RE:RE:RE:RE:RE:RE:RE:News out on Goblet trial with Merck Well, same old same old as generally expected.
Seems like a silly game they play.
I have not listened to the webcast yet, but really expect nothing different in there. So, they really have not provided the Shareholders and Analysts with anything new as requested by the Analysts.
The main head line of this Nov 5th NR starts off with
Clinical breast cancer data indicate pelareorep-induced changes in blood T cell populations may be a predictive biomarker
What is up with this “MAY BE A PREDICTIVE BIOMARKER”? ONC has been verbally stating that have two biomarkers basically confirmed, but this NR only states “may be” and others state “appears to”
In the May 20th NR ONC
announced clinical and biomarker data demonstrating clinical proof-of-concept for pelareorep-checkpoint inhibitor combination therapy in pancreatic cancer.
So ONC is referring to already established biomarker data for this demonstration.
In the May 20th NR ONC also states the GOBLET
study is a phase 1/2 multiple indication biomarker, safety, and efficacy study in advanced or metastatic GI tumors.
Even the GOBLET definition of the May 20th NR ONC is basically stating that ONC is attempting to determine if there are BIOMARKERS for the Gastro, basically similar to as seen in the previous AWARE-1 trail data.
So, reading between the lines here, ONC is attempted to confirm that the biomarkers documented in previous trail data will provide a similar biomarker for gastro. So, again they have designed and new GOBLET trial around AWARE-1 biomarker data, and even drawn in ROCHE again with ROCHE’s Tecentriq for this GOBLET trial, based on the previous AWARE-1 biomarker results, that we have not seen the final data for, and
yet herein this NR ONC is still having to state “MAY BE A PREDICTIVE BIOMARKER”. Silly game there.
I am wondering if they have to wait until the final AWARE-1 data are released before they can actually and officially state they have confirmed the two biomarkers in the AWARE-1. They are holding that data pretty tight to the chest, it seems.
In this Nov 5th NR ONC states for GOBLET
the trial also seeks to validate CEACAM6 and T cell clonality as predictive biomarkers,
From the Nov 3rd NR
In addition to evaluating the safety and efficacy of pelareorep-atezolizumab treatment, the trial also seeks to demonstrate the potential of CEACAM6 and T cell clonality as predictive biomarkers
CEACAM6 was one of the same biomarker discussed in the AWARE-1 interim results. So it would appear ONC is attempting to validate the same CEACAM6 biomarker for Gastro and mBC. So why not just state that. The info is basically here already.
I look forward to the day that ONC actually comes out and confirms the biomarkers, and stops stating “may be a” or “appears to be”.
Until confirming statements are actually made regarding the biomarker(s), the Shareholders and the Analysts have little more to act on than what we have been hearing for the east 2 years.
I do not see the SP moving much upwards until an announcement regarding partnership or buyout. Likley to go down.
I do not not believe that any of these milestones are going to change the SP.
Anticipated Milestones and Catalysts
- Completion of enrollment in phase 2 BRACELET-1 metastatic breast cancer study: Q4 2021/Q1 2022 (ok so they hit full enrllment, yay!)
- Interim safety update from phase 2 IRENE study in triple-negative breast cancer: Q4 2021 (Yes, well tollerated, we already know that, Yay!)
- Multiple myeloma study data: Q4 2021 (This could ne intersting, depending on what they actually release. Not holdfing my breath.)
Oncolytics expects to provide updates on the timing of the following milestones:
- Interim safety update from BRACELET-1 metastatic breast cancer study (Again, well tolerated, getting more exciting by the minute here, yay !)
- Phase 2 BRACELET-1 metastatic breast cancer study: final data (Likley not until mid late 2022)
I see that ONC has even removed (or simply not included) the milestone of the AWARE-1 FINAL BIOMARKER DATA from the list of milestones in this Nov 5th NR.
What does that mean ?
Have we received all that is going to be released on AWARE-1?
Has it been put on the back burner indefinitely?
Or, was it just over looked in the list of milestones? It is still included in the list of milestones in the Oct 2021 Investor Presentation as H2/2021. Why is it not noted in this NR?
It was my understanding that the AWARE-1 trial was specifically set up in part to define/confirm and capture the biomarker data that they did not property capture in the Phase II trial and discussed with the FDA.
So, if ONC is still officially stating that palereorep “MAY BE A PREDICTIVE BIOMARKER”, I can only assume that there is still a FINAL report to come from the AWARE-1 , indicating that the biomarkers are officially confirmed.
And, by the way this biomarker is-data is protected, I can only assume that once it is released we will be looking at a very different SP. Hard to know, but otherwise, why not just come out and confirm it.
Unfortunately, IMHO there is nothing new here to sink our teeth into and get excited about :(
Don’t get me wrong, I am still long on this. New news is always building on previous news, new trials are always building on the positive data of previous trials. No bad news, other than no realy new news. But, it’s all good still IMHO.
I am just ranting some here, as I do not understand why at this point in the process does the first line in the Nov 5 NR have to state “MAY BE A PREDICTIVE BIOMARKER”. Cause reading between the lines of all the other previous NRs and ONC comments it would seem we are already past this a long time ago.
Why hold onto important BioMarker data, while other new expensive trials are being designed and implimented around that data moving forward ?
I can only assume it has to do with gag orders, firstly by ROCHE, as I recall ROCHE has final say on the final AWARE-1 data to be released. And, IMHO, as I am assuming ROCHE will be the one to step up to the plate first for a number of reasons, ROCHE may have a vested interest in holding off on the final AWARE-1 data?
The FDA suggested they say the biomarker in the Phase II trial, ONC has stated similar, many patients have been treaded since then under this biomarker evaluation, yet the first line in the NR is Well, same old same old as generally expected.
Seems like a silly game they play.
I have not listened to the webcast yet, but really expect nothing different in there. So, they really have not provided the Shareholders and Analysts with anything new as requested by the Analysts.
The main head line of this Nov 5th NR starts off with
Clinical breast cancer data indicate pelareorep-induced changes in blood T cell populations may be a predictive biomarker
What is up with this “MAY BE A PREDICTIVE BIOMARKER”? ONC has been verbally stating that have two biomarkers basically confirmed, but this NR only states “may be” and others state “appears to”
In the May 20th NR ONC
announced clinical and biomarker data demonstrating clinical proof-of-concept for pelareorep-checkpoint inhibitor combination therapy in pancreatic cancer.
So ONC is referring to already established biomarker data for this demonstration.
In the May 20th NR ONC also states the GOBLET
study is a phase 1/2 multiple indication biomarker, safety, and efficacy study in advanced or metastatic GI tumors.
Even the GOBLET definition of the May 20th NR ONC is basically stating that ONC is attempting to determine if there are BIOMARKERS for the Gastro, basically similar to as seen in the previous AWARE-1 trail data.
So, reading between the lines here, ONC is attempted to confirm that the biomarkers documented in previous trail data will provide a similar biomarker for gastro. So, again they have designed and new GOBLET trial around AWARE-1 biomarker data, and even drew in ROCHE again with ROCHE’s Tecentriq for this GOBLET trial, based on the previous AWARE-1 biomarker results, that we have not seen the final data for, and
yet herein this NR ONC is still having to state “MAY BE A PREDICTIVE BIOMARKER”. Silly game there.
I am wondering if they have to wait until the final AWARE-1 data are released before they can actually and officially state they have confirmed the two biomarkers in the AWARE-1. They are holding that data pretty tight to the chest, it seems.
In this Nov 5th NR ONC states for GOBLET
the trial also seeks to validate CEACAM6 and T cell clonality as predictive biomarkers,
From the Nov 3rd NR
In addition to evaluating the safety and efficacy of pelareorep-atezolizumab treatment, the trial also seeks to demonstrate the potential of CEACAM6 and T cell clonality as predictive biomarkers
CEACAM6 was one of the same biomarker discussed in the AWARE-1 interim results. So it would appear ONC is attempting to validate the same CEACAM6 biomarker for Gastro and mBC. So why not just state that. The info is basically here already.
I look forward to the day that ONC actually comes out and confirms the biomarkers, and stops stating “may be a” or “appears to be”.
Until confirming statements are actually made regarding the biomarker(s), the Shareholders and the Analysts have little more to act on that we have been hearing for the east 2 years.
I do not see the SP moving much until an announcement regarding partnership or buyout..
I do not not believe that any of these milestones are going to change the SP.
Anticipated Milestones and Catalysts
- Completion of enrollment in phase 2 BRACELET-1 metastatic breast cancer study: Q4 2021/Q1 2022
- Interim safety update from phase 2 IRENE study in triple-negative breast cancer: Q4 2021
- Multiple myeloma study data: Q4 2021
Oncolytics expects to provide updates on the timing of the following milestones:
- Interim safety update from BRACELET-1 metastatic breast cancer study
- Phase 2 BRACELET-1 metastatic breast cancer study: final data
I see that ONC has even removed (or simply not included) the milestone of the AWARE-1 FINAL BIOMARKER DATA from the list of milestones in this Nov 5th NR.
What does that mean ?
Have we received all that is going to be released on AWARE-1?
Has it been put on the back burner indefinitely?
Or, was it just over looked in the list of milestones? It is still included in the list of milestones in the Oct 2021 Investor Presentation as H2/2021. Why is it not noted in this NR?
It was my understanding that the AWARE-1 trial was specifically set up in part to define/confirm and capture the biomarker data that they did not property capture in the Phase II trial and discussed with the FDA.
So, if ONC is still officially stating that palereorep “MAY BE A PREDICTIVE BIOMARKER”, I can only assume that there is still a FINAL report to come from the AWARE-1 , indicating that the biomarkers are officially confirmed.
And, by the way this biomarker is-data is protected, I can only assume that once it is released we will be looking at a very different SP. Hard to know, but otherwise, why not just come out and confirm it.
Unfortunately, IMHO there is nothing new here to sink our teeth into and get excited about :(
Don’t get me wrong, I am still long on this. New news is always building on previous news, new trials are always building on the positive data of previous trials. It’s all good.
I am just ranting some here, as I do not understand why at this point in the process does the first line in the Nov 5 NR have to state “MAY BE A PREDICTIVE BIOMARKER”. Cause reading between the lines of all the other NRs and ONC comments it would seem we are already past this a long time ago.
Only time will tell.
Good luck all!