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Immunotherapy: A New Strategy for the Treatment of Cervical Cancer
European Society of Gynaecological Oncology (ESGO) International Meeting 2017
Advaxis, Inc. cordially invites you to attend “Immunotherapy: A New Strategy for the Treatment of Cervical Cancer,” to be held during the European Society of Gynaecological Oncology 2017 Symposium. This educational (non-CME) symposium will provide attendees with up-to-date clinical information and practical considerations about the role of its novel Lm-TechnologyTM based immunotherapy for the treatment of patients with cervical cancer.
Date: Monday, 6th November, 2017
16:00 – 17:00 Central European Time (CET)
Location: Austria Convention Center, Hall B
Bruno-Kreisky-Platz 1, 1220 Wien, Austria
Agenda
16:00 Opening and Introduction of Speaker Panel – Dr. Christian Marth, Chair
16:05 MOA of the listeria-based immunotherapy Axalimogene Filoslisbac (AXAL) and comparison to other immunotherapies – Dr. Sandro Pignata
16:20 AXAL clinical data in metastatic cervical cancer – Dr. Sharad Ghamande
16:35 Phase 3 clinical trial of AXAL-DUAL in combination with Nivolumab in metastatic cervical cancer – Dr. Christian Marth
16:50 Q&A
18:00 Reception at Melia Hotel, Vienna
I agree completely. Who & why? We can only guess...
From Advaxis website:
Advaxis has seen encouraging data in naturally occurring canine osteosarcoma, which is considered a proxy for human osteosarcoma. Osteosarcoma is the most common primary bone tumor in pet dogs, accounting for roughly 85 percent of tumors on the canine skeleton.1 More than 10,000 dogs per year (predominately middle- to older-aged dogs and larger breeds) are diagnosed with osteosarcoma in the United States.1 2
Advaxis has licensed ADXS-HER2 and three other immunotherapy constructs to Aratana Therapeutics, Inc. for the development of animal therapeutics.
Preliminary data have demonstrated ADXS-HER2, in combination with palliative radiation, delayed tumor progression and prolonged overall survival in pet dogs with treatment-naïve spontaneous Canine Osteosarcoma. Repeat doses of ADXS-HER2 were well tolerated with no systemic or cardiac toxicity.
I can't get the webcast to play. Is it working for anyone?
Pardon if this has already been posted:
Just How Frustrated Should Investors Be with Advaxis, Inc. (ADXS)? H.C. Wainwright Remains Bullish
Analyst defends ADXS' new "astute" clinical development strategy to re-focus on leading product assets.
Julie Lamb, Editor-September 15, 2017, 1:05 PM EDT SHARE ON:
Advaxis, Inc. (NASDAQ:ADXS) shares crashed almost 20% on Tuesday after the biotech firm shared a program overview along with third quarter financial earnings for the year that have left shareholders exasperated with the biotech’s progress- or rather, lack thereof.
Specifically, investors’ point of contention with the firm might point to a halt on its trial evaluating ADXS-HER2, the firm’s orphan drug in Europe for bone cancer. Advaxis tying the pause of its bone cancer drug development in a nice bow of pipeline restructuring, directing focus instead to its lead programs.
These lead programs include placing efforts behind: Axal as a combo treatment in HPV-associated cervical cancer as well as a monotherapy; prostate cancer candidate ADXS-PSA; Amgen-collaboration ADXS-NEO (a potential cancer immunotherapy designed to activate immune system responses against the unique mutations in each patient’s tumor); and ADX-HOT, designed to target hotspot mutations and set for clinical study to kick-off by next year.
H.C. Wainwright analyst Swayampakula Ramakanth chimes in with a bullish take all the same, maintaining a Buy rating on Advaxis stock with a price target of $23, which represents a 377% increase from where the stock is currently trading. (To watch Ramakanth’s track record, click here)
Additionally, ADX posted $3.0 million in deferred revenues for the quarter, stemming from the Amgen deal from August of last year, which aligned with the analyst’s expectations, along with a net loss of $0.80 per share, greater than the analyst’s forecast of $0.51. However, Ramakanth notes, “The difference mainly resulted from higher-than-expected SG&A expenses related to the regulatory application of the company’s lead product, axalimogene filolisbac (Axal), in the EU for the treatment of metastatic cervical cancer.”
In reaction to earnings, the analyst now forecasts revenues of $13.3 million and a net loss of $2.16 per share for the financial year of 2017. Advaxis generated cash and equivalents of $89.4 million when closing out the third quarter of the year, which the analyst finds enough to keep operations funded through the middle of next year.
Ramakanth asserts, “While pediatric osteosarcoma is an area of high unmet medical need, we also note that it is a very limited indication with approximately 400 newly diagnosed patients in the US each year. Previously, we only expected ADXS-HER2 to generate peak risk-adjusted revenues of $4M per year, and we believe this restructuring should only have a small effect on the company’s revenue projections. With higher cash burn expected in the coming quarters as the company move into late-stage Axal studies, we believe it was an astute decision to focus the company’s limited resources on the most promising product candidates.”
In fact, not only is the analyst not fazed by the pullback, he wagers upside is still within sight for the biotech firm yet: “We believe that should the EMA approve Axal on a conditional basis, it would represent upside to our current launch estimate of 2020 and could become a significant catalyst for the stock.”
When it comes to the preliminary word out on the Street for the firm’s opportunity, it for now seems positive, with TipRanks analytics demonstrating ADXS as a Buy. Out of 2 analysts polled by TipRanks in the last 3 months, both are bullish on Advaxis stock. With a return potential of 329%, the stock’s consensus target price stands at $21.00.
https://www.smarteranalyst.com/2017/09/15/just-frustrated-investors-advaxis-inc-adxs-h-c-wainwright-remains-bullish/
Up over 5% on no news? Something's cooking...
Well said. I agree news is just around the corner and it's going to be a good ride. (I believe you meant ...milestone payments potential around a BILLION, not million).
Great video for showing the science. Thx
Thanks for sharing...
Hey Tin,
Since you are looking for a reason and as you say...
Somebody is playing games and somebody has absolutely no fear while doing it.
Have you ever considered the 'somebody' could be the competition or the potential suitor for the ADXS platform? As you say... there is very little to gain as a 'Short' given ADXS decimated sp but yet it continues. And the manipulation continues. Seems obvious that the one entity that would benefit the most from where the sp sits right now is one that wants to come in a buy the whole enchilada or make it darn difficult for the company to proceed on their own.
Well said...
Any down side to this? You still own the shares outright, correct?
What your also saying is the manipulation of the SP by those that we are sure are Shorts/MMs/Hedgies has the unintended consequences of making sure any BP partnership or BO is at the lowest of terms based on where we sit. Those lucky SOB's. Hold tight Dan. I don't believe in the tooth fairy either.
ESGO20 - European Society of Gynaecological Oncology Nov. 4th -7th, Vienna Austria. ESGO Congress is the largest European Gathering in Gynaecological Cancers.
The timing could not be better....
Advaxis’ Axalimogene Filolisbac Data Selected for Poster Presentation at ESGO 2017
PRINCETON, N.J.--(BUSINESS WIRE)-- Advaxis, Inc. (NASDAQ:ADXS), a late-stage biotechnology company developing cancer immunotherapies, today announced that the European Society of Gynaecologic Oncology (ESGO) has accepted an abstract for a poster presentation at its 2017 congress on the identification of potential baseline biomarkers indicative of survival benefit from treatment with the company’s lead immunotherapy candidate, axalimogene filolisbac. ESGO is Europe’s landmark gynecologic oncology meeting. Held biennially, ESGO congress brings together professionals to learn and discuss the latest medical and scientific developments in gynecologic cancers research, treatment and care.
Advaxis researchers identified certain pre-treatment baseline levels of serum proteins that were strongly associated with overall survival (OS) benefit in patients with persistent or recurrent metastatic carcinoma of the cervix (PRmCC) that were treated with axalimogene filolisbac in the Phase 2 GOG/NRG-0265 study. The 12-month survival rate in this study was 38 percent (19/50), and these results were presented at a medical meeting earlier this year.
This analysis of pre-treatment baseline serum proteins of 45 patients from the study showed that levels of a group of four closely-aligned proteins were strongly correlated with OS. One cluster of patients (n=25), had relatively lower levels of all four proteins and exhibited an OS of 56 percent, while the second cluster (n=20), with relatively higher levels, exhibited an OS of 15 percent. These data are statistically significant (HR=0.23; 95% CI: 0.10-0.48; P<.001) and suggest that the baseline levels of these analytes have prognostic value for OS, and high levels of these individual proteins were negatively associated with clinical outcomes in the trial.
Importantly, it was found that much of this effect was due to levels of one particular protein, which was found to be most highly correlated with OS in the study. This particular protein was previously not known to be associated with survival in cervical cancer. Advaxis will continue to evaluate this particular protein as a potential biomarker to help identify patients most likely to benefit from treatment with axalimogene filolisbac.
“In the field of cancer immunotherapy, biomarkers have been playing an increasing role in guiding patient selection and identifying early indicators of treatment response,” said Robert Petit, Chief Scientific Officer of Advaxis. “The discovery of this potential biomarker, which previously has not been known to be associated with survival in cervical cancer, is significant and could be a biomarker to predict efficacy, similar to how PD-L1 expression is used as a biomarker for checkpoint inhibitors. PD-L1 testing has become an important and routine strategy to guide treatment, and this biomarker has the promise to do the same for axalimogene filolisbac.”
Sandy Hayes, PhD, Associate Director of Research and Biomarker Lead at Advaxis, is the first author and presenter of “Baseline Serum Protein Levels Associated with Survival in Axalimogene Filolisbac (Axal)-Treated Metastatic Cervical Cancer Patients: The GOG/NRG-0265 Trial.” The poster will be presented at ESGO 2017, held Nov. 4 to 7 in Vienna, Austria, and will also be published in a supplement to the International Journal of Gynecological Cancer.
I agree Ignatius. The take-down was accomplished with a lot of Short selling but since then we have seen a good amount of covering.... usually in large blocks while pinning the sp as low as possible.
Yes, this is feasible because of the Algos/MMs. It allows last entities to move shares without moving the market by breaking up the buy/sells into small pieces.
Quote: Is it feasible in our current situation for an entity to buy 500k shares in the first 45 minutes, sit back and wait for the price to drift back down by day's end...then repeat the process over a few days without a significant change in share price?
Here is a TED video that can describe it better than I. The video is a couple years old but you can imagine things have only gotten worse...
https://www.ted.com/talks/kevin_slavin_how_algorithms_shape_our_world#t-306328
Draft Order on Drug Prices Proposes Easing Regulations
In the early days of his administration, President Trump did not hesitate to bash the drug industry. But a draft of an executive order on drug prices appears to give the pharmaceutical industry much of what it has asked for — and no guarantee that costs to consumers will drop.
The draft, which The New York Times obtained on Tuesday, is light on specifics but clear on philosophy: Easing regulatory hurdles for the drug industry is the best way to get prices down.
The proposals identify some issues that have stoked public outrage — such as the high out-of-pocket costs for medicines — but it largely leaves the drug industry unscathed. In fact, the four-page document contains several proposals that have long been championed by the industry, including strengthening drugmakers’ monopoly power overseas and scaling back a federal program that requires pharmaceutical companies to give discounts to hospitals and clinics that serve low-income patients.....
https://www.nytimes.com/2017/06/20/health/draft-order-on-drug-prices-proposes-easing-regulations.html
The PR Reports:
As part of his long-term incentive compensation, the reporting person was previously granted a performance based restricted stock award by the Compensation Committee. The specific terms of performance, which were required to be achieved prior to earning the award, have now been met. These performance terms were (i) the FDA acceptance of the ADXS-NEO IND, and (ii) the open ing of a certain pre-defined number of clinical sites for the AIM2CERV study prior to November 1, 2017. The award vests one-third in November 2017, one-third in November 2018, and will be fully vested in November 2019.
Personally, I think #3 or #4 are the most likely reasons....
I agree with you...
Quote: I don't know who exactly is behind this nor exactly why, but I do know that somebody is trying very, very hard to intentionally collapse the PPS in very dramatic fashion. In fact the intent seems to be shock and awe.
So what are the possible reasons for what we have seen over the last week? Here's a few to start... feel free to add your own:
Blatant Manipulation, Why?: 1). Results from one our clinical trials are bad or ADXS suffered a setback (like the patient death that was found to be unrelated to ADXS) & it's yet to be disclosed so it's a money maker in waiting. (there were roughly 3 months of sp decline before the patient death was announced)
2). Shorts are piling on for a future payday and only intent to close out their position when the market overpowers their control.
3). Some nefarious entity wants to take down ADXS because they want what ADXS has on the cheap. They want to negotiate from a position of strength while pinning down the share price. They either wind up with shares on the cheap or a partnership where they hold all the cards.
4). Some nefarious entity wants to take down ADXS because they do not want ADXS to succeed. Keeping the sp in the toilet keeps new investors away and has everyone questioning the technology (even on msg boards). At some point when the company needs to raise more cash they will be in a bind. All company's love to crush the competition.
5). The market believes the CEO is a crook. They believe he is only out for himself and will continue to grab free shares (as well as shares purchased at market price) at every chance. The market sentiment for this stock will not change until he is replaced.
Speaking of Good News and the timing. I keep thinking about the big news of this Sunday when ADXS has a 30 minute show airing internationally on Fox Business Network & Bloomberg where every aspect of the technology and principles will be featured. Maybe the hit needed to come quick and hard to curb any international enthusiasm.
Hey Ignatius, I found this site and plugged in ADXS. Seems to confirm that as a percentage of total volume, most of the sell-off was orchestrated by shorts: http://www.shortstockvolume.com/Chart/ADXS/
There are other sites that offer Daily Short volume for a fee, so it is available.
How can I check the short volume for the day?
2 posters on another board are saying ADXS short volume yesterday was 404.4k
Out of 592.8k total volume or 69%.
Roughly 70% the last 2 days and 50% today.
If this is true we can confirm the take down was nothing more than smoke and mirrors.
Someone better get on the horn to Kathy Ireland. This Sunday She's highlighting a company on the Fox Business Network & Bloomberg International that is in the toilet! She talks up their modern manufacturing site in Princeton, NJ that can very economically produce large batches of LM treatment for cancer. She never once ask the CEO about his compensation package. She's missing the real story here!
He was being sarcastic...
At some point you have to wonder - given there is no bad news to invoke a selloff - what force is behind the takedown? I agree, it does seem specific to ADXS. So why continue to pile-on a stock that is beaten to a new 52 week low verses any other with plenty of room to drop?
Next thing we will hear from this board is how DOC got the distinguished panel of presenters to travel to NY, read from a script, and smile in the appropriate places on Investor Day. They didn't mind placing their collective reputations on the line because they always wanted to see the Empire State Building and Dan picked up the tab at Pizza Hut.
Good point Gantor:
When are you ever going to realize that retail investors place in the Wall St food chain is akin to plankton in the ocean?
Ran across this article - Quantitative investing based on computer formulas and trading by machines directly are leaving the traditional stock picker in the dust and now dominating the equity markets, according to a new report from JPMorgan.
http://www.cnbc.com/2017/06/13/death-of-the-human-investor-just-10-percent-of-trading-is-regular-stock-picking-jpmorgan-estimates.html
Of particular interest:
"$1.3T of S&P 500 options expire on Friday, and this will change dealers' positioning," he said. "This can result in a modest increase of market volatility starting on Friday and into next week."
It was published on June 8th and show airs on Sunday afternoon's so I would think this Sunday (6/18) would be the first opportunity to air this episode. The PR says:
The episode airs on Fox Business Network as sponsored programming at 5:30 p.m. ET / 2:30 p.m. PT (check your local listings) and on Bloomberg International at 10:30 a.m. CT. For more information on Worldwide Business with kathy ireland, visit http://www.tvwwb.com/.
Yes, spread the word by all means...
Thanks runcaly. The video was posted previously through this link:
You called it Iggy. Nice to hear from the voice of reason.
ADXS just PR'ed: Advaxis Details Registrational Trials, EU Regulatory and Commercial Plans at Annual Investor & Analyst Day:
Updates Presented on Cervical, Prostate and Anal Cancer Clinical Programs
ADXS-NEO Ph 1 Trial, ADXS-HOT INDs Coming
PRINCETON, N.J.--(BUSINESS WIRE)-- Advaxis, Inc. (NASDAQ: ADXS), a late-stage biotechnology company developing cancer immunotherapies, held its annual Investor & Analyst Day this week with clinical investigators and company leaders providing updates and details on the company’s Lm Technology™ and nine development programs.
http://ir.advaxis.com/press-releases/detail/1273
Quote 'There are no offers and no product at least for 4 or 5 years and I believe the patents will have expired by then, yesterdays news and timeline very disappointing and will be reflected in the share price over the next few weeks'.
How would you come up with this conclusion? What is disappointing about trials that are going well? Did you not hear the timeline that includes 2018? Would you agree that ADXS-DUEL resets the patent timing? O'be it yes or Obi it no?
Ever heard of 'Fake News'? These come up every so often in concert with a short agenda. No real information is given and nothing ever comes of it.
And how would you possibly know if an offer was discussed but not accepted? An informal discussion would not be public knowledge.
Interesting Read: Cancer drug prices could double or triple thanks to this popular but unproven drug trend. Safety concerns and issues of price hang above the promising immuno-oncology combination trials
Also shows the growth in combo trials since 2015 for some key drugs.
http://www.marketwatch.com/story/cancer-drug-prices-could-double-or-triple-thanks-to-this-popular-but-unproven-drug-trend-2017-06-01
In light of today's news... Video and detailed info on the BioXp™ 3200 System:
https://sgidna.com/bxp3200.html