These CDX-1127 results are very promising but we should keep in mind that these are only preclinical data. The clinical trial results to be released 4Q'13- expected to be positive- will be much more critical re progress of 1127:
Agonist Anti-Human CD27 Monoclonal Antibody Induces T Cell Activation and Tumor Immunity in Human CD27-Transgenic Mice.
He LZ, Prostak N, Thomas LJ, Vitale L, Weidlick J, Crocker A, Pilsmaker CD, Round SM, Tutt A, Glennie MJ, Marsh H, Keler T.
Celldex Therapeutics, Inc., Phillipsburg, NJ 08865;
The CD70/CD27 pathway plays a significant role in the control of immunity and tolerance, and previous studies demonstrated that targeting murine CD27 (mCD27) with agonist mAbs can mediate antitumor efficacy. We sought to exploit the potential of this pathway for immunotherapy by developing 1F5, a fully human IgG1 mAb to human CD27 (hCD27) with agonist activity. We developed transgenic mice expressing hCD27 under control of its native promoter for in vivo testing of the Ab. The expression and regulation of hCD27 in hCD27-transgenic (hCD27-Tg) mice were consistent with the understood biology of CD27 in humans. In vitro, 1F5 effectively induced proliferation and cytokine production from hCD27-Tg-derived T cells when combined with TCR stimulation. Administration of 1F5 to hCD27-Tg mice enhanced Ag-specific CD8+ T cell responses to protein vaccination comparably to an agonist anti-mCD27 mAb. In syngeneic mouse tumor models, 1F5 showed potent antitumor efficacy and induction of protective immunity, which was dependent on CD4+ and CD8+ T cells. The requirement of FcR engagement for the agonistic and antitumor activities of 1F5 was demonstrated using an aglycosylated version of the 1F5 mAb. These data with regard to the targeting of hCD27 are consistent with previous reports on targeting mCD27 and provide a rationale for the clinical development of the 1F5 mAb, for which studies in advanced cancer patients have been initiated under the name CDX-1127.
Sentiment: Strong Buy
NB: "robust antitumor effect" and "protective immunity"
Can you say, "Gold mine"?
LS might have some inside information on the phase-1 clinical data. It would not be too difficult to get information from doctors who have participated in the study.
Sentiment: Strong Buy
The following was reported Sept. 12 for all you rookie investors: First the Stimuvax was conducted only on patients who responded to chemo/rad. And thus was indeed exactly as the Galena trial, trying to keep pts disease free. The second comment is that although aprox 50% of pts would be Her-2/neu low or intermediate, the product is genetically restricted to use with only 50% of those pts. Thus the market is half of what you suggest. Then from that 50% of 50% you must also remove those who did not become disease free on primary treatment (aprox 10%) Next issue is the suggestion that these products require newer adjuvants/approaches and yet this product uses a cytokine that is not an adjuvant at all, and in fact is rather poor at stimulating antigen specific responses (it's OK but it ain't a second or third generation approach, you ignore this fact. as it applies here and make a deal of it regarding other products.
Finally you fall for the subgroup of a subgroup analysis and say 78% disease free. First this is based on 17 pts and second stats say that 78% is almost exactly what should happen with no further treatment.
This 'product' is junk. The peptide is not correct, the science has been rejected for decades. Oh ya, and today after the big pump of the last few weeks the secondary is announced thereby hosing new investors until the next time this game is played. Ya'll may want to think about your investment before spouting dribble.
The words "antitumor effect" and "protective immunity" are music to my ears! If the clinical results to be released in Q4 also demonstrate a "robust" effect, then CLDX will shoot up way, way above $30 per share by the end of the year. We'd be looking at $40 by year-end.
Then -- then -- buyout becomes a real possibility because what major pharma would not want to get its grubby little corporate hands on Rindo, 011 and 1127 and own them completely while CLDX share price is still fairly low? The price would have to be steep -- nothing short of $100 per share if the ReACT and the 1127 data are impressive.
Sentiment: Strong Buy