Oncolytics Biotech Inc ONCY

Conference Call

[Journeytc]

My key take aways. Without being said...ONC is now a Pancreatic Cancer Company with a possible Q1 2025 enrollment.  
ONC demoted Breast Cancer to a Phase 2 opportunity.  The target population for pela is subjugate to  the evolving ADC treatments.  Specifically individuals dropping out of first line ADC treatment. They suggested more details on Breast Cancer forethcoming in three months.    The good is we have a clearer understanding of path and timeline for pancreatic.  Markets will like this.  
The bad...market potential and risking got hammerred by Breast Cancer demotion.
I cant believe the board didnt clean house after last years Breast Cancer fiasco.   The multi year delay to complete AWARE.  They no longer talk about using biomarkers.  And the failure to include tylenol treatment protocals for individuals sufferring flu like symptoms.  They lost the best half of responding population.

[Noteable]

You obviously haven't understood what has been posted ad nauseum on the biomarker selected for the Phase 3 metastatic breast cancer study. The biomarker is progression free survival - PFS.  PFS is an advanced biomarker driven surrogate endpoint that the FDA has recently guided on in granting an accelerated approval - as opposed to ORR which is was the standard measurement. And your

[Noteable]

https://ascopubs.org/doi/10.1200/JCO.2014.57.9557

[Noteable]

FDA current guidance on surrogate endpoints (biomarkers) in solid tumors like breast cancer  "Whether tumor measures such as ORR or PFS are used as an accelerated approval or traditional approval endpoint will depend on the disease context and the magnitude of the effect, among other factors" https://www.fda.gov/media/71195/download https://www.fda.gov/drugs/development-resources

[CaseyL]

Highly curious on Pfizer survival numbers. Hopefully we don't have to wait randomly all the way till November December to see.

[Journeytc]

Im still flummoxed with todays quarterly report. Matt declared ONC a Breast Cancer company many years ago.  There was genuine excitement about the outcome of the IND213 trial and the massive size of the therapeutic market it represented.  I dont know what the opportunity has become with todays news.   But i would guess poor design of the Bracelet trial has now reduced the

[13X2413]

All will be ok. Another fireside chat scheduled. I feel much better now. :)

[CaseyL]

So it sounds like terrible news. We have another two years? 

[CMHarring218431]

???

[Journeytc]

With regard to enrollment in a phase 3 study or a transitional study that leads to a phase 3,  i think we are looking at 8 months for the pancreatic trial.  We'll know early the progression free survival results for Pancreatic disease since death from prognosis advances rapidly.   And ONC will get Accelerated Approval for this one.  Markets will see a clear timeline to

[Noteable]

It has been stated many times and couldn't be more clear: Results from the BRACELET-1 study will be moving into a registrational study.  June 05, 2023 - “Given this exciting finding, our next step is to discuss our data with the FDA to investigate incorporating dual PFS and OS endpoints into our breast cancer program’s registrational study. Including a PFS endpoint could substantially

[Noteable]

ONCY has conducted 2 Phase 2 studies in mBC -  IND-213 & Bracelet-1.  12 month OS was reported in June 2023. 2 year OS data will be reported this half and more likely this quarter - taking ONCY into a registrational study for the pelareorep + paclitaxel combination, with an anticipated Accelerated Approval.