Replies to post #123901 on Biotech Values

[BTH]

Look at the comments in todays SA article and look at Redding's (Redplate) comments. The author made several mistakes, and was made to look like a fool; of course, he didnt respond to any Redplates comments.

Saying the stock is going to 150 is just a big a joke as saying theres a five percent chance of success. He has no basis whatsoever to say that, other than a wild guess. His entire argument is based on the control group having the same OS numbers as the Stimuvax group. This guy just took the opposite side of the bet as the prior SA article. No one knows. Its almost as brutal an argument as saying Stimuvax will fail because Theratope failed (even though they are entirely different drugs acting in an entirely different manner).

Makes for good stocks swings and speculation though, just like DNDN.... and makes for a lot of listening to assinine flawed logic.

[iwfal]

ONTY -

The earlier article was a little more balanced, as it did point out that median survival in the control arm may be longer than 20 months, which is one of the assumptions used when Merck designed the trial

I will strongly disagree with this - at least on the topic of what-are-the-implications-of-trial-taking-a-long-time. Martin did his assumption homework much much better than the previous SA author. He provided cites to similar patient populations I missed when I last looked in 2009:


http://jco.ascopubs.org/content/26/15/2450.short

Median somewhere between 23 and 35 months for a somewhat sicker population (because it took all comers for stage iii)


____________________________________________

http://journals.lww.com/jto/Abstract/2011/05000/Phase_II_Study_of_Pemetrexed_and_Cisplatin,_with.13.aspx

Median survival around 34 months - but the trial needs to be adjusted for differences in protocol between it and START. Subtract a few months for being at an earlier start point (i.e. start time for START is after induction therapy). Add a few months for not including only patients responsive to chemo/rad.


...

The point is that he makes his case that the 20 months talked about by the company and the previous SA articles is, at the very least, very very questionable. (Note: back when I first looked at ONTY I too found a lot of data about stage iii patients of roughly comparable protocol and found longer than expected survival times - but Martin has a better list than I did. Good for him - too many analysts don't do their homework. He should be able to do a better job since he should be able to put more time/dollars into it.)

PS I disagree with Martin on some of the science. E.g. he complains that the drug doesn't produce immune response like a traditional preventative vaccine. So what. Undoubtedly cancer control will be via different immune mechanisms than preventative anti-viral vaccines. Heck, we don't even really understand what marker is the correct marker for Provence efficacy - only what marker seems to imply manufacturing goodness.

[mcbio]

ONTY - files IND for ONT-10 (targets MUC1)

http://finance.yahoo.com/news/Oncothyreon-Files-prnews-573508963.html?x=0

Oncothyreon Files Investigational New Drug Application for ONT-10

SEATTLE, WA , Dec. 20, 2011 /PRNewswire/ - Oncothyreon Inc. (Nasdaq: ONTY - News) today announced the filing of an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for ONT-10, a therapeutic vaccine directed at cancers expressing MUC1. Upon completion of the FDA's review of the IND, Oncothyreon expects to initiate a Phase 1 trial of ONT-10.

"We are pleased to announce the filing of this IND, which is a significant milestone for our therapeutic vaccine development program," said Robert L. Kirkman , M.D., President and Chief Executive Officer of Oncothyreon. "ONT-10 and its adjuvant component, PET-Lipid A, were internally discovered and developed and remain fully owned by Oncothyreon."

About ONT-10

ONT-10 is a therapeutic vaccine targeting MUC1, a tumor-associated antigen present on many types of human malignant tumors, including lung, breast, colorectal, prostate and ovarian cancer. ONT-10 was designed to stimulate both the humoral and cellular arms of the immune response. Preclinical results demonstrated that administration of ONT-10 produces a robust antibody response in mice specific for human tumor MUC1. A strong cellular immune response directed to the target was also shown. Additionally, the adjuvant component of ONT-10, PET-Lipid A, a fully synthetic toll like receptor 4 (TLR4) agonist discovered by Oncothyreon, was shown to have enhanced potency compared to the adjuvant monophosphoryl lipid A (MPL).

About Oncothyreon

Oncothyreon is a biotechnology company specializing in the development of innovative therapeutic products for the treatment of cancer. Oncothyreon's goal is to develop and commercialize novel synthetic vaccines and targeted small molecules that have the potential to improve the lives and outcomes of cancer patients. For more information, visit www.oncothyreon.com.

[DewDiligence]

ONTY was off 7% today despite naming a new CMO:

http://finance.yahoo.com/news/Oncothyreon-Announces-prnews-2804471932.html?x=0

Can a bad CMO make that much of a difference? :- )

[BTH]

The main concern for me is that even if Stimuvax works, the difference may be more modest than in the phase IIb study and the trial will not be sufficiently powered to show a significant difference.

The START trial has nearly 1,500 patients, correct? Where do you think there will be powering issue?