Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Science has always had examples of new ideas being viewed with skepticism and often times ridicule until they go on and supplant the status quo. Science would be a flawed field if we avoided discourse and experiments with new ideas just because they aren't the way things are done currently.
Fun fact: KU Leuven (1425) is older than Harvard (1636).
Fully agree lasers.
Why Bristol-Myers Squibb Has an Edge in Immuno-Oncology
http://marketrealist.com/2016/11/whats-bristol-myers-squibb-stock-been-up-to/
Much appreciated, Twiz! Have a great weekend.
Investigator Sponsored Trials in Oncology
http://arrowsmithoncology.com/IST%20Strategy%20Position%20Paper.pdf
Thanks for highlighting this JR. It was definitely a long presentation and I could have easily missed the "positive discussions" part when I earlier wrote that PD only acknowledged Merck knowing about the data and did not want to comment further, in response to lasers's original post. Accordingly, my apologies, lasers.
Continuing with the same train of thought, what is the scope of a clinical trial protocol modification? Does the current combo trial protocol not allow patients refractory to keytruda to be enrolled? What needs to be modified to the below? Aren't there a few refractory patients already in the combo trial? Is their intent to just increase the number of patients from 41 via this protocol modification?
https://clinicaltrials.gov/ct2/show/NCT02493361?term=algazi+%2B+keytruda&rank=1
Lastly, and this is where I'm going with this...is it heard of, or even possible, for an IST to be modified or merged into an industry-sponsored trial? I couldn't find any instances of this but would be interested in hearing from others.
Starting the registration trial early when the IST is just midway has me wondering why.
Renewed attention for investigator-initiated trials
http://www.centerwatch.com/news-online/2015/12/15/renewed-attention-investigator-initiated-trials/
A very good article that sheds light on investigator initiated trials.
$HTBX Informal Analysis On HTBX's Upcoming Events
http://investify.blogspot.com/2016/11/informal-analysis-on-htbxs-upcoming.html?m=1
Overall survival in cancer drug trials
http://ja.ma/2g3AN49
Have a nice weekend all!
Overall survival in cancer drug trials
http://ja.ma/2g3AN49
Have a nice weekend all!
This is very informative. Thanks for the reply!
This is just me, but I think they might have some external motivation to get the registration trial started when the IST is still midway.
That would be awesome. Let's hope monotherapy data delivers a KO.
Btw, we stack up nicely against BCG but do you think we will do the same against Keytruda (and other checkpoint inhibitors)?
http://www.pharmalive.com/study-stopped-early-as-merck-co-s-immunotherapy-drug-wows-in-bladder-cancer-trial/
All I recall PD saying in response to an investor question on whether Merck was aware of the data, is that they were, and that it would be inappropriate to comment any further. To say "good discussions" were ongoing would have been troublesome for PD (which is why he didn't say it :)
Sanofi Shuts Down Bladder Cancer Drug Production: Inevitable Drug Shortage To Harm Patients
http://www.forbes.com/sites/benjamindavies/2016/11/17/sanofi-shuts-down-bladder-cancer-drug-production-inevitable-drug-shortage-to-harm-patients/#390f8a336f80
Thanks twiz! In a way, it's almost like ending the IST early due to encouraging results and commencing the registration trial sooner. Of course they haven't ended it...maybe they don't want to alarm the market ;)
Thanks as always for sharing your insights. This is very interesting.
I wished I had also asked them this question this morning: so they are going to submit paperwork for a registration trial by end of 2016. Then why do they need to continue the current p2b IST under modified protocol? This IST will probably last till Q3/Q4 2017. I know it will help them get better conclusion on the efficacy of the combo treatment but they're already planning to commence the registration trial in 1H 2017 which does not seem to be contingent on the final results of the UCSF IST. Any thoughts?
Agreed, Dr_Lowenstein has been right all along on the significance of the data because of the size of this trial. I have been appreciative of his posts and his way of analyzing things and statements. I personally do not think he is short btw; I think he just doesn't like unsubstantiated claims/statements, which is good if you want to be a better investor.
In case you missed it, he also sees a signal from this interim data, and feels there need to be more patients enrolled in order for this trial to be conclusive. Accordingly, ONCS is also working with the FDA to modify current trial protocol. What investors need to do is temper their expectations and invest only what they can afford to lose in the near term. I've seen deals being made at preclinical/proof of concept stages, so I don't think ONCS's trial size is a red flag by any means. There just needs to be a balance between paradigm shifting thoughts and doomsday arguments, if you want to make a rational investment decision with any biotech stock.
Per my understanding from what Sharon Gargosky said in the last call (one before today's), the registration trial will not be an investigator sponsored trial (i.e. no involvement from UCSF) and ONCS will be (will have to) fully running the trial themselves. It may be a collaborative effort with Merck (we'll see about that) but I don't believe UCSF will be involved in it.
Well, what I believe will happen is that they will license for sure, but only to Merck (partnership). They have not tested any other anti-PD1/PDL1 yet (Opdivo, Tecentriq, etc) with EP IL12 in clinical trials to my knowledge. They may in the future, but I personally don't see them working with another big pharma. Just my opinion.
I think in terms of funding the registration trial, for that specific question during the Q&A, he said they will look to pursue non-dilutive funding via partnerships. Earlier in the call he said they have no intention of going to market alone and instead would rely on a big pharma partner who already has the resources and infrastructure. I don't think he could get any clearer than this. IMO it will be a waiting game for that collaboration announcement with Merck with upfront money.
Yes, and also they just need a bigger patient population. Imagine this, sometimes when you flip a coin 10 times, once in a blue moon, there's a chance it could land on heads 10/10 times. When you make the sample size bigger, that doesn't happen. The PD numbers could improve in a bigger patient sample. We just need more data to arrive at a conclusion.
They read my question! Re: AA design and earlier approval before 2018! I like the response! Could be an event-driven dialogue with the FDA.
OncoSec’s Inaugural Investor & Analyst Day
http://edge.media-server.com/m/p/i6ug66hu
It seems you can submit questions online on the webcast page.
Understood. Reason why I brought it up was you had written 11-1pm CST. It should be 10-12pm CST as the event starts at 8am PST. Didn't want you to miss an hour of the webcast :)
https://www.timeanddate.com/worldclock/converted.html?iso=20161117T08&p1=770&p2=179&p3=64
I'm sure they are keeping a close watch. ONCS lists them as a collaborator. ONCS would get into trouble from the SEC if they were misleading investors. It's just a collaboration without big $ involvement, so far. PD mentioned they were getting clinical trial design feedback from collaborators at the Stifel presentation. That's helpful.
Even a modest grant from MRK would give ONCS much needed validation and would make raising funds for the registration trial easier at a higher share price. Can they work something out is the question.
So it is fair, it seems, to read into the fact that they have never used the term "phase III" and have stuck with using "registration trial." They think they can get to market sooner unlike through a traditional phase III trial route, which takes longer. They have floated accelerated approval as well, so I would tend to think so.
A registration trial is designed to gain marketing approval. I think it's the same as a p3 trial.
The Role of the U.S. Food and Drug Administration Review Process: Clinical Trial Endpoints in Oncology
http://theoncologist.alphamedpress.org/content/15/suppl_1/13.long
I believe it's 11-1pm Eastern Time Wait.
Thanks for reaching out and sharing.
I meant financing in terms of a partnership with upfront money. Today's filing was re-pricing of employee stock options.
HTBX -
I agree. Let's hope there is a pre-market PR about some financing deal. Otherwise, Punit's publicity of this event since the last 4 weeks could backfire as he would have only brought in more people to join this event (by buying in), get disappointed, and cause a sell-off (by selling/shorting).
I think the "corporate strategic updates" bullet as mentioned in the investor deck fits the bill of a financing agreement/partnership, but let's see.
Updates -> plural -> one could be they are discontinuing melanoma monotherapy (i.e. no phase 3 monotherapy)? I really hope there's another one regarding a partnership.
Looking forward to 11/30. So we know the dates for one of the four data updates this quarter. When do you think HS-410 monotherapy data will come?
HTBX to present top-line phase II data at the Society of Urological Oncology Annual Meeting on 11/30.
TOP-LINE RESULTS FROM VESIGENURTACEL-L (HS-410) IN COMBINATION WITH BCG FROM A RANDOMIZED, BLINDED PHASE 2 TRIAL IN PATIENTS WITH NON-MUSCLE INVASIVE BLADDER CANCER (NMIBC)
Results: Vesigenurtacel-L treatment was well tolerated with no vaccine-related SAEs; primary AEs were mild, most commonly transient injection site reactions. AE profiles (number and severity of AEs) were similar across the treatment arms indicating that vesigenurtacel-L does not significantly alter the known safety profile of BCG. Composite RFS across all arms (prior to the unblinding event at 1-year) was 84.6%, with a 6-month complete response rate in CIS patients of 87.5%. Vesigenurtacel-L antigen expression showed prominent overlap with patient tumors. Additionally, IHC may define a responder and non-responder phenotype by baseline levels of TIL and PD-L1.
Conclusions: The combination of vesigenurtacel-L and BCG is well-tolerated with preliminary evidence of synergistic effect and immunologic responses that are consistent with vaccine mechanism of action. Vesigenurtacel-L warrants further investigation as a potential treatment for NMIBC.
http://suonet.org/meetings/upcoming-meetings/2016-suo-annual-meeting/online-program-viewer.aspx
(poster 21)
It specifically said "Accelerated approval trial design..." I think it's the same trial. Perhaps they're just being a bit cautious with their statements.