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I think most of us here believe the LM platform is efficacious. The company's execution of moving the vaccine along is highly questionable but it appears to work and work very well in some cases. In the ensuing almost three years since this article, more advances have been made with the Listeria vaccine(s). It remains to be seen if we get good to excellent results before we need more and more money and dilution.
I can't see the company or any publicly traded company telling it's employees they're running out of money, though.
Actually, I sent the emails to Biocon asking about their plans for AXAL.
I have sent several emails and never a reply.
I saw that. Smaller buys going through also.
And these are preclinical?
As cattdog pointed out, the company is still currently enrolling patients, per the 8-K so, while anything is possible, it doesn't look like the patient died from the vaccine (I hope).
Excellent point!
The death of a patient would be a material event and reported to the FDA. I don't know how long they could sit on it but, if it was the reason Amgen pulled out of the deal, it would have happened weeks ago, I believe. Of course, there would then be the ensuing hold.
I've seen many bios issue a PR for terminating a deal. I'm sure either company could have issued one.
I think it's safe to say we're all puzzled by the silence. They can't sit on bad news too long so maybe they're working out something for HOT but I won't believe it till I see it. They're supposed to be in talks with multiple parties. The corp presentation needs updating. Advaxis have so much potential. I hope we can hang on till news comes.
Good luck on actually getting a response.
Dawson, I, like you am a serial optimist but I am wavering in my faith here. I do think, if the FDA signs-on, that getting to the interim data sooner is an excellent thing. There are many posts here disparaging KB as being no better than DOC or Big Tony. I am inclined to give him the benefit of the doubt. He IS trying to get the FDA to agree to a trial modification. I doubt he had much (or anything) to do with the Amgen deal termination. If he is being honest, they are in talks for partnering HOT (yes, I know, so was Tony and the talks apparently went nowhere). I expect some kind of clarification next week.
That's a plausible reason.
Merry Christmas to you. Maybe we'll have reason to celebrate by Easter. I would take that.
Canine vaccine conditional approval.
As others have pointed out, it is probably too early to see verifiable signs of efficacy and we know LM, on its own, is efficacious. I am puzzled by the silence from the company. If they cannot shed light on Amgen's decision, they could quickly PR a path-forward. Even if Ken was away, I am sure they would be on the phone to put some CC or PR out. Something afoot?
With apologies to Satchmo:
"I see spikes of red,
Spikes of green,
Seems I'm stuck in a bad dream,
And I say to myself,
What a gigantic turd.
While Ken is gone on vacay,
The PPS is in decay,
And I say to myself,
What a gigantic turd."
I'm surprised at the silence from the company. I expected more of a selloff, too. Volume seems to be drying up starting around 12:30p. Damn if I know what's going on.
Never.
CC tomorrow?
Are these still running? They are all in active, not recruiting status. The company has always been sloppy at keeping trials updated. It would a pleasant surprise (shock, actually) to hear anything regarding results about these:
Phase II Evaluation of ADXS11-001 (NSC 752718) in the Treatment of Persistent or Recurrent Squamous or Non-Squamous Cell Carcinoma of the Cervix
Actual Study Start Date : May 23, 2011
Estimated Primary Completion Date : October 2, 2018
PHASE 1-2 STUDY EVALUATING HIGH DOSE ADXS11-001 (1 x 10^10 CFU) TREATMENT IN WOMEN WITH HPV+ CARCINOMA OF THE CERVIX
Actual Study Start Date : January 2015
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018
Phase 1b Dose Escalation Study of ADXS31-164 in Subjects With HER2 Expressing Solid Tumors
Actual Study Start Date : September 2015
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : December 2018
hov, I appreciate that your posts are articulate and well-reasoned. You have the knowledge to spell out your line of thinking is a sane, rational manner. Of course, I want the company to succeed and your sober postings help me keep realistic expectations of what may come. I do think the next half of the year may be make or break for the company and, if the next data is good to great, we may all be at a place where we feel the company is being fairly valued.
Who are "we"?
They were NOT going to completely shelve AXAL.
"Advaxis has decided to reduce internal investment in axalimogene filolisbac (AXAL) and will seek partnership opportunities for AXAL in most human papillomavirus (HPV)-associated cancers, including cervical cancer. If the company is unable to secure a partner within a limited period of time, Advaxis will wind down the ongoing AIM2CERV trial in high-risk locally advanced cervical cancer, and will not conduct the ADVANCE PD-1 combination trial in metastatic cervical cancer, which has not yet been initiated. Advaxis has determined to focus future development efforts for AXAL on HPV-positive head-and-neck cancer through cost-effective clinical studies that are currently being explored."
oakrock, thanks! Great read!
As I said earlier, if the LM platform elicits an immune response and we know it does, combos make perfect sense and will hopefully increase efficacy even more.
I can't help but feel that DOC may have been asking far too much for a deal with mostly pre-clinical and early data. I remember he once said this could be a $50 company in a few years (which he NEVER should have said) so perhaps that clouded his judgement and he had never been a CEO before, I believe. Ken seems to have more business sense so, until we get more (better?) data, we'll be in a holding pattern.
They did have two drugs fail in trials. As yet, that has not happened to us and hopefully won't. We already know the LM platform is capable of mounting an immune response. We've had some complete responses. I am betting (aren't we all) that AXAL and the other constructs may work even better as NEO, HOT, combined with PD-1 inhibitors and whatever else is coming down the pike. A lot has been posted here of antiquated technology, competition and other obstacles. This holds true for any oncology company now developing a treatment. There will always be a newer, better treatment on the horizon. If the LM platform can evolve to be combined with any, most or all of these, and increase chances of a better outcome we'll be around for a long while.
So, they'll have two ISTs. Even better.
Ig, did anyone ask about the IST as clinicaltrials.gov show it as recruiting.
Thanks, G.B.
Just for cervical or in total?
I'm surprised the HPV-Positive Oropharyngeal Cancer IST start has not been PR'd. It may not be big news but it's still news.
This is a reason why I think the company will (eventually) prevail. The LM platform should be able to be combined with a multitude of existing and future treatments.
This isn't the AIM2CERV trial though I hope they do approve those changes
Here's a link to changes of the trial, I believe, that is the IST the company has referred to in the corp. presentation. I'm surprised no PR as yet. Maybe Monday.
https://clinicaltrials.gov/ct2/history/NCT02002182?A=1&B=11&C=Side-by-Side#StudyPageTop
"The good news: it takes only one injection of the miracle drug. The bad news: it costs $4 million for that one dose."
Yeah, I think we'll be around. There will ALWAYS newer and better treatments coming down the line. The LM approach may be able to be synergistic with some, many or most of them.
Thanks. Looking forward to reading your findings.