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Wink, wink, nudge, nudge? A very nice hint from Ben Kerlin. He's a very nice hinter as evidenced by history. He winked twice just before he announced NEO shutdown, once before Aim2Cerv shutdown and then twice just before it's resuscitation. He repeated those classy moves every time before secondaries. whom were directed those hints to? Yes, you guessed right! Hedgies and friends!
I've started building a position in UDOW. First buy was at 83, next buy will be at around 75.
Also, put a buy order for TQQQ at 67.50.
These indices are highly oversold. Markets will rebound, but not clear when the panic subsides. Crazy.
What exactly makes you believe the data is attractive? From the limited data they have released so far, I cannot fathom how this data could be perceived as impressive to entice Merck. One PR is good, but two patients evaluated in total? They need to show more PRs and CRs before Merck buys this platform.
I thought we had a news. Did you miss the memo?
I'm also watching from the outside -- my ADXS soul separated from the ADXS body and watching it decompose from the above.
PS. My body was cut to death by thousands of cuts and in the end I stopped feeling any pain. It just checked out and got numb.
I think they are delusional and the science comprehension is not their strong suit. They might view the data as positive. But the other (potential partners) know that the data is really weak.
Although ADXS did another secondary a month ago and raised about $9.6MM, it was not sufficient to extend their cash runway longer than a quarter. If you think they are done with secondaries for a while, think again. Pay attention to a rush of PRs issued recently: ADXS had 3 fluff PRs in the past 10 days. Why? If you learn from the history, you should know one thing -- these fluff PRs are pre-cursor to an impending secondary. I would not be surprised to see another offering after the close today. Time will tell, but my bullshit-meter senses a secondary.
There is nothing as of now yet. But I don't doubt they'll come up with some "new shiny thing" once HOT starts fading away. From one thing to the next great thing while collecting their big fat paychecks and bonuses.
As far as the ADXS SP concerns, I think we are done. More than 99% down, and there is no hope ahead. Call me "doom&gloom", but the reality has already settled in.
Just to confirm my impression of the HOT data released this morning, I asked Dennis (aka biotech2k on IV) to comment on the data. He posted the following:
"The best response is Stable Disease? I see no CR or no PR. That means the official RECIST 1.1 ORR is 0% and the Clinical Benefit Rate is 50%. I don't see anything there that makes me want to rush out and buy. I hope that helps."
He has a very good grasp of the science and has been mostly right about many companies. My $0.02.
The data does not look impressive.
We are into a sell off.
https://ir.advaxis.com/news-releases/news-release-details/advaxis-announces-positive-clinical-data-ongoing-phase-12-adxs
February 20, 2020
Download PDF
ADXS-503 safe and tolerable with potential signs of clinical activity in 4 of 7 evaluable patients achieving stable disease in the refractory setting
Patient who previously progressed on pembrolizumab showed stable disease with a 25% reduction in a site lesion in combination arm
PRINCETON, N.J., Feb. 20, 2020 (GLOBE NEWSWIRE) -- Advaxis, Inc. (Nasdaq: ADXS), a clinical-stage biotechnology company focused on the development and commercialization of immunotherapy products today announced results from the monotherapy and combination arms of the Company’s ongoing Phase 1/2 study investigating ADXS-503 in patients with non-small cell lung cancer (NSCLC) at the IASLC 2020 Targeted Therapies of Lung Cancer Meeting in Santa Monica, California. The trial is evaluating ADXS-503, part of the Company’s ADXS-HOT 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, alone and in combination with KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy.
Key findings presented by Jennifer Carlisle, M.D., Assistant Professor Department of Hematology and Medical Oncology, Winship Cancer Institute of Emory University
and study investigator, titled, “A Phase 1/2 Study of ADXS-503 Alone and in Combination with Pembrolizumab in Subjects with Metastatic Squamous or Non-Squamous Non-Small Cell Lung Cancer” include:
Nine patients have been dosed to date; seven in the monotherapy arm and two in the combination arm, with a total of seven evaluable patients
50% (3 of 6) of evaluable patients from the monotherapy arm, from Part A, showed stable disease
The first evaluable patient from the combination arm, Part B, who previously progressed on pembrolizumab, showed stable disease with a 25% reduction in a site lesion
Stable disease was observed in a heavily pretreated patient population with patients failing up to six prior lines of therapy and most patients progressing on prior immunotherapy treatments
ADXS-503 monotherapy and in combination with pembrolizumab appeared safe and tolerable in this heavily pretreated population of patients with no dose limiting toxicities observed
Treatment-related adverse events were mostly Grade 1-2, with no additive toxicity observed with combination therapy
“The presented preliminary data on safety, tolerability and disease stabilization with ADXS-503 in patients with advanced NSCLC provides an important clinical proof-of-concept to the Company’s first off-the shelf, hotspot neoantigen construct tested thus far,” said Dr. Andres Gutierrez, Chief Medical Officer of Advaxis. “These data are important given the highly refractory patient population with most evaluated patients progressing on prior immunotherapies and, while early, we are particularly interested in documenting additional potential signals of synergy with KEYTRUDA®. We look forward to reporting additional clinical and immunogenicity data later this year in addition to starting Part C of the study which will evaluate ADXS-503 in combination with pembrolizumab as a first-line treatment for NSCLC patients.”
The Phase 1/2 clinical trial of ADXS-503 will seek to establish the recommended dose, safety, tolerability and clinical activity of ADXS-503 administered alone and in combination with a checkpoint inhibitor in approximately 50 patients with NSCLC, in at least five sites across the U.S. The two dose levels with monotherapy in Part A, (1 X108 and 5 X108 CFU) have been completed and Part B in combination with a checkpoint inhibitor is currently open to enrollment.
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.
Reposting. We might get some PR/update this morning. Watching. This could shed some insight as to how HOT is working.
-----------------------------------------------------
Advaxis will be presenting ADXS-HOT (NSCLC/ADXS-503) combo data with Keytruda this Thursday at 2:15pm at the IASLC 2020 Lung Cancer Targeted Therapies Meeting, Santa Monica, California, February 19-22, 2020.
Will be interesting to see the 1st HOT combo data this week.
From Benzinga:
https://finance.yahoo.com/news/week-ahead-biotech-agile-baudax-200332124.html
"Advaxis, Inc. (NASDAQ: ADXS) will present at the IASLC Congress Phase 1 data for ADXS-503 monotherapy as well as combo therapy along with Keytruda in metastatic non-small cell lung cancer (Saturday)."
IASLC site:
https://www.iaslc.org/Conferences-Events/Event-Details/iaslc-2020-lung-cancer-targeted-therapies-meeting
The program:
https://www.iaslc.org/Portals/0/TTLC_2020-E-Program.pdf?ver=2020-02-12-234232-883
Then we got kenned.
A robot compiled article without any fact checking. FYI, Advaxis has abandoned the @n@l cancer program some time ago. Check their current pipeline.
https://advaxis.com/wp-content/uploads/2020/02/ADXS-Corporate-Presentation-13-Feb-2020-.pdf
That can be fixed -- let me talk to Ken about shifting more authority over to you. Getting pretty hectic here on College Rd. Exciting bonus times!
Are you apologizing on behalf of Advaxis?
Advaxis will be presenting ADXS-HOT (NSCLC/ADXS-503) combo data with Keytruda this Thursday at 2:15pm at the IASLC 2020 Lung Cancer Targeted Therapies Meeting, Santa Monica, California, February 19-22, 2020.
Will be interesting to see the 1st HOT combo data this week.
From Benzinga:
https://finance.yahoo.com/news/week-ahead-biotech-agile-baudax-200332124.html
"Advaxis, Inc. (NASDAQ: ADXS) will present at the IASLC Congress Phase 1 data for ADXS-503 monotherapy as well as combo therapy along with Keytruda in metastatic non-small cell lung cancer (Saturday)."
IASLC site:
https://www.iaslc.org/Conferences-Events/Event-Details/iaslc-2020-lung-cancer-targeted-therapies-meeting
The program:
https://www.iaslc.org/Portals/0/TTLC_2020-E-Program.pdf?ver=2020-02-12-234232-883
Ha, I have always thought you might be privy to that type of information. I am impressed you are very well aware of those shenanigans.
Nah, they got Terry (aka inoviorulez) on board -- they drugs can be fabricated within hours and tested overnight.
INO is one of the most notorious P&D companies, they are always start 'developing' vaccines for epidemic cases. Recall Zika, Ebola, SARS, and ect. They are first to jump in, then the SP goes exponential and crashes and burns once hysteria goes away. Seen that many times.
Market's are not impressed, Jane. We need more than good results. Either very good data or some paying partner. MRK does not want to jump in, not yet.
Updated corp presentation:
https://advaxis.com/wp-content/uploads/2020/02/ADXS-Corporate-Presentation-Feb-2020-.pdf
I did not know they had an IND for ADXS-HOT prostate cleared by FDA last month.
ADXS PSA update:
https://finance.yahoo.com/news/advaxis-announces-updated-survival-data-130010009.html
Advaxis Announces Updated Survival Data in Phase 1/2 ADXS-PSA Trial at the ASCO Genitourinary Cancers Symposium
GlobeNewswire GlobeNewswire•February 13, 2020
Median overall survival of 16.4 months for advanced prostate cancer patients with visceral metastases treated with ADXS-PSA in combination with KEYTRUDA® compared to an estimated 11 months with Standard of Care
Median overall survival of 33.7 months in all patients treated with ADXS-PSA in combination with KEYTRUDA®
PRINCETON, N.J., Feb. 13, 2020 (GLOBE NEWSWIRE) -- Advaxis, Inc. (ADXS), a clinical-stage biotechnology company focused on the development and commercialization of immunotherapy products today announced updated results from the combination arm of KEYNOTE-46 (Part B), the Company’s ongoing Phase 1/2 study investigating ADXS-PSA with KEYTRUDA® (pembrolizumab) in patients with metastatic, castrate-resistant prostate cancer (mCRPC) at the ASCO Genitourinary Cancers Symposium in San Francisco, California. The KEYNOTE-46 trial was conducted in conjunction with Merck (known as MSD outside the U.S. and Canada) and evaluated ADXS-PSA, one of Advaxis’ Listeria monocytogenes (Lm)-based immunotherapies, alone and in combination with KEYTRUDA®, Merck’s anti-PD-1 therapy.
“The presented survival data in patients with visceral metastases strengthens our confidence that ADXS-PSA in combination with KEYTRUDA® has the potential to provide meaningful increases in median overall survival in patients with advanced, metastatic, castration-resistant prostate cancer,” said Kenneth A. Berlin, President and Chief Executive Officer of Advaxis. “Importantly, these demonstrated impacts on survival have not been previously observed with immunotherapy in this advanced patient population leading us to actively assess next steps for the program with the hope of providing a much-needed new treatment for these patients with limited options.”
Key findings presented by Mark N. Stein M.D., FACS, Associate Professor of Medical Oncology at Columbia University Medical Center and lead study investigator, titled, “KEYNOTE-046 (Part B): Effects of ADXS-PSA in combination with pembrolizumab on survival in metastatic, castration-resistant prostate cancer patients with or without prior exposure to docetaxel” include:
Median overall survival (95% CI) of 33.7 months (15.4-NR) for patients treated with ADXS-PSA in combination with KEYTRUDA® (n=37)
Median overall survival (95% CI) of 16.0 months (6.4-34.6) for patients with prior docetaxel (n=20)
Median overall survival (95% CI) of 16.4 months (4.0-NR) for patients with prior visceral metastasis (n=11; 10 of who had prior docetaxel)
72.4% (21/29) of evaluable patients showed stable disease
38% of patients had PSA declines and 27% had >= 30% PSA decline from baseline
The combination of ADXS-PSA and pembrolizumab appeared safe and tolerable in this heavily pretreated, unselected population of patients with MSI-High-negative mCRPC
Treatment-related adverse events were mostly Grade 1-2, with no additive toxicity observed with combination therapy
Mark N. Stein M.D., FACS said, “These data are encouraging given the advanced nature of the patient population which includes those who have failed next generation hormonal agents and/or docetaxel, and now those with visceral metastasis.” He added, “I am particularly enthusiastic to see increases in median overall survival to 16.4 months as compared to standard of care, which tends to be closer to 11 months in patients with measurable disease/visceral metastasis. This improvement, delivered with a generally safe and well-tolerated treatment regimen, warrants additional evaluation in larger studies and I look forward seeing the potential of a continued evaluation of ADXS-PSA in combination with KEYTRUDA®.”
KEYNOTE-046 was an open-label, multicenter, dose-determining safety and tolerability Phase 1/2 trial of 50 heavily pretreated patients conducted in two parts (Part A and Part B), with a Phase 2 expansion cohort. The objective of the study was to evaluate ADXS-PSA alone (Part A) and in combination with KEYTRUDA® (Part B) for primary endpoints that include safety, tolerability and dosing. Secondary endpoints included anti-tumor activity, progression-free survival and overall survival, and exploratory endpoints that include associations between biomarkers of immunologic response (serum PSA) with clinical outcomes. Enrollment in the study has been completed and the database lock occurred on January 28, 2020. The majority of treatment-related adverse events consisted of transient and reversible Grade 1-2 chills/rigors, fever, hypotension, nausea and fatigue. The combination of ADXS-PSA and KEYTRUDA® has appeared to be well-tolerated, to date, with no additive toxicity observed.
About KEYNOTE-046
KEYNOTE-046 (NCT02325557) was a Phase 1/2 open-label, multicenter, dose-determination and expansion trial that evaluates the safety, tolerability and preliminary clinical activity of ADXS-PSA as monotherapy (Part A; n=14 [13 treated]), and in combination with KEYTRUDA® (Part B; n= 37) in heavily pretreated patients with progressive and refractory mCRPC.
About Advaxis, Inc.
Advaxis, Inc. is a clinical-stage biotechnology company focused on the 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 T cells to eliminate tumors.
I'm pretty sure that's going to occur before Ken's 2nd anniversary. This should ensure he gets a big fat bonus together with a 25% salary raise.
Why not?
This is PR is fluff. I hope the company is not trying to run another secondary.
Let's keep printing money -- we might send some to Batermere and the rest could be spent nicely for a shushi+Sapporo party. Anyone with a sushi and/or beer allergies here?
And $0.01 what a bad news.
Guess what kind of news has been prevalent in the past few years?
Yes, or course, there's no reason not to be a green day -- Ken has now returned from the green pastures of the Canary Islands after enjoying the golf courses for a couple weeks. Then, he flew directly to Miami and watched SB/LIV from the corporate suits. Green Canary Islands, green Florida -- green Advaxis!
PS. We will be 0.83367 without news and 0.001 higher with news!
So, 10MM shares have been issued to 2 major "investors" and no 13-F/G forms filed? Why? They should be exceeding 5% threshold for filing these forms. Like a clockwork -- we almost never see who buys these new shares, just a small fraction of the shares are publicly disclosed. The rest are just used to cover previous short positions. Wash, rinse, and repeat. How this is not criminal?
Nah, Mr MacKay, he happened to stay a night at the Holiday Inn Express on E.College St in Princeton. I originally thought he was with the Department of Media Initiatives, Advaxis Inc. but then I was confirmed he was with one of the short term investment companies that frequently participates in the ADXS secondaries. It's a small world!
They will sell as quickly as possible like the last time around. They actually might already have sold every single share and also covered their oversized short position. Didn't you learn from the last lesson?
Just a small caveat: the former might true, but the latter?
We may ever get back to a buck. Ever.
Wow, just wow. I'm speechless.
Ken's total compensation for 2018 was almost $1.8MM! Unbelievable...
Short interest up by 1.15MM shares.
SETTLEMENT DATE | SHORT INTEREST | AVG. DAILY SHARE VOLUME | DAYS TO COVER
01/15/2020 | 4,455,894 | 9955389 | 1
12/31/2019 | 3,312,352 | 4163463 | 1
12/13/2019 | 3,096,697 | 12230310 | 1
You know very well that they don't need scientists to do payroll and write huge bonus checks for themselves. Bean counters, not scientists!
Of course, if you run the offering/warrants/pricing through the Black-Scholes model, you'll likely come up with the real price of offering at just below 0.70. That's our target.
Think how many shares were shorted before this offering? Wash, rinse, repeat...
Well, they've been cutting costs for almost two years now, and they let a proofreader go last year (he was a buddy of mine, we got our GEDs together when doing our times at the Hotpot Central). As of now, Advaxis has no one to proofread anything they post online or when they communicate with the authorities. Thus, it's possible that when you see the next proxy, you could see an extra or two zeros added to the number of authorized shares. C'est la vie!
Operation “Dump” has now started.