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  • Advaxis, Inc. (ADXS) Is “One To Watch” 5 comments
    Oct 15, 2012 5:29 PM | about stocks: ADXS

    Advaxis is currently advancing three primary candidates through clinical trials for the treatment of various cancers, with over 15 key immunotherapies in various stages of development. The company utilizes a technology platform based on the power of an attenuated live Listeria vaccine (under license from partner/collaborator, the University of Pennsylvania) to jump-start natural immune system functionality using a secreted antigen that is tumor-specific. This is a sweeping method of action that allows the company's tech platform to potentially strike far and wide across the entire oncology spectrum because of how it re-wires the body's own immune response, allowing the individual's immune system to correctly identify and attack cancer cells via the highly-targeted antigen mechanism.

    We are talking live, bioengineered Listeria monocytogenes as a framework for encoding a fusion protein sequence that includes a piece of the Lm-LLO (listeriolysin O) molecule. The bacteria and the body's own powerful immune response to it are used as a vector for leveling the tumor's defense mechanisms, while strongly promoting the innate and adaptive arms of the immune system via the secreted antigen/adjuvant fusion protein. Shutting down T-regulatory cell and immature dendritic cell mechanisms (Treg and MDSC), both vital for tumor defense, while supercharging the background innate/adaptive arms of the immune system, is a wining approach that has already shown empirical fruits through clinical and preclinical testing.

    This kind of buckshot approach using the body's response to strains of Listeria is ingenious to say the least and it is also one main reason why ADXS has been invited to present two key abstracts on some of their most compelling R&D at the upcoming 27th Annual Meeting (October 26-28) of the Society for Immunotherapy of Cancer (SITC). One abstract will include the company's most recent Phase II clinical data (110 patients, India) on this revolutionary Lm-LLO immunotherapy technology's use in treating recurrent/refractory and advanced cervical cancer via targeting the HPV E7 gene (Human Papilloma Virus-related expression of the gene is a primary, identified catalyst for malignancy, dysplasia, and/or other abnormal cell growth). The other abstract to be presented will look at the company's preclinical development work using a novel strain of Listeria for a bivalent Lm-LLO immunotherapy delivering a dual, antigen-adjuvant fusion protein punch (one for the tumor, one for the tumor's blood supply - angiogenesis) via a single bacterial vector.

    This is great coverage for the company's leading ADXS-HPV piepline, which also includes Phase II work in the U.S. on Cervical Intraepithelial Neoplasia (Grade 2/3, CIN or Cervical Dysplasia, 120 patients) using a vaccine called Lovaxin C that shows real promise for preventing cervical cancer from occurring; work on locally advanced cervical cancer with GOG here in the U.S. (National Cancer Institute Gynecologic Oncology Group, 67 patients); as well as work in the UK (27 patients) on HPV-associated head and neck cancers. This research firmly reinforces the technology's other traction through preclinical work in prostate cancer (ADXS-PSA) targeting the PDA antigen, as well as in canine osteosarcoma of large breed dogs (ADXS-HER2) currently in Phase I veterinary trials and targeting HER2 over-expressing cells, which is being carried out at ADXS partner, the University of Pennsylvania's School of Veterinary Medicine.

    The company's development pipeline takes advantage of the tech design marvelously, using both LLO-fused triggering directly inside antigen presenting cells and general inhibition of Treg/MDSC cells in target tumors to circumvent cancer formation and lifecycles. HER2 (human epidermal growth factor receptor 2) also shows broad over-expression in breast/brain, bladder, gastric, ovarian, and pancreatic cancers. This conceptually offers a route whereby ADXS-HER2 could be used to eliminate respective HER2 positive cancer cells (especially those exhibiting/promoting cellular immunity and resistance to treatment), also helping to find and eliminate potential metastases in the brain's of breast cancer patients, while preventing the development of resistance that can occur with antibody treatment.

    No one needs to see the metrics on cancer anymore. The clinical pipeline ADXS is advancing could help countless people across the world, and the company has fully engaged a robust array of important partners in the oncology field to help speed things along, including the National Cancer Institute Gynecologic Oncology Group (ADXS-HPV multi-center Phase 2 clinical trials), Cancer Research UK (ADXS-HPV) and the Albert Einstein College of Medicine and Montefiore Medical Center (ADXS-PSA). With the leading ADXS-HPV candidate in four Phase II clinical trials and having received the Best Therapeutic Vaccine (approved/in development) award in April this year at the 5th Annual Vaccine Industry Excellence Awards (hosted by the industry and by the Expert Reviews of Vaccines journal, sponsored by Novartis Vaccines and Diagnostics), Advaxis has the kind of forward momentum needed to break out with some impressive shareholder returns in coming years. The warm reception by both media and industry should prove very useful as the company moves towards commercialization of the technology.

    Thus far clinical data has shown the pipeline to be very safe, with transient, non-cumulative flu-like symptoms and good survival benefit response from tumors, both standalone and in conjunction with cytotoxic therapy. Preclinical evidence shows reduced immune suppression capability in tumors, a seriously pumped up immune stimulus/response, and what looks to be effectively a more complete and robust therapeutic solution, precisely as predicted. Advaxis has some 80 and growing patents worldwide covering their huge IP portfolio, nailing down everything from composition of matter, to methods, and usage.

    For more information on Advaxis, Inc., investors are encouraged to visit the company's website at: Advaxis.com

    Please see disclaimer on the QualityStocks website: disclaimer.qualitystocks.net

    Stocks: ADXS
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  • Advaxis is a slow moving coach. While there are a LOT of POSITIVES ranging from safety, efficacy in trials so far, potential, cost to produce the vaccine, ease to store, patents, pipeline, institutions involved, etc. there are some REAL NEGATIVES that can harm the investors. Positives are already highlighted in the article and they are indeed very encouraging. They have many trials - some even sponsored by institutes at almost zero cost to the company. All this is good. But every company needs a strong management that pushes hard, keeps investors in good faith while making good but hard choices. We know that many companies fail due to bad management more than anything else. What makes it bad for current investors is that there are companies out there that have a less than stellar or one drug pipeline, single trial in phase II etc. and yet have the pps that is at least 5X than that of ADXS. The company is practically running out of money. The progress is slow - at times too slow to be any good.. For example, they initiated the Canine Osteosarcoma trial during Sept./Oct. last year in 2011 with the goal of enrolling 18 dogs, even as the PR suggested something to the effect that the first dog has been enrolled/entered the trial ( please feel free to correct me if I am wrong). A year later, in 2012 we hear that the first 2 to 3 dogs have been enrolled and given vaccines. By the time they have all the dogs in the trial, watch/monitor their progress for a year and get the results, we may be looking at late fall 2013. Speaks of either lackadaisical management or trying to get too many things done and losing focus along the way either due to lack of funds or other contingencies. ( whatever happened to the supposed deal with Homeland Security concerning vaccine for livestock - I bet no one knows or has heard anything, either positive or negative from the company). Management has done deals in the past with loan sharks that have decimated the price per share. I am not going into the details as you can read some of the SEC filings to know all about it. I am not sure if the current CEO is the right man for the job. He may be the one that needs to get the boot if the company has to do well. With the company having plans to start the prostate cancer Phase I trials later during the year and then get into breast cancer Phase I trials some time next year, ( this as per management) I am not sure if they have enough money to pay for those trials, let alone pay and sustain existing trials that are on going - the India trial for Cervical cancer that is winding down and the CIN Medium Dose trial (also almost done) that will be followed by the High Dose trial next year. In addition, salaries and other operating expenses are going to force management to raise more capital. With the stock price at .06 am not sure how current longs in the stock can digest another round of dilution. The fact that management has another 500 million shares authorized and sitting ready for disposal makes it only a matter of when and not if management will dilute in any form or mode.

     

    While everyone has high hopes(including me) on the India trial ( the next update of results will probably be in Oct.26-28, and I do not expect it to move the pps by much even if there is an improvement - rather would wait for the update some time next year to make more sense from both a clinical and statistical view point - remember that we are talking of immunotherapies - they are slow and take time to bear meaningful results) and the CIN medium dose trials (results to be available early next year - Feb 2013?) any serious investor has to ask himself if he needs to wait for the results/dilution and see if there is a potential for any partnership or licensing, or take the plunge now with so many issues with management and meaningful results (that will move the needle in a positive way) still another few months away.

     

    The science has the potential and the proof of concept is that much closer to reality. I have high hopes that there is light at the end of the tunnel. Question is how can management pull itself up from the big and deep hole that they have dug themselves in and take the company where it truly belongs - beyond the tunnel into the real world where it can make life a lot better for those suffering from various diseases ( yeah that is right - the potential of the science) and keeping investors happy. The next 8-12 months will reveal the truth.
    16 Oct 2012, 05:42 PM Reply Like
  • All valid points. I think Tom Moore should consider reducing his 375k salary and instead work for less, at least until he either secures a partnership and or license agreement, or until positive PII trial results. I've been watching and waiting, as a shareholder and follower for three years and so far have not been impressed with management. This is mainly due to lack of partnership, share dilution, and poor PR or lack of PR. Maybe its not the science as much as it is the management that is holding back ADVAXIS. If the company reveals positive PII updates Oct 26-28 and the price per share remains lower, then I'd have to say it's more management problem than science problem.
    17 Oct 2012, 11:01 PM Reply Like
  • We know the a/s is now 1billion shares so evn if they get to that number in the o/s, at .05, that is only a market cap of $50million. If this stuff works, there's no reason to think that this couldn't trade at a mc of $200-300million on proof of concept.....which would be a sweet 4-5 bagger. Looks bad now from the pps and financials, but this is the time to buy your straw hats. JMHO.
    18 Oct 2012, 04:12 PM Reply Like
  • Mrwnc:

     

    As I have mentioned,I do not have any misgivings about the science. As one would say, - so far so good and seems to me that it is heading towards success. I have no doubt that should the science behind the vaccine work ( and let us hope it does) then with time, a 10 or even a 20 bagger would look inadequate, especially with their pipeline and constructs.

     

    The big big question is if they are going to make a private placement of shares if/when the pps hovering at .05-.06, no investor would touch this unless they have a 20% to 25% discount. I know that many people think that the future dilution is already priced in the current pps. But there is absolutely no way of knowing that. Reality is that the very same investors who believe that the current pps reflects future dilution, will go hammer and tongs should there be a dilution and pps tanks another 20% to 25%. Of course, if the pps stays where it is now, then that would be nice.If they were to offer shares at a discount to the private investors say, for 250 million shares in total, that would yield $10 to $12 million - enough to last them for another year, so as to buy time for meaningful results from India trials and CIN trials and hopefully attract partnerships. If there is any dilution before a partnership is announced, then we all know what wall street does best - when there are nasty surprises ( and as in life, there are many of those compared to pleasant surprises) it can really be hurtful and pps may hit sub.05 or even high .03s and there is nothing anyone can do about it, other than cursing the company or their own luck and ill timing.

     

    I have a very good feeling that ultimately the science will triumph, but also am apprehensive that the horrors of dilution will play one more time.
    22 Oct 2012, 09:31 AM Reply Like
  • Raja...can't argue against you. But even if the pps goes to 2-3 cents via a pp or whatever, I can only say, "don't look a gift horse in the mouth." I concur with your enthusiasm on the science. At this stage, the pps can easily drop 30-50% or it could go up the same. We can only regret our poor timing having gotten in at much higher prices, but hopefully "the spring is being compressed."
    26 Oct 2012, 08:33 AM Reply Like
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