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If I go by the time-frame of the clinical trials website, the PI has an estimated start date of March 2018, a primary completion date of Sept. 2019 and a study completion date of Sept. 2020. So, 2.5 years to POC may be a bit optimistic, depending on how enrollment goes and how long the PII would run. In an ideal world Amgen would step-up and just buy us long before then. Hovacre could shed more clarity on the question.
https://clinicaltrials.gov/ct2/show/NCT03265080?term=advaxis&draw=3&rank=1
This may help, "... This usually begins with Phase IIa clinical trials, in which the goal is to obtain an initial proof of concept (POC). The POC demonstrates that the drug did what it was intended to do, that is, interacted correctly with its molecular target and, in turn, altered the disease. Phases I and IIa are sometimes referred to as “exploratory development” The Phase IIb trials are larger and may use comparator agents and broader dosages to obtain a much more robust POC."
When the appointment of KB was announced there were a number of naysayers here who felt he wasn't a good CEO based on his last job. Advaxis seems a good fit for him and he appears to be a take-charge person who is okay with making tough, possibly unpopular, decisions. I think we're still in the honeymoon stage but I like that he realizes the need to conserve cash and focus on the items that should us net the best bang for the buck. He also seems to have made an impression with those who didn't care for him, at first. Now, let's see him bring on some strong deals and partnerships with up-front cash. C'mon, Ken. You can do it!
"Advaxis (NASDAQ:ADXS) downgraded to Hold with a $2 (9% upside) price target at Jefferies."
I have to question why Ken came out like that about AXAL too as, "Under the terms of the Agreement, Stendhal will pay $10 million toward the expenses of AIM2CERV, a planned global Phase 3 clinical trial in women with high-risk, locally advanced cervical cancer. This payment covers a significant portion of the total planned study costs". I'm hoping a partnership soon as it would same a total waste to let it fall by the wayside. Then again, ADXS-HER2 more than doubled the OS of dogs with osteosarcoma but nobody seemed to want to partner or license it except Aratana.
I think NEO and HOT will be our bread and butter and, I'm guessing, Ken wanted to free up any available cash to push. After PI/II, I believe Amgen will pick up the tab.
Combining AXAL, which had the best results for cervical cancer (per GOG trial) with Keytruda (or maybe Keytruda with NEO?), would appear to be a good idea.
"Advaxis will lead the clinical development of ADXS-NEO through proof-of-concept, retain manufacturing responsibilities, and receive development, regulatory and sales milestone payments of up to $475 million and potential high single digit to mid-double digit royalty payments based on worldwide sales."
Dosen't clarify what development will trigger a payment.
Excellent read. Thanks!
It was well-written and balanced, I believe.
I think he was heavily involved with the cervical trials so I'm guessing we'll see more of the same.
I missed the EU rejection, also. Maybe he'll send both links.
fbg, I have the same thoughts as you. Berlin didn't sugarcoat anything (think, "This could be a $50 stock in a few years". I think DOC said that once or something very similar). He seems certainly to be a hands-on CEO and making moves in the best interest of the company. His staff appears very able and their motives for following the chosen path were well-articulated. Hoping (finally) that this year gets as back to well above $10 (hey, it could happen). Good luck to us all!
You're right, Blue. Ken's not wasting too much time to try and turn things around. I liked a lot of what I heard. NEO dosing very soon and IND for NSCLC, soon. Cost-cutting and force reduction are positives (obviously not for those losing jobs, which I hate to see). New CMO and CFO. I understood the doctor fairly well and, from what it sounds like, Ken has a lot of faith in him. Hoping for a partnership for cervical cancer, also. Should be an interesting rest of the year.
Focusing on NEO and HOT. What do you think is positive?
Would seem to bode well for NEO.
I don't think you're wrong at all. I hope to be very pleasantly surprised when the OS data matures.
Here's an interesting read on that. Apologies if this has already been posted.
https://www.icr.ac.uk/news-archive/asco-2018-major-trial-is-first-to-show-benefits-of-immunotherapy-in-some-men-with-prostate-cancer
The OS hasn't yet been reached for the combo portion, so we could see some added benefit. Also, less side effects can equate to a better quality of life and that may be a consideration for many patients as well as possible lower total cost of treatment.
This is actually better than I had hoped for. I'm sure, when used earlier, the combo would have even better results. Merck should pony-up now and make a deal.
They seem more in business than Knight Therapeutics. Couldn't find anything on Advaxis there.
Just saw this on the Global Biopharma website. I don;t recall seeing this before.
http://www.gbiopharma.com.tw/en_company.php?pid=1
http://www.gbiopharma.com.tw/en_clinical.php?pid=1
I believe I read somewhere that a trial to treat earlier stage prostate cancer was being considered.
rob, I'm still waiting for the list of failed trials. Would you please be so kind as to supply them? Thanks in advance.
May very well be...
The last hold had a conference call with most of the management adamantly saying AXAL could not have caused a patient's death. They gave updates until the hold was lifted. I don't get that sense of urgency here. I assume both companies and the investigators would work together to resolve the situation, though.
He finally responded to my request? LOL!
I share your optimism in the hold being released, I just don't think it's a priority for either company at the moment.
Let the dosing commence!
With the dosing of the first NEO patients probably close and (maybe) a good reaction at ASCO (not historically a price mover) your friends may thank you again. I'm loath to mention the lifting of the hold as I think that will drag on and on.
https://www.inc.com/ed-powers/5-key-numbers-a-buyout-firm-uses-to-value-your-company.html
Glad you're smarter than this guy! He left current share price off his list!
Can't argue with that. Ken needs to turn that around. If he can do that, he may be able to write his own ticket to anywhere.
There is absolutely no reason. Conditional approval for canine vaccine. EU filing, PIII under SPA, best ever cervical cancer results, etc. There are many less advanced companies well over our market cap. It makes no sense. If you haven't read Dr. Petit's article I posted earlier, please do. It illustrates the NEO potential.
https://pdfs.semanticscholar.org/7de3/c6f9e53560cb016d053846c318c1a58701b1.pdf
For your weekend reading pleasure:
https://pdfs.semanticscholar.org/7de3/c6f9e53560cb016d053846c318c1a58701b1.pdf
I think it's great that you never let your negativity cloud your judgement.
Many of us talked with / emailed Adavxis last year. This year was the start of the "cone of silence".
Something for Advaxis to consider: "Inovio Pharmaceuticals, Inc. (INO) today announced that it has bolstered its efforts to attract partnerships and collaborations and increase non-dilutive funding with the hiring of an accomplished business development leader and the promotion of a key R&D leader."
That made me feel good. Among dog owners, I think the news of the canine vaccine is making the rounds.