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What is it then if not a ghost ship already?
Do we really know if CVI actually owns anything? Likely they sold more shares than they "hold". Not sure about Lincoln Park though.
Fund : Shares Held : Change in Shares : % Ownership : Source : Source Date : Date Reported : Qtr 1st Owned
CVI 5,000,000 1,454,438 7.5497% 13G 2020-01-21 2020-01-30 -
LINCOLN PARK 4,594,793 4,594,793 6.9379% 13G 2020-08-03 2020-08-03 -
RENAISSANCE 3,266,143 232,775 4.9317% 13F 2020-09-30 2020-11-13 Q4 2017
BlackRock 870,007 1.3137% 13F 2020-09-30 2020-11-06 Q2 2015
VANGUARD 811,182 1.2248% 13F 2020-09-30 2020-11-16 Q4 2013
We need to breathe a life into ADXS.
DOC did it by going into the Oval Office and doing a photo op with with Trump.
Kenny likely will not be able to meet with Trump. How about meeting BUYden in the Oval Office? Does Ken need to bribe Hunter to arrange a meeting? We don't have $10M to throw around, do we?
Nah, just getting hosed.
Zero-G force makes definitions of top and bottom completely obsolete. Weightlessness! What a fantastic sensation! It means we are on a way to do Moon!
#space
Yeah.
... and money down the drain.
HOT next?
Do I hear a next three-letter acronym? MAD? When will they pivot to MAD?
As a resident etymologist who coined a "BUY BYE BYE" phrase, can you chime in with your expert opinion re: which one correct:
A) BUYden, or
B) BYEden?
fair enough. Thus no one should be surprised the markets big fat 0 (zero) on the value of those GOG results. Unless something changes, it's another grave stone in Advaxis Inc Cemetery run by Kenny the Undertaker.
So, what do you think is going to happen next with those "best-ever" cervical results? If nothing's transpired in the past 4 years, why do you believe they have a shot of getting this over the finish line?
[quote]my money can go to 0.01 and I'd still be bullish about this stock![/quote]
Let's hear your voice once it hits 0.01 after the next 1:25 R/S. Hope you'll stick around by then.
Yes, I looked at the data, and there's no way to spin it as a positive:
Overall Study
Treatment (ADXS11-001)
Started 50
Completed 16
Not Completed 34
Adverse Event 3
Withdrawal by Subject 5
Disease Progression 18
Not otherwise specified 8
Yes, thanks for the info! I thought the cervical program was kaput, but obviously GOG continued the trial. Dosed 50 patients, and the status shows "complete". Data coming out soon?
https://clinicaltrials.gov/ct2/history/NCT01266460?A=26&B=28&C=Side-by-Side#StudyPageTop
The question has never been about if MRK has a pile of cash or not, but whether ADXS is on their acquisition radars or not. Had ADXS demonstrated strong combo data with Keytruda, we would have been taken out not months, but years ago. That's the point. So far, Big Boys have yet to see that type of data from ADXS. Then, we can talk about how much is ADXS worth. Right now, MRK can pick the ADXS leftovers for a few shekels, but even that they consider too expensive. Tells you why.
Someone within ADXS screwed up by releasing the PR? I don't think there'll be any new data released after the embargo. Too short period of time to accumulate anything meaningful.
Don't you assume it was an attempt to run another secondary? Release the news with an expectation that the share prices rises and then, voila! It's not the first time ADXS management tried to follow that script. Fluff PRs, then a secondary. The problem is nobody is left out there to hook, line and sinker. Even the retail dumb a$$e$ got a lot smarter, with a few exceptions.
This is MRTX data:
See the difference between the response rates.
https://ir.mirati.com/news-releases/news-details/2020/Mirati-Therapeutics-Reports-Investigational-Adagrasib-MRTX849-Preliminary-Data-Demonstrating-Tolerability-and-Durable-Anti-Tumor-Activity-as-well-as-Initial-MRTX1133-Preclinical-Data/default.aspx
MIRATI THERAPEUTICS REPORTS INVESTIGATIONAL ADAGRASIB (MRTX849) PRELIMINARY DATA DEMONSTRATING TOLERABILITY AND DURABLE ANTI-TUMOR ACTIVITY AS WELL AS INITIAL MRTX1133 PRECLINICAL DATA
10/25/2020
- 45% confirmed ORR and 96% DCR across Phase 1/1b and Phase 2 monotherapy cohorts in patients with advanced NSCLC
- Median duration of treatment >8 months with 50% of patients and 83% of responders still on treatment in the Phase 1/1b monotherapy cohort in patients with advanced NSCLC
- Well-tolerated safety profile across monotherapy and combination trials
- Initial preclinical data for MRTX1133, the Company's potential first-in-class KRAS G12D selective inhibitor, demonstrate significant tumor regression in mutant animal models; IND filing planned for 1H 2021
- Mirati to host virtual investor event today at 1:30 p.m. PT / 4:30 p.m. ET
SAN DIEGO, Oct. 25, 2020 /PRNewswire/ -- Mirati Therapeutics, Inc. (NASDAQ: MRTX), a clinical-stage targeted oncology company, today announced preliminary results from the Company's mutant KRAS selective inhibitor programs. The preliminary results included updated clinical data of adagrasib (MRTX849), the Company's KRAS G12C inhibitor, presented at the 32nd EORTC-NCI-AACR Symposium on Molecular Targets and Therapeutics ("ENA") and initial preclinical in vivo data of MRTX1133, the Company's selective and potent potential first-in-class KRAS G12D inhibitor.
Adagrasib is a potent and selective inhibitor of KRAS G12C, optimized for a long half-life and a significant volume of tissue distribution to maintain continuous inhibition of KRAS-dependent signaling for the complete dose interval to maximize efficacy demonstrated by the depth and duration of anti-tumor activity.
"The adagrasib preliminary data presented today showed deep and durable anti-tumor activity in non-small cell lung cancer (NSCLC), colorectal cancer (CRC) and other solid tumors, providing renewed hope for patients that harbor a KRAS G12C mutation. A 45% confirmed objective response rate for adagrasib as a monotherapy in advanced NSCLC is compelling. While this data is still maturing, adagrasib also demonstrated clinically meaningful duration of treatment for NSCLC patients in the Phase 1/1b cohort," said Charles M. Baum, M.D., Ph.D., President and Chief Executive Officer of Mirati. "Enrollment is complete in the Phase 2 cohort of adagrasib as a monotherapy treatment for patients in 2nd / 3rd line NSCLC and we anticipate submitting a New Drug Application for accelerated approval in the second half of 2021. Adagrasib has been well tolerated as a monotherapy and in combination with pembrolizumab, cetuximab and TNO-155, a SHP-2 inhibitor. We are initiating additional registration-enabling global clinical studies of adagrasib as both a monotherapy and in combinations as we expand the program to earlier lines of therapy in NSCLC and CRC."
Adagrasib tolerability at a dose of 600 mg BID in both monotherapy and combination trials:
In a pooled assessment of 110 patients harboring a G12C mutation in NSCLC, CRC and other solid tumors, monotherapy adagrasib has been well tolerated
4.5% of treatment-related adverse events led to discontinuation
Over 50 patients have been treated with adagrasib in combination with either pembrolizumab (a PD-1 inhibitor) in NSCLC, cetuximab (an anti-EGFR antibody) in CRC and TNO-155 (a SHP-2 inhibitor) in NSCLC or CRC
Each combination has been well tolerated
The pembrolizumab and cetuximab combination cohorts are ongoing and each have cleared the dose limiting toxicity evaluation period at the full dose of each commercial agent and at a 600 mg BID dose of adagrasib
The TNO-155 combination dose escalation and expansion cohorts are ongoing at a 600 mg BID dose of adagrasib
Preliminary efficacy data as of August 30, 2020 in patients with advanced NSCLC treated with adagrasib as a monotherapy at a 600 mg BID dose:
Patients had a median of two prior systemic treatments, including all patients receiving prior treatment with platinum-based chemotherapy regimens and 92% of patients receiving prior treatment with an anti-PD-1 /L1 inhibitor
Efficacy data from pooled Phase 1/1b cohort and Phase 2 registration-enabling cohort (n=51):
45% (23/51) confirmed objective response rate (ORR)
70% (16/23) of responders had a best tumor response greater than 40%
96% (49/51) disease control rate (DCR)
3.6 months median duration of follow-up
65% (33/51) of patients remain on treatment
83% (19/23) of responders have not progressed and remain on treatment
Efficacy data from the Phase 1/1b cohort (n=14):
43% (6/14) confirmed ORR
100% (14/14) DCR
8.2 months median duration of treatment
50% (7/14) of patients remain on treatment
83% (5/6) of responders remain in response and on treatment
4 of 6 responders have a duration of treatment for >11 months and all 4 patients remain on treatment
Preliminary explorative correlative analysis of co-mutations of KRAS G12C and STK11 in advanced NSCLC showed a 64% (9/14) ORR across pooled Phase 1/1b and Phase 2 cohorts:
Approximately 30% of all KRAS G12C mutant NSCLC patients have a STK11 co-occurring mutation
Co-occurring KRAS and STK11 mutations have been shown to be significantly correlated with poor clinical outcomes when treated with immunotherapy and platinum-based chemotherapy regimens
In a case study presented today from the ongoing clinical trial of adagrasib as a monotherapy, a heavily pre-treated NSCLC patient with an unirradiated, active brain metastases observed a 67% reduction in tumor volume including the disappearance of a metastatic brain lesion:
Preclinical studies demonstrate dose-dependent brain and cerebrospinal fluid (CSF) exposure
The Phase 2 cohort of adagrasib as a monotherapy is currently enrolling additional NSCLC patients with active brain metastases to further explore this patient population which has a high unmet medical need
In a case study presented today from the ongoing clinical trial of adagrasib in combination with TNO-155 (investigational SHP-2 inhibitor) in collaboration with Novartis, a heavily pre-treated NSCLC patient treated in the combination trial of adagrasib and TNO-155 (investigational SHP-2 inhibitor) observed a 60% reduction in tumor volume:
Data was from a scan on August 24, 2020
Prior therapy included treatment with a non-adagrasib monotherapy G12C direct inhibitor (with initial partial response followed by disease progression) and in combination with another SHP-2 inhibitor with chemotherapy (which was discontinued due to an adverse event)
Preliminary efficacy data as of August 30, 2020 in heavily pretreated patients with advanced CRC treated with adagrasib as a monotherapy at a 600 mg BID dose:
Median of 4 prior systemic treatments
Efficacy data from pooled Phase 1/1b and Phase 2 cohorts (n=18)17% (3/18) confirmed ORR with 2 of 3 responders remaining on treatment
94% (17/18) DCR
67% (12/18) of patients remain on treatment
55% (10/18) have a duration of treatment of >4 months
Preliminary efficacy data as of August 30, 2020 in patients with advanced solid tumors, other than NSCLC and CRC, treated with adagrasib as a monotherapy at 600 mg BID dose from a Phase 1/1b cohort:
One patient each (n=4) with pancreatic, ovarian, endometrial and cholangiocarcinoma tumors were treated, and each patient had a confirmed partial response to therapy
2 appendiceal cancer patients had stable disease
All 6 eligible patients remain on treatment
MRTX1133 Preclinical Summary
MRTX1133, the Company's potent, selective and reversible inhibitor of KRAS G12D, binds to and inhibits mutant KRAS protein in both its active and inactive states. MRTX1133 exhibits single digit nanomolar potency and is >1000-fold selective for KRAS G12D compared with wild-type KRAS in cellular assays. Based on preclinical analyses, MRTX1133 has a projected human half-life exceeding 50 hours and exhibits a low propensity for drug interactions or off-target pharmacology. MRTX1133 demonstrated tumor regression in multiple in vivo tumor models, including pancreatic and colorectal cancers.
"MRTX1133, a potential first-in-class compound, continues to advance toward an Investigational New Drug filing in the first half of 2021. The drug properties and antitumor activity we've observed in preclinical tumor models continue to show promise," said James G. Christensen, Ph.D., Executive Vice President and Chief Scientific Officer at Mirati. "MRTX1133 has a low predicted target plasma concentration, based on its potency and high unbound fraction, and our goal is to achieve near complete and sustained target inhibition and maximal anti-tumor activity. To ensure sustained therapeutic levels are achieved, we are pursuing both oral and parenteral routes of administration in parallel as we plan for a Phase 1 clinical trial and intend to select the route that results in the optimal KRAS G12D inhibition. We are driven by the opportunity to positively impact the lives of patients with KRAS mutant cancers who have limited treatment options."
ENA Presentations on Adagrasib Clinical Data:
Pasi A. Janne, M.D., Ph.D., Director of the Lowe Center for Thoracic Oncology at Dana-Farber Cancer Institute, Professor of Medicine, Harvard University and the Scientific Director of the Belfer Center for Applied Cancer Science, presented updated data for adagrasib in NSCLC patients from MRTX849-001. The presentation is titled, "KRYSTAL-1: Activity and Safety of Adagrasib (MRTX849) in Advanced/Metastatic Non-Small Cell Lung Cancer (NSCLC) Harboring KRAS G12C Mutation" (LBA-03).
Melissa L. Johnson, M.D., Associate Director of the Lung Cancer Research Program at Sarah Cannon Research Institute and Partner, Tennessee Oncology, PLLC, presented updated data for adagrasib in other solid tumors harboring a KRAS G12C mutation from MRTX849-001. The presentation is titled, "KRYSTAL-1: Activity and Safety of Adagrasib (MRTX849) in Patients with Colorectal Cancer (CRC) and Other Solid Tumors Harboring a KRAS G12C Mutation" (LBA-04).
"It's an inspiring and exciting time in the oncology field to see potential targeted therapeutic options for patients with the KRAS G12C mutation, a patient population that has historically faced limited treatment options. The clinical outcomes presented today, including the depth and maturing duration of responses in non-small cell lung cancer, colorectal cancers, and other solid tumors, along with the overall favorable safety profile, are highly encouraging," said Dr. Pasi Jänne.
Virtual Investor Event
Mirati will host a virtual investor event on October 25, 2020, at 1:30 p.m. PT/4:30 p.m. ET. Company executives will provide an overview of the adagrasib clinical data presented at the EORTC-NCI-AACR conference and share initial preclinical data for MRTX1133, the Company's KRAS G12D selective inhibitor.
Investors and the general public are invited to listen to a live webcast of the event through the "Investors" section of the Mirati corporate website at http://ir.mirati.com/events-and-presentations. Materials related to the webcast will be available at the same website prior to the event. A replay of the event will be available shortly after the conclusion of the event.
About Adagrasib (MRTX849)
Adagrasib is an investigational, orally available small molecule that is designed to potently and selectively inhibit a form of KRAS which harbors a substitution mutation (G12C). KRAS G12C mutations are frequently linked to negative prognoses and are present in approximately 14% of non-small cell lung cancer (NSCLC) adenocarcinoma patients, 3-4% of colorectal cancer patients (CRC), and subsets of other types of cancer. Adagrasib is being evaluated as a monotherapy to treat patients with KRAS G12C-positive advanced solid tumors, including a registration enabling cohort in NSCLC. Adagrasib is also currently being evaluated in various combination cohorts in NSCLC and CRC with a PD-1 inhibitor, EGFR inhibitor, pan-EGFR inhibitor and SHP2 inhibitor.
About MRTX1133
MRTX1133 is designed to potently and selectively inhibit a form of KRAS which harbors a substitution mutation (G12D). MRTX1133 is in investigational new drug (IND)-enabling studies. KRAS G12D mutations impact an estimated 180,000 patients in the U.S. and Europe. The prevalence of the G12D oncogenic mutation is much higher than others including G12C, ALK, RET and TRK. G12D is present in approximately 36% of pancreatic patients, 12% of colorectal patients, 4% of NSCLC adenocarcinoma patients and 6% of endometrial patients.
About Mirati Therapeutics
Mirati Therapeutics (NASDAQ: MRTX) is a San Diego-based late-stage biotechnology company relentlessly focused on translating drug discovery and research into new treatments for patients by advancing and delivering novel therapeutics that target the genetic and immunologic drivers of cancer. Mirati is advancing a novel pipeline to treat large patient populations across multiple programs and tumor types, including two programs, adagrasib and sitravatinib, in registration-enabling studies to treat non-small cell lung cancer (NSCLC).
Adagrasib is an investigational small molecule and selective KRAS G12C inhibitor in clinical development as a monotherapy and in combinations. MRTX1133 is an investigational small molecule and selective KRAS G12D inhibitor in preclinical development.
Sitravatinib is an investigational spectrum-selective inhibitor of receptor tyrosine kinases (RTK) designed to enhance immune responses through the inhibition of immunosuppressive signaling. Sitravatinib is being evaluated in multiple clinical trials to treat patients who are refractory to prior immune checkpoint inhibitor therapy, including a Phase 3 trial of sitravatinib in combination with nivolumab in NSCLC.
For more information, visit www.mirati.com.
Forward Looking Statements
This press release contains forward-looking statements regarding the business of Mirati Therapeutics, Inc. ("Mirati"). Any statement describing Mirati's goals, expectations, financial or other projections, intentions or beliefs, development plans and the commercial potential of Mirati's drug development pipeline, including without limitation adagrasib (MRTX849), sitravatinib and MRTX1133, is a forward-looking statement and should be considered an at-risk statement. Such statements are subject to risks and uncertainties, particularly those challenges inherent in the process of discovering, developing and commercializing new drug products that are safe and effective for use as human therapeutics, and in the endeavor of building a business around such drugs. These and other risks concerning Mirati's programs are described in additional detail in Mirati's quarterly reports on Form 10-Q and annual reports on Form 10-K, which are on file with the U.S. Securities and Exchange Commission (the "SEC") available at the SEC's Internet site (www.sec.gov).
Mirati's forward-looking statements also involve assumptions that, if they never materialize or prove correct, could cause its results to differ materially from those expressed or implied by such forward-looking statements. Although Mirati's forward-looking statements reflect the good faith judgment of its management, these statements are based only on facts and factors currently known by Mirati. As a result, you are cautioned not to rely on these forward-looking statements. These forward-looking statements are made as of the date of this press release, and Mirati assumes no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those projected in the forward-looking statements, except as required by law.
Don't worry, B.liu, you'll be able to load up in low twenties. That's pennies, not dollars.
Sorry, James, the markets disagree with your assessment.
Look, I'm not a science type guy and I'm not play Zach Hartman here. But if you compare ADXS data with the other companies' NSCLC data, you could see that the ORR is much higher. Doesn't that tell anything?
Data not so impressive. Sad.
https://newsfilter.io/a/2243854cc6ff5b2866df61fd63b12cda
Advaxis’ ADXS-503 (HOT Lung) Demonstrates Pronounced and Sustained Tumor Control in Ongoing Phase 1/2 Lung Cancer Trial
Stocks mentioned: ADXS
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Disease control rate of 67% in first six evaluable patients who had progressed on KEYTRUDA
Approximate 50% improvement in disease control rate versus the rates reported in other checkpoint rechallenge studies
Durable, sustained tumor control of over 43 and 33 weeks observed in first two evaluable patients
PRINCETON, N.J., Oct. 26, 2020 (GLOBE NEWSWIRE) -- Advaxis, Inc. (Nasdaq: ADXS), a clinical-stage biotechnology company focused on the development and commercialization of immunotherapy products today announced updated clinical results from the combination arm of the Company’s ongoing Phase 1/2 study evaluating ADXS-503 in combination with KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy in non-small cell lung cancer (NSCLC). ADXS-503 is the first drug construct from the Company’s ADXS-HOT off-the-shelf, 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.
Key data updates for the first 6 evaluable patients who have received ADXS-503 as an add-on therapy immediately following progression with KEYTRUDA®, include:
Disease control rate of 67% (4/6 patients) and overall response rate of 17% (1/6 patients) achieved after immediate prior progression on KEYTRUDA® with previous best responses of stable disease
Sustained clinical benefit with the first two treated patients remaining on treatment for over 43 and 33 weeks
Updated and new patient level data for the four patients with observed disease control, all of whom remain on study, include:
° Previously reported partial response (PR) with 60% tumor reduction seen on 8-week scan and sustained at 33-week scan in an elderly patient with non-squamous NSCLC who had received Pembrolizumab for approximately 30 months with a best overall response (BOR) of stable disease
° Previously reported stable disease (SD) with a 25% reduction in target lesion sustained at 43-week scan in an elderly patient with non-squamous NSCLC who had received Pembrolizumab for ~32 months with a BOR of stable disease.
° Stable disease (SD) confirmed on 13 week-scan in a patient with squamous NSCLC who had received Pembrolizumab for approximately 15 months with a BOR of stable disease
° Stable disease (SD) on 6 week-scan in a patient with non-squamous NSCLC who had received Pembrolizumab for approximately 14 months, including combination therapy with chemotherapy in the beginning
“I am highly encouraged by these data which suggest that treatment with ADXS-503 has the potential to re-sensitize or enhance response to KEYTRUDA®, even in patients with immediate prior progression on treatment,” said Dr. Andres Gutierrez, Chief Medical Officer of Advaxis. “Other checkpoint inhibitor rechallenge studies have reported disease control rates of approximately 45 percent, with these studies typically including bridging therapy, a change in checkpoint inhibitor, or an interruption in treatment of varying intervals. The 67% disease control rate demonstrated thus far in this ongoing study represents an impressive 50 percent improvement versus the disease control rate observed in other studies in similar settings. This improvement in the setting of uninterrupted treatment on KEYTRUDA® is promising and suggests that ADXS-503 may be capable of re-stimulating the immune system to drive clinically meaningful benefit. The sustained durability of responses is also noteworthy, and I look forward to the continued evaluation of ADXS-503 in additional patients as we advance through the efficacy expansion phase of the study.”
Ken Berlin, Chief Executive Officer of Advaxis, said, “We are pleased that the growing and maturing data from our ongoing ADXS-503 clinical trial suggest that this drug candidate may represent an important new treatment option for patients who have progressed on checkpoint inhibitors. Notably, all patients with disease control were on treatment with KEYTRUDA® for over one year at the time of progression, with prior best responses that were limited to stable disease throughout their treatment. In addition, one patient with squamous histology also achieved stable disease, suggesting this regimen may be broadly applicable across NSCLC. As to the durability of tumor control, the first 2 evaluable patients remain on treatment with sustained clinical benefit for over 10 months, suggesting treatment with ADXS-503 is capable of providing long-term resensitization or enhancement to checkpoint inhibitors after disease progression.”
Mr. Berlin continued, “Our belief is that ADXS-503, as an off-the-shelf neoantigen therapy that to date has a favorable safety and tolerability profile, may be broadly beneficial to lung cancer patients in diverse treatments settings and specifically, those with limited treatment options. These results, paired with our recent biomarker data that show on-mechanism activation of an immune response to ADXS-503 antigens, leave us increasingly confident that ADXS-503 has the potential to restore or enhance sensitivity to checkpoint inhibitors. We look forward to continued progress in our expanded clinical program, now evaluating patients in Part B, the efficacy expansion arm, and Part C, our expansion to the first line setting, both of which are continuing to enroll patients.”
The Phase 1/2 clinical trial of ADXS-503 is seeking to establish the recommended dose, safety, tolerability and clinical activity of ADXS-503 administered alone and in combination with a KEYTRUDA® 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. Part B with ADXS-503 (1 X108 CFU) in combination with KEYTRUDA® is currently enrolling its efficacy expansion for up to 15 patients at dose level 1 (1 X108 CFU + KEYTRUDA®) with the potential to proceed to dose level 2 (5 X108 CFU + KEYTRUDA®) at a later date. Part C, which is evaluating ADXS-503 in combination with KEYTRUDA® (1 X108 CFU + KEYTRUDA®) as a first line treatment for patients with NSCLC with PD-L1 expression ≥ 1% or who are unfit for chemotherapy is currently enrolling patients.
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 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.
To learn more about Advaxis, visit www.advaxis.com and connect on Twitter, LinkedIn, Facebook and YouTube.
KEYTRUDA® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, N.J., USA.
Investor Contact
Tim McCarthy
LifeSci Advisors, LLC
Tim@lifesciadvisors.com
(212) 915-2564
Link to original article
R/M? It’s a next door to R/S. Ken must have his eyes checked. He’s knocking on a wrong door thinking it’s an “S”. Guys inside an “M” room seem to have gotten excited.
Well, this plays out exactly how I expected to happen. Nothing new -- just run the stock up, short into the mini rally. Push it down the next day and then cover. Wash, rinse, repeat...
Well, you will be disappointed once again. Hope dies last. But we get to keep the change.
PS. From BHO’s “Hope and Change” mousetrap.
I don’t think there’ll be any follow up either tomorrow or next week. We have seen several spikes on high volume with no good news to follow.
My best guess is that some short decided to cover and the volume spiked.
Those two expect merger or buyout news will be disappointed once again. Ken wants this story to continue so that he could keep his bloated compensation coming. What exactly he gets if he is no longer in charge? How many shares does he own?
So, you still believe Aim2Cerv trial results will be released any time soon? My opinion is that it'll never happen, possibly, the data could be found in post-bankruptcy filings.
I manage a one-way travel agency Thanatos Ltd.
Kenny the Undertaker is one of my licensed operators.
https://www.britannica.com/topic/Thanatos-Greek-mythology
Aratana terminated the agreement:
https://ih.advfn.com/stock-market/NASDAQ/advaxis-ADXS/stock-news/83423169/current-report-filing-8-k
Snip:
So, how much of that "required payments" will actually be made? Guess it's a very small amount, if nothing at all. Would not cover Ken's next vacation trip to the covid-free Antarctica.
Merck's future does not depend on the success or failure of HOT/ADXS -- they'll be fine if ADXS ceases to exist. Whereas, ADXS's existence heavily depends on MRK's decision to get financially involved with ADXS or not. You can't push on a rope!
You still did not answer the question. Suggesting that Kenny can strong arm Merck is just insane. Remember how that worked out previously? Amgen, for example?
So, how exactly ADXS is going to pay for the trial?
Are you sure it's a carrot? Sounds like it's something else steaming ... It could have been a carrot few hours ago.
You may want to ask for a 2020 version of "Advaxis for Dummies" handbook published by Pearson, Justice and Equality (it's free if you still own a single share of ADXS). It correctly shows ADXS raised (i.e. wasted) just over $300MM in the past 7 years:
https://www.sec.gov/Archives/edgar/data/1100397/000149315220017558/form10-q.htm
Quarterly Report:
Advaxis Reports Third Quarter Ended July 31, 2020 Financial Results and Provides a Business Update
September 10, 2020
Strategic expansion of ADXS-503 HOT program in NSCLC to explore potential to enhance and or restore sensitivity to checkpoint inhibitors
Enrolling in Phase 1/2 Study efficacy expansion of ADXS-503 in NSCLC based on sustained and durable clinical responses in first two of three evaluable patients from Part B combination arm with KEYTRUDA®
Enrolling in Part C for first-line regimen with KEYTRUDA® in NSCLC patients with PD-L1 expression ≥ 1% and patients who are unfit for standard of care combination therapy with KEYTRUDA® and platinum-based chemotherapy
PRINCETON, N.J., Sept. 10, 2020 (GLOBE NEWSWIRE) -- Advaxis, Inc. (Nasdaq: ADXS), a clinical-stage biotechnology company focused on the development and commercialization of immunotherapy products today announced an update on its clinical pipeline and financial results for the third quarter ended July 31, 2020.
Key recent corporate and clinical pipeline updates:
Presented updated clinical data from the ongoing Phase 1/2 trial of ADXS-503 in non-small cell lung cancer (NSCLC) demonstrating durable clinical benefit in two out of 3 evaluable patients with immediate prior progression on KEYTRUDA® including one durable response now out to 34 weeks with 25% reduction in target lesion and another sustained response now out to 33 weeks with a 60% reduction in site lesions. Both patients remain on treatment in Part B, the combination arm with KEYTRUDA®
Clinical benefit achieved after immediate prior progression on KEYTRUDA® with previous best responses of stable disease suggest ADXS-503 may re-sensitize or enhance response to KEYTRUDA®
Initiated ADXS-503 Part B combination arm efficacy expansion which will enroll up to 15 patients to evaluate the potential of ADXS-503 in combination with KEYTRUDA® to restore and/or enhance responsiveness to checkpoint inhibitors in PD-1/L-1 refractory NSCLC patients
Initiated ADXS-503 Part C combination arm to evaluate ADXS-503 in combination with KEYTRUDA® as a first line treatment in patients with NSCLC with PD-L1 expression ≥ 1% or who are unfit for chemotherapy
ADXS-503 monotherapy and in combination with KEYTRUDA® appeared safe and well tolerated with no dose limiting toxicities or added toxicity in the combination setting
Announced common stock purchase agreement for up to $20 million with Lincoln Park Capital
Management Commentary
“We are highly encouraged by the clinical and on-mechanism biomarker data from our ongoing Phase 1/2 study of ADXS-503 in NSCLC and have continued to execute on our expansion of the evaluation of the potential of ADXS-503 to synergistically enhance and/or restore sensitivity to checkpoint inhibitors,” said Kenneth A. Berlin, President and Chief Executive Officer of Advaxis. “This quarter, we have begun enrollment in the expansion of Part B to further evaluate the promising signals of sustained clinical benefit observed in the first dose cohort of Part B in NSCLC patients with immediate prior progression on KEYTRUDA®. This could yet be another strategy to rechallenge the tumor with a checkpoint inhibitor without having to stop the drug at progression. In addition, we have started enrollment in Part C which will evaluate ADXS-503 in combination with KEYTRUDA®, moving our HOT program to a first line treatment for patients with metastatic NSCLC that would receive KEYTRUDA® alone as per label indication (i.e., PD-L1 expression ≥ 1%) and patients who are unfit to receive the standard of care regimen of KEYTRUDA® in combination with platinum based-chemotherapy. We believe these two clinical evaluations in Part B and Part C of this study will elucidate the potential of ADXS-503 to improve responses to checkpoint inhibitors in diverse clinical settings and for patients who have limited treatment options. We anticipate having additional data on this program by the end of the year.”
Mr. Berlin continued, “We are particularly encouraged by the safety and tolerability profile of ADXS-503 as a monotherapy and in combination KEYTRUDA®, and with no dose limiting toxicities observed, we believe this can be an important addition to standard of care for those patients whose illness makes them ineligible for other forms of chemotherapy. Our recently announced common stock purchase agreement allows us to continue the prioritization of our HOT program with the ongoing expansions in NSCLC as well as the initiation of a Phase 1 study of ADXS-504 in prostate cancer patients with biochemical recurrence before year end.”
Third Quarter Ended July 31, 2020 Financial Results
Research and development expenses for the third quarter of fiscal year 2020 were $3.5 million, compared with $7.1 million for the third quarter of fiscal year 2019. The decrease is largely attributable to the winding down of the Phase 3 AIM2CERV and Phase 1 ADXS-NEO studies as announced in June 2019 and October 2019, respectively.
General and administrative expenses for the three months ended July 31, 2020 were approximately $2.4 million compared to $3.1 million in the same three-month period in 2019. The decrease in expenses is mainly attributable to lower legal fees and business development costs.
As of July 31, 2020, the Company had approximately $23.8 million in cash and cash equivalents. The Company believes this is sufficient capital to fund its obligations, as they become due, in the ordinary course of business until July 2021.
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.
To learn more about Advaxis, visit www.advaxis.com and connect on Twitter, LinkedIn, Facebook and YouTube.
Look, the departure of Molly is a big tell of what's to follow. She knows this game is doomed, and the ship is going down. Could she have stayed here for another R/S and few more dilutions? Sure. But she might be trying to save her rear and decided to bail. Collecting her bloated paycheck for one more year is not worth it. After that, her professional career would have been done. Not sure if she has too many career opportunities left now after what she had to do here, but there are some doors still open for her. Maybe, she's not that stupid and had some pride left in her.
Best place to work in Knew Gerzee? I thought that was the award our proud Mareene got few years back. He also did a photo op in the Oval Room. He did lots of things to satisfy his ego. Nothing for the shareholders though. So, everyone saying about the best place to work has been throwing rocks at DOC.
BTW, the CFO is Molly and she is still she as far as I know.
one shoe dropped, waiting for the other to drop.
Or, is it a centipede?
Rats are abandoning the ship. Curious. Why?
Thanks for posting that link. Pretty sad...
On the other hand, does it really matter that the canine studies have turned out a failure, not just for ADXS investors, but for the quad-pedals.
ADXS has buried their LM platform long time ago, so this has a minimal to no impact on the current investors. Just shows how hundreds of millions OPM can disappear in a bio black hole that consists of deep pockets who pumped and shorted this POS for years and greedy, lying management that continues to profit from unsophisticated investors. What a flucking disaster...
Can anyone remind me what Lm stands for?
Lost money?
Last Marine?
Lawyer millionaire?
It's been such a tremendous ride and I'm having a Biden moment...