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Not sure what data you are referring to. Is it this:"ADXS-503: Phase 1/2 combination with KEYTRUDA updated clinical and immune/biomarker data for KEYTRUDA failures and initial readout in first-line patients"? Haven't been following this POS for some time...
Looks like this board is as dead as the company.
Just checked back the corporate presentation and same old, same old. The progress is moving at a snail's speed. What, are they dosing one patient per year? Unfreakingbelievable...
Was driving by 9 Deer Park Dr half an hour ago with a brick in my right hand, and could not find any window to thrown in that brick to stop the shareholders meeting. Got an impression that Suite K-1 is in the basement with no windows. KB knew I was coming and he was prepared!
Is JusticeNoEquality invited? Does anyone have her number?
Biosight? Biosite. Bioshite!
they are now officially bankrupt.
0.15 after the hours. What a clusterfluck...
Just kicked out of NASDAQ:
Advaxis, Inc.
Wed, December 22, 2021, 4:05 PM
In this article:
ADXS
-18.45%
MONMOUTH JUNCTION, N.J., Dec. 22, 2021 (GLOBE NEWSWIRE) -- Advaxis, Inc. (OTCQX: ADXS), a clinical-stage biotechnology company focused on the development and commercialization of immunotherapy products, today announced that the Company has satisfied the requirements for trading of the Company’s common stock on the OTCQX® Best Market (“OTCQX”) and will begin trading on OTCQX at the open of the market on December 23, 2021 under the symbol ADXS. The Company previously traded on Nasdaq.
OTCQX is the top tier of three markets organized by OTC Markets Group Inc. for trading over-the-counter securities, and is designed for established, investor-focused U.S. and international companies. To qualify for the OTCQX market, companies must meet high financial standards, follow best practice corporate governance, demonstrate compliance with U.S. securities laws, and be current with their disclosure. Investors can find current market information and real-time quotes for the Company on www.otcmarkets.com.
Mind blowing numbers...
Imagine if the merger had occurred, the BOD and other a$$holes would have gotten millions and millions of dollars. BTW, why the heell do we have 6 BOD members for a company of 20? Any reasons? Can they increase the number of directors to match the number of employees? Did Sidransky run out of his lackeys?
Merger Agreement
In the event of the closing of the Merger Agreement, the Company may be required under certain circumstances to pay the following:
? Board-approved employee bonuses totaling approximately $1 million
? In the event of involuntary termination, approximately $2.5 million in termination payments to Advaxis’ current executives
? A tail insurance policy with a premium of approximately $2 million
? Success fee to bankers of approximately $0.5 million
"ad
Interesting. Rememeber what happened when Ken Berlin "sold" Rosetta Genomics few years ago for a few shekels? Something "unexpected" also came up and RG had to file for a bankruptcy. The history tends to repeat itself -- first time as a tragedy, next time as a farce. Waiting for the ADXS skeletons to walk out of the closet en masse.
Even one is too many. I've known some who got either obliterated or their retirement timelines got pushed back by a decade or so.
I was not referring to the most recent spike and sell off. This is a stock that has ruined too many lives. Remember retail investors that used to frequent this board and yahoo message board prior finding a new home here? Batermere? Those who put ALL of their dollars in this POS stock? Where are they?
As anticipated, no news came out this morning and the sell off ensued. Down 10% on a big volume. Another groundhog day. What a nightmare...
The volume is almost 72MM shares with over an hour to go. The share price is up by 30%. No news that would warrant this jump. On the other hand, have we not seen this weird jumps before? Someone takes it up to then take it down a day or two later. Wash, rinse, repeat.
Since no PR came out before and/or after the presentation, I'm thinking that no new data was presented there. I'm not going to pay few thousand shekels to register for the conference. It's interesting that the PR about the presentation came out less than 24 hrs before the presentation. When you follow the link, you can see that there's no abstract of the presentation for Andres, and he's not listed among the speakers. I'm guessing he was asked to substitute one of the canceled presentations just last minute. Thus, no new news.
https://nsclc-drug-development.com/whats-on/online-agenda/day-two/
I was talking about the fate of ADXS-PSA program. The start of this Ph1 ADXS-HOT tells us it's not going anywhere.
This means MRK, a potential partner, decided to pass on the opportunity to get ADXS-PSA program. Not a shekel. ADXS-PSA will likely be shelved if not already.
Advaxis Announces Initiation of Phase 1 Clinical Trial of ADXS-504 for the Treatment of Early Prostate Cancer
Study in biochemically recurrent prostate cancer expands off-the-shelf ADXS-HOT program to second indication
MONMOUTH JUNCTION, N.J., July 15, 2021 (GLOBE NEWSWIRE) -- Advaxis, Inc. (Nasdaq: ADXS), a clinical-stage biotechnology company focused on the development and commercialization of immunotherapy products, today announced the initiation of its Phase 1 clinical study evaluating ADXS-504 in patients with biochemically recurrent prostate cancer. The study, being conducted at Columbia University Irving Medical Center, is the first clinical evaluation of ADXS-504, Advaxis’ off-the-shelf neoantigen immunotherapy drug candidate for early prostate cancer. Mark Stein, M.D., associate professor of medicine in the Division of Hematology/Oncology at Columbia University Vagelos College of Physicians and Surgeons, is the study’s principal investigator.
“Evaluating ADXS-504 in patients with biochemically recurrent prostate cancer is the first step in testing whether Lm-based immunotherapies may have a role in the adjuvant setting in cancer patients who have undergone radical therapy and who have no detectable primary tumor or metastatic disease at enrollment,” said Dr. Andres Gutierrez, Chief Medical Officer of Advaxis. “This Phase 1 study will evaluate the safety, tolerability, immunogenicity and clinical activity of ADXS-504 in men who have undergone radical prostatectomy or radiotherapy and whose prostate specific antigen (PSA) levels in the blood are rising, which we believe are ideal patients to evaluate with this approach. Moreover, we believe our multi-neoantigen vector has the potential to drive T cell responses against both hormone-sensitive and hormone-resistant cancer cells, which could result in disease control and may delay the start of androgen blockade therapy and its associated long-term complications. This study will also examine our lowest dose of an Lm-based immunotherapy to date, which could enhance the risk/benefit ratio that we have previously observed in our ADXS-HOT program.”
Kenneth A. Berlin, President and Chief Executive Officer of Advaxis stated, “We are pleased to be launching the first clinical evaluation of ADXS-504, expanding the reach of our off-the-shelf neoantigen immunotherapy program to a second potential indication. Our strong foundation of clinical data generated across both prostate cancer and non-small cell lung cancer suggest Lm-based immunotherapy may bring meaningful clinical benefit to patients and we look forward to continued momentum across the ADXS-HOT program.”
The Phase 1 open-label dose escalation study will evaluate the safety and tolerability of two dose levels (1e7 and 1e8 CFU) of ADXS-504 monotherapy, administered via infusion every four weeks for six total doses in 9-18 patients with biochemically recurrent prostate cancer (i.e., those with elevation of prostate-specific antigen (PSA) in the blood after radical prostatectomy or radical radiotherapy (external beam or brachytherapy) and who are not currently receiving androgen ablation therapy). The study will also evaluate preliminary clinical and immune responses following treatment with ADXS-504 monotherapy.
ADXS-504 is a novel Lm-based immunotherapy, bioengineered to elicit T cell responses against 24 tumor antigens that include 14 peptide antigens derived from frequently occurring and commonly shared hotspot mutations in patients with prostate cancer and 10 peptide antigens derived from sequence-optimized tumor-associated antigens (TAAs) that are differentially expressed or overexpressed in prostate cancer. ADXS-504 is designed to express multiple tumor antigen targets to which patients may generate a broad set of effector T cells for tumor control. Similar to Advaxis’s other Lm-based immunotherapies, ADXS-504 is expected to induce an innate immune response followed by the adaptive response and modification of the immunosuppressive tumor microenvironment (TME) by reducing regulatory T cells (Tregs) and myeloid-derived suppressor cell (MDSC) frequencies in the TME.
Presentation tomorrow. Not sure if any new data will be revealed.
PRINCETON, N.J., July 14, 2021 (GLOBE NEWSWIRE) -- Advaxis, Inc. (Nasdaq: ADXS), a clinical-stage biotechnology company focused on the development and commercialization of immunotherapy products, today announced that Andres Gutierrez, M.D., Executive Vice President and Chief Medical Officer of Advaxis, will present data from Part B of the Company’s Phase 1/2 study of ADXS-503 in combination with Pembrolizumab in patients with metastatic squamous or non-squamous non-small cell lung cancer at the virtual Non-Small Cell Lung Cancer Drug Development Summit on July 15th, 2021.
Presentation Title: Could Neoantigen Immunotherapies Reverse Resistance to PD-1 Inhibitors & Progression in NSCLC?
Session Title: Immunotherapy Strategy for NSCLC
Session Type: Virtual Presentation
Date and Time: 7/15/2021, 9:30 AM (EDT)
IR has not been of any help and non-responsive especially when it comes to touchy subjects.
In any case, that was a rhetorical question -- it's water under the bridge.
PS. I'm planning on using my ADXS shares in brokerage account for tax loss selling this year.
So, Iggy, are you still expecting to see Aim2Cerv results released this year? Next year?
PS. My answer is never, but what do I know...
@wmtgreeter
share price to infinity and higher?
This is Iggy:
Just noticed that our Danny boy resigned from ONCS about 10 days ago. Do you know why and what happened to him? Not following ONCS sheet, but wondering why Danny resigned quietly following his footsteps from ADXS. History repeats itself every 4 years?
Not sure about losses, but he'll get a piece of paper back.
No need for R/S, they just phukced us over ... Game over for us, but Kenny boy is still going to run the show.
The news this morning....
Advaxis and Biosight Announce Entry into Definitive Merger Agreement
ADXS
-1.19%
Advaxis, Inc.
Tue, July 6, 2021, 6:00 AM
ADXS
-1.19%
– Combined Company Will Operate as Biosight Therapeutics to Advance Pipeline of Clinical-Stage Oncology Programs with Lead Program Aspacytarabine (BST-236) in Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS)
– Combined Company Will be Well-Funded with Cash Position of approx.$50 Million Expected at Closing
– Multiple Clinical and Regulatory Pipeline Milestones Planned for Combined Company Over the Next 12-18 Months
– Companies to Host Joint Conference Call on Tuesday, July 6, 2021 at 8:30 am EDT
MONMOUTH JUNCTION, N.J. and AIRPORT CITY, Israel, July 06, 2021 (GLOBE NEWSWIRE) -- Advaxis, Inc. (“Advaxis”) (NASDAQ: ADXS) and Biosight Ltd. (“Biosight”), a privately held pharmaceutical development company developing innovative therapeutics for hematological malignancies and disorders, today announced that the companies have entered into a definitive merger agreement pursuant to which the shareholders of Biosight will become the majority holders of the combined company immediately following completion of the transaction. The proposed merger will create a public company that will prioritize the clinical advancement and commercialization of Biosight’s lead product, aspacytarabine (BST-236). The combined company is expected to have approximately $50 million in cash, cash equivalents and marketable securities at closing. Following the closing, which is expected to occur in the second half of 2021, Advaxis will be renamed Biosight Therapeutics and is expected to trade on the Nasdaq Capital Market under the ticker symbol “BSTX”.
The combined company plans to advance its pipeline through multiple clinical trials, and anticipates the following milestones over the next 12-18 months:
Topline results from the ongoing Phase 2 trial of aspacytarabine, which has completed enrolment, as first-line therapy in AML patients who are unfit for standard chemotherapy
Recent data presented at ASCO showed that aspacytarabine achieved complete remission (CR) rates of 39% across all evaluable patients (n=46) with 63% of cases with negative minimal residual disease (MRD(-)) and median overall survival (OS) of 10 months at present (95% CI, 6- NR). Altogether these results are encouraging considering the high risk factors in this population at baseline;
Results from the Phase 2 trial of aspacytarabine in collaboration with the European cooperative group, Groupe Francophone des Myélodysplasies (GFM) in patients with relapsed/refractory AML and higher-risk Myelodysplastic Syndrome (MDS);
Initiation in the U.S. of a second, Phase 2 trial of aspacytarabine in patients with relapsed/refractory AML and higher-risk MDS;
Results from the ongoing Phase 1/2 trial with ADXS-503 in combination with pembrolizumab in non-small cell lung cancer; and
Results from the Phase 1 trial of ADXS-504 in biochemically recurrent prostate cancer
“After an extensive and thorough review of strategic and potentially transformative options for Advaxis, we are very pleased to announce a proposed merger with Biosight,” said Kenneth A. Berlin, President, Chief Executive Officer and Interim Chief Financial Officer of Advaxis. “We believe the combined company’s strong and diversified oncology pipeline with late stage and early stage assets, near-term milestones, seasoned leadership team and focus on both hematological malignancies and solid tumors have the potential to provide transformative benefits to patients while also providing value to our stockholders.”
“The proposed merger with Advaxis is a unique opportunity for Biosight to build a leading public company in oncology, with a diversified clinical pipeline in both hematological malignancies and solid tumors. The combined company will have the demonstrated expertise and strong balance sheet to advance its lead programs towards multiple anticipated milestones over the next 12 to 18 months,” said Dr. Ruth Ben Yakar, CEO of Biosight. “I would like to express my deepest appreciation to the wonderful Biosight team, including Dr. Liat Flaishon and Dr. Shoshi Tessler who lead our R&D activities, and Dr. Stela Gengrinovitch, the founder of the company. The excellent work and dedication of the entire Biosight team enabled the significant achievements. I would also like to thank our Board of Directors and Shareholders for their support over the years.”
About the Proposed Merger
Pursuant to the merger agreement, Advaxis will acquire all of the outstanding share capital of Biosight in exchange for the issuance of newly issued shares of Advaxis common stock upon closing, subject to the satisfaction or waiver of customary closing conditions, including the receipt of the required approval of the Advaxis stockholders and Biosight stockholders and certain regulatory approvals. Upon completion of the merger, Advaxis’s then-current equity holders will own approximately 25% and the former Biosight equity holders will own approximately 75% percent of Advaxis’s common stock, calculated on a fully diluted basis.
The transaction has been unanimously approved by the board of directors of both companies. The combined company will be headquartered out of new facilities expected to be located in New Jersey and will continue to maintain its presence in Israel.
LifeSci Capital LLC acted as exclusive financial advisor to Advaxis. Morgan, Lewis & Bockius LLP and Herzog Fox & Neeman are serving as legal counsel to Advaxis. White & Case and Horn & Co. are serving as legal counsel to Biosight.
Management and Organization
Effective as of the closing of the transaction, Ken Berlin will be the President and Chief Executive Officer of the combined company. Senior leadership of the combined company will also include Roy Golan, as Chief Financial Officer, Andres Gutierrez, M.D., Ph.D., and Darrel Cohen, M.D., Ph.D. as Chief Medical Officers. Additionally, effective as of the closing of the merger, the Board of Directors of the combined company will be comprised of nine directors: six designated by Biosight and two to be designated by Advaxis, and Dr. David Sidransky will be nominated as Chairman of the Board.
Conference Call Details
Biosight and Advaxis will host a live conference call and webcast on Tuesday, July 6, 2021, at 8:30 am EDT to discuss the proposed transaction. To access the call, please dial 877-407-0784 (toll-free) or 201-689-8560 (international) and provide the conference ID 13721200.
To access the live webcasts and subsequent archived recordings of these and other company presentations, please visit the investor section of Advaxis's website at www.Advaxis.com or Biosight’s website at www.Biosight-pharma.com. The archived webcasts will remain available for replay on Advaxis’s and Biosight’s websites for 90 days.
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
About Biosight Ltd.
Biosight is a private Phase 2 clinical stage biotech company developing innovative therapeutics for hematological malignancies and disorders. Biosight’s lead product, aspacytarabine (BST-236), is an innovative proprietary anti-metabolite which addresses unmet medical needs by enabling high-dose chemotherapy with reduced systemic toxicity. Aspacytarabine is currently being investigated as a single agent in a Phase 2b clinical trial for the first-line treatment of AML. Interim results demonstrate tolerability with promising efficacy in the challenging population of AML patients unfit for intensive standard-of-care chemotherapy. Additional Phase 2 studies to be initiated in 2021 include a study in patients with relapsed/refractory AML and MDS, including a study in collaboration with the European cooperative group, Groupe Francophone des Myélodysplasies (GFM). For additional information, please visit www.biosight-pharma.com.
Non-Solicitation
This communication is for informational purposes only and does not constitute a recommendation, an offer to sell or solicitation of an offer to buy any securities, nor will there be any sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction.
Important Information and Where to Find It
This communication may be deemed to be solicitation material in respect of the proposed transaction between Advaxis and Biosight. In connection with the proposed transaction, Advaxis intends to file relevant materials regarding the transaction with the Securities and Exchange Commission (“SEC”) and otherwise provide such materials to its stockholders, including a registration statement on Form S-4 that will contain a proxy statement, prospectus and information statement. This communication is not a substitute for the proxy statement, prospectus, information statement or any other document that may be filed by Advaxis with the SEC. BEFORE MAKING ANY VOTING OR INVESTMENT DECISION, INVESTORS AND STOCKHOLDERS ARE URGED TO READ THESE MATERIALS CAREFULLY AND IN THEIR ENTIRETY WHEN THEY BECOME AVAILABLE AND ANY OTHER DOCUMENTS FILED WITH THE SEC IN CONNECTION WITH THE PROPOSED TRANSACTION OR INCORPORATED BY REFERENCE THEREIN BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT THE PROPOSED TRANSACTION. Stockholders may obtain, free of charge, copies of the definitive proxy statement and any other documents filed by Advaxis with the SEC in connection with the proposed transaction at the SEC's website (http://www.sec.gov) and at Advaxis’s website (www.Advaxis.com).
Participants in the Solicitation
Advaxis and its directors, executive officers and certain employees and other persons, and Biosight and its directors, executive officers and certain employees and other persons, may be deemed to be participants in the solicitation of proxies from Advaxis’s stockholders in connection with the proposed transaction. Information regarding the special interests of these directors and executive officers in the merger will be included in the proxy statement, prospectus and information statement referred to above. Additional information regarding the directors and executive officers of Advaxis and their security holdings is included in Advaxis’s Definitive Proxy Statement on Schedule 14A relating to the 2020 Annual Meeting of Stockholders, filed with the SEC on March 24, 2020. This document is available free of charge at the SEC website (www.sec.gov) or at Advaxis’s website(www.Advaxis.com). To the extent the security holdings by Advaxis’s directors and executive officers have changed since the amounts set forth in Advaxis’s Definitive Proxy Statement on Schedule 14A relating to the 2020 Annual Meeting of Stockholders, such changes have been or will be reflected on Statements of Change in Ownership on Form 4 filed with the SEC.
Cautionary Note on Forward-Looking Statements
Certain of the statements made in this press release are forward looking for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including those relating to the benefits of the merger, future management and the board of directors of the combined company, statements regarding the expected ownership in the combined company of the former Biosight securityholders and securityholders of Advaxis as of immediately prior to the Merger, Advaxis’s and Biosight’s respective businesses, the strategy of the combined company, future operations, advancement of its product candidates and product pipeline, clinical development of the combined company’s product candidates, including expectations regarding timing of initiation and results of clinical trials of the combined company, cash resources of the combined company following closing of the proposed transaction, the ability of Advaxis to remain listed on the Nasdaq Stock Market. In some cases, you can identify these statements by forward-looking words such as “may,” “will,” “continue,” “anticipate,” “intend,” “could,” “project,” “expect” or the negative or plural of these words or similar expressions. Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties that could cause actual results and events to differ materially from those anticipated, including, but not limited to, the risk that the proposed transaction may not be completed in a timely manner or at all, which may adversely affect Advaxis’s business and the price of the common stock of Advaxis; the failure of either party to satisfy any of the conditions to the consummation of the proposed transaction, including the adoption of the merger agreement by Advaxis’s stockholders and the receipt of certain governmental and regulatory approvals; uncertainties as to the timing of the consummation of the proposed transaction; the occurrence of any event, change or other circumstance that could give rise to the termination of the merger agreement; the effect of the announcement or pendency of the proposed transaction on Advaxis’s business relationships, operating results and business generally; risks that the proposed transaction disrupts current plans and operations and the potential difficulties in employee retention as a result of the proposed transaction; risks related to diverting management’s attention from Advaxis’s ongoing business operations; the outcome of any legal proceedings that may be instituted against Advaxis related to the merger agreement or the proposed transaction; unexpected costs, charges or expenses resulting from the proposed transaction; Advaxis’s history of net operating losses and uncertainty regarding its ability to achieve profitability; Advaxis’s ability to develop and commercialize product candidates; Advaxis’s ability to use and expand technology platforms to build a pipeline of product candidates; Advaxis’s ability to obtain and maintain regulatory approval of product candidates; Advaxis’s ability to operate in a competitive industry and compete successfully against competitors that have greater resources; Advaxis’s reliance on third parties; Advaxis’s ability to obtain and adequately protect intellectual property rights for product candidates; and the effects of COVID-19 on clinical programs and business operations. Advaxis discusses many of these risks in greater detail under the heading “Risk Factors” contained in its quarterly report on Form 10-Q for the quarter ended April 30, 2021, filed with the SEC on June 14, 2021, and its other filings with the SEC. Any forward-looking statements in this press release speak only as of the date of this press release. Neither Advaxis nor Biosight assumes any obligation to update forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.
Contacts:
Tim McCarthy, LifeSci Advisors, LLC
212.915.2564
tim@lifesciadvisors.com
Chuck Padala, LifeSci Advisors, LLC
646.627.8390
chuck@lifesciadvisors.com
It's been over 3 years since Kenny became a CEO of ADXS. Frankly, I can't believe he survived for so long, and I thought this company would have gone bankrupt a year or two years ago. He proved me wrong. Kenny is a survivor, much more survivor than DOC albeit both are scambags. The common denominator that enables this scam to go on is the BOD chairman -- Sidransky. Without him, Kenny would have been a toast long ago, and ADXS would have filed for Chapter 11. Instead, we witness how they continue raising cash via outrageous secondaries, warrants, and reverse splits. This may actually continue for a while, and likely it will. I don't see any way to stop this as our votes don't matter. There's no way SEC is going to care. It's all legal. C'est la vie.
This has been a pre-revenue biotech, and earnings are meaningless. I'd start with asking more relevant question -- where's a paying partner that wants to put a cash to support this shit show? Yes, we used to have one few years back, but AMGN decided to walk away after getting to know ADXS, its leadership and NEO program. No takers for HOT so far.
Thank you, hovacre! Your contribution is greatly appreciated! Hoping that you could post (even occasionally) here. Best wishes to you.
PS. Yes, the troubling thing here is the pace of the progress. The patient accrual, dosing is at extremely slow. To completely finish dosing Parts B and C patients in the efficacy phase for Phase 1/2 would take 3(!) more years and a year extra to see how the last dosed patients progress. Four more years means few more dilutions until a paying partner steps in. The legacy holders will be obliterated (as if they haven't been already).
from today PR:
ASCO PR:
https://finance.yahoo.com/news/advaxis-presents-updated-clinical-data-210100239.html
Advaxis Presents Updated Clinical Data from Ongoing Phase 1/2 Trial of ADXS-503 in NSCLC at the American Society of Clinical Oncology (ASCO) 2021 Annual Meeting
ADXS
+18.65%
Advaxis, Inc.
Wed, May 19, 2021, 5:01 PM
In this article:
ADXS
Advaxis
0.5758
+18.65%
Updated data show disease control rate of 44% with durable clinical benefit observed beyond one year in patients with disease progression on pembrolizumab
Translational data support potential of ADXS-503 to restore and/or enhance sensitivity to checkpoint inhibitors
PRINCETON, N.J., May 19, 2021 (GLOBE NEWSWIRE) -- Advaxis, Inc. (Nasdaq: ADXS), a clinical-stage biotechnology company focused on the development and commercialization of immunotherapy products today announced updated data from the Company’s ongoing Phase 1/2 study evaluating ADXS-503 in combination with KEYTRUDA® which will be presented as a poster at the American Society of Clinical Oncology (ASCO) 2021 Annual Meeting. ADXS-503 is the first drug construct from the 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.
“These early results, which include a disease control rate of 44% in the first 9 evaluable patients treated with ADXS-503 as an add on therapy at progression with pembrolizumab, are particularly encouraging given the durable nature of disease control in 3 patients,” said Suresh Ramalingam, M.D., Roberto C. Goizueta Chair for Cancer Research, Director, Division of Medical Oncology and Deputy Director of the Winship Cancer Institute at Emory University School of Medicine. “The translational results from the study provide interesting insights on the potential mechanism of action by which the addition of ADXS-503 may may be effective in this patient population.”
Ken Berlin, Chief Executive Officer of Advaxis, said, “We are encouraged by these updated results which continue to support the potential of ADXS-503 to enhance and/or restore sensitivity to checkpoint inhibitors. The clinical activity observed to date in this challenging patient population, combined with a favorable safety profile, suggest that ADXS-503 may be an important new off-the-shelf immunotherapy treatment option. We look forward to continued progress in the clinic with our ADXS-HOT products which includes the ongoing Phase 1/2 study of ADXS-503 in NSCLC, and the expansion of the program to our planned Phase 1 Study of ADXS-504 for the treatment of early prostate cancer.”
Key presentation highlights:
Highlights from the poster presentation titled, “A phase 1 study of an off-the-shelf, multi-neoantigen vector (ADXS-503) in patients with metastatic non-small-cell lung cancer (NSCLC) progressing on pembrolizumab as last therapy” presented by Missak Haigentz, M.D., Section Chief of Hematology and Oncology at Morristown Medical Center and Medical Director of Hematology and Oncology for Atlantic Health, and Study Investigator, include:
10 patients have been treated with ADXS-503 as an add on therapy to patients failing pembrolizumab as last therapy with 10 patients evaluable for safety and 9 patients evaluable for efficacy
Combination therapy was well tolerated with no DLTS or added toxicity of the two drugs. Grade 1 and 2, transient and reversible events included chills, fever, fatigue, in approximately half of the patients
The Disease Control Rate (DCR) was 44% (4/9)
Clinical benefit was durable, with an observed partial response (PR) and stable disease (SD) sustained for over a year, and another observed SD lasting over 6 months. An additional PR was maintained for approximately 4 months
Biomarker data demonstrate that patients who seem to achieve clinical benefit include those with PD-L1 expression ≥50%, secondary resistance disease to pembrolizumab and those who show proliferation and/or activation of NK and CD8+ T cells within the first weeks of therapy
Translational studies show:
Antitumoral T-cell responses elicited against hot-spot mutation antigens and/or tumor associated antigens (TAAs)
Emergence of naive CD8+ Tcell clones, suggesting reactivity against novel antigens
Induction of proliferation and/or activation of pre-existing CD8+ T-cell clones, including PD-1 upregulation
Enrollment in Part B of the ongoing study will continue to further evaluate the clinical benefit and immune effects of adding on ADXS-503 to patients progressing on pembrolizumab
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 18 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.
65MM shares traded within 1 hour, that's 50% of the float.
it's not unexpected. This has been happening is cycles -- pump up the stock, rump up expectations, and then a nothing burger followed by a secondary and/or reverse split and stock tanks. Why do you think this time is different? I expect this to follow the old script. Sell if you have some shares/traders when the stock reaches a proximity of a buck.
I'm also puzzled why the Sun keeps rising from the East. Why so predictable?
BEC CEO is in a solitary. Should be released on parole soon. Hold that mail.
You're underestimating the capacity of the ADXS cash-burning crematory furnace. Kenny, as a funeral director, has been using his well run paper-bill operated furnace 24/7, and has gone through $320MM over the years. Give also some credit to a former marine -- Danny Boy!
As you know, the Part B (combo at DL1) data were presented this month at AACR. Do you think the data matured enough for ASCO? I think they are going to show almost the same data, but the hope is they could show the data for more patients as they state 6 patients are "evaluable" out of 9 dosed. Will the data show more responses? Let's see. But I'm really waiting for the data from DL2 (5e-8 CFU). Those are yet to be dosed.
even greater news after the close! We're getting $1M! Enough to pay KB's 2021 bonus and few shekels for Sideratskiy.