Results from the Phase 2 trial of CDX-011 are planned for release at ASCO meeting in June. If the
data can convince investors and researchers that GPNMB is a valid target to treat breast cancer,
and CDX-011 is the first-in-class antibody for such a new target, Celldex will potentially have a
Herceptin-caliber cancer drug in its pipeline. Or, a drug bigger than even Herceptin. GPNMB is
expressed in 65% of breast cancers, whereas HER2 is only in 20% of breast cancers. Sales of
Herceptin in 2011 are estimated to be around $5.5 billion.
* The Phase 2 CDX-011 trial was conducted in 120 patients, with 2:1 randomization between the
drug and "investigator's choice" standard therapy in the salvage setting. These are advanced
breast cancer patients who are refractory or resistant to all approved therapy. All patients are
selected for GPNMB positivity. As this was a controlled study, we are most interested to see if
there is a marked difference between the 2 treatment groups. If the CDX-011 group does better
(ORR and/or PFS), it will validate both the drug and the target. In such a case, this new targeted
therapy could become the single-most commercially meaningful advance in breast cancer
treatment since Herceptin (and, we wanted to say Avastin, but that is no longer the case). Not
the least reason for which is the large percentage of breast cancer patients expressing this
surface antigen. And, we note CLDX has a market capitalization of only $130 million.
* We don't expect expediency from the Phase 2 trial. More than likely, just as in the early days of
Herceptin development, CLDX will have to refine the patient population, such as the degree of
GPNMB expression, and take into consideration the existing therapies in different segments of
breast cancer. Do they take the drug forward in triple-negative and GPNMB-positive patients
first, considering the unmet medical need; or do they go forward broadly in all GPNMB-positive
patients, which would require multiple trials, each combined with the standard therapy of that
particular segment? This could be a drug that is best developed under the roof of a large
company - which begs the question, why wouldn't a large cancer player be interested in
acquiring CLDX if the trial yields convincing results? They are spending billions of dollars chasing
far smaller commercial opportunities in breast cancer.
Frank, relax man! There's no crime in being wrong. Let's not over-blow the situation into a supernova.
I personally don't have the experience that you all carry in Bios but I learn by reading your opinions and asking you guys the right questions. It's not the end of the world having a contrarian. It adds an edge to the debate.
I have to say; this is the most active this board has been on a weekend. Monday couldn't come any sooner!
sonqiqua...YOU STARTED THIS BARRAGE w/ your INCORRECT(25-40% GPNMB number)...
...than U insulted us by telling us we were OVER inflating the GPNMB relative frequency....
...all of this came on this board w/ your very first posting, like U own it!
...some of us have been here for years, we are well versed in Bios, some of us have $1M portfolios!
you attacked a well thought of poster in marc...told him he was WRONG on his 65% figure w/o asking where he got this number.That would have been the CORRECT thing to do...but not you..you simply fired back he was WRONG!
You @$$-umed he was wrong w/ your own first glance look at the 25-40% number which is taken from all BC cases and is correct in the general population, however 011 is very special and MBC and TNBC which are two different animals, from the general population is where 011 shows its POWER!
It was the way U came on our well studied and well versed board!We know all about this topic, and we have done our homework...do not come on this board and try to laud it over PROs!
...if U can't stand the HEAT, than get out of the Kitchen...
...you owe marc an apology because U were wrong and he was right, and I further proved U wrong w/ a high of 71% in one study of MBC cases or 10/14 having the vaunted GPNMB mutation and my showing the board a reputable source in wiki numbers...
... clearly put U in the WRONG as you like to say!
Personally I do not care if you ever return..and why NOT try a little Humility next time soniqua and maybe U will be shown similar RESPECT!
I am not touchy, I can be abrasive when I see some "KNOW IT ALL shooting off their BIG MOUTH" like U did, and on your VERY FIRST POST, particularly when YOU are the WRONG party!
want to try again, or can U not admit the truth?
Based on Immunohistochemical analysis, two studies have shown that GPNMB epression is commonly expressed in breast tumors. In the first study, GPNMB was detected in 71% (10/14) of breast tumors. In the second study, 64% of human breast tumors express GPNMB in the tumor stroma and an additional 10% of tumors express GPNMB in the tumor epithelium. In this study it was reported that GPNMB expression in the tumor epithelium was an independent prognostic indicator of breast cancer recurrence. Moreover, epithelial GPNMB expression was most abundant in triple negative breast cancers and it was found to be a prognostic marker for shorter metastasis-free survival times within this breast cancer subtype. Finally, GPNMB expression in breast cancer cells is capable of promoting cell migration, invasion, and metastasis both in vitro and in vivo.
I will take wiki over you anonymous!