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Expert Financial Analysis and Reporting

ImmunoCellular Therapeutics Trading Opportunity (IMUC, Not rated, $1.19, Paid Subscribers)

ImmunoCellular Therapeutics just announced that an abstract describing the phase II trial of its dendritic cell-based cancer vaccine ICT-107 in newly diagnosed glioblastoma (GBM) has been accepted for an oral presentation at the 2014 American Society for Clinical Oncology (ASCO) annual meeting, to be held in Chicago May 30-June 3, 2014.  I believe that this creates a trading opportunity in IMUC and could have a positive carry over to the stock of Northwest Biotherapeutics (NWBO).

The abstract is titled, "A randomized, double-blind, placebo-controlled phase 2 trial of dendritic cell (DC) vaccination with ICT-107 in newly diagnosed glioblastoma (GBM) patients." The principal investigator on the study, Patrick Y. Wen, MD, Director, Center for Neuro-Oncology, Dana Farber Cancer Institute, and Professor Neurology, Harvard Medical School, will present during the session titled, Central Nervous System Tumors, on Sunday, June 1st at 8:00-11:00 am CT. Dr. Wen's presentation is scheduled for 10:00-10:12 am CT. The abstract number is 2005.

Being selected for an oral presentation is an indication that the organizers of the meeting feel that these results have important scientific information as only a small percentage of submitted abstracts are accepted for a prestigious oral presentation. IMUC said that it will present updated overall survival results for both the whole trial population and key predefined sub-groups, as well as important immunological analyses that can provide insights relative to vaccine potency and response. This larger and richer data set will be the basis for designing its phase III design and execution strategies.

After the phase 2 results were reported, ICT-107 was written off as dead. I think that this news on an oral presentation at ASCO is totally unexpected and could trigger a trading rally in the stock. I am not a trader, but for those who do like to trade, I think this is an opportunity. There could be and probably is some significantly positive new information in this abstract.

ICT-107 has a long four to five year development period ahead before it could complete a phase 3 trial and if successful gain commercial approval. However, if this trial and the trials that Northwest Biotherapeutics (NWBO) is doing with DCVax-L and DCVax-Direct arouse interest in dendritic cell cancer vaccines, as I believe may be the case, the leadership of both companies in this technology platform could lead to shareholder enhancing collaborations or an outright takeover.

So what might the trading upside pric be? There are no rules or valuation measure that we can apply, Setting an upside is essentially intuitive. My judgement is that based on the magnitude of the surprise that the upside could be significant, perhaps on the order of $2.00 to $3.00, but it is hard for me to lay out a logical algorthrim that supports this estimate. In the end, it is feel and intuition.

Tagged as , , + Categorized as Smith On Stocks Blog


  1. I think ICT-107 will reach statistical significance regarding overall survival before the end of the year. Am I the only one who thinks biotech has a plethora of phoenixes that can rise from the ashes? As you, Mr. Smith, determined some time ago; IMUC did not set up a proper trial design for phase 2. Still it will succeed, after the fact, in the next 6 months. I think you knew this would happen as well. Now they are considering “PFS” for a phase 3 primary endpoint.

    IMUC’s science is old school subgroup targeting. Nonetheless, hybrids like this might be able to fill the rare holes that NWBO’s broad spectrum falls slightly short of treating.

    With large pharmaceuticals looking to leap-frog back into competition by taking over immunotherapy startups; currently, there is no better “best in show” than IMUC.

    (I have not nor plan to invest in IMUC. I still like their future prospects)

  2. I would prefer that you call me Larry.

    Perhaps the most striking feature of immunotherapy is that some patients experience extremely durable results. I believe in the case of Yervoy that about 15% of metastatic melanoma patients experienced very long survival and despite its dreadful side effects, the drug was approved and is doing over $1 billion in sales.We certainly saw the same phenomenon with both ICT-107 and DCVax-L in phase 1 trials showing over 55% of patients surviving beyond three years. This was what attracted me to both companies.We may see some durable survival data for some patients treated with ICT-107 at ASCO..

    Based on theoretical biology, I feel that using tumor lysate to load dendritic cells as used by DCVax-L is superior to pre-selecting six antigens common to glioblastoma as used by ICT-107. However, I have learned that theoretical biology is not precise like theoretical physics. We really need to see the data and so far the phase 1 data suggests comparability of the two drugs.

    The problem that ICT-107 encountered was that the prior management mis-characterized the trial as a pivotal study and set the expectation that the drug could be approved off the results. With more reasonable guidance, the initial results would have been seen as encouraging and the more complete results as shown at ASCO might (still might) be seen as proof of concept.

    Anyway, since I first began to study the role of the dendritic cell in acquired immunity, it seemed to me to have enormous potential in treating cancer and infectious disease. This is why I am so persistent with my NWBO recommendation.

    Flipper, thanks as always to improving the initial blog that I put up.

  3. Robert Dorney says:

    It seems to me the NWBO vaccine is intended to address a specific patient’s existing cancer. The IMUC vaccine approach, if successful, could implement a general immunization against undiagnosed cancers. This would be similar to the widespread use of seasonal flu vaccines, or vaccines for childhood diseases. Is this a plausible goal for IMUC?

  4. The IMUC vaccine ICT-107 and DCVax-L are a product specifically made for each patient. The difference is this. Cancer cells have certain molecules or antigens on their surfaces which mark them as being foreign. The body’s adaptive immune system can recognize these antigens as foreign substances and initiate an immune response with antibodies and T cells to eradicate cells that have these molecules on their surface while ignoring normal cells that lack these molecules. There are many such antigens on cancer cells. The DCVax-L approach is to take tumor tissue obtained during the surgical resection that almost every glioblastoma patient goes through. This tissue is ground up and exposed to dendritic cells (both IMUC and NWBO obtain these cells by taking blood for each patient treated) which take up these antigens and then the antigen loaded dendritic cells are reintroduced into the body. The aim is to have the immune system launch an immune response against as many antigens as possible. Cancer cells are not homogeneous among patients and in fact are continually mutating so that the antigens they express may vary from patient to patient. ICT-107 uses six antigen mimics (man made peptides that are similar to the antigen) that it has selected beforehand. The issue with ICT-107 is that these antigens may or may not be expressed on the tumor or may not be expressed in great quantities. The theory behind DCVax-L is that whatever the antigens that are found in the tumor, it will trigger an immune response. SO which approach is better? I don’t know, both have shown biological activity.

  5. Larry made an interesting point. “That cancer cells are continually mutating so the antigens they express may very.” If DC Vax Direct picks up all the antigens as soon as the drug touches the tumor than I would guess the cancer has no way to mutate and to create new antigens to be missed like DC Vax L and ICT-107 would. DC Vax L gets it’s antigens from the tumor after it’s has been operated on and it takes days to produce the vaccine. Giving the cancer time to mutate and evolve. Allowing for possible new antigens to be missed by DC Vax L. Than of course there is ICT-107 with it’s six only synthetic antigens that will miss tons of antigens.

    Also one of my big concerns with ICT-107 is that even if the drug get’s accepted by the a FDA. Why would cancer patients want six synthetic antigens expressed when they can get hundreds of REAL antigens expressed by a vaccine. I do think ICT-107 works, it’s just a primitive version of DC Vax L and Direct. All I know is if I had cancer than I would want the best product to save me.

  6. Intuitively, the DCVax-L approach seems better, but there is limited data to draw firm comparisons. I hope they are both effective. Remember that this dendritic cell technology has been shown to have a biological effect in prostate, ovarian, kidney cancer and melanoma. This may not just be about glioblastoma. The Germans and British allow use beyond GBM.

    There is one major differentiation between the two products that is readily apparent. ICT-107 can only work in a certain immune types (HLA A1 and A2 positive) and not in the rest of the glioblastoma population. In the phase II trial of ICT-107, about 50% of patients were HLA A1/A2 positive suggesting that ICT-107 can only address half the patient population. (Despite this result, ImmunoCellular management believes that the ratio is closer to 75%.) Along the same line, DCVax-L may be somewhat limited because in 10% of patients, there is insufficient tumor tissue needed to make a full three year supply of the drug, although a smaller amount can still be made.

  7. Also I have nothing against IMUC. I just can not see what part of ICT-107 gives it any advantage over DC Vax L in quality of the product. ICT-107 might win in cost, but that is the only advantage I can see for it. “Best case scenario is ICT-107 has the six only antigens that matters in immunotherapy and DC Vax L is it’s equal in everything but cost of the product.” I just do not believe that this is the case.

  8. The issue is somewhat moot as ICT-107 will have to go through a phase 3 trial and then the regulatory process so that assuming success in the trial, it would not make it to the market until late 2018 or 2019. In the DCVax-L trial is successful, it could reach the market in 2016. The price of these products could be in the $50,000 to $100,000 per course of therapy. Manufacturing costs will not be an issue.

  9. I stand corrected. I never considered tumor size in making DC Vax-L vaccine. I can see how there might be a small market for ICT-107 in the (HLA A1 and A2 positive) population now. Thank you for your thoughts.

  10. How does Provenge from Dendreon relate to these newer vaccines. I believe that it also is based on the use of dendritic cells although i must confess I know very little about the biology involved.

  11. A report I wrote on April 26, 2012 may help you. I t was called The Rationale Behind Dendritic Cell-Based Cancer Vaccines and How They are Manufactured. The link is

  12. well sincerely do IMUC have still a potential risk with possible limitation , i understand the reward can be surprising at those level if a good news are on the way , but what represent this risk %??

    or NWBO its a better investment and a saver play,?????what is the target and cash flow of the company

    what is the cash reserve of IMUC and NWBO, and do we have a bigger risk of reverse split with IMUC???

    well lets wait the oral presentation as you say they been selected and its a good sign
    but how many company are presented?and how many are selected for the oral presentation
    what are normally the condition to be selected for oral presentation??

    well i cross my finger ,i took a large position at 1.25 in IMUC and still thinking if is not to risky

    any commendation are welcome



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