I'm wondering, given more positive results with TNBC (compared to the wider gpnmp expressing disease) why management is not more aggressively pursuing or focusing on this particular disease, for which (at the moment) chemotherapy is the only "therapeutic."
Although, considering the reversal of fortune of Iniparib (in phase 3), there may be some merits with this broad investigational approach... anyway, I think CDX-011 is the most promising drug in CLDX's pipeline.
1. The CDX011 trial in triple-negative breast cancer pts is a well-designed PIIb (randomized 2:1, controlled against "investigator's choice", and with crossover option after progression with IC).
2. Based on a recent amendment in the trial protocol to include eribulin (a recently approved BC drug with good efficacy) in the IC arm, I think CLDX is planning to apply for FDA approval for 011 based on the PIIb data if the results are good. 011 was granted fast-track designation by the FDA, and there are no good treatment options for triple-negative breast cancer currenlty, so IMO the FDA may look favorably on an NDA for CDX110 if the PIIb trial results are robust.
3. CDX011 was also tested in a PI/II in melanoma pts, where it showed some efficacy but not as good as in breast cancer.
I think the new VP's major deal will be partnering CDX011 for GPNMB(+) cancers, to include but not limited to breast cancer.
I agree Long...but even more importantly is the Big Picture like Lillys CEO states regarding AMNOG and shows that the Entrepreneurial spirit is strong but the Political FLESH is weak at least in Germany a hotbed of Pharma tradition a la Bayer et al!
We must find common grounds to be successful today...all the low hanging easy to cure fruit is PICKED...we are now in the land of hard to treat disease!