated the effectiveness of pelareorep + immune checkpoint inhbitors. The Adlai Nortye trials were designed as monotherapy pelareorep with

[Capitalista]

I'm not sure I follow your logic here, Noteable.  Wouldn't the applicant just have to exclude the AN trial from the FDA application?  AN is an independent company working in a different regulatory environment.  Can you clarify? 

[Noteable]

Adlai Nortrye's 3 cohort bridging trial investigated pelareorep dosing in combination with paclitaxel. The first 2 cohorts investigated pelareorep + paclitaxel in doses that were equivalent to the IND-213 trial, with the final cohort dosing regimen being equivalent to ONCY's Phase 2 Bracelet - 1 trial. In March 2022 Adlai Nortye reported that it had advanced to the third and final

[Noteable]

Should read .. " In March 2022 Adlai Nortye reported that it had advanced to the third and final dose escalation cohort of the bridging clinical trial evaluating the safety, tolerability, and preliminary efficacy of pelareorep-paclitaxel combination therapy in Chinese patients with advanced or metastatic breast cancer. Adlai Nortye's pelareorep + paclitaxel dose escalation

[Noteable]

Have I answered your question Capitalista?

[Capitalista]

Sorry for the slow reply on this, Noteable - I've been out of internet access for the past few days.   You've partially answered my question.  I'm wondering why AN would willingly embargo study results when they don't receive any particular benefit from doing so.  In fact, AN would incur some time risk from delaying results, assuming the results are positive

[Noteable]

Adlai Nortye's study was a dose escalation study wih pelareorep + paclitaxel and did not involve an immune checkpoint inhibitor to improve efficacy. Perhaps ONCY is closer to an acquition than anticipated. 

[jimsenior]

Yes. I was thinking that this needs to be neatly tied together, and perhaps that was the thinking from the get-go. Anyway, just speculation on my part; big bucks and big brains needed. Will someone step up? We wait. Good luck.

[jimsenior]

In re AN. After thinking about this, it is quite possible that AN is not continuing with pela. They did sort of imply that in that email response. If that speculation is correct, I am not alarmed yet as it could mean a development. It was never very clear what AN was doing, as they did seem to be working at cross purposes; that is to say ONC did not seem to know what their game plan was. Hopefully

[Noteable]

And then of course, Bidens's executive order may have also had some affect on ONCY's potential acquisitor and their globalization plans.

[inthno]

Nothing personal Noteable, but you have no idea as to whether or not the results have been embargoed. It is your opinion only and you should state such. Also you are suggesting that Merck pfizer is fliling for a BLA. Where did you get that information. A lot of your posts are very informative and appreciated but enough of your 2 cents and analysis as no one has been right to date about what is

[Buckhenry]

I second that... about 20% of the posts here have any useful information.

[Noteable]

Just read what I posted. I stated that ONCY ( or acquirer) could file an accelerated approval (BLA) on the cumulative results of the IND-213, AWARE-1 and Bracelet-1 hase 2 clinical studies.   We know that Merck KGaA and Pfizer are ONCY's collaborators on the Bracelet-1 clinical trial through the numerous quarterly presentations given by ONCY's management team, and where they

[Noteable]

Just keeping it real as possible for someone like you with 3 seperate aliases - aka 'Da-Man' aka "dreamer" aka 'inthno". Just sayn'

[inthno]

Why don't you ask AN what they meant. At least I reached out and got an answer now it's your turn. And how do you know that pfizer could file a bla, you are suggesting to people that you know. AN is a different jursidiction and what they do there should not affect what happens in other jurisdictions. There are drugs that are approved in one jurisdiction but not another.True they said they

[Noteable]

I know what I know. And I don't need to pester anyone like you seem to do, to have arrived at what I know.

[inthno]

Believe it or not I do appreciate a lot of your posts and they are a good reminder of what has happened in the past. Going forward we all have our ideas of what may or may not be and that is okay, but all I am asking is that everyone's opinions be respected. We do not know what the future may hold for the company be we are in unison hoping that something is finally going to give for the

[Buckhenry]

yes...you are a legend in your own mind. NO ONE .. unless your are an insider..like Martha Stuart... has no idea what or when something may happen with this stock. Been reading the same ole regurgitated posts for the last 3 years.