RE:RE:News out on Goblet trial with MerckIt would appear that the market has absolutely ZERO confidence in ONC bringing anything new to the table in the Nov 5 Earnings Call meeting, as there has been no real increase in SP regarding expectation or speculation.
I am expecting nothing of significance, unless there is a NR at the end of day Thursday for ONC to discuss Friday. Otherweise, unfortunsately it's same old - same old.
Even this latest NR has had no bump to SP. In fact it fell back a bit today after release.
GOBLET (Gastrointestinal tumOrs exploring the treatment comBinations with the oncolytic reovirus peLarEorep and anTi-PD-L1)
WOW, They sure worked hard to come up with that name GOBLET....LOL
But yes, all the news in this last NR is all positive.
The GOBLET study builds on data that was recently presented at...
so designing the trial on previous positive data. All good. but then drop they old
clinical proof-of-concept
that we are all getting so tired of hearing, then
supported by prior early clinical data showing that pelareorep-based combination treatments stimulated an adaptive immune response and led to a greater than 90% clinical benefit rate
and a greater than 80% increase in progression-free survival in pancreatic cancer patients with low levels of CEACAM6 expression
As they saw the CEACAM6 response in previous mBC they expect they will see the same/similar response in gastro. So caputure that data, great, and supported by previous clinical data completed by ONC. All good. But let's remember, this Gastro has nothing to do with the Phase III mBC trail. So it should not hold up the mBC Phase III trial at all. It's a side trial with a different disease.
the trial also seeks to demonstrate the potential of CEACAM6 and T cell clonality as predictive biomarkers
Biomarkers are money in the bank. Again, all solid news that takes time to complete. Yet, not even a blip in SP.
As these are all long term trials, there has been no response from the market. No excitement. This NR changes nothing for today, or even next week, or even next month. SP remains rather flat with little volume. I am actually expecting the SP to drop off after the Earnings Call Meeting.
I am beginning to wonder if ROCHE, PFIEZER, MERECK, etc all have a heavy gag orders on ONC and thus ONC connot state anything of substance until those trails are finalized.
Coming Milestones
Interim Safety Data for IRENE is due before end of H2 2021. IMHO not going to be big news, it's safety data. More of the 'well tolerated'.
Interim Safety Data for WINSHIP is due before end of H2 2021. IMHO not going to be big news. More of the 'well tolerated'. Also not connected to the Phase III mBC trial, so should not delay mBC Phase III start.
AWARE-1 FINAL results are due before end of H2 2021. Will we see more than what has been released to date is the big question in my mind ???
If there is nothing significanltly new, the SP will not climb either on that NR.
While I was expecting to see a drop in ONC SP in late Sept and early Oct, and it did, I did pick up some more shares, but in watching the market lately, it's getting hard to imagine that any of these projected coming NR milestones are going to make a difference to the market or SP.
Even the analysis are stating ONC needs to give Shareholders something more. So, it will be interesting what 'forward looking' statements are made on Friday, if any. And it will be interesting to see what happens with the target prices, like possibly down graded ??? I would not be surprised.
It would be really intersting to know where ONC is with discussions regarding timing on a partnership deal. Although again, ONC is likley under a gag order for any of that as well.
ONC cannot discuss any buy-out timing as there would be a gag order on that for sure. I read somewhere in a chat room that someone suggested that there have already been a couple buyout offers on the table for ONC that were turned down. Again probably gag ordered on those as well. But why? It sure would be nice to know where those rumours come from? What was offered? Why was it turned down, etc? What $$$ is ONC willing to accept and present to the Shareholders for a buyout? But I am sure we will never know what those offers were, or if they really occured.
IMHO I think the only 'forward looking statements' that ONC might be able to suggest at the Earnings Call would be potential timing on starting the Phase III mBC trial. Which I thought I read that ONC was anticpating end of H1 2022 (June-July 2022) for the start of the Phase III trial. Cannot find where I thoiught I read that. Which would mean ONC needs a partnership or buyout in the next 6 months for a June-July start.
Tough to watch right now, I agree, but I am still long on this, news keeps building on older news, new trials are desgined around previous positive trial data, no bad news, etc.
I am here until either a partnertship or a buyout. I am still leaning towards a buyout vs partnership within the next 6 months. As both Mereck and Pfiezer CEOs have stated they looking to buy first in class, best in class and Phase III ready companies so they can run the Phase III trials the way that they want to. ONC is all of that.
And, I have stated this before, I am looking to ROCHE to step up before the others do. Tecentriq is 66% of ROCHE's revenue in North America and Pelareorep makes Tecentriq work better. ROCHE does not need to wait to finish BRACELET or IRENE to know what pelereorep does in combination with Tecentriq. The combination of Pelareorep and ROCHE's Tecentriq will open up the European healthcare systems to Tecentriq, as the combination will increase the afficacy of Tecentriq. Tecentriq was denied market there due to it's cost and low afficay rate on it's own. And with biomarkers ROCHE can target exactly who it will work on with a much higher afficacy rate. So, no wasted healthcare funds on people that it will not work on. A Win-Win for ROCHE. The Europe healthcare systm approval would significantly increase ROCHE's annual revenue. IMHO, it just seems like a no brainer there. Why would ROCHE want to wait for Pfiezer of Mereck to finish thier trials, and for Pfiezer or Mereck to decide they want to buy ONC and possibly loose access to palereorep. Makes no sense to me IMHO.
And if pelareoprep did not work well in the AWARE-1 trail, (as some rant in chat groups that it does not work) ROCHE would not have signed up for the GOBLET looking to confirm similar biomarkers for gastro. Design of the GOBLET trial was based on previous positive AWARE-1 data because it works. All good.
A CAR-T partnership might provide a boost to SP. Short term only I believe, as the shorters will hack it down again. But, I have been considering this timing a lot on the Phase III mBC trial, and if it is truly to start end of H1 2022 or start of H2 2022, that is only 8 months away, and if ONC is currently in discussions with potential partners for partnership or buyout, those interested big pharma parties are likley stating "Do not sign a deal with anyone for CAR-T, we want to do that ourselves!" So, IMHO there will be no CAR-T deal until after there is either a partnership agreement in place or a buyout. Cause, if I was big pharma, I would not want a company that I was interested in buying, going out and signing a bunch of long term deals with other companies, when I could do all that within my big pharma corp and control it all internally.
So IMHO, unfortunaltely and for all my reasons above, I am in total agreement with you that NOTHING is really going to drive the SP up in this market with ONC's history of 'well tolerated' reports, or with respect to any of these up coming milestone NRs, other than a partnership or buyout NR. Six months ago I was thinking $8-$9 in Dec 2021, but based on what we have been seeing, I no longer believe that.
As noted, I believe that either a partnership or more likley a buyout must occur within the next 6 months in order for ONC to start a mBC Phase III trial in mid 2022, and those shorters better hold on to their underware, cause with how tight lipped ONC has been in the past, it will just happen one day, and then we will all look at this differently. :)
But, let's start with and see what Friday morning brings!