NR 2022-03-09https://ir.oncolyticsbiotech.com/press-releases/detail/562/oncolytics-biotech-announces-phase-1b-data-demonstrating
Even though it's Phase 1... it was long ago enough that they have long term overall results. Nice !
Results from the trial showed that the combination was well-tolerated and led to prolonged progression-free survival (PFS) of over three years in a subset of patients.
It is nice to see this NR states more than just well tolerated. And to actually hear
progression-free survival of >3 years achieved
is a much better step forward news wise as to where ONC is headed.
Additionally, biomarker data demonstrated increased infiltration of T and NK cells in the tumor immune microenvironment post-treatment.
and....
These post-treatment increases in anti-cancer immune cells correlated with both clinical response and changes in T cell clonality, which has previously been identified as a potential predictive biomarker that could increase the likelihood of success in future trials of pelareorep by informing patient selection.
oh... it's almsot there.... they correlated with... but oh... almost there.... (big breath)... which has previously been identified as a potential predictive biomarker ... but oh... (big sigh) ... oh well... they still are not able to come out and state the biomarkers are confirmed... lol
oh well... we are still demonstrating proof of concept... I guess.
but awesome to hear...
"To see patients resistant to prior therapies achieve multi-year PFS is a remarkable finding that speaks to pelareorep's potential to synergistically combine with anti-cancer agents and provide sustained clinical benefit,"
Don't get me wrong.... I am not negative on ONC... just having a chuckle with this NR as I just find some of this almost comical that they just cannot come out and spill the beans on confirmation of the biomarks. Yes, I understand Bracelet does not wrap until Q4 but they are seeing leve data and do have and idea what is going on. So as long as the trail does not get cancelled, I have to assume things are moving in the right direction in Bracelet-1.
But, it does demonstrate where ONC is headed. It's been a slow painfull process and I have a cr@p load of warrants that are going to expire on June 1st, 2022, and I have to question the warrants fate with timing on all this. The Letter to Share Holders was a nice carrot, but will it help with my expiring warrants? Only time will tell.
I have read many posts here and on other boards stating that ONC is worth nothing without the biomark proven. I just want to state that could not be further from the truth.
Pelareorep has gone through Phase I and II trials with such great results (and as even demonstarted here with progression free survival > 3 years, which is significant) and the FDA has written ONC a letter of Special Protocol that currently allows ONC to move into a Phase III trial based solely on the Phase II results. And those results where so good that the Special protocol letter stated that the FDA would reduce the Phase III trial from 800-850 patient down to 400-450 patients. Cutting it in half. That is significant and has nothing to do with the biomarkers tey are trying to confirm.
The biomarkers only came into play after the completion of the Phase II trial, when reviewing final Phase II data, the FDA and ONC felt that they had captured date on what appeared to be a biomarker. But that data had not been officially collected so that data could not be formally used for apporvals. Which later tuned out to be possibly two biomarkrs, and if I under stand this correctly, with this last added chohort in AWARE-1 there may be other biomarkers that they are looking at confirming as well. That's a bit over my head there. But...
ONC actually has the opion to move into a PHASE III trial at any time if they wanted to. But they chose to hold off on the Phase III trial while they attempt to confirm these biomarkers for a few reasons;
1) if ONC confirms biomarkers and the more the better, the more dialed the Phase III trial can be, because they know exactly who pelareorep will work
2) the FDA also sent a letter to ONC that stated if ONC can confirm the biomarkers and dail in the Phase III trail to patients who by the biomarker will respond to pelareorep, the FDA would drop the trial from 400-450 patients down to 225-250 patients. Again cutting the patient count in half. And the reason for dropping the patient count/number is again, they will know who/which patients will bennefit from pelareorep and they will not have a bunch of failures in the trail with patients that pelareorep will not work for...so...
3) the biomarkers will increase the likelyhood of success of the Phase II trial.
4) as ONC stated in a CC years back, proving a biomarker(s) will significantly increase the value of pelareorep in the health care market cause it is dialed to specific people with the right biomarker, which makes it more valuable to potential buyers of ONC.
But don't mis-understand the biomarker chase. That does not mean that if they cannot cornfirm the biomakers that ONC is worth nothing. It just means that the will have to complete a Phase III trail under the previously granted Special Protocol of 400-455 patient, and it's chance of success is less, cause the trial will have a bunch of patients in it that potentially may not respone to pelareorep.
But in any case, ONC can/will still move into a Phase III trial based on the great results of the Phase II trial that many seem to forget about and focus solely on the biomarker.
Yes, under the path they are on, the actual share price will/may not be worth much until the biomarkers are confirmed, because ONC will not move forward with the Phase III trial until the FDA is either satisfied with or denies the biomarker.
So we wait...
But in either case, a Phase III trail will commence based either solely on the Phase II data and no biomarkers, or with the confirmed biomarkers.
It just means that if the biomarkers are not confirmed, it will be a number of years more before the share price is worth a bunch more money. We wil basically be waiting until the end approval of the Phase II regisytartion Trial. But in either case I am here long.
If they confirm the biomarkers, I still think ONC will be bought out in 2022.
But, over all I am excited to hear
progression-free survival of >3 years achieved
I just hope there is enough significant news in the NRs between now and June 1st, 2022 that my warrants aren't toilet paper... lol