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EXP is a graduate from The University of Wall Street and serves as the CEO / Chief Stock Strategist at EXPstocktrader.com research firm. With over 30 years of trading the market, EXP is an experienced investor using a fundamental and technical approach as a market analyst, chartist, visual... More
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  • A Few Stocks To Accumulate

    Here are a few stocks to accumulate on the biotech turbulence that is occurring.

    Sorrento Therapeutics (NASDAQ:SRNE) - I like this company's collaboration with NantWorks the brainchild of Dr. Patrick Soon-Shiong the inventor of Abraxane. Remember that on March 16, Sorrento announced a $110 million collaboration agreement with NantCell, a subsidiary of NantWorks, to develop anti-cancer immunotherapies. This is the company's second agreement with NantWorks in three months. Under the new agreement, Sorrento could license a number of immune-checkpoint antibodies, immuno-oncology antibodies, antibody-drug conjugates, and CAR-TNK products.

    Sorrento is also involved with Conkwest. Conkwest is focused on developing CAR-TNK cancer therapies (Natural Killer Cells). This could get exciting and we await further details of the Conkwest IPO that should happen in 2015.

    BioTime (NYSEMKT:BTX) - A pioneer in regenerative medicine has multiple projects that they have been working on for years. This stock is still relatively undiscovered, but seems to be starting to gain some attention with investors lately. I have this company as a Top pick for 2015. I believe that patient investors will be rewarded.

    BioTime is aware that it needs to Balance the short term projects as it looks out to its longer term stem cell initiatives. As a stem cell leader, it is developing a plethora of stem cell and other biomedical products for the advancement of its proprietary technology, research, therapeutics, mHealth and diagnostic expertise through its multiple subsidiaries worldwide:

    BioTime Subsidiary

    Business

    % Ownership

    Country

    Asterias Biotherapeutics (click)

    Stem Cells

    71.60%

    USA

    BioTime Asia (No link)

    Stem Cells for Research

    81%

    Hong Kong

    Cell Cure Neurosciences (click)

    Cancer Diagnostics

    62.50%

    Israel

    ESI BIO (click)

    Stem Cell Products

    100%

    Singapore

    LifeMap Sciences (click)

    Genetic, Disease,

    73.20%

    USA

    Stem Cell Databases

    LifeMap Solutions (click)

    Mobile Health

    Owned by LifeMap Sciences

    USA

    OncoCyte (click)

    Cancer Diagnostics

    75.30%

    USA

    OrthoCyte (click)

    Orthopedic Diseases

    100%

     

    ReCyte Therapeutics (click)

    Vascular Disorders

    94.80%

    USA

    Source: BioTime 10Q

    Karyopharm Therapeutics (NASDAQ:KPTI) - There is significant news flow expected for the coming year from the company's pipeline regarding its Selinexor therapies. It has a potential initiation in 1Q15 as a single-agent in a directed trial in multiple myeloma, and then numerous PII combination treatments to follow. Most analyst targets are in the $50's for KPTI. Positive news will be needed.

    ZIOPHARM (NASDAQ:ZIOP) - A biopharmaceutical company currently in developmental stage that seeks to acquire, develop and commercialize, on its own or with commercial partners, a diverse portfolio of cancer therapies. ZIOP has a Sleeping Beauty agent. ZIOPHARM's technology platform employs Intrexon Corporations (NYSE:XON) RheoSwitch® system that is uniquely positioned as the first clinically-evaluated gene switch with in vivo data showing the ability to control gene expression with a broad dynamic range.

    The RheoSwitch® platform further provides a mechanism for titrating therapeutic effects on a patient-­specific and predictable basis, as well as a safety switch to rapidly turn off gene-­expression. Importantly, the ability to administer or withdraw veledimex to sustain continued treatment cycles is a key benefit of such a switch technology. (Source: dna.com)

    Mar 25 11:32 AM | Link | 1 Comment
  • Cynviloq: The Next Gen Paclitaxel

    Sorrento Therapeutics (NASDAQ:SRNE) is an oncology company developing new treatments for cancer and associated pain. Sorrento's most advanced asset Cynviloq is focused on the next-generation nanoparticle "paclitaxel," (trade name Abraxane) a drug marketed by Celgene Corporation to treat a number of types of cancer including; ovarian cancer, breast cancer, lung cancer and pancreatic cancer among others.

    News: On Jan. 12, 2015 -- Sorrento Therapeutics, an oncology company developing new treatments for cancer and associated pain, announced today that over 80 patients randomized in the ongoing TRIBECA™ (TRIal establishing bioequivalence [BE] between Cynviloq™ and Albumin-bound paclitaxel*) registrational trial have been dosed. Sorrento intends to continue enrolling all qualified patients in the current screening process and anticipates having the "last patient in" by the end of January. Patients were recruited globally from over 20 sites in USA, Eastern Europe, and Asia. The initial safety assessment from treated patients revealed no unexpected adverse events and the data is consistent with the toxicity profile reported in the literature with albumin-bound paclitaxel.

    Previously, Sorrento announced positive pharmacokinetic (PK) data from the first eight (8) patients enrolled in the TRIBECA study. Based on the reported positive data, sample size estimates suggest that only 53 patients are needed to meet regulatory guidelines for bioequivalence.

    Henry Ji, Ph.D., President and Chief Executive Officer of Sorrento stated; "We are pleased with the imminent completion of the TRIBECA study." Additionally, "Our plan is to continue to enroll patients until the end of January to have a robust safety database of patients treated with Cynviloq (paclitaxel nanoparticle polymeric micelle) at 260 mg/m2 infused over 30-minutes. The completion of patient enrollment in January will allow us to make topline pharmacokinetic results available in March, and facilitate the planned NDA submission to the FDA seeking marketing approval for Cynviloq."

    On March 16 -- Sorrento announced a $110 million collaboration agreement with NantCell, a subsidiary of NantWorks, to develop anti-cancer immunotherapies. NantWorks is the brainchild of one the most successful and "visionary" doctors in cancer research today, Dr. Patrick Soon-Shiong a scientist, inventor, entrepreneur and health care visionary, who is dedicating his life to disrupt, revolutionize and beat cancer.

    Note: Cynviloq bioequivalence [BE] news can come at almost any time. The inherent risk is noted in a few statistical observation points that are distant from other observations; however the probability of success seems to outweigh any negatives per my due diligence. More research should be coming in the next few days/weeks/months.

    Some DD: Sorrento's Presentations:

    sorrentotherapeutics.com/investors/event.../

    (click to enlarge)

    SRNE1

    --------------

    (click to enlarge)

    SRNE2

    ----------------

    Disclosures:
    Abraxane® (paclitaxel albumin-bound particles for injectable suspension) (albumin-bound), registered trademark of and marketed by Celgene Corp.
    Cynviloq, G-MAB, CAR.TNK, Chimeric Antigen Receptor Tumor-attacking Neukoplast and TNK are trademarks owned by Sorrento Therapeutics, Inc.

    Mar 22 10:47 PM | Link | Comment!
  • Idera Pharmaceuticals' Proof Of Concept Goal Was Met

    If you have been following Idera Pharmaceuticals (NASDAQ:IDRA), which I wrote about in my prior article here, you will see that they have been ramping up as one of the most cutting edge companies in the field of discovery and development of novel synthetic DNA- and RNA- based drug candidates which I believe could radically change gene therapies in medicine today.

    Lets Stay Focused On The Goals:

    The primary objective of the latest trial was to evaluate the "safety and tolerability" of its lead antagonist IMO-8400 over a 12-week treatment period, with a secondary objective to evaluate the "clinical activity" of IMO-8400.

    In the news that was released on March 28, 2014, the company announced that its randomized, double-blind, placebo controlled Phase 2 trial of IMO-8400 in 32 patients with moderate-to-severe plaque psoriasis resulted in "positive top-line data." Quite simply, this translates into meaning that they met both safety and tolerability at all dose levels. This particular low-dose IMO-8400 treatment was "safe."

    About the Phase 2 Trial

    As explained by the company in its press releases: This Phase 2 trial was a randomized, double-blind, placebo-controlled trial, in which the Company enrolled 32 patients with moderate-to-severe plaque psoriasis, with a minimum PASI score of 12 or above. All patients were withdrawn from prior therapies with an appropriate wash-out period, and were randomized equally to receive subcutaneous IMO-8400 monotherapy at dose levels of 0.075 mg/kg, 0.15 mg/kg and 0.3 mg/kg or placebo, weekly for 12 weeks, with a six-week follow-up period. The primary objective of the trial was to evaluate the safety and tolerability of IMO-8400. A secondary objective of the trial was to evaluate the clinical activity of IMO-8400 as assessed using standard clinical metrics, including Psoriasis Area and Severity Index (PASI) scores.

    Remember that this trial was only 12 weeks, not a full year:

    While the cohorts (groups) only lasted 12 short weeks, the trial was able to successfully meet a secondary objective of demonstrating clinical activity based on PASI scores. In layman's terms, a PASI score is a tool used to measure the severity and extent of psoriasis (Psoriasis Area and Severity Index).

    Furthermore, the company stated that among patients who completed 3 months of treatment per protocol, PASI 50 was achieved in nine (45%) of 20 who received IMO-8400 at any dose level, and in one (14%) of seven who received placebo. PASI 75 was achieved in four (20%) of IMO-8400 treated patients at any dose level, and in zero placebo patients. PASI 50 and PASI 75 are defined as 50% and 75% improvement, respectively, compared to baseline PASI.

    The Two Platforms Can Now Advance

    Specifically, Idera Pharmaceuticals is working towards two very unique platforms. One is focusing in on autoimuune diseases (in which there are many) and the other is a novel approach in the treatment of certain genetically defined forms of B-cell lymphoma. So, the very astute scientific team at Idera is very strategically working on developing two key drug discovery platforms based on nucleic acid therapeutics:

    1. Toll-like Receptor (NYSEMKT:TLR) antagonists
    2. Gene Silencing Oligonucleotides (GSOs)

    I strongly believe that this company is still pretty much under the radar. Also, as stated in my article in March, if Idera could show positive "proof of concept" (which it just did) in psoriasis, and it's treatment can show "clinical activity" then it would only make sound business sense to go after many more serious unmet indications including, but not limited to, lymphomas, lupus and other various autoimmune diseases.

    Now For The Disconnect:

    On March 24, 2014 only a few days prior to the announcement of the Idera P2 trial, Celgene (NASDAQ:CELG) announced that the U.S. Food and Drug Administration (FDA) has approved OTEZLA® (apremilast), the Company's oral, selective inhibitor of phosphodiesterase 4 (PDE4), for the treatment of adult patients with active "psoriatic arthritis." While I do believe that the approval of this "pill" is great news for Celgene, this is not and was not the intended goal that Idera was striving for in its IMO-8400 trial. According to my research, Idera has never intended to go into this already crowded space (but has stated in its webcasts and news releases that they could partner this out).

    Given these recent announcements, I do believe that investors sold on this news which I believe is unwarranted, hence the disconnect. Maybe investors aren't looking deep enough into the real translation of the data to see that we are actually are on the cusp of something very remarkable. The positive Top-Line data seems to be clearly overlooked, misunderstood and misrepresented by the individual investor. In simple terms, the current stock evaluation of $4.10 (in my sincere opinion) is not representative of what is lurking under the hood. Investors might think we have a 6 cylinder engine, but as far as I can interpret the data, it seems as though we just might have a 427 big block hemi. I could be wrong, but I don't believe that I am and I will be anxiously waiting for more data from the "higher dose" cohorts to be announced soon enough.

    These Are My Thoughts At The Present Time:

    First, as shown in this biotech ETF chart below, symbol IBB (NASDAQ:IBB) which I have been mentioning to investors from the $90's a few years back, you will see that even the largest biotech investments may be in a brief correction phase. With good news or bad news sometimes it doesn't even matter when the "powers to be" are selling off. At this juncture, we just need to dust ourselves off and get ready for the next bull run. Is this correction bad? No, actually not at all. On the contrary, its quite healthy to have these brief pullbacks from time-to-time as we trend higher in the current economic recovery process. I'm calling the recovery a process, because the global rebound that started a few years ago isn't a one time event, but rather a "process" of upward and downward waves in stock valuations. These waves are not entirely in our control week after week or month to month. Preferably, we would like to see higher highs and higher lows. Remember that at the present time, the U.S. economy is still only advancing from a modest 2%-2.5% growth rate, but at least we are moving in the right direction, and that is up.

    (click to enlarge)

    Moving Forward:

    Despite getting caught up in the recent biotech correction in the past few weeks (as seen in the chart above) I still very firmly believe (as a biotech investor) that DNA- and RNA- therapies are the place to be as these novel types of medical advancements make significant progress. Advancements in science take time and a great deal of patience. So far, it has taken takes many years to get us to where we stand today; decades.

    The company has developed first, second and now third generation science (at Idera's labs) which is taking place right now. Hiccup's do occur in science and there is no question that it has been a long haul for the many dedicated scientists and lab technicians. These are the folks who have been working month after month to discover and develop novel synthetic DNA- and RNA- based drug candidates standing right before our very eyes. Yes, without question, these are exciting times. Some of us just don't realize how lucky we are to stand witness to these new breakthrough discoveries.

    I truly believe that we are at the forefront of controlling the behavior of DNA and proteins. Imagine a company who has the technology to target specific molecules that could either increase or decrease their activity or even silence bad genes causing cancers or diseases to patients around the world. What kind of value would this be worth?

    This question that I pose is exactly why I believe that Idera Pharmaceuticals has amassed what I would call the elite team of biotech leaders and investment bankers over the past several quarters. What I am referring to is Idera's highly gifted management team, it's board, leadership, and two main investment banking firms; Pillar Invest Corp. and Baker Brothers Advisors. See the company news releases for more information if you need to get up to speed here.

    (click to enlarge)idra

    Future Catalysts:

    Idera Pharmaceuticals clinical development for IMO-8400 is focused on B-cell lymphomas harboring the MYD88 L265P mutation, and on orphan autoimmune disease indications this could be a very big deal as the company maintains its focus in the area for in 2014. Expect further updates on its IMO-8400 trials for Waldenstroms toll-like receptor antagonists and more details about its - gene silencing oligonucleotides (GSO) program.

    Also, on March 27, 2014 PiperJaffray stated that Idera Pharmaceuticals' weakness appeared to be overdone and they maintain a PT of $7.00. This would be a respectable percentage move from where it sits today.

    Note: PiperJaffray has been very successful in its coverage of this company quarter after quarter, as well as with many other successful companies in the biotech industry such as JAZZ, Vanada, ACADIA and others. Cowen & Co has provided excellent coverage too.

    Disclosure: I am long IDRA.

    I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it. I have no business relationship with any company whose stock is mentioned in this article.

    Tags: IDRA
    Apr 01 10:33 AM | Link | 10 Comments
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