The recent news about MM121 in both the ovarian and breast cancer studies is good news. Don't listen to anybody that states this is a "failed drug". Will it go on to be approved by the FDA and pull in billions of dollars a year? I have no clue, but I do know that the results thus far have been consistent from the very early mouse studies to the Phase II results.
In the conference call on the ovarian study results management pointed to a subset of patients, approximately 1/3rd, that were positive for two biomarkers with a HR of 0.37 compared to the non-biomarker positive group that had an HR of 1.54. While they don't disclose what the biomarkers are I can tell you with 99% assurance that it is for expression of ERBB3 and heregulin (HRG). How do I know? Because of these two studies: Sheng, Q. et al, Cancer Cell 17, 298-310, 2010 and Schoeberl, B et al., Cancer Res. 70, 2485-94, 2010. Sheng et al showed that ~1/3rd of the primary human ovarian cancer cell lines (that is, cancer cells taken from patients) they examined showed at least some level of expression of HRG and then Schoeberl et al. showed a correlation between high HRG expression and responsiveness to MM121 in a panel of various cancer cell lines. Looks to me as if the ~1/3rd of ovarian cancer patients they found in the Sheng paper with HRG expression is what they found in the Phase II trial and, consistent with the Schoeberl paper, those are the patients that are responding positively to MM121.
We are very rapidly approaching the era of "personalized medicine" and what that means is there are no more one size fits all cancer treatments. Very soon your doctor will take a piece of your tumor, analyze it to determine what it is or is not expressing, and direct your treatment accordingly. Merrimack is on the cutting edge of this process with what they are doing with MM121 and identifying the exact patient population that will benefit from their drugs.
Agreed, science is finally looking at the disease as (diseases) and must attack it in that manner. The bottom line here is the compound did in fact show it's value add when a Monte Carlo analysis (random core sampling) model was followed and tissue extraction evidentiary verified the presence of MM-121. This event coupled with notes that the liposomal protein index showed positive signs of regression is the Peer Review's publications "smoking gun". It worked, period with and without coupling to other small molecule deliverables.
The next (Phase III) now is a larger population with more controls and a different selected tissue for marker analysis. If that validates the prior biopsys with a statistical significance equal to or better then MM-121 has been verified and it's of to a pre-NDA
All in all this product seems like it is gaining positive momentum. We should change gears and look to MM-398. Interesting stuff, it really is.