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"Something is rotten in the state of Denmark", Hamlet.
Friday morning tidbits:
1) It's been a month since Aim2Cerv trial was put on a partial hold;
2) Ken's 5-day vacation trip to the Sandals is scheduled for the next Thursday.
Q:What do you expect happens between now and next Wednesday?
A1: Nothing.
A2: R/S and a secondary.
A3: We will tank.
Last year, the proxy results were out just after the close, the same day. Form 8-K filed with SEC.
So, where's 8-K with the proxy results? The delay seems to be more on the how the votes went than Miriam Weber Miller's ability to "release the news". Another surprise this Friday?
Nah, it's much more entertaining here than in NYC. Several transformational suggestion have been offered on this message board to revise the past of Advaxis. Why bother traveling to a cold and breezy Big Apple?
Part of a 3D chess game Ken's been playing with the big pharmas?
Haven't we already heard dozens of conspiracy theories about dark funds and large pharmas accumulating ADXS shares w/o filing any SEC forms? What about HFT manipulations? Hedge funds putting inept and greedy CEOs to run Advaxis? Company going into radio silence to start B/O rumors? Hiring spree while the money is about to run out? It all pointed towards the "fact" that the company management knew something was about to happen when the ordinary mortal investors had to clue about it. Insider buys last summer? The list goes on and on...
Don't you get tired of those "prophecies"? When the facts are obscure, this board tends to make up "the facts" to promote their agenda. The reality is simpler and much harsher than we most tend to acknowledge -- we are in rough waters and the ship has a gaping hole in the hull. The sharks circle in the water waiting for bipedals to jump in it... Occam's razor.
We got 8-K re: ASM meeting after the close in 2018. Looks like they'll release proxy results also after 4pm.
If you look at the IMDZ chart, don't you find huge similarities between them and us? They were just above $30 four years ago when ADXS was at $30 and a change. Now they are taken out when the SP is around $1.40. Their MC was less than $70M before acquisition. Their legacy shareholders got wiped out, like here. Life goes on...
This trial is going to take 4 more years to complete. How they are going to pay for this? ADXS did not even get free Keytruda, are they expecting Merck to sign up for this? Clear as mud.
Estimated Study Start Date : February 2019
Estimated Primary Completion Date : January 15, 2023
Estimated Study Completion Date : March 17, 2023
Outcome Measures
Go to sections
Primary Outcome Measures :
Safety/Tolerability of ADXS-503 monotherapy in Part A and ADXS-503 with pembrolizumab in Part B: graded per comment terminology criteria for adverse events (CTCAE) version 4.03 [ Time Frame: 12 Months ]
Safety Measures include: Adverse events (AEs); dose-limiting toxicities (DLTs) graded per comment terminology criteria for adverse events (CTCAE) version 4.03
Preliminary anti-tumor activity of ADXS-503 + pembrolizumab in Part C [ Time Frame: 4 years ]
Anti-tumor activity per RECIST v1.1
Secondary Outcome Measures :
Preliminary anti-tumor activity of ADXS-503 alone in Part A and ADXS-503 with Pembrolizumab in Part B [ Time Frame: 3 years ]
Anti-tumor activity per RECIST v1.1
Progression-free survival (PFS) and PFS rates for subjects treated with ADXS-503 monotherapy in Part A and ADXS-503 + pembrolizumab in Part B and Part C. [ Time Frame: 4 years ]
PFS and PFS rate per RECIST v1.1
Overall survival (OS) and OS rates for subjects treated with ADXS-503 monotherapy in Part A and ADXS-503 with pembrolizumab in Part B and Part C [ Time Frame: 4 years ]
Overall survival and milestone OS rate
Safety/Tolerability of ADXS-503 with pembrolizumab in Part C: graded per comment terminology criteria for adverse events (CTCAE) version 4.03 [ Time Frame: 5 years ]
Safety Measures include: Adverse events (AEs); dose-limiting toxicities (DLTs) graded per comment terminology criteria for adverse events (CTCAE) version 4.03
Other Outcome Measures:
Preliminary anti-tumor activity of ADXS-503 monotherapy in Part A and ADXS-503 + pembrolizumab in Part B and Part C [ Time Frame: 5 years ]
Anti-tumor activity per iRECIST
Progression-free survival (PFS) and PFS rate per iRECIST for subjects treated with ADXS-503 monotherapy in Part A and ADXS-503 with pembrolizumab in Part B and Part C. [ Time Frame: 5 years ]
PFS and PFS rate per iRECIST
Immunological activity of ADXS-503, administered as monotherapy in Part A and in combination with pembrolizumab in Part B. [ Time Frame: up to 5 years ]
Pre-and on-treatment blood samples evaluate the changes in the states of activiation and differentiation in various immune cells by flow cytometry and profiling of gene expression.
Evaluate changes in serum levels of cytokines, chemokines and other analytes by multiplex assays and mass spectrometry.
Evaluate changes in the peripheral T cell repertoire by immunosequencing.
Evaluate the frequency of functional tumor antigen-specific T cells by ELISpot analysis.
HOT trial on clinicaltrials.gov:
Study of ADXS-503 With or Without Pembro in Subjects With Metastatic Non-Small Cell Lung Cancer
https://clinicaltrials.gov/ct2/show/NCT03847519?term=advaxis&draw=1&rank=2
Pembro (aka Keytruda) is our PD/L1 inhibitor for HOT combo trials.
What a sudden change of attitude in just few weeks, Ken.
You are a helluva angry ADXS "investor" who is about to lose it all. Wow!
Don't you think the tight window to bring in a cash deal is now closed? They had a chance to sign a partner before the ASM and the consequent R/S and nothing transpired? Why is that? It takes two to tango, and the other party decided to pass for now. Face the inevitable.
Sans a Hail Mary within the next 24 hours, we know what transpires next. There is always a chance that KB drops a bomb about a cash deal, but one in a million?
KB<->BK
That's a pipe dream. Entire proxy will likely pass. We should know tomorrow. We are screwed.
Why do you guys think CVI is the worst of the worst? Not even close, my friends.
In order to "appreciate" CVI-like companies, you have to see what sharks like Hudson Bay Capital do. Google them, and read what they actually do. CVI would look like a sheep compared to those bastards. When ADXS management attracts HBC as an "investor" -- run!
Does anyone have plans on attending the ASM this year? Bourbon? He as an ihub poster was the sole attendee last year. Anyone traveling to NYC to listen and ask questions this year? Would be a pity if no ihubber is there.
The consensus market expectations are already baked in the share price — the reverse split followed by a secondary. The markets are not anticipating any monetary deals before this happens. Since their cash burden just went up due to NEO trials funding or lack of thereof, the need to raise cash accelerated. They need to do that within a month or so. The company probably expected the share price rise as they keep releasing some PRs , but absent any strong clinical data or cash deals the share price will be stagnant.
The company can not afford to wait until June 2019 when NEO or HOT data is available. PSA data is a wild card, however. We shall see.
Previous years, when the proxy was out and shareholder votes were needed badly, Advaxis via hired guns used to inundate investors with their phone calls. What about this year? I have not seen anyone complaining about those phone calls re: proxy votes. Is the company confident they have sufficinet number of votes for this proxy and no more phone calls?
PS. I do not doubt they get their wishes granted, and the proxy will be passed, including Item 7 -- just curious what has changed this year? Ken's decision?
From what I recall, average cost to run oncology clinical trials per person is estimated at $100K. Could be higher for HOT patients, though.
CVI Investments also reduced by 600K shares.
2019-02-14 13G/A CVI Investments, Inc. 4,166,666 3,545,562 -14.91
CalPERS is microscopic to move anything through. Had their position been in millions of shares, they would have been able to enforce some long-overdue changes. Otherwise, they are barking on a wrong tree. Pissing in the wind.
https://whalewisdom.com/stock/adxs
fintel is flaky, sometimes...
DB added a quite a bit (over half a million shares):
DEUTSCHE BANK AG 562,294 4176 553,031 1.0686% 13F 2018-12-31 2019-02-14
As expected, CVI started to unload (reduced by 1.24M shares, kept 2.2M shares):
CVI HOLDINGS, LLC 2,195,432 5.35 14 1,243,916 4.1721% 13F 2018-12-31 2019-02-14
Also, Vanguard reduced by 915K shares.
VANGUARD GROUP INC 1,715,393 0.00 3812 915,265 3.2599% 13F 2018-12-31 2019-02-14
Once they hire a Senior Vice President for the Clinical Affairs and two assistants, they'll update the clinicaltrials.gov site. Until then, you have to be patient.
Snip:
Advaxis Announces Enrollment of the First Patient in its Phase 1/2 Trial for ADXS-HOT in the Treatment of Non-Small Cell Lung Cancer
Business Wire Business Wire•February 14, 2019
PRINCETON, N.J.--(BUSINESS WIRE)--
Advaxis, Inc. (ADXS), a late-stage biotechnology company focused on the discovery, development and commercialization of immunotherapy products, announced it has initiated its Phase 1/2 clinical trial to evaluate ADXS-503, part of the Company’s ADXS-HOT program, in the treatment of non-small cell lung cancer (NSCLC) and has enrolled the first patient in the trial. ADXS-HOT is a cancer-type specific immunotherapy program which leverages Advaxis’ proprietary Lm technology platform to target hotspot mutations that commonly occur in specific cancer types as well as other proprietary, tumor-associated antigens. To date, more than 10 drug candidates have been designed for different tumor types under the ADXS-HOT program.
“Coming on the heels of the presentation of data from our immunotherapy platform at the I/O 360 conference last week, we are excited to announce the enrollment of the first ADXS-HOT patient in our Phase 1/2 trial evaluating ADXS-503 for the treatment of NSCLC. The data presented at I/O 360 suggest that our neoantigen-directed constructs from both our ADXS-NEO and ADXS-HOT programs have the potential to demonstrate best-in-class CD+8 T cell response for neoantigen therapies,” said Kenneth A. Berlin, President and Chief Executive Officer of Advaxis. He continued, “We believe our ADXS-HOT drug constructs have significant advantages compared to certain other neoantigen-focused therapies in development as our ADXS-HOT drug constructs are off-the-shelf and immediately available to administer to the patient and have a favorable cost to manufacture.” He concluded, “The ADXS-HOT program supports our goal of leveraging the significant experience we have gained from our proprietary platform in order to advance programs in the fight against cancer for patients in need of new therapeutic options and we look forward to studying these constructs in the clinic.”
The Phase 1/2 clinical trial for ADXS-503 will seek to establish the recommended dose, safety, tolerability and clinical activity of ADXS-503 administered alone (initially) and in combination with a checkpoint inhibitor in approximately 50 patients with NSCLC in different lines of therapy, at up to 20 centers across the U.S. Advaxis anticipates initial data from the first cohort of ADXS-503 in the first half of 2019.
About ADXS-HOT
ADXS-HOT is a program that leverages the Company’s proprietary Lm technology to target hotspot mutations that commonly occur in specific cancer types. ADXS-HOT drug candidates are designed to target acquired shared or “public” mutations in tumor driver genes along with other proprietary cancer-testes and oncofetal tumor-associated antigens that also commonly occur in specific cancer types. ADXS-HOT drug candidates are an off-the-shelf treatment, designed to potentially treat all patients with a specific cancer type, without the need for pretreatment biomarker testing, DNA sequencing or diagnostic testing.
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 programs 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.
Thanks, Hov.
Their last corporate presentation lists "PSA update on survival rates and correlative biomarkers expected in Q1/2019". Sounds like soon?
MRK prostate cancer news (when do we get our PSA news?):
https://seekingalpha.com/news/3433298-keytruda-combo-therapies-show-positive-effects-prostate-cancer-study
Keytruda combo therapies show positive effects in prostate cancer study
Feb. 14, 2019 7:27 AM ET|About: Astellas Pharma, Inc. ADR (ALPMY)|By: Douglas W. House, SA News Editor
Preliminary data from an open-label Phase 1b/2 clinical trial, KEYNOTE-365, evaluating Merck's (NYSE:MRK) Keytruda (pembrolizumab), combined with various agents, in patients with metastatic castration-resistant prostate cancer (mCRPC) showed a treatment effect across three cohorts. The results are being presented at the ASCO GU Cancers Symposium in San Francisco.
Cohort A: Keytruda + AstraZeneca's (NYSE:AZN) Lynparza (olaparib): Prostate specific antigen (PSA) response rate was 12% (n=5/41). Median time to PSA progression was 15.3 weeks in patients with measurable disease. The disease control rate (DCR) (responders + stable cancer) was 29% (n=12/41). 49% (n=21/41) of patients experienced a serious or life-threatening treatment-related adverse events, the most common being anemia (27%).
Cohort B: Keytruda + docetaxel and prednisone: PSA response rate was 31% (n=22/72). Median time to PSA progression: 24.1 weeks. DCR: 57% (n=41/72). 36% (n=26/72) experienced a serious, life-threatening or fatal treatment-related adverse event. Two patients died from pneumonitis (lung tissue inflammation).
Cohort C: Keytruda + Pfizer (NYSE:PFE) and Astellas Pharma's (OTCPK:ALPMY) Xtandi (enzalutamide): PSA response rate: 26% (n=18/69). Median time to PSA progression: 18.4 weeks. DCR: 33% (n=23/69). 41% (n=28/69) of patients experienced a serious or life-threatening treatment-related adverse event, the most common being a rash (10%).
Merck is initiating three new pivotal prostate cancer trials: KEYLYNK-010 (Keytruda + Lynparza), KEYNOTE-921 (Keytruda + docetaxel and prednisone) and KEYNOTE-621 (Keytruda + Xtandi).
Interesting, Adage did not sell last Q (they used to shed by 0.5M shares per Q):
ADAGE CAPITAL PARTNERS GP, L.L.C. 2,500,000 0.01 701 4.7509% 13G 2018-12-31 2019-02-13
Have not heard from Tinfoillurker for a long time. If you are around, please chime in.
That MAGA hat comes with pom-poms. I can't fancy you wearing those accessories...
MANTA: Make Advaxis Non-Toxic Again
Renaissance Tech increased their position by almost 1.7M shares.
https://fintel.io/so/us/adxs
2019-02-12 13F Renaissance Technologies LLC 1,191,846 2,900,836 143.39 1,120 551 -50.80
I think it's not contracts, it's shares. CITI as a trader had a three-legged position in Advaxis, then closed puts, while increasing the calls and reducing the number of shares. If the data were to reflect the number of contracts, that would have led to a huge disparity in their trading bias. Notice that the number of shares (held, and options) has to be on the same order.
Did you not see the number of shares they hold? That's about few thousand dollars worth of shares -- a very BIG investment for CITI. Hilarious!
CITIGROUP INC 3,906 7572 8,600 0.0074% 13F 2018-12-31 2019-02-12
CITIGROUP INC(PUT) 7891 8,600 13F 2018-12-31 2019-02-12
CITIGROUP INC(CALL) 6,400 7571 6,000 13F 2018-12-31 2019-02-12