Andrew J. Norris

Long/short equity, growth
Andrew J. Norris
Long/short equity, growth
Contributor since: 2011
This is a very academic article but at the end of the day, a major criticism is that there are too many variables that make this modeling so unreliable it is approaching randomness. in the end, if this were coke or other large institutions, it is a lot of work but somewhere in the ballpark of reality. For a mid phase biotech, this is not realistic. Trying to set up manufacturing facilities and getting them up and running in other countries ..... 10 year target price......
Bottom line, all these articles with predictions are highly over confident in their ability to predict an outcome. It is now in the hands of the diabetes community. If patient sentiment is good, it will be adopted. This is the point to watch. If it is adopted, the technology shows potential for a shift in drug delivery for some drugs (not all). This is also important. I just want to hit this point home because some of these articles are getting a little funny and not sure if short positions are doing the communicating here but 10 year projection is not realistic to say you are doing a service. Try 1 year and 2 years. This would be meaningful and within the timeframe of logical investing.
Ha, this is not the first time Feuerstein has exhibited misleading or false information. He does it over and over and over again. It must be understood clearly that he has no education in this area(technical, biomedical, medical, regulatory). None. So this is what you get. On the other hand, if you have colleagues whose fund hold short positions on the stock which is doing too well, then launch mis-information campaigns, you may be the go to guy to get them out of trouble. These are the two possible conditions I can see for such repetitive and very consistent outcomes over the last several years.
yes, that is correct. ATC based therapeutics are distinct from the dendridic based technology.
Just listened. thanks for the heads up on this.
I agree and most countries are ahead on this (Ex: NICE in the UK). I think the immuno therapies can be highly reduced in price over time as well.
Likely. let me find out more. I still dont know the reason (in UK at the moment). The leadership is important but it will likely be better understood as time goes on.
that's interesting, but many people in leadership are on patents in early phase biotech if they have played a role in the claims of the patent, in fact it is required. The patents must be assigned to an entity however (there is authorship and then ownership of patents which is typically assigned to a company). Steve Jobs was on quite a few patents.
I should also say that information that will principally move stock will be acquisition (which is a likely case for IMUC) or Phase trial announcements. Exactly when any of this happens, I do not know and neither will others until release. Good question.
this is a very good article. I encourage the readers of this article to see it. thanks slowdive!
Joe, I will look into this. Thanks for the tip.
Ok, will check later
Michel, do you have further documentation or explanation for the device you are working with?
Interesting thought michelodu. My guess would be that it would not help the immunotherapies because they are already targeted via the already endogenous seek and destroy aspect of the system. i.e. you have an infection in your tonsils or foot, the immune system, if turned against it, will go to the sight and deal with it. However, your approach would be highly applicable to small molecule drugs where toxicity limits the drug. one of the compounds I wrote on here on SA, TH-302 may, would be a good example. the more local concentration you can give, the better assuming you know where to put it (sub mm tumors may escape your view of course).
well put sambmean.
Actually I did not see anything on those two programs in the presentation. there were two presentations and both regarding ICT-107. If I hear anything, I will let you know.
clue me in?
Great inputs LarryWh. That will be an interesting trial to watch. Thanks.
I think your question is great and I did not look into that. I think it is the case, though with Exelixis as I vaguely remember a study sponsored by a larger partner but dont quote me on that. They had a lot going on in different places.
For Exelixis, they had ~ 10 presentations and BMS I attended one. They were all well attended. The oral presentation was ~ 400-500 each.
I would say they were both well received by the clinical community. Hurdles will likely be tox issues but they are innovative and address unmet needs.
yes. will try to get that out soon. trying to capture everything at the moment.
Yes, they have quite a few trials going on for Cabozantinib (XL184). I will comment on that (I guess releases from SA are on Monday.
While people are entitled to their opinion, I think it is useful to look at what goes on around a person when considering their credibility:
Generex sues TheStreet, Feuerstein for $250M
http://bit.ly/JMLo1j
http://bit.ly/LtcZ2p
http://bit.ly/zcz1QE
I see no background in science but a writing history in business software, technology and commercial real estate. Commenting on clinical trial data and scientific subjects, as we have seen, is best left to those who know this. It is also simple to consult an outside expert.
While people are entitled to their opinion, I think it is useful to look at what goes on around a person when considering their credibility:
Generex sues TheStreet, Feuerstein for $250M
http://bit.ly/JMLo1j
http://bit.ly/LtcZ2p
http://bit.ly/zcz1QE
Adam has no background in science and has a writing history in business software, technology and commercial real estate. Commenting on clinical trial data, as we have seen, is best left to those who know this. It is simple to consult an expert.
Anjali, I just saw your question. Simple. 50 percents COGS predicted in future when they reach $500 million in sales. $93K of selling price means $46K of cost of making for 3 shots. $15K each shot of vaccine.
No problem, statistics can be confusing. if you have 20 patients who have recurrence with standard of care and a new therapy has 10 patients with recurrence, then the reduction in recurrence is 50% in this example. it is based upon the number of people in the recurrence category. I hope this helps.

Thank you for pointing this out as a potential patient selection bias and the company has addressed this in the past (see resentation available on website). The patients who go through complete resection have a median survival of about 18.0 months compared to 14.6 for the overall population. ICT-107 has demonstrated a median survival of 38 months which is more than twice for the fully resection patients. This makes it challenging for me to assign the difference solely to the bias you suggest.

The company has also compared its product to another cohort with same level of resection and treated with a tumor lysate vaccine on dendritic cells. Patients on tumor lysate (with same levels of resection) lived about 20 months roughly half of ICT-107’s 38 months.

I agree with you that any phase I data should be viewed with caution and only randomized phase II data gives any degree of comfort. However, these survival numbers are significantly different than any existing treatment in GBM. Current status: 40% of patients free of disease over 3-4 years at this point, which GBM experts agree is quite astounding. If phase II holds, this will be a game changer as patient will want such a treatment. And more importantly, people with lower grade diseases (gliomas and astrocytomas) will be treated as well. I hope this sheds some light on the subject and again, thank you for bringing that up.
Pete, thanks for the response. Both IMUC and NWBO products could be used for multiple different indications, however, they are using different strategies. NWBO primarily uses tumor lysate from patient’s own tumor which give a broad immune response against a large number of antigens. In contrast, IMUC is creating an immune response only against the dominant antigens and cancer stem cell antigens. ICT-107 for example has Her-2 and MAGE which are expressed on breast cancer and ovarian cancer, gp-100 and TRP-2 which are expressed on melanoma. There hasn’t been many comparisons of these two approaches directly, except for recent work presented by IMUC which showed ICT-107 to have longer survival compared to a tumor lysate vaccine (not DCVax) prepared from patients own tumors. Interestingly, the origin of both of these technologies is UCLA where Keith Black used to work back in 1990s.
ICT-107 as well as DCVax are currently in phase II randomized trial for Glioblastoma, the most aggressive brain cancer. ICT-107 trial is a 2:1 randomized; double blinded trial targeting 102 patients and the primary end point is overall survival. DCvax trial is a 240 patient trial, also 2:1 randomized and the primary end point is progression free survival (PFS). In the world post Avastin, where Avastin showed PFS improvements but failed to show OS and those indications such as breast cancer were not approved, I think FDA would prefer ICT-107 trial as a superior trial design for product approval. However, both of these trials are not pivotal trials but could be used for registration if the trial results are extraordinary.
When comparing these two companies, one should look into three additional factors: (1) Execution capabilities, (2) Cash position and (3) Intellectual Property. IMUC has been very aggressive in its enrollment and has already enrolled more than 75% of patients while it is not clear where NWBO stands. IMUC also has about $16 million in cash which should be sufficient to complete phase II trial while NWBO is trying to raise money slowly through ATM which continues to dilute shareholders. Lastly, IP is a complex subject but tumor lysate as a source of antigen is difficult to enforce as any physicians could use surgically removed tumor as an antigen source. Interestingly, you can find doctors in Mexico, India and Asia who are actually practicing this already using patients own tumors.
Time line for ICT-107 completion of enrollment is June 2012, Interim analysis in 1Q, 2013 and Final analysis in 3Q, 2013 based on their presentation on their website. NWBO has not given a clear projection, but if they just completed initiation of 30 sites and the target is 240 patients, I think they are significantly behind. The usual enrollment rate for these kinds of trials is no more than 0.25-0.5 patients/center/month, so you can do the math.
Thanks to Sam for his comments. My focus is to speak in common language so that people can learn about the significance.
In particular, times have changed. Big Pharma is much less dominant as the innovator of the field and these early phase companies are the future, by which Big Pharma is acting more and more in a financial capacity through support / M&A etc. So our understanding of the smaller companies is more critical as well as de-convoluting the science behind it.
For the timeline on Immunocellular pipeline see: http://bit.ly/xGMZEG
As for GALE, I write on many emerging biotech products, many of which I may or may not have shares in myself (cant buy each one). GALE is important because it has positioned its self in a market that no one is going after with a well established cancer target.
Data yielding a p-value of 0.098 means there is only a 9.8% chance obtaining the observed result if no real effect exists. It is true that the if the similar results of 48% are achieved in the trial with 700 patients then the p value would drop much more. Most importantly, almost half the recurrence rate compared to standard of care is encouraging.