As I write this column on Thursday morning, Celldex shares are down about 5%. Hard to attribute the selling to anything specific, but I know the timelines for the '011 trial are a bit longer than what management told investors during the roadshow leading up to last month's stock offering.
The trial is certainly not without risk, which could also be weighing on the stock. Earlier-stage patients should, theoretically, respond better to CDX-011 but then it's more difficult to use results from the completed CDX-011 trial as an accurate comparator. [And don't forget, the old trial was quite small.]
Cancer drug expert, consultant and blogger Sally Church (@maverickNY) pointed to this study (via Twitter) of Avastin in second-line triple negative breast cancer patients. Median PFS was 6 months for Avastin plus chemotherapy versus 2.7 months for chemotherapy alone.
Church tweeted:"If Avastin can achieve 6 mon after taxanes in TNBC, then comparing 011 to capecitabine 2nd line will need to match that." Lots to think about in terms of handicapping the results from the CDX-011 trial. There's also plenty of time. Celldex is more than just CDX-011. On its call Thursday morning, the company said to expect patient enrollment in the phase III study of rindopepimut in brain tumor patients to wrap at the end of the year. The first interim look at data from the study will take place in mid-2014. An earlier-stage drug candidate, the complement inhibitor CDX-0135, has also generated some investor interest. A small pilot study in Dense Deposit Disease should have data by year's end.
Simon R. asks, "What do you know about TG Therapeutics?" Not much, except the bulletin board stock has generated some Twitter buzz over its PI13K delta inhibitor TGR-1202. Investors have fallen in love with companies developing PI13K inhibitors for various blood-related cancer and inflammatory diseases. [PI13K refers to the molecular pathway that the drug blocks.] Infinity Pharmaceuticals' market cap approaches $1.8 billion and growing due largely to its P113K inhibitor INFI-145. Gilead Sciences has idelalisib. And then there's Pharmacyclics (market cap $6.5 billion) and its BTK inhibitor ibrutinib, which is related mechanistically to P113K inhibition.
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