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Reread my post to see that I did not say ALLO is further along CHRONOLOGICALLY. But the glacial speed ADXS trials move to the finish line (with so many false starts), and the speeds the competition gets things done suggest that ALLO-type companies have much better chance of getting drugs to the markets and sooner than ADXS-type companies. It's all relative.
Yes, and recall the flurry of PR a year ago. Most PRs were fluff, rehash of what was previously known or released. Then, a secondary followed. BTW, most smelled that a secondary was coming in a wake of miserable attempt to pump the stock by the management, and the stock did not rise. This time, I do not see such a deliberate pumping, so hopefully, something tangible?
Advaxis to Present an Overview of its Lm Platform and New Information on its Neoantigen-Directed Therapy Programs at the Immuno-Oncology 360° Conference
https://finance.yahoo.com/news/advaxis-present-overview-lm-platform-130500379.html
PRINCETON, N.J.--(BUSINESS WIRE)--
Advaxis, Inc. (ADXS), a late-stage biotechnology company focused on the discovery, development and commercialization of immunotherapy products, today announced that an overview of the Company’s proprietary Lm platform and new information regarding the Company’s neoantigen-directed therapy programs, ADXS-NEO (customized, personalized neoantigens) and ADXS-HOT (off-the-shelf, hotspot or shared neoantigens and other antigens), will be presented during a plenary session at the Immuno-Oncology 360° conference on February 6, 2019. The conference is being held at the Crowne Plaza Times Square in New York City; the plenary session begins at 4:00 p.m. ET and the Advaxis presentation is scheduled to begin at 4:40 p.m. ET.
The presentation will be made by Andres A. Gutierrez, M.D., Ph.D., Chief Medical Officer and Executive Vice President of Advaxis, and Robert G. Petit, Ph.D., Chief Scientific Officer and Executive Vice President of Advaxis. Advaxis intends to issue a news release on February 6, 2019, that summarizes the presentation by Drs. Gutierrez and Petit.
ADXS-NEO, the Company’s personalized neoantigen program, is in an ongoing Phase 1 dose-escalation study to treat a variety of cancers. ADXS-HOT is the Company’s off-the-shelf program and consists of several different drug constructs which target hotspot or shared neoantigens, and other antigens. The first drug construct from this program is ADXS-503, or HOT-Lung, for the treatment of non-small cell lung cancer. ADXS-503 is expected to enter the clinic this quarter.
About Advaxis, Inc.
Advaxis, Inc. is a late-stage biotechnology company focused on the discovery, development and commercialization of proprietary Lm-based antigen delivery products. These immunotherapies are based on a platform technology that utilizes live attenuated Listeria monocytogenes (Lm) bioengineered to secrete antigen/adjuvant fusion proteins. These Lm-based strains are believed to be a significant advancement in immunotherapy as they integrate multiple functions into a single immunotherapy and are designed to access and direct antigen presenting cells to stimulate anti-tumor T cell immunity, activate the immune system with the equivalent of multiple adjuvants, and simultaneously reduce tumor protection in the tumor microenvironment to enable the T cells to eliminate tumors. Advaxis has four franchises in various stages of clinical and preclinical development: HPV-associated cancers, personalized neoantigen-directed immunotherapy, off-the-shelf, hotspot/cancer antigens neoantigen-directed immunotherapy and prostate cancer.
To learn more about Advaxis, visit www.advaxis.com and connect on Twitter, LinkedIn, Facebook and YouTube.
View source version on businesswire.com: https://www.businesswire.com/news/home/20190128005189/en/
Short interest jumped by almost 400K shares, from the lowest levels.
Settlement Date Short Interest Avg Daily Share Volume Days To Cover
1/15/2019 2,469,156 1,700,038 1.452412
12/31/2018 2,073,019 840,088 2.467621
Evolution of Advaxis:
RSU -> RS -> S
From restricted stock units to reverse split and a secondary. Dropping a letter at a time.
Thanks, Hov, for dissecting the PR. Most here care what you have to say.
A collaboration with BMY (ADXS-DUAL) was DOA as there was no funding for the trial. Had the trail started when it was supposed to start, we would have had some data by now. If the data was compelling, BMY would have jumped to sign a deal. Why would they do anything now? They have literally hundreds of those combo therapy studies going on, and vast majority of them have no financial commitment. If lucky, only a free supply of Opdivo is provided. We have a much better chance of Merck making a move if the PSA combo data is good.
CMC issues have been a big negative thing for Ziopharm. They stumbled into a huge roadblock for the GBM program when they telegraphed jumping from Ph1 directly to the pivotal trial, which has never occurred although it's been almost 2 years ago since that announcement. This past summer, their POC IND was put on hold even before getting IND approved. Again, related to CMC issues, partially. These cmc-based holds could last for months, and years as evidenced by these above examples and others.
I would not read too much into Petit's appointment on the IMM Scientific Advisory Board. Likely, RP started looking for Plan B before this ADXS thing blows up completely. I don't expect any merger with that company.
Does not appear to be some sort of exponential growth in the number of treated patients. Recall that a year ago during Hold 2, they PR'd about just over 250 patients treated with AXAL.
From July 13, 2018 PR:
“We are pleased to have resolved this issue with the FDA and will implement these guidelines across Advaxis’ portfolio as needed, to ensure patient safety. We remain confident in the safety of axalimogene filolisbac based on our experience in treating approximately 400 patients and more than 1200 doses across multiple trials in HPV-associated cancers,” said Kenneth A. Berlin, President and Chief Executive Officer of Advaxis.
From the last PR:
“Our AXAL product has demonstrated a manageable safety profile in the over 400 patients we have dosed to date and we look forward to enrolling new patients in our AIM2CERV trial after FDA agrees that the information we submit is responsive to its requests.”
I initially thought that they'd try to persuade the FDA to relax p-values for an interim look, but I think they want to reduce the # of events for an interim efficacy analysis.
Recall that:
1) They need 450 patients with 2:1 randomization;
2) Primary outcome: DFS (5-year time frame);
3) Secondary outcome: S&T, OS (again, 5-yr time frame);
4) First patient dosed: Q1/17;
5) Expected initially: 50% patient enrollement: 1H/18;
6) Last patient enrollment: 4Q/18;
7) Study completed: 2H/20;
8) 184 events (death or recurrence) needed for an efficacy analysys.
They should have completed an enrollment by now, but given that they have not provided any update on the enrollment, we must assume they are not close to completion. The company might want to:
a) reduce the # number of event from 184 to, say, 120 to trigger an interim look;
b) reduce 5-yr time frame to 3-year time;
c) maybe, just reduce the # of patients from 450 to 300 or so;
Maybe, the hold has something to do with the dosage, or the frequency of the dosage.
We need answers from the management. Ken, schedule the call. Shed some lights!
Hov,
Your last SA article was published on 11/05/18. You have mentioned some time ago that not a lot of things changed fundamentally, thus you would not write an article. In the past two months or so, a lot of things have happened that affected Advaxis fundamentals: Amgen termination, a new proxy, and this partial hold. Would you agree with this assessment? If so, would you consider writing a new article and share your thoughts?
Thanks,
@wmtgreeter
What a good company's management would do once the news like yesterday hits? Correct, they would announce a time for a conference call. We are almost certain that Advaxis is not in that category and would not hold a CC.
Ken needs to step up and schedule a call. He owes the explanation. Calm the waters, shed some light on the state of the FDA negotiations and provide some timelines. If the hold is longer than a month, then how this hold would impact the Aim2Cerv trial? We all remember how severe the impact was from the hold 3 years ago. I hope this will be much swifter. But you never know with this crappy management.
what can be more pathetic:
Partially shutdown FDA puts Aim2Cerv into a partial shutdown mode. Ahem, hold. And we get a partial pull back to a fraction of these current share prices...
fractions rule.
I am afraid this is an aftermath of an excessive cost cutting that Ken did last year. More or less adequate employees left, while less experienced, clueless folks are doing in-house manufacturing. Chickens are coming to roost...
Wow, just wow...
Asking me? Why don't Kenny step up and hold a conference call and explain? How hard would that be?
That Hold # 3. Ouchie...
Advaxis’ Phase 3 AIM2CERV Study Placed On Partial Clinical Hold By FDA Related To CMC Requests
January 23, 2019
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Enrolled Patients Continue to be Treated
"Our AXAL product has demonstrated a manageable safety profile in the over 400 patients we have dosed to date and we look forward to enrolling new patients in our AIM2CERV trial after FDA agrees that the information we submit is responsive to its requests."
PRINCETON, N.J.--(BUSINESS WIRE)--Advaxis, Inc. (NASDAQ:ADXS), a late-stage biotechnology company focused on the discovery, development and commercialization of immunotherapy products, today announced receipt of notification from the U.S. Food and Drug Administration (FDA) that the Company’s ongoing Phase 3, randomized, double-blinded, placebo-controlled, pivotal study of axalimogene filolisbac (AXAL) in high-risk, locally advanced cervical cancer (AIM2CERV) has been placed on partial clinical hold. The FDA’s recent communication, received late last week, states that the partial hold is related to their requests for additional information pertaining to certain AXAL chemistry, manufacturing and controls (CMC) matters. The Agency did not cite any safety issues related to the trial and all currently enrolled patients will continue to receive treatment, per the trial protocol. However, no new patients can enroll in AIM2CERV until resolution of this partial hold.
“FDA’s review of the AXAL Investigational New Drug (IND) application was prompted by our proposal to modify the AIM2CERV trial’s analysis plan to include, among other things, allowance for a second formal interim analysis for both safety and efficacy,” said Kenneth A. Berlin, President and Chief Executive Officer of Advaxis. “The primary focus of the items raised by the Agency relates to providing additional clarifying details for CMC information previously provided in support of Phase 3 development and which will help support a future Biologics License Application. We have already begun efforts to address the Agency’s requests for information and are working to respond as promptly as we can.” He concluded, “Our AXAL product has demonstrated a manageable safety profile in the over 400 patients we have dosed to date and we look forward to enrolling new patients in our AIM2CERV trial after FDA agrees that the information we submit is responsive to its requests.”
About Advaxis, Inc.
Advaxis, Inc. is a late-stage biotechnology company focused on the discovery, development and commercialization of proprietary Lm-based antigen delivery products. These immunotherapies are based on a platform technology that utilizes live attenuated Listeria monocytogenes (Lm) bioengineered to secrete antigen/adjuvant fusion proteins. These Lm-based strains are believed to be a significant advancement in immunotherapy as they integrate multiple functions into a single immunotherapy and are designed to access and direct antigen presenting cells to stimulate anti-tumor T cell immunity, activate the immune system with the equivalent of multiple adjuvants, and simultaneously reduce tumor protection in the tumor microenvironment to enable the T cells to eliminate tumors. Advaxis has four franchises in various stages of clinical and preclinical development: HPV-associated cancers, neoantigen therapy, hotspot/cancer antigens and prostate cancer.
To learn more about Advaxis, visit www.advaxis.com and connect on Twitter, LinkedIn, Facebook and YouTube.
Advaxis Forward-Looking Statement
Some of the statements included in this press release may be forward-looking statements that involve a number of risks and uncertainties. For those statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. The factors that could cause our actual results to differ materially include: the success and timing of our clinical trials, including subject accrual; our ability to avoid any clinical holds; our ability to obtain and maintain regulatory approval and/or reimbursement of our product candidates for marketing; our ability to obtain the appropriate labeling of our products under any regulatory approval; our plans to develop and commercialize our products; the successful development and implementation of our sales and marketing campaigns; the size and growth of the potential markets for our product candidates and our ability to serve those markets; our ability to successfully compete in the potential markets for our product candidates, if commercialized; regulatory developments in the United States and other countries; the rate and degree of market acceptance of any of our product candidates; new products, product candidates or new uses for existing products or technologies introduced or announced by our competitors and the timing of these introductions or announcements; market conditions in the pharmaceutical and biotechnology sectors; our available cash; the accuracy of our estimates regarding expenses, future revenues, capital requirements and needs for additional financing; our ability to obtain additional funding; our ability to obtain and maintain intellectual property protection for our product candidates; the success and timing of our preclinical studies including IND-enabling studies; the timing of our IND submissions, the ability to resolve FDA’s partial clinical hold, the ability to get FDA approval for study amendments, the timing of data read-outs, the ability of our product candidates to successfully perform in clinical trials; our ability to initiate, enroll, and execute pilots and clinical trials; our ability to maintain collaborations; ; our ability to manufacture and the performance of third-party manufacturers; the performance of our clinical research organizations, clinical trial sponsors and clinical trial investigators; our ability to successfully implement our strategy; and other risk factors identified from time to time in our reports filed with the SEC. Any forward-looking statements set forth in this press release speak only as of the date of this press release. We do not intend to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof.
No, he's not new, he posted before starting July '16.
I'm not a science person (albeit there's a science behind opening the doors at Walmart and greeting all types of folks, but it's not immuno-oncology), and I am not here to judge if the science works or not. I'd say 99% here have no relevant background. Even Hov will be hard pressed to predict if the science is going to succeed or not. Only the clinical trials will be the judges, after all. I'm judging by the management I'll make money or lose it. So far, it looks like I made a wrong bet. Good science can be killed by the bad management.
Virty Financial added 155K shares per last report, hold 176K shares
VIRTU FINANCIAL LLC 176,213 $33,000 1317 155,246 13F 2018-12-31 2019-01-16
CC transcript posted on SA:
https://seekingalpha.com/article/4233592-advaxis-inc-adxs-ceo-ken-berlin-q4-2018-results-earnings-call-transcript?part=single
Good read/listen, particularly a Q&A section.
I got an impression that the NEO data will not be earth-shattering. I guess it's what expected, but did we not want to see if not a PR but a CR? Not at a max dose yet? Dose escalation to continue?
KB stated:
If anyone is going to listen to the call, please post here if anything new from KB.
Can't listen, busy greeting folks @ Walmart.
Form the new corporate presentation:
1) Astra Zeneca finally gone;
2) HOT prostate IND submission moved from 2018 into 2019;
3) HOT NSCLC 1st patient dosing delayed into Q1/2019;
4) HOT target #4 gone;
5) NEO and HOT are now relegated to the bottom of the presentation, while focus now seems to be on AXAL and PSA -- that's a dramatic U-turn from 6 months ago. What a mood swing!
I was curious why KB released a "To my Fellow Bagholders" letter last night. Was he trying to prepare us for some news next morning (i.e. today)? Was he trying to pre-announce a non-event for Tuesday CC and released a statement that he would read to us at 11am today? Something else?
After spending a sleepless night, I have come to a conclusion that this will be a non-event. Just a rehash of what we already know. Even Amgen will not be discussed, let alone the reason they bailed. My expectations are low, very low for today and for the next few months. Then, our worries might over by this summer...
It also was in 10K. We discussed it yesterday. It’s still IST, no upfront cash is coming. Sigh...
Expected a NEWS this morning and nothing. Although there is a chance they could announce something before the open tomorrow, but I'm afraid it's not going to happen.
1) Head and neck trial to start this quarter as an investigator sponsored trial. No cash is coming, so much for Merck.
2) The headcount down to 58 as of 10/31/18 vs 108 year earlier. That's 48% reduction instead of promised 24% this June. The headcount could be below 50 now. Just a boutique shop now.
3) Cash is really getting tight, and they'll do a RS and a secondary right after the ASM. The approval of the proxy is almost guaranteed. The history tells that. The shareholders activism will not be too strong to overcome this trend.
Shorting at these prices into a CC could be a good idea, but I never short.
PS. Barak Obama's slogan: "Hope and Change".
Now Advaxis has delivered: "Hope's gone, and we can keep the change. A whole quarter per share...".
#lifegoeson
If you believe in what Zacks has got to say, then must have met Santa.
They are nothing but Gen 1 robots deployed from Pune, India.
Hudson Bay. I said that before. Google it.
Short interest continues to drop:
Settlement Date Short Interest Avg Daily Share Volume Days To Cover
12/31/2018 2,073,019 840,088 2.467621
12/14/2018 2,228,243 816,486 2.729065
11/30/2018 2,471,946 452,107 5.467613
It's down by another 150K shares, and maybe the lowest in a long while.
I've been contemplating about a sudden share price spike in the past few days, and all comes to my mind is the following:
1) it was a short covering, for the naked short position. The dark pool of shares if existed would no budge the share price. This was a real buying;
2) Someone knows something, and taking a position in an anticipation of the news. Timelines are not set, but something leaked.
I'm leaning towards the latter, albeit it's very uncharacteristic for ADXS to deliver anything positive. The shares bought was too substantial to be naked short positions. Of course, the traders jumped in and they are selling now as no news has come, not yet.
I'll keep the fingers crossed for the next week, but would not be surprised if same old, same old happens and a nothing burger is served. if that were to happen, we'll be printing brand new lows.
PS. ADXS more likely cannot sign a new NEO deal as the AMGN/ADXS deal is not officially terminated. We need to wait until the deal expires for ADXS to re-sign a deal with another pharma. But I am not a lawyer, and I don't run a microcap biotech, nor play one on TV.
"He that lieth down with dogs shall rise up with fleas", Benjamin Franklin.
@wmtgreeter and a proud GED holder in Ancient American Literature
Yeah, that statement does not tell us much though. 2018 was supposed to be an "inflexion" year for Advaxis, but it was a total disaster. I don't trust them until I see a signed deal. Until then, it's nothing but a hot air from Berlin. They need to walk the walk, enough of talking the talk.
Not a blip about why Amgen bailed. Not surprising.
https://finance.yahoo.com/news/advaxis-reports-fiscal-2018-financial-210500973.html
Merck And Advaxis Must Enter Global Cancer Immunotherapies Collaboration
Collaboration To Advance Highly Targeted, Patient-Specific Treatment Approach
Advaxis Needs to Hold a Teleconference at 9:30 a.m. ET Sometime This Year
Under the terms of the agreement, Merck should receive exclusive worldwide rights to develop and commercialize ADXS-NEO. Merck must make an upfront payment to Advaxis of $90 million and purchase $55 million of Advaxis common stock. Merck must be fully responsible for funding clinical and commercial activities. Advaxis must receive development, regulatory and sales milestone payments of up to $975 million and potential high single digit to mid-double digit royalty payments based on worldwide sales.
This is how the next PR should look like