Joe Springer's  Instablog

Joe Springer
Send Message
It is very hard or impossible to time the broad market consistently — there are no famous investors that got rich by consistently knowing what the broad market would do next. This only makes sense, as there are just too many variables in the broad market. But there are many famous investors who... More
My company:
My blog:
The Wall Street Exclusive
  • IMUC Can Get Accelerated Approval And The Data Will Decide 17 comments
    Nov 12, 2013 9:25 AM | about stocks: IMUC

    I feel like I have to re-repeat re-re-again that IMUC can get accelerated approval and the data will decide. Because of the manufacturing process some observers do not think so, and have told everyone on Earth.

    If the data is strong then there will finally be a treatment option for some people with this most lethal cancer. That is what accelerated approval was made for.

    What about the manufacturing process? If the data is strong enough the FDA will show flexibility like they do in most orphan drugs. It's not like they could not agree on a working manufacturing process when they have data from two clinical studies.

    From the last CC (thank you Vanmaarsum!):

    <Q - Ryan S. Martins>: Hi. Thanks for taking my questions. Just to follow-up on the manufacturing-related questions. Initially - so can you talk about what you will need to show the FDA in order to demonstrate comparability of your manufacturing process of the three different sites that you've used, and what you eventually do come up with for phase III for commercial and clinical?

    <A - Andrew Gengos>: Thanks, Ryan. It's a complicated question. Let me try to give you a simple answer. When we moved from the University of Pennsylvania to include PCT for the phase II ICT-107 clinical supplies, we went to FDA an went through a brief process with them to demonstrate that we were using the
    same process at both facilities. That's really all that FDA requires. But I think your question is sort of deeper than that. What we're trying to do witthe results of this Phase II trial and the assay work that we're doing in the context of manufacturing but also in monitoring patients in that trial, is show both that we have a consistent product lot to lot. Now remember, a lot
    is a patient, in this case, so we had 124 lots in the phase II trial. So again, we're going to try to be showing consistency lot-to-lot and then we'r also going to be trying to show assay information about the vaccine that is connected to the clinical outcome in the trial. Those are the two essentiall key sets of assays, identity of the product and characterization of the response in the patient. Those are the two things generally that we'll be talking with FDA about in the end-of-phase II meeting in the CMC section. It's a lot more than that, but I think those are the two at the heart of you question.

    Disclosure: I am long IMUC.

    Stocks: IMUC
Back To Joe Springer's Instablog HomePage »

Instablogs are blogs which are instantly set up and networked within the Seeking Alpha community. Instablog posts are not selected, edited or screened by Seeking Alpha editors, in contrast to contributors' articles.

Comments (17)
Track new comments
  • Vanmaarsum
    , contributor
    Comments (43) | Send Message
     
    From the last CC:

     

    <Q - Ryan S. Martins>: Hi. Thanks for taking my questions. Just to follow-up on the manufacturing-related questions. Initially - so can you talk about what you will need to show the FDA in order to demonstrate comparability of your manufacturing process of the three different sites that you've used, and what you eventually do come up with for phase III for commercial and clinical?

     

    <A - Andrew Gengos>: Thanks, Ryan. It's a complicated question. Let me try to give you a simple answer. When we moved from the University of Pennsylvania to include PCT for the phase II ICT-107 clinical supplies, we went to FDA an went through a brief process with them to demonstrate that we were using the
    same process at both facilities. That's really all that FDA requires. But I think your question is sort of deeper than that. What we're trying to do witthe results of this Phase II trial and the assay work that we're doing in the context of manufacturing but also in monitoring patients in that trial, is show both that we have a consistent product lot to lot. Now remember, a lot
    is a patient, in this case, so we had 124 lots in the phase II trial. So again, we're going to try to be showing consistency lot-to-lot and then we'r also going to be trying to show assay information about the vaccine that is connected to the clinical outcome in the trial. Those are the two essentiall key sets of assays, identity of the product and characterization of the response in the patient. Those are the two things generally that we'll be talking with FDA about in the end-of-phase II meeting in the CMC section. It's a lot more than that, but I think those are the two at the heart of you question.
    12 Nov 2013, 09:42 AM Reply Like
  • Joe Springer
    , contributor
    Comments (2388) | Send Message
     
    Author’s reply » Thank you Vanmaarsum, I'll put that right into the post...did you transcribe that? I can't find that transcription.
    12 Nov 2013, 09:47 AM Reply Like
  • Vanmaarsum
    , contributor
    Comments (43) | Send Message
     
    The whole transcript is posted on Bloomberg, no link. But it will become avaiable on http://bit.ly/HKTZlJ in a while, just like the transcript from the previous two CC are availble.
    12 Nov 2013, 09:52 AM Reply Like
  • Dennis R. Mahon
    , contributor
    Comments (449) | Send Message
     
    Looking forward to another deja vu!
    12 Nov 2013, 10:44 AM Reply Like
  • Bio Bull
    , contributor
    Comments (252) | Send Message
     
    Smith's article is likely the reason for the drop in IMUC yesterday. It's down a good bit today too. I think regardless of whether approval is accelerated, success in such a large scale trial would be incredible news for the company's technology (not only in GBM) and should reflect favorably in the stock price.
    12 Nov 2013, 11:05 AM Reply Like
  • Vanmaarsum
    , contributor
    Comments (43) | Send Message
     
    From: Immunocellular Therapeut Earnings Q2 2013 Earnings Call Transcript:

     

    <A - Andrew Gengos>:
    (...) if we get a very positive, unambiguous efficacy signal
    in this Phase II trial, we will go to FDA and we will make the best case possible for how they think about the next steps for getting this treatment to patients, whether that's a Phase III or some other accelerated way to get it to patients."
    12 Nov 2013, 11:06 AM Reply Like
  • Robert Vasquez
    , contributor
    Comments (42) | Send Message
     
    Thanks for this article Joe! I am already long IMUC. And now that I see Smith on Stocks is against IMUC - i am going to double my position.
    12 Nov 2013, 11:23 AM Reply Like
  • vireoman
    , contributor
    Comments (1186) | Send Message
     
    I appreciated Smith for his reasonable, experience-based attempt at tempering overly high (investor) expectations for outsized results from the ICT-107 Phase II trial. Quote:"I have learned from long experience that predicting trial outcomes is hazardous." As an investor in IMUC, I want to hear things like that. The results can be highly encouraging even if they fail to achieve their endpoints. If you want to hear nothing but cheerleading, go to a high school football game. And, for the record, Smith is long on IMUC.
    12 Nov 2013, 06:53 PM Reply Like
  • blebleman
    , contributor
    Comments (28) | Send Message
     
    Thank Joe for your good work on IMUC. Dr. Yu and his team at Cedars-Sinai spent 15 years to develop a dendritic cells vaccine for GBM. They clearly identified which antigens to target. I went trough their research papers, and I noticed that they did comparable phase I and phase II studies. In all their studies, the vaccine used always prolonged the life of their patients and increase their number of T-cells.
    On this Phase II studies, patients in the control arm received 4 injections instead of 3 ( Phase I patients got 3 injections of ICT-107). I do not want to be too optimistic, but hey Dr. John S. Yu did not spent years of research for nothing. If the vaccine did not work, IMUC will not be here today!!! This is not a one trick pony. They have patients still alive and free of GBM from their phase I study.We are talking about 5 years survival after diagnosis. Incredible.
    12 Nov 2013, 11:46 AM Reply Like
  • Joe Springer
    , contributor
    Comments (2388) | Send Message
     
    Author’s reply » Thank you blebleman, I agree.
    12 Nov 2013, 11:52 AM Reply Like
  • The Reluctant Fundamentalist
    , contributor
    Comments (24) | Send Message
     
    blebleman, you said you went through their work, can you please post the link to the studies. I would love to take a peek.
    9 Dec 2013, 12:51 PM Reply Like
  • blebleman
    , contributor
    Comments (28) | Send Message
     
    icamber, please go through their publications on the IMUC site. Particularly, read those two:
    http://bit.ly/1aOZsPw
    http://bit.ly/1aOZuqo

     

    Some of their old publications are not there anymore.
    9 Dec 2013, 02:20 PM Reply Like
  • Vanmaarsum
    , contributor
    Comments (43) | Send Message
     
    Take a look at this paper, wich will be posted at SNO 23 november in San-Francisco:
    http://bit.ly/1a1j0Uo

     

    "Long term remission over 5 years in patients with newly diagnosed glioblastoma (GBM) treated with ICT-107 vaccine: a follow up study"

     

    RESULTS: Seven patients of 16 GBM patients are alive at 56, 60, 60, 62, 66, 73, 79 months. Of the 16 patients, 6 were disease free over 5 years. One of these 6 patients later died from leukemia without recurrent GBM and one progressed at 62 months. Four patients are still disease free. TAA expression by qRT-PCR showed 7 patient tumors expressed at least 5 TAA with 86% expressing all six and 100% of 4 antigens (AIM-2, TRP-2, HER2/neu, IL-13Ra2).
    12 Nov 2013, 12:20 PM Reply Like
  • Dennis R. Mahon
    , contributor
    Comments (449) | Send Message
     
    Vanmaarsum that was GREAT in my opinion... I went to the site and hunted and found it, and printed it out. How the heck did you ever find it? Anyway, nice job! Most encouraging. Nice to see that 13 of the 16 authors/presenters are Neuroscience Institute, Cedars-Sinai Medical Center, LA, CA... the other 3 IMUC. (John Yu represents both). Thanks!
    12 Nov 2013, 02:12 PM Reply Like
  • Vanmaarsum
    , contributor
    Comments (43) | Send Message
     
    "CONCLUSION: Long term remission in this group was correlated with cancer-stem-associated TAA expression, and exhibited a trend toward greater CD8 T cell cytokine responses relative to the short term survival group."
    12 Nov 2013, 02:05 PM Reply Like
  • Joe Springer
    , contributor
    Comments (2388) | Send Message
     
    Author’s reply » Thanks Vanmaarsum...it looks like NWBO finally ran out of steam or else took a breather, could be the end of the pain..
    12 Nov 2013, 02:09 PM Reply Like
  • tgar13
    , contributor
    Comments (204) | Send Message
     
    Joe

     

    based on the fact that we haven't heard re a 64th event yet - isn't that great news in itself - I mean there were 120 patients randomized and that means greater than 56 are alive right now and this is a disease with an average life expectancy of 6-8 months - how many months are we since Randomization of the last of the 120?
    12 Nov 2013, 07:17 PM Reply Like
Full index of posts »
Latest Followers

StockTalks

More »

Latest Comments


Most Commented
  1. Fire Away ( Comments)
  2. I Am You See ( Comments)
  3. What Is Tonix Worth? ( Comments)
  4. Hooked On Tonix ( Comments)
  5. Seattle Super-Tonix ( Comments)
Instablogs are Seeking Alpha's free blogging platform customized for finance, with instant set up and exposure to millions of readers interested in the financial markets. Publish your own instablog in minutes.